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Standards of medical care in diabetes—2016
... Diabetes mellitus presents a considerable challenge in management and care, requiring a comprehensive approach that includes glycemic control, patient education, selfmanagement, and routine monitoring. Multidisciplinary interventions often lead to better outcomes by addressing the disease and its associated risk factors [1]. Effective diabetes management reduces the risk of complications and improves overall quality of life, underscoring the importance of continued research and adaptation of strategies [2]. ...
... Essential key points about its usefulness are as follows: (1) It identifies areas where patients need more education and support. (2) It explores psychosocial barriers like stress and social support, revealing why some people struggle with self-care. ...
Background/Objectives: Diabetes mellitus presents significant management challenges, requiring comprehensive glycemic control, patient education, self-management, and routine monitoring. The study aims to evaluate existing tools and develop a customized questionnaire to investigate the multifaceted impact of diabetes mellitus on patients’ lives through a novel questionnaire. Methods: Utilizing Survey Monkey, we efficiently collected data from 150 diabetic patients during annual evaluations over five months (March 2024–July 2024). The sample included 88 men (58.67%) and 62 women (41.33%), with a notable representation of participants having a family history of diabetes (63.42%) and varying levels of education (20% with higher education). Statistical analyses were conducted using IBM SPSS (Version 20.0), and structural equation modeling (SEM) through Amos, including exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) to validate the instrument and assess its psychometric properties. Results: The questionnaire targets four critical domains: the role of physical activity in diabetes management, the effects of diabetes on social relationships, the emotional status of diabetic patients, and the influence of diet on metabolic control. Conclusions: The findings provide valuable insights into patient attitudes toward diabetes management, emphasizing the importance of physical activity, social dynamics, emotional well-being, and dietary practices in improving health outcomes for individuals with diabetes.
... Self-management is recommended for people living with T2D [4], empowering them to actively participate in their care by adhering to medications, conducting regular blood glucose monitoring, and following exercise and diet recommendations [4,5]. However, patients may face barriers in adhering to selfmanagement activities. ...
... Self-management is recommended for people living with T2D [4], empowering them to actively participate in their care by adhering to medications, conducting regular blood glucose monitoring, and following exercise and diet recommendations [4,5]. However, patients may face barriers in adhering to selfmanagement activities. ...
Background
The prevalence of type 2 diabetes (T2D) is rapidly increasing in India. Evidence suggests that adherence to both pharmacological and nonpharmacological treatment regimens combined with support from carers may help in the optimal management of T2D. However, adherence to treatment and the role of carers is not clearly understood in the management of T2D in India.
Objective
To explore the perceptions of people living with T2D and the role of carers in the management of T2D.
Methods
Semi‐structured face‐to‐face interviews were conducted with people living with T2D in Mysuru, India, and their carers. A total of 22 participants were included, of which 12 were supported by carers. All interviews were conducted in the participant's home, were audio recorded, transcribed verbatim and thematically analyzed.
Results
Two themes were identified (a) the illness journey of people living with T2D; (b) the role of carers in supporting the illness journey of their family members living with T2D. The beliefs and perceptions of people living with T2D impacted their adherence to T2D management. Lack of rapport and open‐ended discussions regarding medication use with doctors are some factors that contributed to self‐medication practices. In addition, there was little trust towards Western medicines, thereby increasing self‐medication of traditional medicines. Carers provided support to their family members in managing T2D, however perceived a sense of powerlessness in their ability to effectively provide support for the management of the disease.
Conclusion
Participants reported non‐adherence to the T2D treatment regimen prescribed by their doctor despite support from carers. There were multiple individual and systemic factors that encouraged self‐medication for people living with T2D. Strategies to garner trust between doctors and patients as well as inclusion of carers during consultations should be considered. This may allow for more open communication and disclosure of self‐medicating and use of traditional forms of medicine.
Patient Contribution
Participants were interviewed by one researcher and contributed to recruitment of additional participants through snowball referral. Participation in the study was voluntary and no financial compensation was provided. Participants also provided feedback to the researcher by reviewing their own interview transcript to ensure clarity.
... Various health organizations, including the ADA, ACOG, FIGO, and IADPSG, have reached a consensus that early screening for pre-existing overt diabetes is a beneficial practice during pregnancy, either for all pregnant women or for those with risk factors [68]. According to the ADA recommendation [20], an FPG ≥ 126 mg/dL (7.0 mmol/L), random plasma glucose (RPG) ≥ 200 mg/dL (11.1 mmol/L), 2 h plasma glucose during a 75 g OGTT ≥ 200 mg/dL (11.1 mmol/L), or glycated hemoglobin (HbA1c) ≥ 6.5% would constitute grounds for a diagnosis (see Table 3). An RPG of ≥200 mg/dL (11.1 mmol/L) should be used for diagnosis in a woman presenting with typical symptoms of hyperglycemia or a hyperglycemic crisis. ...
... Owing to these reasons, IADPSG issued a statement in 2016 recommending the discontinuation of the FPG cut-off during early pregnancy [67]. Evidence supporting the use of first-trimester FPG alone to diagnose GDM remains insufficient, and current guidelines do not recommend screening or treatment of GDM before 24 weeks of gestation [20,71]. Nonetheless, elevated FPG levels can still be considered a significant risk factor for GDM. ...
Currently, there is a lack of standardized diagnostic criteria for gestational diabetes mellitus (GDM), making it a subject of ongoing debate. The optimal diagnostic method and screening strategy for GDM remain contentious. In this review, we summarize the criteria and methods for diagnosing GDM, and perform a comparison between universal and selective screening strategies. Therefore, this review aims to highlight the following: (1) The most widely adopted criteria for GDM are those established by the International Association of Diabetes and Pregnancy Study Groups (IADPSG). (2) Evidence from cohort studies suggests that the one-step diagnostic method is associated with improved pregnancy outcomes and appears more cost-effective compared to the two-step method. (3) Universal screening is more cost-effective than selective screening, which may overlook a significant number of women with GDM. Additionally, various methods have been proposed for early pregnancy screening (before 14 weeks). Finally, an outlook is presented for the diagnosis of GDM, emphasizing the importance of large-scale randomized controlled trials (RCTs) to provide stronger evidence for future support.
... Since FPG is less affected by diet, it is considered a more reliable measurement of blood glucose levels compared to random blood glucose levels (38). FPG is more reliable than admission blood glucose in evaluating glucose metabolism and predicting the 90-day prognosis in AIS patients. ...
Background
To evaluate the clinical significance of human plasma lipoprotein-associated phospholipase A2 (Lp-PLA2), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), high-sensitivity C-reactive protein (hs-CRP), leukocyte count, fasting plasma glucose (FPG), and glycated hemoglobin (HbA1c) in patients with Type 2 diabetes mellitus (T2DM) and acute ischemic stroke (AIS).
Methods
A total of 155 T2DM patients with AIS, admitted to the Second Affiliated Hospital of Shantou University Medical College between October 2023 and October 2024, were included in the stroke group. Additionally, 86 T2DM subjects from the same period were included in the T2DM control group. Serum levels of Lp-PLA2, LDL-C, HDL-C, hs-CRP, leukocyte count, FPG, and HbA1c were compared between the T2DM-AIS group and the T2DM control group, as well as among T2DM-AIS patients with different infarct sizes and degrees of neurological impairment. The clinical value of the above indexes in the diagnosis of T2DM with AIS was analyzed by receiver operating characteristic curve (ROC curve).
Results
Serum levels of Lp-PLA2 (142.9 [115.8, 178.3] ng/L), LDL-C (3.4 [2.6, 4.2] mmol/L), hs-CRP (3.6 [1.5, 11.2] mg/L), leukocytes (8.0 [6.8, 10.3] × 10^9/L), FPG (10.2 [7.5, 14.4] mmol/L), and HbA1c (10.2 [7.5, 14.4] %) were significantly higher in the T2DM-AIS group compared to the T2DM control group (Lp-PLA2: 102.1 [76.6, 121.9] ng/L, LDL-C: 3.2 [2.4, 3.7] mmol/L, hs-CRP: 2.4 [0.9, 5.2] mg/L, leukocytes: 7.0 [6.1, 8.1] × 10^9/L, FPG: 7.4 [6.1, 10.3] mmol/L, HbA1c: 7.0 [6.4, 8.2] %). In contrast, serum HDL-C levels (1.1 [0.9, 1.3] mmol/L) were significantly lower than those in the control group (1.3 [1.1, 1.5] mmol/L), which correlated with larger infarct size and greater neurological injury. ROC curve analysis indicated that the combined use of seven tests had an AUC of 0.906, with a sensitivity of 77.40% and a specificity of 95.30%.
Conclusion
Monitoring serum levels of Lp-PLA2, LDL-C, HDL-C, hs-CRP, leukocyte count, FPG, and HbA1c provides a comprehensive assessment of cerebral infarction in T2DM patients with AIS and serves as auxiliary indicators for evaluating disease severity.
... The inclusion criteria were as follows: (1) ≥18 years of age; (2) chronic hepatitis C with HCV viremia; and (3) indicated for DAA therapy (according to the Taiwan practice guidelines, DAA therapy is recommended for all HCV-viremic patients with a life expectancy of ≥1 year) [18]. The exclusion criteria were as follows: (1) not achieving SVR12 after DAA treatment; (2) DM defined as fasting plasma glucose ≥ 126 mg/dL, percentage of glycosylated hemoglobin (HbA1c) ≥ 6.5% and/or under treatment for diabetes [19]; (3) under anti-hyperlipidemia medications; (4) hepatitis B virus or human immunodeficiency virus co-infection; (5) pregnancy; or (6) incomplete study data collection. ...
Background: The triglyceride-glucose (TyG) index has emerged as a novel surrogate marker of insulin resistance, but its changes after hepatitis C virus (HCV) eradication remain unclear. This study aimed to evaluate changes in the TyG index following direct-acting antiviral (DAA) treatment. Methods: HCV-infected patients achieving sustained virological response 12 weeks post-treatment (SVR12) were prospectively enrolled from May 2015 to June 2023. Exclusion criteria included the following: (1) failure to achieve SVR12; (2) use of anti-diabetes or anti-hyperlipidemia medications; and (3) hepatitis B virus or human immunodeficiency virus co-infection. Changes in lipid profiles, TyG index, and homeostasis model assessment of insulin resistance (HOMA-IR) were evaluated from baseline to SVR12. Insulin resistance was defined as HOMA-IR ≥ 2.5. The optimal TyG index cut-off for predicting insulin resistance was determined using the Youden Index. Results: A total of 111 patients (median age: 61.0 years; 45.9% male) were included. The TyG index correlated positively with HOMA-IR (Pearson’s r = 0.32, p < 0.001). Among patients with pre-existing insulin resistance, significant improvements were observed at SVR12 in both HOMA-IR (4.0 [IQR: 3.1–5.4] vs. 2.5 [IQR: 2.0–3.9]; p < 0.001) and TyG index (8.47 [IQR: 8.08–8.68] vs. 8.36 [IQR: 8.00–8.71]; p = 0.028). Using 8.27 as the optimal TyG index cut-off, similar improvements were noted in HOMA-IR (2.8 [IQR: 2.0–4.3] vs. 2.3 [IQR: 1.5–3.8]; p = 0.031) and TyG index (8.62 [IQR: 8.46–8.83] vs. 8.52 [IQR: 8.27–8.89]; p = 0.003). Conclusions: The TyG index is a valuable tool for monitoring changes in insulin resistance after HCV eradication, particularly in patients with baseline insulin resistance.
... Chronic hyperglycemia is associated with long-term damage and dysfunction of distinct organs, including eyes, kidneys, nerves, heart, and blood. 3,4 Additionally, diabetes is often associated with other comorbidities, such as obesity and hypertension, which further exacerbate the systemic complications. 5 Evidence in diabetic patients and experimental hyperglycemic animals has reinforced the occurrence of male reproductive dysfunction, affecting men during their reproductive lifetime. ...
Background
Diabetes mellitus has increased significantly over the past decades. This disease affects the reproductive competence of diabetic men by disrupting spermatogenesis, fertility potential, penile erection, and ejaculation. However, hyperglycemic conditions' effects on the epididymis remain elusive despite its importance for sperm maturation.
Objective
We aimed to determine the effects of diabetes on the epididymis, using qualitative (systematic review) and quantitative (meta‐analysis) approaches, to address the question: Can diabetes disrupt epididymal structure and function?
Materials and Methods
We performed an extensive literature search identifying 66 eligible studies through PubMed, Web of Science, and Embase databases. Outcomes extracted from the studies included alterations in epididymal cell metabolism and morphology under hyperglycemic conditions. Pre‐clinical studies published in murine were evaluated under a meta‐analytical approach, whereas clinical investigations in humans were analyzed qualitatively (PROSPERO number is CRD42020208658).
Results
Type 1 diabetic patients presented post‐ejaculatory epididymal hypotonia/atonia, whereas type 1 and 2 diabetic patients exhibited perturbation in the epididymal advanced glycation end‐product axis. In murine, high glucose levels disturb the metabolism of epididymal cells, the androgenic profile, and the expression of hormone receptors within the organ. The low activity of antioxidant enzymes promoted an elevation of oxidative metabolite levels, creating a pro‐oxidant microenvironment toxic to spermatozoa. All these deleterious mechanisms of diabetes trigger molecular and biochemical responses contributing to the deterioration of epididymis structure and function.
Discussion and Conclusion
Our data indicated that diabetes may affect epididymis morphology and function through hormonal imbalance, glucose metabolism disturbance, and oxidative stress generation. These mechanisms may alter the luminal microenvironment and epithelial function, impairing organ functionality with consequences for sperm maturation. This review also highlighted several points that need investigation by further studies associating diabetes and epididymis to fill the knowledge gaps better.
... Anyone who reported smoking cigarettes prior to or during admission was classified as a smoker. A fasting blood glucose level of ≥126 mg/dL, a known history of diabetes mellitus, and the use of hypoglycemic medications to regulate blood sugar were all considered indicators of diabetes mellitus (6). A history of hypertension, a systolic blood pressure ≥ 140 mm Hg, a diastolic blood pressure ≥ 90 mm Hg, and the use of antihypertensive medications were all considered indicators of hypertension (7). ...
Background
Although fecal occult hemoglobin is commonly valued as a screening tool for colorectal cancer, few studies have examined the clinical significance of fecal immunochemical testing (FIT) in other diseases. This study aimed to explore the association between occult blood in feces and functional outcomes of acute ischemic stroke (AIS) patients who received intravenous thrombolysis treatment.
Methods
Patients diagnosed with acute ischemic stroke and received thrombolytic therapy were recruited from the neurology department of the Affiliated Hospital of Hangzhou Normal University. FIT was conducted for patients during hospitalization. Functional outcome was assessed by the modified Rankin Scale (mRS). A favorable outcome was defined as mRS 0–2 and a poor outcome as mRS 3–6.
Results
A total of 214 patients were included for analysis. The proportion of FIT-positive patients was higher in the poor outcome group than in the favorable group (12.3% vs. 45.6%, p < 0.001). Logistic regression models showed that FIT-positive patients had an increased risk of a poor outcome (OR: 4.188, 95% CI: 1.424–11.51, p = 0.005) after adjusting for possible variables. Moreover, in addition to gastrointestinal bleeding, NIHSS score at baseline (OR: 1.092, 95% CI: 1.013–1.176, p = 0.021) and white blood cell level (OR: 1.215, 95% CI: 1.018–1.448, p = 0.031) were also the independent risk factors for positive FIT after thrombolytic therapy in AIS.
Conclusion
Positive FIT was related to the poor outcomes in AIS patients who received thrombolytic therapy. High NIHSS scores at baseline and high white blood cell levels were the risks of FIT.
... The timeline change patterns observed in our study go along with multiple significant developments in clinical practice and population health [13]. The increased rates in diabetes incidence between 2000-2004 and 2010-2014 parallel the utilization of updated diagnostic criteria, including revised HbA1c thresholds and expanded screening recommendations in the clinical guidelines [14][15][16][17]. However, this period also faced unprecedented changes in population-level risk factors, especially the rising prevalence of obesity and sedentary lifestyle patterns. ...
Introduction: Diabetes mellitus represents a significant public health challenge, however, the current trends in its epidemiology remain incompletely characterized. This study aimed to analyze epidemiological changes and demographic patterns in diabetes incidence and prevalence across the United States from 1990 to 2024. Methods: We conducted a retrospective cohort study utilizing the TriNetX Global Health Research Network, analyzing de-identified electronic health records from 52,922,301 patients across 92 U.S. healthcare organizations. Time-based changes in disease trends regarding diabetes incidence and prevalence were targeted, and stratified by age, sex, race, and diabetes type. Results: Combined diabetes incidence increased from 3.98 per 1,000 in 1990-1994 to 60.98 per 1,000 in 2020-2024, while prevalence doubled from 6.26% to 12.00%. T2DM showed a twenty-fold increase in incidence (3.52 to 59.30 per 1,000), while T1DM peaked at 7.46 per 1,000 in 2010-2014 before declining to 4.59 per 1,000. Significant disparities were observed across demographic groups, with the highest rates among Native Hawaiians/Pacific Islanders (incidence: 94.75 per 1,000; prevalence: 20.65%) and consistent male predominance (incidence: 69.40 vs 54.07 per 1,000). Conclusions: These findings reveal concerning trends in diabetes epidemiology, characterized by a prominent and significant elevation in disease burden and persistent demographic disparities. The results call for the urgent need for optimized preventive strategies, targeted interventions for high-risk populations, and systematic changes in healthcare delivery to address this growing public health challenge effectively.
... Diabetes is a chronic disease characterized by impaired insulin regulation and elevated blood sugar levels, leading to severe complications such as cardiovascular disease, renal failure, and neuropathy. Previous research underscores the importance of exercise in improving glycemic control and reducing cardiovascular risks [45][46][47]. Regular physical activity reduces adiposity, enhances insulin sensitivity, and improves endothelial function [48][49][50]. Moreover, exercise has broader physiological and psychological benefits, including improved lipid profiles, muscle strength, and reduced daily insulin requirements [13]. ...
Objective: FKBP5 is a critical gene involved in regulating the hypothalamic–pituitary–adrenal (HPA) axis and stress response. Aberrant DNA methylation at FKBP5 cytosine–phosphate–guanine (CpG) sites, such as cg22363520 and cg00862770, has been implicated in mental health disorders and metabolic diseases, including Type 2 diabetes. Exercise is a modulator of DNA methylation and metabolic health. This study investigates the interaction between exercise, diabetes, and FKBP5 methylation at cg22363520 and cg00862770 and explores their implications for mental health and disease development.
Materials and Methods: FKBP5 methylation levels at cg22363520 and cg00862770 were analyzed in a cohort stratified by diabetes and exercise. Multiple linear regression models assessed the main effects and interactions of exercise and diabetes on FKBP5 methylation, with further stratified analyses for site-specific effects.
Results: Exercise and diabetes showed significant and site-specific effects on FKBP5 methylation at cg22363520 and cg00862770. At cg22363520, exercise significantly reduced methylation levels in nondiabetic participants (β=−0.00195, p=0.0157), while no significant effect was observed in diabetic individuals. Conversely, at cg00862770, exercise significantly decreased methylation levels in diabetic participants (β=−0.00611, p=0.0081), with no significant effect in the nondiabetic group. Diabetes itself was associated with increased FKBP5 methylation at both sites, particularly in individuals without regular exercise. Additionally, significant interaction effects between exercise and diabetes were identified for both cg22363520 (p=0.0336) and cg00862770 (p=0.0021), highlighting the interplay between metabolic status and physical activity in regulating FKBP5 methylation.
Conclusion: This study demonstrates that the effects of exercise on FKBP5 methylation are site-specific and influenced by diabetes status. Exercise reduces methylation at cg22363520 in nondiabetics and at cg00862770 in diabetics, indicating its role in modulating epigenetic regulation of stress and metabolic pathways. These findings underscore the interplay between exercise, diabetes, and FKBP5 methylation, with potential implications for improving mental health and metabolic outcomes.
... The non-diabetic class has target values ranging from 0 to 1, with a tendency towards lower values. This range is dictated by a specific constraint [68]. ...
Diabetes Mellitus (DM) is a global health challenge, and accurate early detection is critical for effective management. The study explores the potential of machine learning for improved diabetes prediction using microarray gene expression data and PIMA data set. Researchers utilizing a hybrid feature extraction method such as Artificial Bee Colony (ABC) and Particle Swarm Optimization (PSO) followed by metaheuristic feature selection algorithms as Harmonic Search (HS), Dragonfly Algorithm (DFA), Elephant Herding Algorithm (EHA). Evaluated the performance of a system by using the following classifiers as Non-Linear Regression—NLR, Linear Regression—LR, Gaussian Mixture Model—GMM, Expectation Maximization—EM, Bayesian Linear Discriminant Analysis—BLDA, Softmax Discriminant Classifier—SDC, and Support Vector Machine with Radial Basis Function kernel—SVM-RBF classifier on two publicly available datasets namely the Nordic Islet Transplant Program (NITP) and the PIMA Indian Diabetes Dataset (PIDD). The findings demonstrate significant improvement in classification accuracy compared to using all genes. On the Nordic islet transplant dataset, the combined ABC-PSO feature extraction with EHO feature selection achieved the highest accuracy of 97.14%, surpassing the 94.28% accuracy obtained with ABC alone and EHO selection. Similarly, on the PIMA Indian diabetes dataset, the ABC-PSO and EHO combination achieved the best accuracy of 98.13%, exceeding the 95.45% accuracy with ABC and DFA selection. These results highlight the effectiveness of our proposed approach in identifying the most informative features for accurate diabetes prediction. It is observed that the parametric values attained for the datasets are almost similar. Therefore, this research indicates the robustness of the FE and FS along with classifier techniques with two different datasets.
... DM was defined according to the American Diabetes Association diagnostic criteria [20]. Patients with T1DM were excluded from the study, and there were no other exclusion criteria. ...
Background and Objectives: Recent studies have shed light on the association between genetic factors and diabetic retinopathy (DR) onset and progression. The purpose of our study was to investigate the association between rs4885322 single-nucleotide polymorphism (SNP) of the UCHL3 gene and rs11558538 SNP of the HNMT gene with the risk of DR in Greek patients with type 2 diabetes mellitus (T2DM). Materials and Methods: In our case–control study, we included 85 T2DM patients with DR and 71 T2DM patients without DR (NDR), matched by ethnicity and gender. Demographic and clinical data of all patients were collected, and then patients went through a complete ophthalmological examination and were genotyped for rs4885322 SNP of UCHL3 gene and for the rs11558538 SNP of HNMT gene. Statistical analysis was implemented by STATA v.16.1. Results: No significant differences in demographic and clinical data were observed between the DR and the NDR group (p-value ≥ 0.05), except for the lower mean of age, longer duration of DM, more frequent use of insulin therapy, and higher levels of hemoglobin A1c (HbA1c) in the DR group. The allelic effect of rs488532 increases the risk of DR by 2.04 times, and in the dominant genetic model, the risk of DR is elevated by 123%, while both associations are statistically significant (p-value < 0.05). Moreover, the allelic effect of rs11558538 is associated with a 3.27 times increased DR risk and, in the dominant genetic model, reveals an augmented risk of DR by 231%, while both associations are also statistically significant (p-value < 0.05). Conclusions: The rs4885322 SNP of the UCHL3 gene and the rs11558538 SNP of the HNMT gene are associated with DR risk in Greek patients with T2DM. However, further studies with larger samples and different ethnicities should be implemented to clarify the exact association of these SNPs and DR onset.
... The 75-g oral glucose tolerance test (OGTT) and fasting plasma glucose (FPG) tests were recommended by the American Diabetes Association (ADA) for screening T2DM at the 6 to 12 weeks postpartum and every 1-3 years thereafter [41]. Another study also recommended that women at high risk of T2DM should be evaluated for A1C levels [42]. Despite these recommendations, screening of GDM after pregnancy remains notably inadequate, with very low compliance rates [28,43], though the integrated healthcare system reported a screening rate of 60% [44]. ...
Background
This systematic review aims to explore the early predictive value of machine learning (ML) models for the progression of gestational diabetes mellitus (GDM) to type 2 diabetes mellitus (T2DM).
Methods
A comprehensive and systematic search was conducted in Pubmed, Cochrane, Embase, and Web of Science up to July 02, 2024. The quality of the studies included was assessed. The risk of bias was assessed through the prediction model risk of bias assessment tool and a graph was drawn accordingly. The meta-analysis was performed using Stata15.0.
Results
A total of 13 studies were included in the present review, involving 11,320 GDM patients and 22 ML models. The meta-analysis for ML models showed a pooled C-statistic of 0.82 (95% CI: 0.79 ~ 0.86), a pooled sensitivity of 0.76 (0.72 ~ 0.80), and a pooled specificity of 0.57 (0.50 ~ 0.65).
Conclusion
ML has favorable diagnostic accuracy for the progression of GDM to T2DM. This provides evidence for the development of predictive tools with broader applicability.
... Exclusion criteria: ① Patients with type 1 diabetes or other specific types of diabetes; ② Non-diabetic nephropathy patients with chronic kidney disease; ③ Patients with an estimated glomerular filtration rate (eGFR) less than 10 mL/min/ 1.73 m² requiring dialysis; ④ Patients with acute complications of diabetes, such as diabetic ketoacidosis or diabetic lactic acidosis; ⑤ Patients with recent (within 6 months) cerebrovascular accidents, such as cerebral infarction, or cardiovascular conditions, such as acute myocardial infarction and peripheral vascular obstructive disease; ⑥ Patients with acute infections, malignancies, or liver diseases; ⑦ Pregnant women. The diagnosis of T2DM was based on the 2014 American Diabetes Association guidelines, which define T2DM as a fasting plasma glucose level of ≥7.0 mmol/L, glycated hemoglobin (HbA1c) concentration of ≥6.5%, or a 2-hour postload plasma glucose concentration of ≥11.1 mmol/L (following a 75 g oral glucose tolerance test) (12). A total of 163 patients with T2DM from the Fourth People's Hospital of Shenyang were included in the study. ...
Introduction
China has the largest population of individuals with diabetes, and the prevalence of various complications among patients with type 2 diabetes remains high. Diabetic nephropathy affects approximately 20% to 40% of diabetic patients, becoming a major cause of chronic kidney disease and end-stage renal disease. Furthermore, around 50% of patients develop diabetic peripheral neuropathy (DPN), which is closely associated with physical disability, increased healthcare costs, and reduced work productivity. There is an urgent need for novel strategies in prevention, diagnosis, and treatment to improve patient outcomes.
Methods
In this study, 163 patients with type 2 diabetes were selected as the observation group and further divided into three subgroups based on homocysteine (HCY) levels. The study measured several clinical parameters, including homocysteine, blood glucose, blood lipids, glycated hemoglobin, urinary microalbumin, urinary albumin-to-creatinine ratio (ACR), electromyography, and highly-sensitive C-reactive protein (CRP), among others. The levels of these indicators were analyzed and compared across the subgroups.
Results
The results revealed significant differences in uric acid, creatinine, urinary microalbumin, urinary ACR, and nerve conduction velocity (right tibial nerve sensory conduction) among different HCY levels in patients with type 2 diabetes (P < 0.05). Linear regression analysis indicated that homocysteine levels were associated with systolic blood pressure, glycated hemoglobin, fasting C-peptide, uric acid, creatinine, urinary microalbumin, and nerve conduction velocity (including motor conduction velocity of the ulnar nerve and sensory conduction velocity of the sural nerve).
Discussion
The clinical assessment of homocysteine in diabetic patients holds significant importance in the prevention of microvascular complications. Lowering HCY levels may offer a promising therapeutic approach for managing microvascular disease in diabetes.
... Managing Type 2 diabetes requires regular self-care and significant lifestyle changes, primarily dietary modifications (5). Diabetes patients who fail to adhere to the recommended dietary regimen are at risk of developing life-threatening complications (6). ...
Introduction
Non-adherence to dietary guidelines is a significant challenge in managing diabetes mellitus and its complications. Its consequences were significantly associated with a deterioration in patients’ quality of life and an increased socioeconomic burden on healthcare delivery systems. This study aimed to assess the magnitude of adherence to recommended diet and associated factors among patients with diabetes mellitus type 2 on follow-up care at Adama Hospital Medical College Oromia, Ethiopia.
Methods
A hospital-based cross-sectional study design was conducted. Participants were selected through systematic random sampling. Data were collected using structured, interviewer-administered questionnaires. The perceived dietary adherence questionnaire was used to assess the level of dietary adherence. A simple binary logistic regression was used to identify candidate variables, while a multivariable logistic regression assessed factors associated with adherence to the recommended diet. A p-value <0.05 were considered as statistically significant. All analyses were performed using SPSS and R programming software.
Result
A total of 405 participants were included in the study, with a response rate of 96.2%. The magnitude of non-adherence to the recommended diet was 64.2% (95% confidence interval [CI]: 59.8, 68.6). In the multivariable logistic regression model, patients with low and middle income (AOR = 8.0; 95% CI: 3.4, 19.2) and (AOR = 2.75; 95% CI: 1.49, 5.55) respectively, high glycemic level (AOR = 2.15; 95% CI: 1.17, 3.94), food insecure (AOR = 12.7; 95% CI: 5.79, 28.2), poor diabetic knowledge (AOR = 2.88; 95% CI: 1.49, 5.55) and low perceived susceptibility (AOR = 2.97; 95% CI: 1.62, 5.45) were significantly associated factors for non-adherence to recommended diet among patients with diabetes mellitus type 2.
Conclusion
This study revealed that approximately two-thirds of patients with type 2 diabetes mellitus experienced non-adherence to the recommended diet. Key factors linked to dietary non-adherence among T2DM patients include low to middle income, elevated glycemic levels, household food insecurity, limited diabetes knowledge, and low perceived susceptibility. An integrated approach that combines socioeconomic support, nutritional guidance, and risk awareness may greatly enhance dietary adherence and optimize diabetes management.
... Also, eligible were women presenting postpartum intermediate hyperglycaemia (fasting plasma glucose>100 mg/dL (5.6 mmol/L) or 2-hour plasma glucose>140 mg/dL (7.8 mmol/L)). 14 We excluded those with (1) confirmed diabetes on two occasions (fasting plasma glucose≥126 mg/ dL (7.0 mmol/L) or 2-hour glucose≥200 mg/dL (11.1 mol/L)) or unequivocal values on one occasion (both fasting and 2-hour plasma glucose values reaching these standard diabetes thresholds, fasting plasma glucose≥140 mg/dL (7.8 mmol/L) or 2-hour glucose≥270 mg/dL (15 mol/L)); (2) current use of antidiabetic medication; (3) poor attendance during trial preparation; or (4) presence of a health condition, such as a body mass index>40 kg/m 2 , restricting the ability to practice physical activity, affecting glucose tolerance or limiting participation or survival. ...
Objectives
To evaluate a postpartum telephone-based lifestyle intervention to prevent diabetes in high-risk women with recent gestational diabetes mellitus (GDM).
Design
Multicentre parallel randomised clinical trial.
Setting
Specialised antenatal clinics in the Brazilian National System.
Methods
Lifestyle Intervention for Diabetes Prevention After Pregnancy compared (1:1) postpartum telephone support for lifestyle changes with conventional care in women with recent GDM at substantial risk for diabetes. Randomisation started on 28 March 2015 and ended on 13 March 2020, with the onset of the COVID-19 pandemic. We used Cox regression to estimate HRs for diabetes and analysis of covariance adjusted for follow-up time to assess weight change.
Outcomes
The primary outcome was incident diabetes ascertained with blinded measurements of oral glucose tolerance tests. The secondary outcome was a change in measured weight.
Results
We enrolled 5323 women with GDM, 2735 (51%) being at high risk. After invitations, baseline assessment and exclusions, we assigned 466 women to intervention (231) or control (235) groups. Attendance was satisfactory (≥7/20 phone sessions) in 75%. Over an average follow-up of 29.7 (15.6) months, 142 (30.5%) women progressed to diabetes, 75 (32%) in the control and 67 (29%) in the intervention group. There was no reduction in the incidence of diabetes (HR=0.84; 0.60–1.19) and only a non-significant 0.97 kg less weight gain (p=0.09). Among the 305 women randomised more than 1 year before the COVID-19 pandemic, the intervention did not reduce the incidence of diabetes (HR=0.71; 0.48–1.04) despite a 2.09 kg (p=0.002) lesser weight gain.
Conclusion
The strategy to identify women with GDM at high risk proved valid, as women often gained weight and frequently developed diabetes. Over a 30-month follow-up, telephone support for lifestyle changes at postpartum did not reduce weight gain or diabetes incidence, although only 75% attended the minimum number of telephone sessions. The COVID-19 pandemic negatively impacted trial conduction.
Trial registration number
NCT02327286 .
Background
Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance, leading to elevated blood glucose levels. Cellular therapies offer promise for improving hyperglycemia in T2DM. This retrospective study aimed to assess the clinical effectiveness of intravenous allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusion in T2DM patients through various clinical evaluations, focusing on systemic inflammation, metabolic dysfunction, and insulin resistance.
Methods
The data from a total of 218 T2DM patients who attended for follow-up after 6 months, and 83 patients after 12 months after receiving 50–100×10⁶ allogeneic UC-MSCs were analyzed. Blood and urine samples were collected at baseline and follow-up. Key evaluations included changes in anthropometry, diabetes indices, lipids, liver, renal, hormonal, and inflammatory markers.
Results
All patients demonstrated satisfactory outcomes, without adverse effects. Significant reductions in HbA1c levels were observed at 6-months (p<0.001) and 12-months (p=0.016). Insulin (p=0.048) and HOMA-IR (p=0.007) levels significantly reduced within 6-months, with same trend at 12-months. ALT and GGT levels significantly decreased (p<0.05), indicating a reduction in liver inflammation. hs-CRP level among patients with higher inflammation were also reduced at 6-months (p=0.073) and significantly at 12-months (p=0.016). Testosterone (p=0.050) and estradiol (p=0.043) levels increased in males and females, respectively, during 12-month follow-up. Additionally, estimated glomerular filtration rate (eGFR) and creatinine levels improved in stage 2 chronic kidney disease (CKD) at 6- and 12-month (p<0.05), indicating recovered renal function for those in early stage of CKD.
Conclusion
Allogeneic UC-MSCs infusion is safe for patients with T2DM and is associated with overall health outcomes, with sustained benefits up to 12 months. Notably, the treatment significantly improved metabolic indices including glycemic control, liver and renal profile and systemic subclinical inflammation. These findings provide a basis for further exploration of UC-MSCs in managing T2DM in proper randomized control trial, by addressing both metabolic dysregulation and inflammation.
This research investigates the adherence levels to diabetes treatment among patients and explores the factors influencing adherence, glycemic control, and the occurrence of diabetes‐related complications. A cross‐sectional study involving 296 diabetes patients was conducted to evaluate their demographic and clinical profiles, treatment strategies, and adherence levels using the eight‐item Morisky Medication Adherence Scale (MMAS‐8). Statistical analyses identified variables affecting adherence and their relationships with glycemic control and complications. The study population comprised 56% men, with an average age of 49.4 years. Obesity was observed in 24.3% of participants, while the median disease duration was 5 years. The average HbA1c level was 8.4%. Microvascular complications were present in 48.6% of patients, and 18.2% experienced macrovascular complications. Most patients were prescribed oral antidiabetic medications (OAD), with 25% receiving insulin therapy. Adherence rates were suboptimal, with only 3.4% achieving good adherence, 30.4% moderate adherence, and 66.2% poor adherence. Men had higher rates of poor adherence compared to women (72.3% vs. 58.5%). Interestingly, adherence was better in patients with a longer disease duration and a higher body mass index (BMI). The study further examined adherence’s impact on glycemic outcomes, finding that poor adherence strongly correlated with elevated HbA1c levels. Among individuals with HbA1c ≥ 7 % , 70.5% exhibited poor adherence, whereas 40% of patients with good adherence still had suboptimal glycemic control. Conversely, among those with HbA1c < 7 % , 24.5% demonstrated poor adherence compared to 40% with good adherence. Random blood sugar (RBS) levels were significantly higher in poorly adherent patients (237 mg/dL) versus those with good adherence (141 mg/dL). Although adherence was not statistically linked to complication prevalence, patients with reported adherence challenges were more prone to both microvascular and macrovascular complications. Different treatment regimens were also analyzed, revealing that sulfonylureas (SUs) were associated with poor adherence (85%), while sodium–glucose cotransporter 2 inhibitors (SGLT2i) showed better adherence rates (16.7%). Missed doses were strongly linked to poor glycemic outcomes but had a lesser impact on complication development. These findings underscore the need for individualized strategies to enhance adherence and optimize glycemic control, ultimately reducing diabetes‐related complications.
Background
Gestational diabetes mellitus (GDM) presents significant risks to both maternal and infant health, making adherence to health‐promoting behaviours crucial for optimal maternal outcomes. Identifying distinct health behaviour patterns and understanding their association with prenatal depression can offer important insights for targeted interventions.
Objective
This study classifies health‐promoting behaviour patterns among women with GDM and examines their association with prenatal depression to inform tailored interventions.
Design
A cross‐sectional study with latent class analysis.
Method
A total of 570 women with GDM participated in this study. Data were collected through structured questionnaires, including the Health‐Promoting Lifestyle Profile (HPLP) and the Edinburgh Postnatal Depression Scale (EPDS) to assess health‐promoting behaviours and prenatal depression levels. Latent class analysis was used to identify distinct health‐promoting behaviour patterns, while logistic regression was conducted to identify factors influencing behaviour classification. A comparative analysis of prenatal depression scores across different behaviour subgroups was also performed.
Result
Four distinct health‐promoting behaviour patterns were identified: Comprehensive Health Promotion type, health neglect type, psychologically vulnerable type and lifestyle improvement needed type. Factors influencing behaviour patterns included region, education level, working hours, income, primiparity, adherence to prenatal check‐ups and partner support. Significant differences in prenatal depression scores were observed across the behaviour patterns ( p < 0.05).
Conclusion
This study reveals the heterogeneity in health‐promoting behaviours among women with GDM and underscores the link between these behaviour patterns and prenatal depression. Targeted interventions addressing socio‐economic and psychosocial factors can improve adherence to health‐promoting behaviours and mitigate prenatal depression risks. Strengthening prenatal care adherence and encouraging partner involvement are effective strategies for improving maternal well‐being in women with GDM.
Patient or Public Contribution
Participants were involved in providing data for this study through self‐reports on health‐promoting behaviours and prenatal depression. No other contributions from patients or the public were made.
Objective
to assesses the psychometric properties of the Problem Area in Diabetes (PAID) scale for Ethiopian patients with type 2 diabetes.
Results
The confirmatory factor analysis for the Ethiopian Problem Area in Diabetes (Eth-PAID) scales demonstrated good model fit to the one, two, three, and four factor structures. The one-factor model Eth-PAID-20 scale showed acceptable internal consistency (α = 0.82), but the “Diabetes distress” subscale of two, three, and four-factor structures partially satisfied the internal consistency (ranged α = 0.74-77). The Eth-PAID-20 scale correlated negatively with self-care efficacy (r = 0.131, P = 0.06) and positively with Fasting Blood Sugar (FBS) level (r = 0.02, P = 0.86), which implies poor convergent validity. Moreover, “lack of confidence,” “food-related problem,” and “support-related problem” subclasses of two, three, and four-factor models showed very weak convergent validity. Discriminative validity revealed that female patients (30.16 ± 13.11), t = − 2.73, p = 0.007, d = 0.4) and patients who lived alone (28.05 ± 12.98), t = 2.542, p = 0.021, d = 0.5) had significantly higher distress scores in Eth-PAID-20 as one factor model.
Background
Type 1 diabetes is an autoimmune disease affecting over 400,000 children and adults in the United Kingdom for which currently the only available therapy is insulin.
Objective(s)
To determine the efficacy and safety of the monoclonal antibody ustekinumab targeting the interleukin 12/interleukin 23 immune pathway that generates T helper 1/T helper 17 T cells to slow down the autoimmune process and preserve beta cell production in type 1 diabetes.
Design
Randomised, double-blind, placebo-controlled, parallel-group phase II trial.
Setting
Paediatric and young adult diabetes clinics across 16 sites in the United Kingdom.
Participants
Newly diagnosed with type 1 diabetes and aged 12–18 years.
Eligibility criteria
Type 1 diabetes confirmed by islet autoantibody testing, within 100 days of first insulin injection, and with residual beta cell function (stimulated C-peptide level > 0.2 nmol/l).
Interventions
Ustekinumab at the highest approved doses or control (saline) subcutaneously at weeks 0, 4 and 12 and subsequently every 8 weeks to week 44 (seven doses).
Main outcome measures
Preservation of Mixed Meal Tolerance Test stimulated 2-hour insulin C-peptide area under the curve at week 52 as compared to control (saline) treatment by analysis of covariance adjusted for baseline parameters.
Randomisation
2 : 1 Remote computerised randomisation with minimisation by age and baseline C-peptide groups.
Blinding
Blinding of participants, investigators, laboratory and trial staff.
Numbers randomised
Seventy-two participants were randomised, 60% male, 18% aged 16–18 years.
Recruitment
Two hundred and eight potentially eligible patients were approached, and 88 patients were screened. Four participants were lost to follow-up (6%). Four participants withdrew from the treatment but attended the primary end-point assessment.
Numbers analysed
Six participants were missing baseline data for the primary analysis. The final analysable sample was n = 62.
Outcome
Ustekinumab was associated with a 49% higher endogenous stimulated insulin production than control at week 52 after adjustments for baseline factors [geometric ratio of ustekinumab to control was 1.49 (95% confidence interval 1.08 to 2.06; p = 0.02)].
Secondary analyses showed no difference in C-peptide at week 28 suggesting that the effect was ‘late’ or ‘delayed’. Ancillary analysis showed a significant reduction in activated T helper 17.1 T cells ( p < 0.001) in the treatment group which was associated with C-peptide preservation from week 28 to week 52.
Harms
No severe adverse events were reported and there were no differences between ustekinumab and control groups in the proportion of participants overall experiencing mild (87% vs. 88%) or moderate (32% vs. 32%) events.
Limitations
Sensitivity analysis showed the primary end point to be robust to exclusion of small numbers of participants with some protocol deviations and extreme values in key covariates, but not to imputation of all missing data.
Conclusions
Ustekinumab appears to slow down the autoimmune process providing the first clinical trial evidence that interleukin 17-secreting T cells play a pathogenic role in type 1 diabetes. Alone, it is insufficient to halt the autoimmune process.
Future work
Replication of this result is ongoing in a trial with a similar design in Canada. If confirmed, consideration may be given to testing other drugs targeting the interleukin 17 pathway, using ustekinumab in combination with other agents or using it earlier in the disease pathway (preclinical disease) since it is so well tolerated and simple to use.
Study registration
Current Controlled Trials ISRCTN14274380.
Funding
This award was funded by the National Institute for Health and Care Research (NIHR) Efficacy and Mechanism Evaluation (EME) programme (NIHR award ref: 16/36/01) and is published in full in Efficacy and Mechanism Evaluation ; Vol. 12, No. 1. See the NIHR Funding and Awards website for further award information.
It is said that practicing medicine is both a science and an art. Understanding how our colleagues in medicine approach dilemmas in diabetes care is essential to learning how to provide our patients with effective treatment. In Diabetes Case Studies, leading diabetologists from around the world discuss more than 100 challenging cases from their practices. See the problems these clinicians faced and the solutions they used to solve diagnostic and therapeutic dilemmas.
It is said that practicing medicine is both a science and an art. Understanding how our colleagues in medicine approach dilemmas in diabetes care is essential to learning how to provide our patients with effective treatment. In Diabetes Case Studies, leading diabetologists from around the world discuss more than 100 challenging cases from their practices. See the problems these clinicians faced and the solutions they used to solve diagnostic and therapeutic dilemmas.
Background
The circadian rhythm of myocardial infarction (MI) in patients with obstructive sleep apnea (OSA) remains disputable and no studies have directly evaluated the relationship between nocturnal hypoxemia and the circadian rhythm of MI. The aim of the current study was to evaluate the association of OSA and nocturnal hypoxemia with MI onset during the night.
Methods
Patients with MI in the OSA‐acute coronary syndrome (ACS) project (NCT03362385) were recruited. The time of MI onset was identified by patient's report of the chest pain that prompted hospital admission. All patients underwent an overnight sleep study using a type III portable sleep monitoring device after clinical stabilization during hospitalization. The difference in circadian variation of MI onset was evaluated between patients with moderate/severe OSA and non/mild OSA and those with or without nocturnal hypoxemia. Nocturnal hypoxemia was evaluated using 3 variables, including oxygen desaturation index, minimum oxygen saturation, and total sleep time with saturation <90%.
Results
Among 713 patients enrolled, 398 (55.8%) had moderate/severe OSA (apnea‐hypopnea index ≥15 events·h − 1). Compared with the non/mild OSA group, the MI onset was significantly increased in the moderate/severe OSA group between midnight to 5:59 am in 6‐hour epochs analysis (26.9% versus 18.4%, P =0.008). Only in patients with both moderate/severe OSA and nocturnal hypoxemia, including oxygen desaturation index ≥15, minimum oxygen saturation ≤86%, and total sleep time with saturation <90% ≥2%, the incidence of MI onset between midnight to 5:59 am was significantly increased. Moderate/severe OSA (adjusted odds ratio 1.66 [95% CI, 1.13–2.43]; P =0.01) and nocturnal hypoxemia (oxygen desaturation index ≥15 model, adjusted odds ratio 1.80, [95% CI, 1.21–2.66]; minimum oxygen saturation ≤86% model, adjusted odds ratio 1.70 [95% CI, 1.16–2.47]; P =0.006; total sleep time with saturation <90% ≥2% model, adjusted odds ratio 1.54 [95% CI, 1.04–2.27]; P =0.03) significantly predicted MI occurrence from midnight to 6:00 am .
Conclusions
A peak of incident MI onset between midnight to 5:59 am was observed in patients with moderate/severe OSA, especially in those presenting with nocturnal hypoxemia.
Type 2 Diabetes is a highly prevalent chronic disorder that affects multiple systems through microvascular complications. Complications such as diabetic peripheral neuropathy, diabetic retinopathy, and diabetic vestibular dysfunction (vestibulopathy) all directly interfere with the sensory components of balance and postural stability. The resulting impairments cause increased falls risk and instability, making it difficult to perform daily task or exercise. This commentary will provide clarity on the causes and relationship between the sensory complications of T2D, balance, and excise, while also providing recommendations and precautions for exercising with one of these sensory complications.
The Very Low-Energy Ketogenic Therapy (VLEKT) is a structured, multi-phase dietary regimen characterized by a carbohydrate intake of less than 50 g/day and a daily caloric intake of fewer than 800 kcal, which induces ketosis and facilitates significant weight loss. Evidence suggests that this nutritional therapy can improve glycemic control, lipid profiles, and blood pressure, making it a promising option for managing type 2 diabetes (T2D) and reducing cardiovascular risk. These benefits are achieved through reductions in triglycerides and low-density lipoprotein cholesterol (LDL-c), alongside increases in high-density lipoprotein cholesterol (HDL-c). However, the effects of the VLEKT on lipid metabolism remain controversial. The review emphasizes the urgent need for further research to validate the long-term safety and efficacy of the VLEKT. It also highlights the critical role of personalized dietary plans, supervised by healthcare professionals, to optimize health outcomes and address individual patient needs.
Background
Bariatric and metabolic surgery tourism (BMT) is becoming an increasingly popular route to treatment for patients living with obesity. Recent reports have highlighted that some patients travelling abroad for bariatric surgery have received inadequate care, fraudulent care, and, tragically, some cases have resulted in death. This study aimed to define consensus in Europe regarding safe practices concerning BMT.
Materials and methods
IFSO-EC, EASO and ECPO initiated a task force to delineate safe practices in BMT. Two expert European panels were convened, one comprised of healthcare professionals (identified from EASO and IFSO-EC) and the other of patient representatives (identified from ECPO). The study utilised a modified Delphi consensus methodology, and 135 questions were administered. Surveys were conducted anonymously online, and consensus was defined as 70% agreement. Themes analysed regarding BMT included regulation, pre-operative evaluation, operative care, post-operative care, advertising and online information.
Results
One hundred and nineteen healthcare professionals and 88 patient representatives participated from 26 countries. The healthcare professional panel included 66 bariatric surgeons, 28 endocrinologists, 18 dietitians, three nurses, two psychologists, one general practitioner and one gastroenterologist. Three questionnaire rounds were conducted for the healthcare professional panel, and two were performed for the patient representative panel. Consensus recommendations were given across all themes relevant to BMT. These included evaluating and managing psychological health, sleep apnoea, cardiovascular disease, liver health and dietetic assessment. The recommendations covered the requirements for regulatory standards, including surgeon accreditation and procedural volume. They also included recommendations regarding patient education, standardised operative care, online information provision, and follow-up.
Conclusions
Through collaboration with healthcare professionals and patients living with obesity, we provide European recommendations regarding safe practices concerning BMT. Further evaluation is required regarding outcomes following BMT. These data, alongside the Delphi consensus recommendations, will inform BMT clinical guideline development.
Graphical Abstract
The healthcare and medicine industries are being shaped by Artificial Intelligence (AI), which is changing the game in everything from patient care to diagnostics, as well as treatment. AI-driven tools can help increase the accuracy of a diagnosis, by detecting subtle patterns in troves and troves of medical data (of which we have historical access) or spotting changes precisely on an imaging study beyond what we humans are capable. These applications include predicting disease progression or risk assessment, abnormality detection in medical images and recommendation to personalized treatments based on individual patient trips. By using AI-powered NLP, for example clinicians can automate much of their administrative recordkeeping and insurance claims so they may concentrate on patient care. AI analyzes chemical structures and predicts drug interactions in the pharmaceutical sector to speed up discovery development, cutting time cycles down while diminishing costs.
The definition of hyperfiltration, the main pathogenesis in renal impairment in obesity and diabetes mellitus, is uncertain. Glomerular filtration rate (GFR) declines physiologically with aging, and there is inaccuracy in GFR in obesity due to body surface area (BSA) correction. Here, we defined hyperfiltration using GFR without BSA correction, but with inclusion of aging, and investigated hyperfiltration using this definition and absolute GFR > 125 mL/min. The subjects were 180 kidney donor candidates (56.4 ± 11.3 years old, 79 males). GFR was evaluated using inulin clearance. A two-hour 75-g oral glucose tolerance test was also performed. The subjects were divided into four groups with and without a combination of glucose tolerance disorder and BMI. Normal glucose tolerance (NGT) and BMI < 25 kg/m2 were defined as normal, and hyperfiltration was defined as the upper 95% confidence interval of the relationship of aging and GFR in normal cases, and compared with GFR > 125 mL/min. RESULTS: GFR without BSA correction and UAE in non-NGT subjects with obesity were higher than in other groups, but GFR with BSA correction did not show this relationship. In multiple regression analysis, BMI was independently associated with GFR without BSA correction, but not with BSA correction. Aging was consistently associated with GFR. The prevalence of hyperfiltration by our definition (GFR = -0.883 × Age + 167.398) was significantly higher than that using GFR > 125 mL/min (P < 0.0001). Hyperfiltration in obesity and/or glucose tolerance disorder should be evaluated using GFR without BSA correction and including the decline of GFR due to aging.
The healthcare landscape is undergoing a profound transformation with the integration of cutting-edge technologies such as Augmented Reality (AR), Virtual Reality (VR), Smart Wearables and Intelligent Systems. Autonomous Robotics is reshaping healthcare delivery by introducing automation into various aspects of patient care. Robotic systems are being used to assist or even perform complex procedures with precision and minimal invasiveness. This continuous data stream enhances early detection of health issues and supports proactive interventions. The incorporation of Augmented and Virtual Reality, Smart Wearables and Intelligent Systems which is coupled with the rise of Autonomous Robotics, heralds a new era in healthcare. This futuristic healthcare ecosystem is characterized by precision, personalization and autonomy, where technology seamlessly integrates with patient care, diagnostics and treatment. This chapter explores the junction of these technologies which emphasizing the role of autonomous robotics in shaping the future of healthcare.
Introduction
In people living with chronic obstructive pulmonary disease (COPD), we aimed to estimate: (1) the prevalence of glucocorticoid‐induced hyperglycaemia (GIH); (2) whether the prevalence of GIH varies by age, baseline diabetes status, treatment duration, ascertainment of glycaemia, definition of hyperglycaemia, study design and year of publication; and (3) the relative risk (RR) of new‐onset hyperglycaemia in exposed vs non‐exposed to systemic glucocorticoids.
Methods
We searched electronic databases until 9 November 2023 for randomised controlled trials and observational studies including adults diagnosed with COPD, with or without diabetes at baseline, using systemic glucocorticoids equivalent to prednisolone ≥5 mg/day for ≥3 days if exposed. Hyperglycaemia was defined as a blood glucose above a study‐specific cut‐off. We extracted data on study and participant characteristics, exposure and outcome. We performed random‐effects meta‐analysis to calculate pooled prevalence estimate of GIH. Prevalence was expressed as the proportion of people who developed hyperglycaemia among all exposed to systemic glucocorticoids during follow‐up. We calculated RR of new‐onset hyperglycaemia in exposed vs non‐exposed to systemic glucocorticoids from eight studies.
Results
Of 25,806 citations, we included 18 studies comprising 3642 people of whom 3125 received systemic glucocorticoids and 1189 developed hyperglycaemia. Pooled prevalence of GIH was 38.6% (95%CI 29.9%–47.9%) with significant heterogeneity, I ² = 96% ( p < 0.010), which was partially explained by differences in study design. Pooled RR = 2.39 (95%CI 1.51–3.78). Publication bias was present.
Conclusion
The prevalence of GIH was 38.6%. Being treated with systemic glucocorticoids for COPD was associated with 2.4 times higher risk of new‐onset hyperglycaemia versus no glucocorticoid treatment.
The advent of augmented reality (AR) and virtual reality (VR) technology has completely changed health expansions and medical training. The in-depth analysis and compilation of these technologies noteworthy contributions shows how they have the ability to significantly increase student performance and engagement as well as educational outcomes. The use of haptic feedback technology is an important advancement in medical education. With providing a very lifelike simulation of clinical operations, haptic interfaces, which enable tactile engagement in virtual environments, are redefining the acquisition of surgical skills. AR and VR technologies are changing education by fusing interactive experiences with real-world applications in ways that conventional lecture-based techniques are unable to do that. This chapter focuses on how immersive VR and AR technologies, in medical education and training contexts, enhance certain competencies in healthcare professionals when compared to no intervention or traditional teaching techniques.
Blockchain governance in healthcare plays a vital role at the crossroads of technology and medical services. With Blockchain transforming how healthcare operates, having a strong governance structure is essential. This framework addresses ethical and regulatory issues while also ensuring that AI-driven tools and algorithms are used responsibly, ethically, and securely in the healthcare sector. The regulation of AI in healthcare and its associated challenges at national, regional, and international levels is a topic of both complexity and importance. These reports offer guidelines and key principles for the ethical and responsible implementation of AI systems. Specifically, blockchain in healthcare must be designed and used in ways that uphold human dignity, fundamental rights, and core values. This chapter comprehensively explores the diverse arena of AI systems which should foster equity, fairness, inclusiveness and accountability.
Purpose:
This study aimed to explore the expression profile of miR-185-5p in proliferative DR (PDR), and further evaluate its diagnostic value and possible mechanism of miR-185-5p in PDR.
Methods:
The level of miR-185-5p was detected by qRT-PCR. The ROC curve was established to estimate the diagnostic ability of miR-185-5p. Transwell experiment and cell counting kit-8 (CCK-8) assays were conducted to assess the effect of miR-185-5p on the migration and proliferation of human retinal endothelial cells (HRECs) induced by high glucose. Enzyme linked immunosorbent assay (ELISA) was used to detect the concentrations of inflammatory factors. The luciferase reporter gene experiment was used to prove the interaction between miR-185-5p and CXCR4.
Results:
Compared to the control group, the expression of miR-185-5p was significantly up-regulated in both the type 2 diabetes mellitus (T2DM) group and the PDR groups, with higher levels in the PDR group than in the T2DM group. The ROC curve reveals that serum miR-185-5p can distinguish PDR patients from T2DM patients. MiR-185-5p levels in HRECs increased significantly after high glucose induction. High glucose induction also promoted the migration, proliferation and inflammation response of HRECs. However, when the intracellular miR-185-5p level was down-regulated by miR-185-5p inhibitor transfection, these effects were inhibited. The luciferase reporter gene assay showed that miR-185-5p directly targets CXCR4.
Conclusion:
The expression of miR-185-5p is out of balance in PDR and it may be involved in regulating the migration and proliferation of HRECs by regulating CXCR4.
Introduction: Type 2 Diabetes Mellitus (T2DM) is a chronic and progressive disease that poses a challenge to global public health. The World Health Organization (WHO) estimates that approximately 422 million people worldwide suffer from the condition, with a particularly high prevalence in low- and middle-income countries. The main physical complications associated with T2DM include diabetic neuropathy, diabetic retinopathy, and chronic kidney disease. The impact of these complications on an individual’s quality of life is significant, often leading to functional disability. Despite widespread recognition of the adverse impacts on the health and quality of life of affected individuals, significant gaps remain in understanding the main complications related to T2DM. Objective: To analyze, based on scientific literature, the state of knowledge regarding the main complications associated with Type 2 Diabetes Mellitus. Methodology: This is a scoping review that encompasses the items of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) Checklist. The data were presented descriptively, based on the tabulation of the findings. Results: Infections emerged as the leading cause of mortality among study participants, followed by cardiovascular diseases. The study documented a high prevalence and/or incidence of macrovascular complications (such as severe peripheral arterial disease) and microvascular complications (such as ulcers in the lower limbs). Furthermore, the most frequently recurring variables related to complications are those associated with the cardiovascular system, particularly hypertension. Findings regarding the lipid profile are highly valuable, as well as the alterations related to peripheral polyneuropathies. Conclusion: This work reviewed the main complications associated with Type 2 Diabetes Mellitus (T2DM), highlighting its complexity and multifactorial nature. The results reveal that T2DM is associated with various emotional, physical, and social complications that affect patients' quality of life, including cardiovascular diseases, nephropathy, retinopathy, and peripheral neuropathy. These issues are often exacerbated by risk factors such as hypertension and dyslipidemia.
Diabetes mellitus (DM) has emerged as an international health epidemic due to its rapid rise in prevalence. Consequently, scientists and or researchers will continue to find novel, safe, effective, and affordable anti-diabetic medications. The goal of this review is to provide a thorough overview of the role that lifestyle changes play in managing diabetes, as well as the standard medications that are currently being used to treat the condition and the most recent advancements in the development of novel medical treatments that may be used as future interventions for the disease. A literature search was conducted using research databases such as PubMed, Web of Science, Scopus, ScienceDirect, Wiley Online Library, Google Scholar, etc. Data were then abstracted from these publications using words or Phrases like “pathophysiology of diabetes”, “Signe and symptoms of diabetes”, “types of diabetes”, “major risk factors and complication of diabetes”, “diagnosis of diabetes”, “lifestyle modification for diabetes”, “current antidiabetic agents”, and “novel drugs and targets for diabetes management” that were published in English and had a strong scientific foundation. Special emphasis was given to the importance of lifestyle modification, as well as current, novel, and emerging/promising drugs and targets helpful for the management of both T1DM and T2DM.
Background: Effective insulin therapy is crucial for managing diabetes, with recent advancements in glucose monitoring technologies significantly enhancing patient outcomes. Continuous glucose meters (CGMs), insulin pumps, and glucometers play vital roles in improving glycemic control, thereby enhancing the quality of life for individuals with diabetes. Aim: This review aims to evaluate the role of pharmacists in managing diabetes through the application of CGMs, insulin pumps, and glucometers, highlighting innovations in technology and their impact on patient care. Methods: A comprehensive literature review was conducted to analyze the efficacy of various glucose monitoring systems, including real-time continuous glucose monitoring (RT-CGM) and self-monitoring of blood glucose (SMBG) devices. Clinical trials and recent advancements in diabetes management technologies were examined. Results: The review found that RT-CGM devices significantly reduced HbA1c levels and the incidence of hypoglycemia compared to traditional SMBG methods. Long-term CGM use improved glycemic control, patient satisfaction, and quality of life, with evidence supporting its effectiveness across diverse patient populations. Pharmacists play an essential role in educating patients about these technologies and optimizing diabetes management strategies. Conclusion: The integration of advanced glucose monitoring technologies into diabetes management represents a substantial improvement in patient care.
Objective: Atlantia monophylla is an indigenous medicinal plant, with a folk reputation as hypoglycemic agent throughout India. Considerable research has shown that plants rich in flavonoids content with anti-oxidant potential are known to be bioactive for the management of diabetes mellitus (DM). In the present investigation, hypoglycemic activity of aqueous fruit peel extract of A. monophylla was evaluated using alloxan-induced hyperglycemic mice. Methods: Aqueous extract of the fruit peel of A. monophylla (AEAM) was subjected to preliminary phytochemical screening and acute oral toxicity study as per Organization for Economic Cooperation and Development guidelines 425. AEAM was evaluated for hypoglycemic activity, Alloxan induced DM in mice, oral glucose tolerance test in fasted mice. In vitro α- amylase inhibitory in albino mice method was employed for evaluation of hypoglycemic activity. Results: All of the mice in each group had their blood glucose levels measured both before and after the treatments on fasting animals. The extract was given at doses of 200 mg/kg and 400 mg/kg body weight, or 100 mg/kg body weight of the conventional antidiabetic medication Metformin. A glucometer was used to measure the blood glucose level. After 1 h, 2 h, and 4 h, the extract-treated diabetic mice had a substantial (p≤0.05) drop in blood glucose levels. The hypoglycemic action was similar to that of the medication Metformin used as a benchmark. Conclusion: The results of this study indicate that AEAM has strong hypoglycemic properties. One such method might include the activation of insulin receptors and subsequent release of insulin once β cells are stimulated. The hypoglycemic effect of the plant could be achieved through increasing insulin release from the pancreas.
Objectives: Continued use of a digital health assistant that helps patients living with diabetes to self-manage and deal with complex problems in order to enhance their health status is a healthcare priority. The objective was to explore the barriers related to the use of a mobile personal health assistant for patients with type 2 diabetes. Methods: Eighty-one participants were offered a personal health assistant through a smartphone application. They completed a questionnaire after initial training (T0) and after 1 month’s experience (T1). Results and Conclusion: Most had a positive behavioral intention before using it, but the opposite was found after 1 month. There were positive correlations between behavioral intention and the eight related factors. The strongest correlations were with satisfaction and perceived usefulness at T0 and T1, respectively. The factors’ mean values decreased after 1 month. The best predictors of behavioral intention were satisfaction and performance expectancy at T0 and T1, respectively, which predicted the status of 88.4% and 82.7% of the sample. Our findings will help health experts to build better tools that satisfy patients and meet their expectations.
Prescribing Pattern of Antidiabetic Drugs and Its Adherence to American Diabetes Association Guidelines in Patients of Type 2 Diabetes Mellitus with and Without Comorbidities.
This new edition of the Complete Nurse’s Guide to Diabetes Care is a comprehensive resource for all nurses who work with diabetes patients. Inside, readers will find expert advice on:
The Complete Nurse’s Guide to Diabetes Care, 3rd Edition, gives nurses the tools they need to give quality care to the person with diabetes.
This new edition of the Complete Nurse’s Guide to Diabetes Care is a comprehensive resource for all nurses who work with diabetes patients. Inside, readers will find expert advice on:
The Complete Nurse’s Guide to Diabetes Care, 3rd Edition, gives nurses the tools they need to give quality care to the person with diabetes.
Gestational diabetes mellitus is the most common medical condition in pregnancy, disproportionately affecting overweight or obese women and those from non-White populations. The lack of standardised screening and diagnostic consensus contributes to varying prevalence. Conventional risk factor-based screening can leave women undiagnosed, leading to increased risk of harm. If diet and lifestyle modifications fail to achieve glycaemic targets, prompt treatment should be initiated to manage glucose levels. A planned birth is crucial to ensure the best outcomes. Postpartum, women need screening for type 2 diabetes and other cardiometabolic risk factors, enrollment in diabetes prevention programmes, and counselling on the increased risk of future cardiometabolic disease for themselves and their offspring, highlighting the importance of ongoing prevention and management strategies.
This research examines the implementation challenges of Indonesia’s Strategic Logistics Reserve Development Program (CLS), specifically focusing on cassava cultivation in Gunung Mas Regency. Launched as part of the 2020-2024 National Strategic Program (PSN), the initiative aims to address potential food security issues exacerbated by the COVID-19 pandemic, land degradation, and climate change. The program's primary goal is to develop food estates to enhance national food security. The study employs a mixed-methods approach, including interviews with key stakeholders, analysis of program documentation, and community surveys to assess the program’s effectiveness and impact. Key findings reveal significant obstacles, including policy misalignment, unsuitable land conditions for cassava, inadequate infrastructure, and a top-down implementation strategy that lacks local community involvement. Results indicate that while the program has led to some positive outcomes, such as job creation and increased food independence, it has also faced severe criticism. Issues such as suboptimal cassava growth, environmental damage, and socio-cultural impacts have led to negative public perceptions. The failure to issue a crucial Presidential Decree, poor inter-governmental coordination, and inadequate understanding of the program by local communities have compounded these challenges. Analysis suggests that the program’s shortcomings are due to a combination of regulatory delays, environmental mismatches, and insufficient stakeholder engagement. To address these issues, the research recommends a comprehensive evaluation of the program, restoration of damaged lands, enhanced community participation, and stronger environmental safeguards. Improved collaboration between central and regional governments and better alignment of policies and infrastructure are essential for the program’s success in achieving its food security objectives.
Gestational Diabetes Mellitus (GDM) is a collection of symptoms that arise in pregnant women caused by an increase in blood glucose levels due to a progressive decrease in insulin secretion, variables that influence the incidence of gestational diabetes include age, history of diabetes mellitus, can occur at any time, but this disease usually begins to attack in the 24th week of pregnancy. The prevalence of Gestational Diabetes Mellitus in Indonesia is still relatively small, namely around 3-5%, but this figure could be higher because cases of GDM are rarely detected. Even though it can heal on its own, that doesn't mean gestational diabetes is not dangerous. If not treated properly, this disease can increase the risk of the baby being born with excess weight, being born prematurely, or being born with low blood sugar or hypoglycemia. For pregnant women, gestational diabetes has the potential to cause complications, such as preeclampsia and hypertension. In Indonesia, all pregnant women are recommended to undergo DMG screening. However, not many pregnant women do this. The aim of this research is to determine the relationship between the perceptions of pregnant women and the behavior of early detection of Gestational Diabetes Mellitus at the Plumbon health center, Indramayu Regency in 2024. This research is quantitative research with a cross-sectional study design. The respondents in this study were 107 pregnant women who lived in the working area of the Plumbon Health Center, Indramayu Regency and used health services at the health center in 2024. Samples were taken using the Accidental Sampling technique, a technique for determining samples based on chance, namely any patient who happened to meet the researcher. and data were analyzed univariate and bivariate. The results of the research show that the characteristics of respondents, namely age, education, employment and income, do not have a significant relationship with early detection behavior of GDM, however, the perception of pregnant women with behavior of early detection of Gestational Diabetes Mellitus has a significant relationship as does mother's knowledge of early detection of Gestational Diabetes Mellitus. have a significant relationship.
Background:
We investigated whether intensive glycemic control, combination therapy for dyslipidemia, and intensive blood-pressure control would limit the progression of diabetic retinopathy in persons with type 2 diabetes. Previous data suggest that these systemic factors may be important in the development and progression of diabetic retinopathy.
Methods:
In a randomized trial, we enrolled 10,251 participants with type 2 diabetes who were at high risk for cardiovascular disease to receive either intensive or standard treatment for glycemia (target glycated hemoglobin level, <6.0% or 7.0 to 7.9%, respectively) and also for dyslipidemia (160 mg daily of fenofibrate plus simvastatin or placebo plus simvastatin) or for systolic blood-pressure control (target, <120 or <140 mm Hg). A subgroup of 2856 participants was evaluated for the effects of these interventions at 4 years on the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study Severity Scale (as assessed from seven-field stereoscopic fundus photographs, with 17 possible steps and a higher number of steps indicating greater severity) or the development of diabetic retinopathy necessitating laser photocoagulation or vitrectomy.
Results:
At 4 years, the rates of progression of diabetic retinopathy were 7.3% with intensive glycemia treatment, versus 10.4% with standard therapy (adjusted odds ratio, 0.67; 95% confidence interval [CI], 0.51 to 0.87; P=0.003); 6.5% with fenofibrate for intensive dyslipidemia therapy, versus 10.2% with placebo (adjusted odds ratio, 0.60; 95% CI, 0.42 to 0.87; P=0.006); and 10.4% with intensive blood-pressure therapy, versus 8.8% with standard therapy (adjusted odds ratio, 1.23; 95% CI, 0.84 to 1.79; P=0.29).
Conclusions:
Intensive glycemic control and intensive combination treatment of dyslipidemia, but not intensive blood-pressure control, reduced the rate of progression of diabetic retinopathy. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov numbers, NCT00000620 for the ACCORD study and NCT00542178 for the ACCORD Eye study.)
Severe hypoglycaemia is a major barrier to optimising glycaemic control. Recent changes in therapy, however, may have altered the epidemiology of severe hypoglycaemia and its associated risk factors. The aim of this study was to examine the incidence rates and risk factors associated with severe hypoglycaemia in a contemporary cohort of children and adolescents with type 1 diabetes.
Subjects were identified from a population-based register containing data on >99% of patients (<16 years of age) who were being treated for type 1 diabetes in Western Australia. Patients attend the clinic approximately every 3 months, where data pertaining to diabetes management, demographics and complications including hypoglycaemia are prospectively recorded. A severe hypoglycaemic event was defined as an episode of coma or convulsion associated with hypoglycaemia. Risk factors assessed included age, duration of diabetes, glycaemic control, sex, insulin therapy, socioeconomic status and calendar year.
Clinical visit data from 1,770 patients, providing 8,214 patient-years of data between 2000 and 2011 were analysed. During follow-up, 841 episodes of severe hypoglycaemia were observed. No difference in risk of severe hypoglycaemia was observed between age groups. Good glycaemic control (HbA1c <7% [53 mmol/mol]) compared with the cohort average (HbA1c 8-9% [64-75 mmol/mol]) was not associated with an increased risk of severe hypoglycaemia. When compared with patients on injection regimens, subjects aged 12-18 years on pump therapy were at reduced risk of severe hypoglycaemia (incidence risk ratio 0.6; 95% CI 0.4, 0.9).
In this population-based sample of children and adolescents with type 1 diabetes, contemporary therapy is associated with a changed pattern and incidence of severe hypoglycaemia.
Background: Periodontal disease and diabetes mellitus are common, chronic diseases worldwide. Epidemiologic and biologic evidence suggest periodontal disease may affect diabetes.
Objective: To systematically review non‐experimental, epidemiologic evidence for effects of periodontal disease on diabetes control, complications and incidence.
Data sources: Electronic bibliographic databases, supplemented by hand searches of recent and future issues of relevant journals. Study eligibility criteria and participants: Longitudinal and cross‐sectional epidemiologic, non‐interventional studies that permit determination of directionality of observed effects were included. Study appraisal and synthesis methods: Four reviewers evaluated pair‐wise each study. Review findings regarding study results and quality were summarized in tables by topic, using the PRISMA Statement for reporting and the Newcastle‐Ottawa System for quality assessment, respectively. From 2246 citations identified and available abstracts screened, 114 full‐text reports were assessed and 17 included in the review. Results: A small body of evidence supports significant, adverse effects of periodontal disease on glycaemic control, diabetes complications, and development of type 2 (and possibly gestational) diabetes.
Limitations: There were only a limited number of eligible studies, several of which included small sample sizes. Exposure and outcome parameters varied, and the generalizability of their results was limited. Conclusions and implications of key findings: Current evidence suggests that periodontal disease adversely affects diabetes outcomes, and that further longitudinal studies are warranted.
BACKGROUND: Observational cohort studies and a secondary prevention trial have shown an inverse association between adherence to the Mediterranean diet and cardiovascular risk. We conducted a randomized trial of this diet pattern for the primary prevention of cardiovascular events.
METHODS: In a multicenter trial in Spain, we randomly assigned participants who were at high cardiovascular risk, but with no cardiovascular disease at enrollment, to one of three diets: a Mediterranean diet supplemented with extra-virgin olive oil, a Mediterranean diet supplemented with mixed nuts, or a control diet (advice to reduce dietary fat). Participants received quarterly individual and group educational sessions and, depending on group assignment, free provision of extra-virgin olive oil, mixed nuts, or small nonfood gifts. The primary end point was the rate of major cardiovascular events (myocardial infarction, stroke, or death from cardiovascular causes). On the basis of the results of an interim analysis, the trial was stopped after a median follow-up of 4.8 years.
RESULTS: A total of 7447 persons were enrolled (age range, 55 to 80 years); 57% were women. The two Mediterranean-diet groups had good adherence to the intervention, according to self-reported intake and biomarker analyses. A primary end-point event occurred in 288 participants. The multivariable-adjusted hazard ratios were 0.70 (95% confidence interval [CI], 0.54 to 0.92) and 0.72 (95% CI, 0.54 to 0.96) for the group assigned to a Mediterranean diet with extra-virgin olive oil (96 events) and the group assigned to a Mediterranean diet with nuts (83 events), respectively, versus the control group (109 events). No diet-related adverse effects were reported.
CONCLUSIONS: Among persons at high cardiovascular risk, a Mediterranean diet supplemented with extra-virgin olive oil or nuts reduced the incidence of major cardiovascular events. (Funded by the Spanish government's Instituto de Salud Carlos III and others; Controlled-Trials.com number, ISRCTN35739639.).
Background:
There is no evidence from randomized trials to support a strategy of lowering systolic blood pressure below 135 to 140 mm Hg in persons with type 2 diabetes mellitus. We investigated whether therapy targeting normal systolic pressure (i.e., <120 mm Hg) reduces major cardiovascular events in participants with type 2 diabetes at high risk for cardiovascular events.
Methods:
A total of 4733 participants with type 2 diabetes were randomly assigned to intensive therapy, targeting a systolic pressure of less than 120 mm Hg, or standard therapy, targeting a systolic pressure of less than 140 mm Hg. The primary composite outcome was nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.
Results:
After 1 year, the mean systolic blood pressure was 119.3 mm Hg in the intensive-therapy group and 133.5 mm Hg in the standard-therapy group. The annual rate of the primary outcome was 1.87% in the intensive-therapy group and 2.09% in the standard-therapy group (hazard ratio with intensive therapy, 0.88; 95% confidence interval [CI], 0.73 to 1.06; P=0.20). The annual rates of death from any cause were 1.28% and 1.19% in the two groups, respectively (hazard ratio, 1.07; 95% CI, 0.85 to 1.35; P=0.55). The annual rates of stroke, a prespecified secondary outcome, were 0.32% and 0.53% in the two groups, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P=0.01). Serious adverse events attributed to antihypertensive treatment occurred in 77 of the 2362 participants in the intensive-therapy group (3.3%) and 30 of the 2371 participants in the standard-therapy group (1.3%) (P<0.001).
Conclusions:
In patients with type 2 diabetes at high risk for cardiovascular events, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, did not reduce the rate of a composite outcome of fatal and nonfatal major cardiovascular events. (ClinicalTrials.gov number, NCT00000620.)
The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown.
In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here.
During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P=0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P=0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P=0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P=0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups.
Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).
Aims/hypothesis:
The study aimed to compare the effects of a 2 year intervention with a low-fat diet (LFD) or a low-carbohydrate diet (LCD), based on four group meetings to achieve compliance.
Methods:
This was a prospective randomised parallel trial involving 61 adults with type 2 diabetes consecutively recruited in primary care and randomised by drawing ballots. Patients that did not speak Swedish could not be recruited. The primary outcomes in this non-blinded study were weight and HbA(1c). Patients on the LFD aimed for 55-60 energy per cent (E%) and those on LCD for 20 E% from carbohydrate.
Results:
The mean BMI and HbA(1c) of the participants were 32.7 ± 5.4 kg/m(2) and 57.0 ± 9.2 mmol/mol, respectively. No patients were lost to follow-up. Weight loss did not differ between groups and was maximal at 6 months: LFD -3.99 ± 4.1 kg (n=31); LCD -4.31 ± 3.6 kg (n=30); p < 0.001 within groups. At 24 months, patients on the LFD had lost -2.97 ± 4.9 kg and those on LCD -2.34 ± 5.1 kg compared with baseline (p = 0.002 and p = 0.020 within groups, respectively). HbA(1c) fell in the LCD group only (LCD at 6 months -4.8 ± 8.3 mmol/mol, p = 0.004, at 12 months -2.2 ± 7.7 mmol/mol, p = 0.12; LFD at 6 months -0.9 ± 8.8 mmol/mol, p = 0.56). At 6 months, HDL-cholesterol had increased with the LCD (from 1.13 ± 0.33 mmol/l to 1.25 ± 0.47 mmol/l, p = 0.018) while LDL-cholesterol did not differ between groups. Insulin doses were reduced in the LCD group (0 months, LCD 42 ± 65 E, LFD 39 ± 51 E; 6 months, LCD 30 ± 47 E, LFD 38 ± 48 E; p = 0.046 for between-group change).
Conclusions/interpretation:
Weight changes did not differ between the diet groups, while insulin doses were reduced significantly more with the LCD at 6 months, when compliance was good. Thus, aiming for 20% of energy intake from carbohydrates is safe with respect to cardiovascular risk compared with the traditional LFD and this approach could constitute a treatment alternative.
Trial registration:
ClinicalTrials.gov NCT01005498
Funding:
University Hospital of Linköping Research Funds, Linköping University, the County Council of Östergötland, and the Diabetes Research Centre of Linköping University.
Observational studies have shown improvement in patients with type 2 diabetes mellitus after bariatric surgery.
In this randomized, nonblinded, single-center trial, we evaluated the efficacy of intensive medical therapy alone versus medical therapy plus Roux-en-Y gastric bypass or sleeve gastrectomy in 150 obese patients with uncontrolled type 2 diabetes. The mean (±SD) age of the patients was 49±8 years, and 66% were women. The average glycated hemoglobin level was 9.2±1.5%. The primary end point was the proportion of patients with a glycated hemoglobin level of 6.0% or less 12 months after treatment.
Of the 150 patients, 93% completed 12 months of follow-up. The proportion of patients with the primary end point was 12% (5 of 41 patients) in the medical-therapy group versus 42% (21 of 50 patients) in the gastric-bypass group (P=0.002) and 37% (18 of 49 patients) in the sleeve-gastrectomy group (P=0.008). Glycemic control improved in all three groups, with a mean glycated hemoglobin level of 7.5±1.8% in the medical-therapy group, 6.4±0.9% in the gastric-bypass group (P<0.001), and 6.6±1.0% in the sleeve-gastrectomy group (P=0.003). Weight loss was greater in the gastric-bypass group and sleeve-gastrectomy group (-29.4±9.0 kg and -25.1±8.5 kg, respectively) than in the medical-therapy group (-5.4±8.0 kg) (P<0.001 for both comparisons). The use of drugs to lower glucose, lipid, and blood-pressure levels decreased significantly after both surgical procedures but increased in patients receiving medical therapy only. The index for homeostasis model assessment of insulin resistance (HOMA-IR) improved significantly after bariatric surgery. Four patients underwent reoperation. There were no deaths or life-threatening complications.
In obese patients with uncontrolled type 2 diabetes, 12 months of medical therapy plus bariatric surgery achieved glycemic control in significantly more patients than medical therapy alone. Further study will be necessary to assess the durability of these results. (Funded by Ethicon Endo-Surgery and others; ClinicalTrials.gov number, NCT00432809.).
Roux-en-Y gastric bypass and biliopancreatic diversion can markedly ameliorate diabetes in morbidly obese patients, often resulting in disease remission. Prospective, randomized trials comparing these procedures with medical therapy for the treatment of diabetes are needed.
In this single-center, nonblinded, randomized, controlled trial, 60 patients between the ages of 30 and 60 years with a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 35 or more, a history of at least 5 years of diabetes, and a glycated hemoglobin level of 7.0% or more were randomly assigned to receive conventional medical therapy or undergo either gastric bypass or biliopancreatic diversion. The primary end point was the rate of diabetes remission at 2 years (defined as a fasting glucose level of <100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of <6.5% in the absence of pharmacologic therapy).
At 2 years, diabetes remission had occurred in no patients in the medical-therapy group versus 75% in the gastric-bypass group and 95% in the biliopancreatic-diversion group (P<0.001 for both comparisons). Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline glycated hemoglobin level (8.65±1.45%) had decreased in all groups, but patients in the two surgical groups had the greatest degree of improvement (average glycated hemoglobin levels, 7.69±0.57% in the medical-therapy group, 6.35±1.42% in the gastric-bypass group, and 4.95±0.49% in the biliopancreatic-diversion group).
In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures. (Funded by Catholic University of Rome; ClinicalTrials.gov number, NCT00888836.).
In patients with established cardiovascular disease, residual cardiovascular risk persists despite the achievement of target low-density lipoprotein (LDL) cholesterol levels with statin therapy. It is unclear whether extended-release niacin added to simvastatin to raise low levels of high-density lipoprotein (HDL) cholesterol is superior to simvastatin alone in reducing such residual risk.
We randomly assigned eligible patients to receive extended-release niacin, 1500 to 2000 mg per day, or matching placebo. All patients received simvastatin, 40 to 80 mg per day, plus ezetimibe, 10 mg per day, if needed, to maintain an LDL cholesterol level of 40 to 80 mg per deciliter (1.03 to 2.07 mmol per liter). The primary end point was the first event of the composite of death from coronary heart disease, nonfatal myocardial infarction, ischemic stroke, hospitalization for an acute coronary syndrome, or symptom-driven coronary or cerebral revascularization.
A total of 3414 patients were randomly assigned to receive niacin (1718) or placebo (1696). The trial was stopped after a mean follow-up period of 3 years owing to a lack of efficacy. At 2 years, niacin therapy had significantly increased the median HDL cholesterol level from 35 mg per deciliter (0.91 mmol per liter) to 42 mg per deciliter (1.08 mmol per liter), lowered the triglyceride level from 164 mg per deciliter (1.85 mmol per liter) to 122 mg per deciliter (1.38 mmol per liter), and lowered the LDL cholesterol level from 74 mg per deciliter (1.91 mmol per liter) to 62 mg per deciliter (1.60 mmol per liter). The primary end point occurred in 282 patients in the niacin group (16.4%) and in 274 patients in the placebo group (16.2%) (hazard ratio, 1.02; 95% confidence interval, 0.87 to 1.21; P=0.79 by the log-rank test).
Among patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of less than 70 mg per deciliter (1.81 mmol per liter), there was no incremental clinical benefit from the addition of niacin to statin therapy during a 36-month follow-up period, despite significant improvements in HDL cholesterol and triglyceride levels. (Funded by the National Heart, Lung, and Blood Institute and Abbott Laboratories; AIM-HIGH ClinicalTrials.gov number, NCT00120289.).
An impaired glomerular filtration rate (GFR) leads to end-stage renal disease and increases the risks of cardiovascular disease and death. Persons with type 1 diabetes are at high risk for kidney disease, but there are no interventions that have been proved to prevent impairment of the GFR in this population.
In the Diabetes Control and Complications Trial (DCCT), 1441 persons with type 1 diabetes were randomly assigned to 6.5 years of intensive diabetes therapy aimed at achieving near-normal glucose concentrations or to conventional diabetes therapy aimed at preventing hyperglycemic symptoms. Subsequently, 1375 participants were followed in the observational Epidemiology of Diabetes Interventions and Complications (EDIC) study. Serum creatinine levels were measured annually throughout the course of the two studies. The GFR was estimated with the use of the Chronic Kidney Disease Epidemiology Collaboration formula. We analyzed data from the two studies to determine the long-term effects of intensive diabetes therapy on the risk of impairment of the GFR, which was defined as an incident estimated GFR of less than 60 ml per minute per 1.73 m(2) of body-surface area at two consecutive study visits.
Over a median follow-up period of 22 years in the combined studies, impairment of the GFR developed in 24 participants assigned to intensive therapy and in 46 assigned to conventional therapy (risk reduction with intensive therapy, 50%; 95% confidence interval, 18 to 69; P=0.006). Among these participants, end-stage renal disease developed in 8 participants in the intensive-therapy group and in 16 in the conventional-therapy group. As compared with conventional therapy, intensive therapy was associated with a reduction in the mean estimated GFR of 1.7 ml per minute per 1.73 m(2) during the DCCT study but during the EDIC study was associated with a slower rate of reduction in the GFR and an increase in the mean estimated GFR of 2.5 ml per minute per 1.73 m(2) (P<0.001 for both comparisons). The beneficial effect of intensive therapy on the risk of an impaired GFR was fully attenuated after adjustment for glycated hemoglobin levels or albumin excretion rates.
The long-term risk of an impaired GFR was significantly lower among persons treated early in the course of type 1 diabetes with intensive diabetes therapy than among those treated with conventional diabetes therapy. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; DCCT/EDIC ClinicalTrials.gov numbers, NCT00360815 and NCT00360893.).
Background:
Increased levels of the inflammatory biomarker high-sensitivity C-reactive protein predict cardiovascular events. Since statins lower levels of high-sensitivity C-reactive protein as well as cholesterol, we hypothesized that people with elevated high-sensitivity C-reactive protein levels but without hyperlipidemia might benefit from statin treatment.
Methods:
We randomly assigned 17,802 apparently healthy men and women with low-density lipoprotein (LDL) cholesterol levels of less than 130 mg per deciliter (3.4 mmol per liter) and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher to rosuvastatin, 20 mg daily, or placebo and followed them for the occurrence of the combined primary end point of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from cardiovascular causes.
Results:
The trial was stopped after a median follow-up of 1.9 years (maximum, 5.0). Rosuvastatin reduced LDL cholesterol levels by 50% and high-sensitivity C-reactive protein levels by 37%. The rates of the primary end point were 0.77 and 1.36 per 100 person-years of follow-up in the rosuvastatin and placebo groups, respectively (hazard ratio for rosuvastatin, 0.56; 95% confidence interval [CI], 0.46 to 0.69; P<0.00001), with corresponding rates of 0.17 and 0.37 for myocardial infarction (hazard ratio, 0.46; 95% CI, 0.30 to 0.70; P=0.0002), 0.18 and 0.34 for stroke (hazard ratio, 0.52; 95% CI, 0.34 to 0.79; P=0.002), 0.41 and 0.77 for revascularization or unstable angina (hazard ratio, 0.53; 95% CI, 0.40 to 0.70; P<0.00001), 0.45 and 0.85 for the combined end point of myocardial infarction, stroke, or death from cardiovascular causes (hazard ratio, 0.53; 95% CI, 0.40 to 0.69; P<0.00001), and 1.00 and 1.25 for death from any cause (hazard ratio, 0.80; 95% CI, 0.67 to 0.97; P=0.02). Consistent effects were observed in all subgroups evaluated. The rosuvastatin group did not have a significant increase in myopathy or cancer but did have a higher incidence of physician-reported diabetes.
Conclusions:
In this trial of apparently healthy persons without hyperlipidemia but with elevated high-sensitivity C-reactive protein levels, rosuvastatin significantly reduced the incidence of major cardiovascular events. (ClinicalTrials.gov number, NCT00239681.)
Background
The value of continuous glucose monitoring in the management of type 1 diabetes mellitus has not been determined.
Methods
In a multicenter clinical trial, we randomly assigned 322 adults and children who were already receiving intensive therapy for type 1 diabetes to a group with continuous glucose monitoring or to a control group performing home monitoring with a blood glucose meter. All the patients were stratified into three groups according to age and had a glycated hemoglobin level of 7.0 to 10.0%. The primary outcome was the change in the glycated hemoglobin level at 26 weeks.
Results
The changes in glycated hemoglobin levels in the two study groups varied markedly according to age group (P=0.003), with a significant difference among patients 25 years of age or older that favored the continuous-monitoring group (mean difference in change, −0.53%; 95% confidence interval [CI], −0.71 to −0.35; P<0.001). The between-group difference was not significant among those who were 15 to 24 years of age (mean difference, 0.08; 95% CI, −0.17 to 0.33; P=0.52) or among those who were 8 to 14 years of age (mean difference, −0.13; 95% CI, −0.38 to 0.11; P=0.29). Secondary glycated hemoglobin outcomes were better in the continuous-monitoring group than in the control group among the oldest and youngest patients but not among those who were 15 to 24 years of age. The use of continuous glucose monitoring averaged 6.0 or more days per week for 83% of patients 25 years of age or older, 30% of those 15 to 24 years of age, and 50% of those 8 to 14 years of age. The rate of severe hypoglycemia was low and did not differ between the two study groups; however, the trial was not powered to detect such a difference.
Conclusions
Continuous glucose monitoring can be associated with improved glycemic control in adults with type 1 diabetes. Further work is needed to identify barriers to effectiveness of continuous monitoring in children and adolescents. (ClinicalTrials.gov number, NCT00406133.)
Hyperglycemia and insulin resistance are common in critically ill patients, even if they have not previously had diabetes. Whether the normalization of blood glucose levels with insulin therapy improves the prognosis for such patients is not known.
We performed a prospective, randomized, controlled study involving adults admitted to our surgical intensive care unit who were receiving mechanical ventilation. On admission, patients were randomly assigned to receive intensive insulin therapy (maintenance of blood glucose at a level between 80 and 110 mg per deciliter [4.4 and 6.1 mmol per liter]) or conventional treatment (infusion of insulin only if the blood glucose level exceeded 215 mg per deciliter [11.9 mmol per liter] and maintenance of glucose at a level between 180 and 200 mg per deciliter [10.0 and 11.1 mmol per liter]).
At 12 months, with a total of 1548 patients enrolled, intensive insulin therapy reduced mortality during intensive care from 8.0 percent with conventional treatment to 4.6 percent (P<0.04, with adjustment for sequential analyses). The benefit of intensive insulin therapy was attributable to its effect on mortality among patients who remained in the intensive care unit for more than five days (20.2 percent with conventional treatment, as compared with 10.6 percent with intensive insulin therapy, P=0.005). The greatest reduction in mortality involved deaths due to multiple-organ failure with a proven septic focus. Intensive insulin therapy also reduced overall in-hospital mortality by 34 percent, bloodstream infections by 46 percent, acute renal failure requiring dialysis or hemofiltration by 41 percent, the median number of red-cell transfusions by 50 percent, and critical-illness polyneuropathy by 44 percent, and patients receiving intensive therapy were less likely to require prolonged mechanical ventilation and intensive care.
Intensive insulin therapy to maintain blood glucose at or below 110 mg per deciliter reduces morbidity and mortality among critically ill patients in the surgical intensive care unit.
Intensive insulin therapy reduces morbidity and mortality in patients in surgical intensive care units (ICUs), but its role in patients in medical ICUs is unknown.
In a prospective, randomized, controlled study of adult patients admitted to our medical ICU, we studied patients who were considered to need intensive care for at least three days. On admission, patients were randomly assigned to strict normalization of blood glucose levels (80 to 110 mg per deciliter [4.4 to 6.1 mmol per liter]) with the use of insulin infusion or to conventional therapy (insulin administered when the blood glucose level exceeded 215 mg per deciliter [12 mmol per liter], with the infusion tapered when the level fell below 180 mg per deciliter [10 mmol per liter]). There was a history of diabetes in 16.9 percent of the patients.
In the intention-to-treat analysis of 1200 patients, intensive insulin therapy reduced blood glucose levels but did not significantly reduce in-hospital mortality (40.0 percent in the conventional-treatment group vs. 37.3 percent in the intensive-treatment group, P=0.33). However, morbidity was significantly reduced by the prevention of newly acquired kidney injury, accelerated weaning from mechanical ventilation, and accelerated discharge from the ICU and the hospital. Although length of stay in the ICU could not be predicted on admission, among 433 patients who stayed in the ICU for less than three days, mortality was greater among those receiving intensive insulin therapy. In contrast, among 767 patients who stayed in the ICU for three or more days, in-hospital mortality in the 386 who received intensive insulin therapy was reduced from 52.5 to 43.0 percent (P=0.009) and morbidity was also reduced.
Intensive insulin therapy significantly reduced morbidity but not mortality among all patients in the medical ICU. Although the risk of subsequent death and disease was reduced in patients treated for three or more days, these patients could not be identified before therapy. Further studies are needed to confirm these preliminary data. (ClinicalTrials.gov number, NCT00115479.)
Available studies have shown few quality-related advantages of electronic health records (EHRs) over traditional paper records. We compared achievement of and improvement in quality standards for diabetes at practices using EHRs with those at practices using paper records. All practices, including many safety-net primary care practices, belonged to a regional quality collaborative and publicly reported performance.
We used generalized estimating equations to calculate the percentage-point difference between EHR-based and paper-based practices with respect to achievement of composite standards for diabetes care (including four component standards) and outcomes (five standards), after adjusting for covariates and accounting for clustering. In addition to insurance type (Medicare, commercial, Medicaid, or uninsured), patient-level covariates included race or ethnic group (white, black, Hispanic, or other), age, sex, estimated household income, and level of education. Analyses were conducted separately for the overall sample and for safety-net practices.
From July 2009 through June 2010, data were reported for 27,207 adults with diabetes seen at 46 practices; safety-net practices accounted for 38% of patients. After adjustment for covariates, achievement of composite standards for diabetes care was 35.1 percentage points higher at EHR sites than at paper-based sites (P<0.001), and achievement of composite standards for outcomes was 15.2 percentage points higher (P=0.005). EHR sites were associated with higher achievement on eight of nine component standards. Such sites were also associated with greater improvement in care (a difference of 10.2 percentage points in annual improvement, P<0.001) and outcomes (a difference of 4.1 percentage points in annual improvement, P=0.02). Across all insurance types, EHR sites were associated with significantly higher achievement of care and outcome standards and greater improvement in diabetes care. Results confined to safety-net practices were similar.
These findings support the premise that federal policies encouraging the meaningful use of EHRs may improve the quality of care across insurance types.
To assess whether Medicare fee-for-service beneficiaries with depression and diabetes had a higher mortality rate over a 2-year period compared with beneficiaries with diabetes alone.
Evidence of depression was based on a physician diagnosis or self-reported prescription of an antidepressant in the year prior to screening, or a score of > or = 3 on the Patient Health Questionnaire two-item questionnaire. Mortality was assessed bi-monthly by checking Medicare claims and eligibility files or from information from telephone contact with the participant's family. Cox proportional hazard regression models were used to calculate adjusted hazard ratios of death in depressed versus nondepressed beneficiaries with diabetes.
A total of 10,704 beneficiaries with diabetes enrolled in a disease management program were surveyed with a health assessment questionnaire and followed over a two-year period.
Comorbid depression in Medicare beneficiaries with diabetes participating in a disease management program was associated with an increased risk for all-cause mortality over a two-year period of approximately 36% to 38%, depending on the definition of depression that was used. No significant increase in rates of cause-specific mortality from macrovascular disease were found in depressed versus nondepressed beneficiaries.
Among a large Medicare cohort of fee-for-service beneficiaries with diabetes, comorbid depression was associated with an increase in all-cause mortality over a two-year period. Future research will be required to determine whether the increase in mortality associated with depression is due to potential behavioral mediators (i.e., smoking, poor adherence to diet) or physiologic abnormalities (i.e., hypothalamic-pituitary axis dysregulation) associated with depression.
Trials comparing the effectiveness and safety of weight-loss diets are frequently limited by short follow-up times and high dropout rates.
In this 2-year trial, we randomly assigned 322 moderately obese subjects (mean age, 52 years; mean body-mass index [the weight in kilograms divided by the square of the height in meters], 31; male sex, 86%) to one of three diets: low-fat, restricted-calorie; Mediterranean, restricted-calorie; or low-carbohydrate, non-restricted-calorie.
The rate of adherence to a study diet was 95.4% at 1 year and 84.6% at 2 years. The Mediterranean-diet group consumed the largest amounts of dietary fiber and had the highest ratio of monounsaturated to saturated fat (P<0.05 for all comparisons among treatment groups). The low-carbohydrate group consumed the smallest amount of carbohydrates and the largest amounts of fat, protein, and cholesterol and had the highest percentage of participants with detectable urinary ketones (P<0.05 for all comparisons among treatment groups). The mean weight loss was 2.9 kg for the low-fat group, 4.4 kg for the Mediterranean-diet group, and 4.7 kg for the low-carbohydrate group (P<0.001 for the interaction between diet group and time); among the 272 participants who completed the intervention, the mean weight losses were 3.3 kg, 4.6 kg, and 5.5 kg, respectively. The relative reduction in the ratio of total cholesterol to high-density lipoprotein cholesterol was 20% in the low-carbohydrate group and 12% in the low-fat group (P=0.01). Among the 36 subjects with diabetes, changes in fasting plasma glucose and insulin levels were more favorable among those assigned to the Mediterranean diet than among those assigned to the low-fat diet (P<0.001 for the interaction among diabetes and Mediterranean diet and time with respect to fasting glucose levels).
Mediterranean and low-carbohydrate diets may be effective alternatives to low-fat diets. The more favorable effects on lipids (with the low-carbohydrate diet) and on glycemic control (with the Mediterranean diet) suggest that personal preferences and metabolic considerations might inform individualized tailoring of dietary interventions. (ClinicalTrials.gov number, NCT00160108.)
Microalbuminuria is an early predictor of diabetic nephropathy and premature cardiovascular disease. We investigated whether treatment with an angiotensin-receptor blocker (ARB) would delay or prevent the occurrence of microalbuminuria in patients with type 2 diabetes and normoalbuminuria.
In a randomized, double-blind, multicenter, controlled trial, we assigned 4447 patients with type 2 diabetes to receive olmesartan (at a dose of 40 mg once daily) or placebo for a median of 3.2 years. Additional antihypertensive drugs (except angiotensin-converting-enzyme inhibitors or ARBs) were used as needed to lower blood pressure to less than 130/80 mm Hg. The primary outcome was the time to the first onset of microalbuminuria. The times to the onset of renal and cardiovascular events were analyzed as secondary end points.
The target blood pressure (<130/80 mm Hg) was achieved in nearly 80% of the patients taking olmesartan and 71% taking placebo; blood pressure measured in the clinic was lower by 3.1/1.9 mm Hg in the olmesartan group than in the placebo group. Microalbuminuria developed in 8.2% of the patients in the olmesartan group (178 of 2160 patients who could be evaluated) and 9.8% in the placebo group (210 of 2139); the time to the onset of microalbuminuria was increased by 23% with olmesartan (hazard ratio for onset of microalbuminuria, 0.77; 95% confidence interval, 0.63 to 0.94; P=0.01). The serum creatinine level doubled in 1% of the patients in each group. Slightly fewer patients in the olmesartan group than in the placebo group had nonfatal cardiovascular events--81 of 2232 patients (3.6%) as compared with 91 of 2215 patients (4.1%) (P=0.37)--but a greater number had fatal cardiovascular events--15 patients (0.7%) as compared with 3 patients (0.1%) (P=0.01), a difference that was attributable in part to a higher rate of death from cardiovascular causes in the olmesartan group than in the placebo group among patients with preexisting coronary heart disease (11 of 564 patients [2.0%] vs. 1 of 540 [0.2%], P=0.02).
Olmesartan was associated with a delayed onset of microalbuminuria, even though blood-pressure control in both groups was excellent according to current standards. The higher rate of fatal cardiovascular events with olmesartan among patients with preexisting coronary heart disease is of concern. (Funded by Daiichi Sankyo; ClinicalTrials.gov number, NCT00185159.).
To the Editor: We wish to update our report on the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Eye study (July 15, 2010, issue).1 We made a mistake in the calculation of vision loss that also affected another article.2 Our intent was to define moderate vision loss as a 15-letter decrease on the visual acuity score from baseline in either eye. However, in the analyses described in the published reports,1,2 this calculation was erroneously made on the basis of the right eye only, resulting in fewer events as well as fewer people in whom a change in visual . . .
Patients with depression and poorly controlled diabetes, coronary heart disease, or both have an increased risk of adverse outcomes and high health care costs. We conducted a study to determine whether coordinated care management of multiple conditions improves disease control in these patients.
We conducted a single-blind, randomized, controlled trial in 14 primary care clinics in an integrated health care system in Washington State, involving 214 participants with poorly controlled diabetes, coronary heart disease, or both and coexisting depression. Patients were randomly assigned to the usual-care group or to the intervention group, in which a medically supervised nurse, working with each patient's primary care physician, provided guideline-based, collaborative care management, with the goal of controlling risk factors associated with multiple diseases. The primary outcome was based on simultaneous modeling of glycated hemoglobin, low-density lipoprotein (LDL) cholesterol, and systolic blood-pressure levels and Symptom Checklist-20 (SCL-20) depression outcomes at 12 months; this modeling allowed estimation of a single overall treatment effect.
As compared with controls, patients in the intervention group had greater overall 12-month improvement across glycated hemoglobin levels (difference, 0.58%), LDL cholesterol levels (difference, 6.9 mg per deciliter [0.2 mmol per liter]), systolic blood pressure (difference, 5.1 mm Hg), and SCL-20 depression scores (difference, 0.40 points) (P<0.001). Patients in the intervention group also were more likely to have one or more adjustments of insulin (P=0.006), antihypertensive medications (P<0.001), and antidepressant medications (P<0.001), and they had better quality of life (P<0.001) and greater satisfaction with care for diabetes, coronary heart disease, or both (P<0.001) and with care for depression (P<0.001).
As compared with usual care, an intervention involving nurses who provided guideline-based, patient-centered management of depression and chronic disease significantly improved control of medical disease and depression. (Funded by the National Institute of Mental Health; ClinicalTrials.gov number, NCT00468676.).
The Diabetes Control and Complications Trial demonstrated that intensive diabetes therapy effectively delays the onset of clinically apparent neuropathy in patients with insulin-dependent diabetes mellitus. A total of 1,441 patients with insulin-dependent diabetes mellitus were randomly assigned to receive intensive treatment or conventional treatment. Of these, 1,290 were randomized at least 4% years or more prior to study termination. Nerve conduction studies were performed at baseline and repeated after approximately 5 years for 1,243 of these patients, 96% of the eligible population. After 5 years of treatment, significant nerve conduction differences were observed between the intensive and conventional treatment groups, all favoring better performance (faster sensory and motor conduction velocities and shorter F-wave latencies) in the intensive treatment group. Moreover, while performance generally deteriorated among the conventionally treated patients, most attributes remained stable or showed modest improvement in the intensively treated group. Treatment group differences were consistent across strata defined by duration of diabetes and the presence of neuropathy at baseline. A nonparametric multivariate test of all ten nerve conduction measures established a strong effect in favor of intensive treatment. These data confirm that the electrophysiological abnormalities associated with diabetic neuropathy are delayed or prevented by intensive diabetes treatment.
BACKGROUND
Long-term microvascular and neurologic complications cause major morbidity and mortality in patients with insulin-dependent diabetes mellitus (IDDM). We examined whether intensive treatment with the goal of maintaining blood glucose concentrations close to the normal range could decrease the frequency and severity of these complications.
METHODS
A total of 1441 patients with IDDM -- 726 with no retinopathy at base line (the primary-prevention cohort) and 715 with mild retinopathy (the secondary-intervention cohort) were randomly assigned to intensive therapy administered either with an external insulin pump or by three or more daily insulin injections and guided by frequent blood glucose monitoring or to conventional therapy with one or two daily insulin injections. The patients were followed for a mean of 6.5 years, and the appearance and progression of retinopathy and other complications were assessed regularly.
RESULTS
In the primary-prevention cohort, intensive therapy reduced the adjusted mean risk for the development of retinopathy by 76 percent (95 percent confidence interval, 62 to 85 percent), as compared with conventional therapy. In the secondary-intervention cohort, intensive therapy slowed the progression of retinopathy by 54 percent (95 percent confidence interval, 39 to 66 percent) and reduced the development of proliferative or severe nonproliferative retinopathy by 47 percent (95 percent confidence interval, 14 to 67 percent). In the two cohorts combined, intensive therapy reduced the occurrence of microalbuminuria (urinary albumin excretion of ≥ 40 mg per 24 hours) by 39 percent (95 percent confidence interval, 21 to 52 percent), that of albuminuria (urinary albumin excretion of ≥ 300 mg per 24 hours) by 54 percent (95 percent confidence interval, 19 to 74 percent), and that of clinical neuropathy by 60 percent (95 percent confidence interval, 38 to 74 percent). The chief adverse event associated with intensive therapy was a two-to-threefold increase in severe hypoglycemia.
CONCLUSIONS
Intensive therapy effectively delays the onset and slows the progression of diabetic retinopathy, nephropathy, and neuropathy in patients with IDDM.
AimsThe second Diabetes Attitudes, Wishes and Needs (DAWN2) study aimed to assess psychosocial outcomes in people with diabetes across countries for benchmarking. Methods
Surveys included new and adapted questions from validated questionnaires that assess health-related quality of life, self-management, attitudes/beliefs, social support and priorities for improving diabetes care. Questionnaires were conducted online, by telephone or in person. ResultsParticipants were 8596 adults with diabetes across 17 countries. There were significant between-country differences for all benchmarking indicators; no one country's outcomes were consistently better or worse than others. The proportion with likely depression [WHO-5 Well-Being Index (WHO-5) score ≤ 28] was 13.8% (country range 6.5–24.1%). Diabetes-related distress [Problem Areas in Diabetes Scale 5 (PAID-5) score ≥ 40] was reported by 44.6% of participants (17.2–67.6%). Overall quality of life was rated ‘poor’ or ‘very poor’ by 12.2% of participants (7.6–26.1%). Diabetes had a negative impact on all aspects investigated, ranging from 20.5% on relationship with family/friends to 62.2% on physical health. Approximately 40% of participants (18.6–64.9%) reported that their medication interfered with their ability to live a normal life. The availability of person-centred chronic illness care and support for active involvement was rated as low. Following self-care advice for medication and diet was most common, and least common for glucose monitoring and foot examination, with marked country variation. Only 48.8% of respondents had participated in diabetes educational programmes/activities to help manage their diabetes. Conclusions
Cross-national benchmarking using psychometrically validated indicators can help identify areas for improvement and best practices to drive changes that improve outcomes for people with diabetes.
Background:
The threshold-suspend feature of sensor-augmented insulin pumps is designed to minimize the risk of hypoglycemia by interrupting insulin delivery at a preset sensor glucose value. We evaluated sensor-augmented insulin-pump therapy with and without the threshold-suspend feature in patients with nocturnal hypoglycemia.
Methods:
We randomly assigned patients with type 1 diabetes and documented nocturnal hypoglycemia to receive sensor-augmented insulin-pump therapy with or without the threshold-suspend feature for 3 months. The primary safety outcome was the change in the glycated hemoglobin level. The primary efficacy outcome was the area under the curve (AUC) for nocturnal hypoglycemic events. Two-hour threshold-suspend events were analyzed with respect to subsequent sensor glucose values.
Results:
A total of 247 patients were randomly assigned to receive sensor-augmented insulin-pump therapy with the threshold-suspend feature (threshold-suspend group, 121 patients) or standard sensor-augmented insulin-pump therapy (control group, 126 patients). The changes in glycated hemoglobin values were similar in the two groups. The mean AUC for nocturnal hypoglycemic events was 37.5% lower in the threshold-suspend group than in the control group (980 ± 1200 mg per deciliter [54.4 ± 66.6 mmol per liter] × minutes vs. 1568 ± 1995 mg per deciliter [87.0 ± 110.7 mmol per liter] × minutes, P<0.001). Nocturnal hypoglycemic events occurred 31.8% less frequently in the threshold-suspend group than in the control group (1.5 ± 1.0 vs. 2.2 ± 1.3 per patient-week, P<0.001). The percentages of nocturnal sensor glucose values of less than 50 mg per deciliter (2.8 mmol per liter), 50 to less than 60 mg per deciliter (3.3 mmol per liter), and 60 to less than 70 mg per deciliter (3.9 mmol per liter) were significantly reduced in the threshold-suspend group (P<0.001 for each range). After 1438 instances at night in which the pump was stopped for 2 hours, the mean sensor glucose value was 92.6 ± 40.7 mg per deciliter (5.1 ± 2.3 mmol per liter). Four patients (all in the control group) had a severe hypoglycemic event; no patients had diabetic ketoacidosis.
Conclusions:
This study showed that over a 3-month period the use of sensor-augmented insulin-pump therapy with the threshold-suspend feature reduced nocturnal hypoglycemia, without increasing glycated hemoglobin values. (Funded by Medtronic MiniMed; ASPIRE ClinicalTrials.gov number, NCT01497938.).
Aims:
The second Diabetes Attitudes, Wishes and Needs (DAWN2) study examined the experiences of family members of people with diabetes for benchmarking and identifying unmet needs or areas for improvement to assist family members and those with diabetes to effectively self-manage.
Methods:
In total, 2057 family members of people with diabetes participated in an online, telephone or in-person survey designed to assess the impact of diabetes on family life, family support for people with diabetes and educational and community support.
Results:
Supporting a relative with diabetes was perceived as a burden by 35.3% (range across countries 10.6-61.7%) of respondents. Over half of respondents [51.4% (22.5-76.0%)] rated their quality of life as 'good' or 'very good'. However, distress about the person with diabetes was high, with 61.3% (31.5-86.4%) worried about hypoglycaemia. The impact of diabetes on aspects of life was felt by 51.8% (46.9-58.6%). The greatest negative effect was on emotional well-being [44.6% (31.8-63.0%)], although depression was less common [11.6% (4.2-20.0%)]. Many respondents did not know how to help the person with diabetes [37.1% (17.5-53.0%)] and wanted to be more involved in their care [39.4% (15.5-61.7%)]. Participation in diabetes educational programmes was low [23.1% (9.4-43.3%)], although most of those who participated found them helpful [72.1% (42.1-90.3%)].
Conclusions:
Diabetes has a negative impact on family members of people with diabetes. DAWN2 provides benchmarking indicators of family members' psychosocial needs that will help identify the support required for, and from, them to improve the lives of people with diabetes and their families.
Background:
Weight loss is recommended for overweight or obese patients with type 2 diabetes on the basis of short-term studies, but long-term effects on cardiovascular disease remain unknown. We examined whether an intensive lifestyle intervention for weight loss would decrease cardiovascular morbidity and mortality among such patients.
Methods:
In 16 study centers in the United States, we randomly assigned 5145 overweight or obese patients with type 2 diabetes to participate in an intensive lifestyle intervention that promoted weight loss through decreased caloric intake and increased physical activity (intervention group) or to receive diabetes support and education (control group). The primary outcome was a composite of death from cardiovascular causes, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for angina during a maximum follow-up of 13.5 years.
Results:
The trial was stopped early on the basis of a futility analysis when the median follow-up was 9.6 years. Weight loss was greater in the intervention group than in the control group throughout the study (8.6% vs. 0.7% at 1 year; 6.0% vs. 3.5% at study end). The intensive lifestyle intervention also produced greater reductions in glycated hemoglobin and greater initial improvements in fitness and all cardiovascular risk factors, except for low-density-lipoprotein cholesterol levels. The primary outcome occurred in 403 patients in the intervention group and in 418 in the control group (1.83 and 1.92 events per 100 person-years, respectively; hazard ratio in the intervention group, 0.95; 95% confidence interval, 0.83 to 1.09; P=0.51).
Conclusions:
An intensive lifestyle intervention focusing on weight loss did not reduce the rate of cardiovascular events in overweight or obese adults with type 2 diabetes. (Funded by the National Institutes of Health and others; Look AHEAD ClinicalTrials.gov number, NCT00017953.).
Background:
We investigated whether combination therapy with a statin plus a fibrate, as compared with statin monotherapy, would reduce the risk of cardiovascular disease in patients with type 2 diabetes mellitus who were at high risk for cardiovascular disease.
Methods:
We randomly assigned 5518 patients with type 2 diabetes who were being treated with open-label simvastatin to receive either masked fenofibrate or placebo. The primary outcome was the first occurrence of nonfatal myocardial infarction, nonfatal stroke, or death from cardiovascular causes. The mean follow-up was 4.7 years.
Results:
The annual rate of the primary outcome was 2.2% in the fenofibrate group and 2.4% in the placebo group (hazard ratio in the fenofibrate group, 0.92; 95% confidence interval [CI], 0.79 to 1.08; P=0.32). There were also no significant differences between the two study groups with respect to any secondary outcome. Annual rates of death were 1.5% in the fenofibrate group and 1.6% in the placebo group (hazard ratio, 0.91; 95% CI, 0.75 to 1.10; P=0.33). Prespecified subgroup analyses suggested heterogeneity in treatment effect according to sex, with a benefit for men and possible harm for women (P=0.01 for interaction), and a possible interaction according to lipid subgroup, with a possible benefit for patients with both a high baseline triglyceride level and a low baseline level of high-density lipoprotein cholesterol (P=0.057 for interaction).
Conclusions:
The combination of fenofibrate and simvastatin did not reduce the rate of fatal cardiovascular events, nonfatal myocardial infarction, or nonfatal stroke, as compared with simvastatin alone. These results do not support the routine use of combination therapy with fenofibrate and simvastatin to reduce cardiovascular risk in the majority of high-risk patients with type 2 diabetes. (ClinicalTrials.gov number, NCT00000620.)
Tracking national progress in diabetes care may aid in the evaluation of past efforts and identify residual gaps in care.
We analyzed data for adults with self-reported diabetes from the National Health and Nutrition Examination Survey and the Behavioral Risk Factor Surveillance System to examine risk-factor control, preventive practices, and risk scores for coronary heart disease over the 1999-2010 period.
From 1999 through 2010, the weighted proportion of survey participants who met recommended goals for diabetes care increased, by 7.9 percentage points (95% confidence interval [CI], 0.8 to 15.0) for glycemic control (glycated hemoglobin level <7.0%), 9.4 percentage points (95% CI, 3.0 to 15.8) for individualized glycemic targets, 11.7 percentage points (95% CI, 5.7 to 17.7) for blood pressure (target, <130/80 mm Hg), and 20.8 percentage points (95% CI, 11.6 to 30.0) for lipid levels (target level of low-density lipoprotein [LDL] cholesterol, <100 mg per deciliter [2.6 mmol per liter]). Tobacco use did not change significantly, but the 10-year probability of coronary heart disease decreased by 2.8 to 3.7 percentage points. However, 33.4 to 48.7% of persons with diabetes still did not meet the targets for glycemic control, blood pressure, or LDL cholesterol level. Only 14.3% met the targets for all three of these measures and for tobacco use. Adherence to the recommendations for annual eye and dental examinations was unchanged, but annual lipid-level measurement and foot examination increased by 5.5 percentage points (95% CI, 1.6 to 9.4) and 6.8 percentage points (95% CI, 4.8 to 8.8), respectively. Annual vaccination for influenza and receipt of pneumococcal vaccination for participants 65 years of age or older rose by 4.5 percentage points (95% CI, 0.8 to 8.2) and 6.9 percentage points (95% CI, 3.4 to 10.4), respectively, and daily glucose monitoring increased by 12.7 percentage points (95% CI, 10.3 to 15.1).
Although there were improvements in risk-factor control and adherence to preventive practices from 1999 to 2010, tobacco use remained high, and almost half of U.S. adults with diabetes did not meet the recommended goals for diabetes care.
Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.
In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.
On nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.
Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. (Funded by Sanofi and others; ClinicalTrials.gov number, NCT01238406.).
Education is the keystone of diabetes care, and structured self-management education is the key to a successful outcome. Existing guidelines provide comprehensive guidance on the various aspects of education and offer general and organizational principles of education, detailed curricula at different ages and stages of diabetes, and recommendations on models, methods, and tools to attain educative objectives. The International Society for Pediatric and Adolescent Diabetes guidelines give the most elaborate and detailed descriptions and recommendations on the practice of education, which other national guidelines address on specific aspects of education and care. The aim of the work package on education developed by Better Control in Paediatric and Adolescent Diabetes in the European Union: Working to Create Centers of Reference (SWEET) project was not to generate new guidelines but to evaluate how the existing guidelines were implemented in some pediatric diabetes reference centers. The SWEET members have completed a questionnaire that elaborates on the many aspects of delivery of education. This survey highlights a profound diversity of practices across centers in Europe, in terms of organization as well as the practices and the content of initial and continuing education. A toolbox is being developed within SWEET to facilitate exchanges on all aspects of education and to establish a process of validation of materials, tools, written structured age-adjusted programs, and evaluation procedures for the education of children and adolescents with diabetes.
Background:
Reducing symptom burden is paramount at the end-of-life, but typically considered secondary to risk factor control in chronic disease, such as diabetes. Little is known about the symptom burden experienced by adults with type 2 diabetes and the need for symptom palliation.
Objective:
To examine pain and non-pain symptoms of adults with type 2 diabetes over the disease course - at varying time points before death and by age.
Design:
Survey follow-up study.
Participants:
13,171 adults with type 2 diabetes, aged 30-75 years, from Kaiser Permanente, Northern California, who answered a baseline symptom survey in 2005-2006.
Main measures:
Pain and non-pain symptoms were identified by self-report and medical record data. Survival status from baseline was categorized into ≤ 6, >6-24, or alive >24 months.
Key results:
Mean age was 60 years; 48 % were women, and 43 % were non-white. Acute pain was prevalent (41.8 %) and 39.7 % reported chronic pain, 24.6 % fatigue, 23.7 % neuropathy, 23.5 % depression, 24.2 % insomnia, and 15.6 % physical/emotional disability. Symptom burden was prevalent in all survival status categories, but was more prevalent among those with shorter survival, p< .001. Adults ≥ 60 years who were alive >24 months reported more physical symptoms such as acute pain and dyspnea, whereas participants <60 years reported more psychosocial symptoms, such as depressed mood and insomnia. Adjustment for duration of diabetes and comorbidity reduced the association between age and pain, but did not otherwise change our results.
Conclusions:
In a diverse cohort of adults with type 2 diabetes, pain and non-pain symptoms were common among all patients, not only among those near the end of life. However, symptoms were more prevalent among patients with shorter survival. Older adults reported more physical symptoms, whereas younger adults reported more psychosocial symptoms. Diabetes care management should include not only good cardiometabolic control, but also symptom palliation across the disease course.
This paper systematically reviews published randomised controlled trials, to determine the educational focus and effectiveness of type 2 diabetes multi-component self-management interventions. PubMed, PsycINFO, Web of Science and reference lists of included studies were searched for English-language articles published 2000–2010. Descriptive information was summarised; when possible, effect sizes were calculated. Fourteen studies, described in 19 articles, were reviewed: six one-on-one interventions; six group interventions; two interventions comprising both intervention types. Four studies used learning as an intervention method; seven used learning and planning; three used learning, planning and practising. Self-management interventions seemed effective for diet, self-monitoring of blood glucose, knowledge and diabetes specific quality of life (QoL) there were mixed results for exercise and clinical outcomes. Findings showed that dietary behaviour seemed relatively easy to change with self-management interventions. Group interventions with a practise component had the greatest potential to improve metabolic control. Self-management interventions had positive effects on diabetes-specific QoL, and interventions using a collaborative learning approach improved knowledge. Multi-component self-management interventions potentially lead to clinically relevant improvements in behaviour and some clinical parameters. Further research is needed to explain the mixed effects on exercise and to identify processes underlying behaviour change. Copyright © 2010 FEND
The Cardiovascular Autonomic Neuropathy (CAN) Subcommittee of the Toronto Consensus Panel on Diabetic Neuropathy worked to update CAN guidelines, with regard to epidemiology, clinical impact, diagnosis, usefulness of CAN testing, and management. CAN is the impairment of cardiovascular autonomic control in the setting of diabetes after exclusion of other causes. The prevalence of confirmed CAN is around 20%, and increases up to 65% with age and diabetes duration. Established risk factors for CAN are glycaemic control in type 1 and a combination of hypertension, dyslipidaemia, obesity, and glycaemic control in type 2 diabetes. CAN is a risk marker of mortality and cardiovascular morbidity, and possibly a progression promoter of diabetic nephropathy. Criteria for CAN diagnosis and staging are: (1) one abnormal cardiovagal test result identifies possible or early CAN; (2) at least two abnormal cardiovagal test results are required for definite or confirmed CAN; and (3) the presence of orthostatic hypotension in addition to abnormal heart rate test results identifies severe or advanced CAN. Progressive stages of CAN are associated with increasingly worse prognosis. CAN assessment is relevant in clinical practice for (1) diagnosis of CAN clinical forms, (2) detection and tailored treatment of CAN clinical correlates (e.g. tachycardia, orthostatic hypotension, non-dipping, QT interval prolongation), (3) risk stratification for diabetic complications and cardiovascular morbidity and mortality, and (4) modulation of targets of diabetes therapy. Evidence on the cost-effectiveness of CAN testing is lacking. Apart from the preventive role of intensive glycaemic control in type 1 diabetes, recommendations cannot be made for most therapeutic approaches to CAN. Copyright © 2011 John Wiley & Sons, Ltd.
Aim There is increasing interest in the role that peers may play to support positive health behaviours in diabetes, but there is limited evidence to inform policy and practice. The aim of this study was to systematically review evidence of the impact and effectiveness of peer support in adults living with diabetes.
Methods We searched the Cochrane Library, MEDLINE, PubMed, EMBASE and CINHAL for the period 1966–2011, together with reference lists of articles for eligible studies. Data were synthesized in a narrative review.
Results Twenty-five studies, including fourteen randomized, controlled or comparative trials, met the inclusion criteria. There was considerable heterogeneity in the design, setting, outcomes and measurement tools. Peer support was associated with statistically significant improvements in glycaemic control (three out of 14 trials), blood pressure (one out of four trials), cholesterol (one out of six trials), BMI/weight (two out of seven trials), physical activity (two out of five trials), self-efficacy (two out of three trials), depression (four out of six trials) and perceived social support (two out of two trials). No consistent pattern of effect related to any model of peer support emerged.
Conclusions Peer support appears to benefit some adults living with diabetes, but the evidence is too limited and inconsistent to support firm recommendations. There remains a need for further well-designed evaluations of its effectiveness and impact. Key questions remain over its suitability to the needs of particular individuals, populations and settings, how best to implement its specific components and the sustainability of its effects.
To evaluate the influence of ω-3 polyunsaturated fatty acid (ω-3 PUFA) supplementation on body composition, insulin resistance, and lipemia of women with type 2 diabetes, the authors evaluated 41 women (60.64 ± 7.82 years) with high blood pressure and diabetes mellitus in a randomized and single-blind longitudinal intervention study. The women were divided into 3 groups: GA (2.5 g/d fish oil), GB (1.5 g/d fish oil), and GC (control). The capsules with the supplement contained 21.9% of eicosapentaenoic acid and 14.1% of docosapentaenoic acid. Biochemical (glucose, glycated hemoglobin, total and fractional cholesterol, triglycerides, and insulin) and anthropometric (body mass, stature, waist circumference [WC], and body composition) evaluations were performed before and after the 30 days of intervention. Homeostasis model assessment-insulin resistance and the Quantitative Insulin Sensitivity Check Index were used to evaluate the insulin resistance and insulin sensitivity (IS), respectively. GB presented a greater loss of body mass and WC (P < .05), greater frequency of glycemic and total cholesterol reduction, and an increase of high-density lipoprotein cholesterol compared with GA. Thus, a high dose of ω-3 PUFA can reduce IS. A lower dose of ω-3 PUFA positively influenced body composition and lipid metabolism.
Foot infections are a common and serious problem in persons with diabetes. Diabetic foot infections (DFIs) typically begin in a wound, most often a neuropathic ulceration. While all wounds are colonized with microorganisms, the presence of infection is defined by ≥2 classic findings of inflammation or purulence. Infections are then classified into mild (superficial and limited in size and depth), moderate (deeper or more extensive), or severe (accompanied by systemic signs or metabolic perturbations). This classification system, along with a vascular assessment, helps determine which patients should be hospitalized, which may require special imaging procedures or surgical interventions, and which will require amputation. Most DFIs are polymicrobial, with aerobic gram-positive cocci (GPC), and especially staphylococci, the most common causative organisms. Aerobic gram-negative bacilli are frequently copathogens in infections that are chronic or follow antibiotic treatment, and obligate anaerobes may be copathogens in ischemic or necrotic wounds.
Wounds without evidence of soft tissue or bone infection do not require antibiotic therapy. For infected wounds, obtain a post-debridement specimen (preferably of tissue) for aerobic and anaerobic culture. Empiric antibiotic therapy can be narrowly targeted at GPC in many acutely infected patients, but those at risk for infection with antibiotic-resistant organisms or with chronic, previously treated, or severe infections usually require broader spectrum regimens. Imaging is helpful in most DFIs; plain radiographs may be sufficient, but magnetic resonance imaging is far more sensitive and specific. Osteomyelitis occurs in many diabetic patients with a foot wound and can be difficult to diagnose (optimally defined by bone culture and histology) and treat (often requiring surgical debridement or resection, and/or prolonged antibiotic therapy). Most DFIs require some surgical intervention, ranging from minor (debridement) to major (resection, amputation). Wounds must also be properly dressed and off-loaded of pressure, and patients need regular follow-up. An ischemic foot may require revascularization, and some nonresponding patients may benefit from selected adjunctive measures. Employing multidisciplinary foot teams improves outcomes. Clinicians and healthcare organizations should attempt to monitor, and thereby improve, their outcomes and processes in caring for DFIs.
Adults with type 2 diabetes mellitus often have limitations in mobility that increase with age. An intensive lifestyle intervention that produces weight loss and improves fitness could slow the loss of mobility in such patients.
We randomly assigned 5145 overweight or obese adults between the ages of 45 and 74 years with type 2 diabetes to either an intensive lifestyle intervention or a diabetes support-and-education program; 5016 participants contributed data. We used hidden Markov models to characterize disability states and mixed-effects ordinal logistic regression to estimate the probability of functional decline. The primary outcome was self-reported limitation in mobility, with annual assessments for 4 years.
At year 4, among 2514 adults in the lifestyle-intervention group, 517 (20.6%) had severe disability and 969 (38.5%) had good mobility; the numbers among 2502 participants in the support group were 656 (26.2%) and 798 (31.9%), respectively. The lifestyle-intervention group had a relative reduction of 48% in the risk of loss of mobility, as compared with the support group (odds ratio, 0.52; 95% confidence interval, 0.44 to 0.63; P<0.001). Both weight loss and improved fitness (as assessed on treadmill testing) were significant mediators of this effect (P<0.001 for both variables). Adverse events that were related to the lifestyle intervention included a slightly higher frequency of musculoskeletal symptoms at year 1.
Weight loss and improved fitness slowed the decline in mobility in overweight adults with type 2 diabetes. (Funded by the Department of Health and Human Services and others; ClinicalTrials.gov number, NCT00017953.).
The Michigan Neuropathy Screening Instrument (MNSI) is used to assess distal symmetrical peripheral neuropathy in diabetes. It includes two separate assessments: a 15-item self-administered questionnaire and a lower extremity examination that includes inspection and assessment of vibratory sensation and ankle reflexes. The purpose of this study was to evaluate the performance of the MNSI in detecting distal symmetrical peripheral neuropathy in patients with Type 1 diabetes and to develop new scoring algorithms.
The MNSI was performed by trained personnel at each of the 28 Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications clinical sites. Neurologic examinations and nerve conduction studies were performed during the same year. Confirmed clinical neuropathy was defined by symptoms and signs of distal symmetrical peripheral neuropathy based on the examination of a neurologist and abnormal nerve conduction findings in ≥ 2 anatomically distinct nerves among the sural, peroneal and median nerves.
We studied 1184 subjects with Type 1 diabetes. Mean age was 47 years and duration of diabetes was 26 years. Thirty per cent of participants had confirmed clinical neuropathy, 18% had ≥ 4 and 5% had ≥ 7 abnormal responses on the MNSI questionnaire, and 33% had abnormal scores (≥ 2.5) on the MNSI examination. New scoring algorithms were developed and cut points defined to improve the performance of the MNSI questionnaire, examination and the combination of the two.
Altering the cut point to define an abnormal test from ≥ 7 abnormal to ≥ 4 abnormal items improves the performance of the MNSI questionnaire. The MNSI is a simple, non-invasive and valid measure of distal symmetrical peripheral neuropathy in Type 1 diabetes.
To examine the association between atypical antipsychotic medications and incident treatment for diabetes mellitus or hyperlipidemia in elderly adults without diagnoses of schizophrenia or bipolar disorder.
Two case-control studies using medical and pharmacy claims data.
United States managed care population from multiple insurance plans.
Individuals aged 65 and older enrolled in a Medicare Advantage or commercial (health maintenance organization) managed care health plan in the western United States with no claims indicating diagnosis of schizophrenia or bipolar disorder in the 1 year pre-index period. Cases were defined as persons newly initiated on an antidiabetic (n = 13,075) or antihyperlipidemic (n = 63,829) medication on the index date. For the new diabetes mellitus analysis, 65,375 controls were matched to cases based on age, sex, health-plan type, and index date year. In the new hyperlipidemia analysis, 63,829 controls were matched to cases based on the same variables.
Conditional logistic regressions were performed to determine the odds of initiated antidiabetic or antihyperlipidemic medication for participants exposed to atypical antipsychotics compared with those with no exposure. The models included comorbidities possibly associated with the outcome.
Exposure to atypical antipsychotics was associated with significantly greater adjusted odds of starting an antidiabetic medication (1.32, 95% confidence interval (CI) = 1.10-1.59) but significantly lower odds of starting an antihyperlipidemic medication (0.76, 95% CI = 0.67-0.87).
Use of atypical antipsychotics in older adults for conditions other than schizophrenia and bipolar disorder was associated with incident treatment of diabetes mellitus but not of hyperlipidemia, suggesting that older adults may be susceptible to the adverse metabolic consequences of these agents.
Within the 2000 pages of the 2010 Patient Protection and Affordable Care Act (ACA) is a short section authorizing the creation of the Patient-Centered Outcomes Research Institute (PCORI) — a research organization dedicated to the support and promotion of comparative clinical effectiveness research. The establishment of PCORI represents the culmination of long-standing interest in comparative effectiveness research, a lengthy legislative gestation, and compromise among varied congressional perspectives and priorities.1 PCORI responds to a widespread concern that, in many cases, patients and their health care providers, families, and caregivers do not have the information they need to make choices aligned with . . .
In this randomized controlled trial we evaluated the effectiveness of medical nutritional therapy on Arab patients with Type 2 diabetes in Oman delivered by a dietitian.
Patients with Type 2 diabetes (n = 170) were randomly assigned to a group receiving usual nutritional care (n = 85) or a group receiving practice guidelines nutritional care (n = 85). Anthropometric (weight, height, BMI and waist circumference) and biochemical (fasting blood glucose, HbA1c ) variables were measured at baseline and after each appointment. Patients were given 1-3 appointments with a dietitian over 6 months.
Those in the group receiving practice guidelines nutritional care (n = 85) had significant changes in HbA(1c) (-0.8%, P = 0.001), fasting plasma glucose (-1.3 mmol\l, P = 0.003) and weight (-5.1 kg, P = 0.05), whereas the patients in the usual nutritional care group (n = 85) had no significant improvements in either HbA(1c) (-0.4%, P = 0.248) or fasting plasma glucose (-0.2 mmol/l, P = 0.638) during the same period. We also found a significant difference between the group receiving practice guidelines nutritional care and the usual nutritional care group, respectively, in waist circumference (96.9 ± 7.9 vs. 100.0 ± 8.7 cm, P = 0.019), triglycerides levels (1.42 ± 0.58 vs. 1.98 ± 0.96 mmol\l, P = 0.001), cholesterol levels (5.1 ± 1.0 vs. 5.5 ± 0.9 mmol/l, P = 0.009) and LDL cholesterol levels (3.58 ± 0.98 vs. 3.89 ± 0.98 mmol/l, P = 0.046).
Medical nutrition therapy provided by dietitians to Arab patients with Type 2 diabetes in Oman resulted in significant improvements in anthropometric and biochemical outcomes in both the usual nutritional care group and the group receiving practice guidelines nutritional care. Subjects with Type 2 diabetes tended to do better with practice guidelines nutritional care than with usual nutritional care. Ongoing medical counselling in nutrition by a trained dietitian is important for better long-term metabolic control.
In April, the Centers for Medicare and Medicaid Services (CMS) issued a long-awaited Notice of Proposed Rulemaking with a proposed policy for the accountable care organization (ACO) program authorized by the Affordable Care Act (ACA). Under this policy, ACOs could participate in one of two types of 3-year arrangements. In the first path, in years 1 and 2 they would be eligible to share any savings they achieved relative to a spending target without accepting “downside” risk. In year 3, the ACOs would be required to repay Medicare for a percentage of any spending over their target level. In the . . .
Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries. We evaluated the renoprotective effects of dual blockade of the renin-angiotensin-aldosterone system by adding treatment with aliskiren, an oral direct renin inhibitor, to treatment with the maximal recommended dose of losartan (100 mg daily) and optimal antihypertensive therapy in patients who had hypertension and type 2 diabetes with nephropathy.
We enrolled 599 patients in this multinational, randomized, double-blind study. After a 3-month, open-label, run-in period during which patients received 100 mg of losartan daily, patients were randomly assigned to receive 6 months of treatment with aliskiren (150 mg daily for 3 months, followed by an increase in dosage to 300 mg daily for another 3 months) or placebo, in addition to losartan. The primary outcome was a reduction in the ratio of albumin to creatinine, as measured in an early-morning urine sample, at 6 months.
The baseline characteristics of the two groups were similar. Treatment with 300 mg of aliskiren daily, as compared with placebo, reduced the mean urinary albumin-to-creatinine ratio by 20% (95% confidence interval, 9 to 30; P<0.001), with a reduction of 50% or more in 24.7% of the patients who received aliskiren as compared with 12.5% of those who received placebo (P<0.001). A small difference in blood pressure was seen between the treatment groups by the end of the study period (systolic, 2 mm Hg lower [P=0.07] and diastolic, 1 mm Hg lower [P=0.08] in the aliskiren group). The total numbers of adverse and serious adverse events were similar in the groups.
Aliskiren may have renoprotective effects that are independent of its blood-pressure-lowering effect in patients with hypertension, type 2 diabetes, and nephropathy who are receiving the recommended renoprotective treatment. (ClinicalTrials.gov number, NCT00097955 [ClinicalTrials.gov].).
We examined the impact of an aspart insulin protocol for treatment of hyperglycemia in the emergency department (ED) coupled with rapid initiation of a detemir-aspart insulin protocol for patients admitted to the hospital.
ED patients with type 2 diabetes mellitus and a blood glucose (BG) ≥ 200 mg/dL were randomized to intervention (INT) or usual care (UC). INT patients (n = 87) received aspart every 2 hours when BG > 200 mg/dL, and if admitted, began daily detemir in the ED. UC patients (n = 89) were treated per hospital physicians.
The initial ED BG was 304 ± 76 mg/dL. The final ED BG differed: 217 ± 71 mg/dL for INT patients versus 257 ± 89 mg/dL for UC patients (P < .01). No INT patients and 3 UC patients had a BG < 50 mg/dL (P = .5). ED length of stay (LOS) was similar: 5.4 ± 1.8 hours for INT patients versus 4.9 ± 1.9 hours for UC patients (P = .06). Sixty-nine percent from each group were admitted. Admission BG was 184 ± 74 mg/dL for INT patients versus 224 ± 93 mg/dL for UC patients (P < .01). Patient-day weighted mean glucose was 163 ± 39 mg/dL for INT patients versus 202 ± 39 mg/dL for UC patients (P < .01). One INT patient and 6 UC patients had a BG < 50 mg/dL (P = .11). Hospital LOS was similar: 2.7 ± 2.0 versus 3.1 ± 1.9 days, respectively (P = .58).
An aspart insulin protocol safely lowers BG levels in the ED without prolonging LOS. During hospitalization, a detemir-aspart protocol achieves significantly better glycemic control compared with guideline-driven use of NPH-aspart or glargine/detemir-aspart (usual care) without increasing hypoglycemia. Standardization of insulin protocols in the ED and hospital settings leads to improvement in overall glycemic control with greater safety and efficacy than usual care.
Following the recommendations of The International Society for Pediatric and Adolescent Diabetes (ISPAD) in 2000, our clinic started routine screening of children with type 1 diabetes (T1D) for coeliac disease (CD).
To determine the short-term clinical and metabolic effects of gluten free diet (GFD) in a group of children with T1D and confirmed CD.
Data were collected on all children with T1D and CD between November 2000 and November 2007 before and 12 months after commencement of GFD. Data included the presence of gastrointestinal (GI) symptoms, episodes of severe hypoglycaemia, daily insulin requirements, height, weight, body mass index (BMI), glycosylated haemoglobin (HbA1c), haemoglobin, and persistence of autoantibodies. The effects of GFD on these parameters were studied and compared with those from the revised ISPAD Guidelines in 2007.
Four hundred and sixty-eight children with T1D were screened, of whom 23 patients were diagnosed with CD. The mean age at diagnosis of T1D and CD was 6.8 years and 11.1 years, respectively. Ten out of 11 children showed improvement in their GI symptoms, while 6 out of 8 patients had no further severe hypoglycaemic episodes. Nine patients remained positive for antiendomysial antibodies after GFD. There was no significant change in the standard deviation score for height, weight, and BMI or the mean HbA1c and Hb before and after GFD. However the mean insulin requirement increased from 0.88 to 1.1 units/kg/day, which was statistically significant (p < 0.005).
In our experience, GFD showed short-term benefits by reducing GI symptoms and severe hypoglycaemia while the insulin requirement increased significantly.
Microvascular complications occur in adolescents with type 1 diabetes, although guidelines vary as to when screening should commence and prevalence data for those with ≤5-yr duration are limited. We therefore investigated trends in prevalence of early microvascular complications over 17 yr.
819 adolescents (54% female) aged 11-17 yr with 2- to 5-yr diabetes duration were assessed for complications at a tertiary pediatric diabetes clinic between 1990 and 2006. Early retinopathy was detected using seven-field fundal photography, albumin excretion rate (AER) by timed overnight urine collections and peripheral nerve function by thermal/vibration threshold at the foot. Results were analyzed by age, time period of assessment, and duration.
Early retinopathy declined from 1990 to 2002 (16-7%, p < 0.01), then remained unchanged until 2006. Early elevation of AER (≥7.5 µg/min) and microalbuminuria (≥20 µg/min) did not change over time, whereas peripheral nerve abnormalities increased (14-28%, p < 0.01). Median hemoglobin A1c improved (8.7-8.2%, p < 0.01), in parallel with increased total daily insulin dose and injections per day (p < 0.01). Body mass index standard deviation score increased over time (0.55-0.79, p < 0.01). In multivariate logistic regression, early retinopathy was associated with earlier time period [odds ratio (OR) 0.68, confidence interval (CI) 0.55-0.85, p < 0.01] and older age (OR 1.19, CI 1.02-1.39, p = 0.03). AER ≥ 7.5 µg/min was associated with older age (1.19, 1.06-1.34, p < 0.01) and longer diabetes duration (OR 1.28, CI 1.02-1.62, p = 0.04) and height-adjusted peripheral nerve abnormalities with later time period (OR 1.26, CI 1.05-1.50, p = 0.01).
Early complications are not uncommon in adolescents with 2- to 5-yr diabetes duration, despite more intensive management in recent years.
Severe hypoglycemia may increase the risk of a poor outcome in patients with type 2 diabetes assigned to an intensive glucose-lowering intervention. We analyzed data from a large study of intensive glucose lowering to explore the relationship between severe hypoglycemia and adverse clinical outcomes.
We examined the associations between severe hypoglycemia and the risks of macrovascular or microvascular events and death among 11,140 patients with type 2 diabetes, using Cox proportional-hazards models with adjustment for covariates measured at baseline and after randomization.
During a median follow-up period of 5 years, 231 patients (2.1%) had at least one severe hypoglycemic episode; 150 had been assigned to intensive glucose control (2.7% of the 5571 patients in that group), and 81 had been assigned to standard glucose control (1.5% of the 5569 patients in that group). The median times from the onset of severe hypoglycemia to the first major macrovascular event, the first major microvascular event, and death were 1.56 years (interquartile range, 0.84 to 2.41), 0.99 years (interquartile range, 0.40 to 2.17), and 1.05 years (interquartile range, 0.34 to 2.41), respectively. During follow-up, severe hypoglycemia was associated with a significant increase in the adjusted risks of major macrovascular events (hazard ratio, 2.88; 95% confidence interval [CI], 2.01 to 4.12), major microvascular events (hazard ratio, 1.81; 95% CI, 1.19 to 2.74), death from a cardiovascular cause (hazard ratio, 2.68; 95% CI, 1.72 to 4.19), and death from any cause (hazard ratio, 2.69; 95% CI, 1.97 to 3.67) (P<0.001 for all comparisons). Similar associations were apparent for a range of nonvascular outcomes, including respiratory, digestive, and skin conditions (P<0.01 for all comparisons). No relationship was found between repeated episodes of severe hypoglycemia and vascular outcomes or death.
Severe hypoglycemia was strongly associated with increased risks of a range of adverse clinical outcomes. It is possible that severe hypoglycemia contributes to adverse outcomes, but these analyses indicate that hypoglycemia is just as likely to be a marker of vulnerability to such events. (Funded by Servier and the National Health and Medical Research Council of Australia; ClinicalTrials.gov number, NCT00145925.).
Epidemiological studies suggest a higher prevalence of metabolic syndrome and its components among individuals with vitamin D deficiency. The aim of the present study was to determine whether vitamin D treatment improves glucose control and insulin sensitivity in Type 2 diabetes mellitus (T2DM).
Subjects with T2DM and serum 25-hydroxyvitamin D (25(OH)D) concentrations <25 ng/mL were randomized to receive 400 IU (Group 1) or 1200 IU (Group 2) cholecalciferol for 4 months. Fasting plasma glucose, glycosylated hemoglobin (HbA1c), Quantitative Insulin Sensitivity Check Index (QUICKI), serum lipid levels and serum adiponectin were measured at baseline and at 4 months.
Mean 25(OH)D levels increased in both groups (from 17.6±1.5 to 25.5±1.8 ng/mL in Group 1 and from 15.6±1.4 to 27.4±2.4 ng/mL in Group 2; P≤0.001 vs baseline for each group). No significant differences were noted in fasting plasma glucose, HbA1c, QUICKI, serum adiponectin, and lipid levels compared with baseline within groups or between the two groups. Conclusions: In the present pilot study, conventional vitamin D treatment at a level improving, but not optimizing, serum 25(OH)D did not improve glycemia, insulin sensitivity, or lipid profile. However, diabetes and lipids were relatively well controlled at baseline. Future studies should be designed to achieve optimal concentrations of serum 25(OH)D (at least >32 ng/mL) and should include subjects showing more abnormal parameters of glycemia, lipid, and insulin sensitivity at baseline.