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2018 Guidelines on the management of diabetic patients. A position of Diabetes Poland

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... Guideline characteristics (Table 1) Eligible guidelines were published from 2009 to 2018 in the following countries: the United States (n = 3), the United Kingdom (n = 2), Canada (n = 2), Columbia (n = 1), East Africa (country unspecified, n = 1), Germany (n = 1), India (n = 1), Japan (n = 1), Malaysia (n = 1), the Netherlands (n = 1), Pakistan (n = 1), Poland (n = 1), and Qatar (n = 1) [17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33]. The guidelines were funded and/or developed by professional associations or societies (n = 16) and an international agency (n = 1). ...
... Appraisers agreed in their overall recommendation for 1 of 17 guidelines including 1 ''Yes with modifications" [33]. Of the remaining 16 guidelines, 3 were rated by the two appraisers as ''No" and ''Yes with modifications" [20,25,30], while 13 guidelines were rated as ''Yes" and ''Yes with modifications" [17][18][19][21][22][23][24][26][27][28][29]31,32] (See Table 2). ...
... The overall objectives and health questions were generally well-defined in most guidelines, however some guidelines did not have clear statements of the objectives [17,18,20,29], and in the introduction, did not always identify the types of treatments that are discussed in the guideline. The health questions were not clearly presented in the introduction sections for some of the guidelines [18,20,29]. ...
... Patients with following risk factors should be consulted by a cardiologist during the pregnancy planning period [10,11]: 1. Presence of symptoms suggestive of coronary artery disease, limited exercise tolerance and/or congestive heart failure 2. Abnormal ECG results mentioned in patient history 3. Atherosclerotic changes in the carotid or peripheral arteries evidenced in patient history 4. Diabetes lasting longer than 15 years 5. In addition to diabetes presence of two or more ischemic heart disease (IHD) risk factors: a) Age above 35 b) Abnormal lipid profile c) Hypertension d) Smoking e) Family history of early onset atherosclerosis f ) Albuminuria (microangiopathy) g) Autonomic neuropathy (macroangiopathy) Successfully treated coronary artery disease (pharmacologically, PCI, and/or surgically) is not a contraindication for pregnancy [12]. ...
... This distinction has an important prognostic value to both pregnant women and their fetuses. For this reason, we propose the following classification and diagnostic scheme [10,40,41]: ...
... It is recommended to perform a 75 g oral glucose tolerance test six weeks after delivery with the results interpreted according to WHO guidelines for the general population). In case of negative OGTT results, the test should be repeated every year [10]. ...
... Among those, ISPAD target ≤7%/53 mmol/mol was defined as the primary outcome of the study. [13][14][15] Univariate relationships between continuous variables were assessed with Pearson correlation, with coefficients <0.2 interpreted as weak or not likely to be clinically impactful and >0.2 as moderate. ...
... However, the advantage is only relative-as few as 20% of children and 25% of adults met the national HbA1c target. 15 Recently published national registries and multicenter studies showed large between-countries and between-centers differences in mean HbA1c. Anderzen et al. 7 showed average HbA1c ranging from 60 to 73 mmol/mol (7.6-8.8%) in eight high-income countries, with 63 mmoL/L (7.9%) reported in German/Austrian DPV Registry 16 and 62 mmol/mol (7.8%) in Italian multicenter study. ...
... Diabetes Poland issues stricter guidelines for metabolic control than those the ADA or ISPAD. [13][14][15] This policy is partly based on the studies demonstrating that more demanding targets tend to be associated with better patient outcomes. 32 For the last 15 years, Diabetes Poland has therefore promoted HbA1c ≤48 mmol/mol (6.5%) as a therapeutic goal for young patients with T1D. ...
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Youth with type 1 diabetes (T1D) (16-18y.o.) present worst disease control of all age groups and need structured interventions. Those should be based on unbiased, national-scale outcomes, which have not yet been successfully assessed in Poland. To evaluate the glycemic control in young patients with T1D in Poland. All pediatric diabetes care centers and the nine largest centers for adults with T1D were invited to this cross-sectional study, conducted in March 2018. Eligibility was defined as age ≤ 30 years and diabetes duration ≥1 year. Blinded samples of capillary blood and clinical questionnaires were sent to coordinating center, where HbA1c was measured by HPLC . Nine adult and 25/28 pediatric centers participated, providing data for 1255 patients [50.8%males], mean age 12.3 years (95%CI:12.1–12.6) for children and 23.2 years (22.9–23.6) for adults; mean diabetes duration 7.1 years (6.8–7.3). This covered ~8% of pediatric population and 2% of 18-30-years-olds with T1D. Mean HbA1c was comparable between children and adults [57 mmol/mol (7.4%), 95%CI:56-57 mmol/mol (7.3–7.4%) vs 57 mmol/mol (7.4%), 95%CI:56-60 mmol/mol (7.3–7.6%), p = 0.1870]. Overall, 45.2% of patients achieved ISPAD target [<53 mmol/mol (<7.0%)]. During the month preceding the study, 0.9% of patients experienced severe hypoglycemia and 0.4% suffered ketoacidosis. HbA1c was related to the method of insulin therapy, continuous glucose monitoring use and body weight (p < 0.0001) In Polish children and young adults with T1D glycemic control expressed as HbA1c is promising in the light of ISPAD guidelines. Our results confirm the known associations between better glycemic control and the use of new technologies and maintaining optimal body weight. This article is protected by copyright. All rights reserved.
... For patients with PAD and co-occurring diabetes, strict glycemic control is recommended according to the general standards [1,40]. It is also believed that glycemic control is particularly important for improving the lower extremities treatment outcomes, including reducing the frequency of amputations in patients with critical limb ischemia and improving the patency after revascularization in the lower leg [41,42]. ...
... According to the guidelines of the Polish Diabetological Association, the first-line drug for patients with type 2 diabetes is metformin (unless there are contraindications for use) [40]. Choosing the anti-diabetic medications, it should be taken into account that the benefit of reducing the cardiovascular risk has been confirmed for only a handful of those agents. ...
... Choosing the anti-diabetic medications, it should be taken into account that the benefit of reducing the cardiovascular risk has been confirmed for only a handful of those agents. The results of large randomized clinical trials published in recent years show a reduction of the overall and cardiovascular mortality by some GLP-1 receptor agonists (liraglutide among those available in Poland), and SGLT-2 inhibitors (empagliflozin) [40]. It appears that the most beneficial effects were achieved with empagliflozin which significantly reduced the overall mortality, cardiovascular mortality and morbidity (overall mortality caused by cardiovascular disorders, heart attack and stroke), and the risk of hospitalization due to heart failure [43]. ...
... Clinical manifestations of LADA do not always allow a definite diagnosis, presenting diagnostic challenges when differentiating with T2DM. A definite diagnosis of LADA requires identification of auto-antibodies typical for T1DM, mostly antiGAD65, and/or a low serum peptide C level [13]. ...
... A definite diagnosis of monogenic diabetes is a result of genetic testing. The most common form of MODY is associated with HNF1A and glucokinase gene mutations [13]. ...
... Typical clinical presentation of MODY due to an HNF1Agene mutation includes: (1) Early onset of diabetes (typically before 25 years of age; (2) No insulin dependence and keto acidosis, low insulin requirement, detectable peptide C levels despite the disease being present for several years or even longer; (3) Diabetic family history over at least 2 generations, with early-onset diabetes in at least two family members. OGTT performed at an early stage of diabetes usually shows high postprandial glucose level elevation with often normal fasting blood glucose; (4) Absence of auto antibodies typical for T1DM;and (5) Glycosuria higher than expected based on blood glucose levels [13]. ...
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Type 2 Diabetes mellitus, as one of the major universal public health disorders wide spread, requires patients’ lifestyle modulation which would be conducive in dominating blood glucose. The aim of the study was to evaluate the effect of lifestyle modification on glycemic control of type 2 diabetic patients at Suez Canal University Hospitals at Ismailia city. A quasi-experimental design made up of a control group and a study group with pre- and post-test administration was applied. This study was carried out at the Family Medicine Outpatient Clinic and the Diabetic Outpatient Clinic of Suez Canal University Hospitals at Ismailia city in Egypt. 92 type 2 diabetic patients were included in this study. The Diabetes Knowledge Questionnaire; Health promoting lifestyle profile II Scale; and Physical assessment sheet were used for data collection in the two groups. After implementing of the program, those patients who received lifestyle modification intervention achieved better total score of knowledge & knowledge related practice about DM, health promoting lifestyle domains values and glycated hemoglobin, compared with the control group. Factors related to lower glycated hemoglobin in the present study were lower fasting blood sugar level and increasing physical activity. Overall, lifestyle modification program has a positive influence on blood glucose control of patients with type 2 diabetes mellitus. Therefore, it is recommended to that lifestyle modification interventions should be integral part of the curative management of type 2 diabetic patients, and further study in other places to investigate the effect of lifestyle modification on glycemic control of those patients.
... The general recommendations [13][14] from 2017-2018 were similar to those from previous years. The goals of nutritional treatment were the same, as is the strategy of nutritional treatment which, in addition to the evaluation of individual diet, nutritional diagnosis, nutritional intervention, and monitoring, also includes corrective measures if therapeutic goals are not met. ...
... In 2017-2020, the position was upheld [13][14][15][16] that no adequate scientific evidence was available to inform a recommendation regarding the total dietary carbohydrate content but it was suggested to be at about 45% of the total caloric intake. However, the total dietary carbohydrate content may be up to 60% of the total caloric intake if low-glycaemic index products with a high fibre content are the major dietary source of carbohydrates, and in individuals with a high level of physical activity. ...
... In 2018, these recommendations [14] underwent some modifications. According to these recommendations, dietary fat intake should be similar to that recommended in healthy individuals, at 25-40% of the total caloric intake. ...
... Standard treatment for individuals with T1DM is an intensive insulin therapy that allows imitating the natural secretion of insulin. 1 Nowadays, the main challenge in the treatment of T1DM is the maintenance of optimal long-term control of glycemia to prevent the development of insulin resistance (IR), diabetic complications, and preterm mortality. 2 Erectile dysfunction (ED) is a durable inability to achieve and/or maintain an adequate erection to perform sexual intercourse. ...
... Diabetic foot syndrome was defined as the presence of a foot ulcer, neuropathic osteoarthropathy, or history of lower limb amputation due to diabetes complications. 1 IR was assessed using the estimated glucose disposal rate (eGDR) formula 28 where arterial hypertension if present, count as 1, and if not present, count as 0, and HbA1c-glycated hemoglobin (%). eGDR formula is easy to utilize in clinical practice. ...
... Of them, n ¼ 40 (57.1%) had no ED (22-25 points), n ¼ 21 (30.0%) mild ED (17-21 points), n ¼ 6 (8.6%) mild-to-moderate ED (12)(13)(14)(15)(16), n ¼ 2 (2.9%) moderate ED (8)(9)(10)(11), and n ¼ 1 (1.4%) severe ED (1)(2)(3)(4)(5)(6)(7). The characteristics of the study group and the comparison of individuals with ED versus those without ED are presented in ►Table 1. ...
Article
Background Erectile dysfunction (ED) affects approximately 38% of individuals with type 1 diabetes (T1DM). Skin autofluorescence (AF) reflects skin advanced glycation end product (AGE) deposits and is a marker of long-term glycemia control. Objective The study investigates the relationship between ED and diabetes control in patients with T1DM. Methods Adult patients with T1DM visiting the Diabetology Department were cross-sectionally investigated. Medical history, anthropometric features, and laboratory findings were collected. All individuals filled the International Index of Erectile Function (IIEF-5). IIEF-5 total score < 22 represented the presence of ED. AF was measured on the volar aspect of the forearm using AGE Reader. Insulin resistance (IR) was assessed by the estimated glucose disposal rate. Descriptive statistics and multivariate logistic regression analyses were performed. The adjusted covariates were general risk factors of ED. Results Of a total of n = 70 patients, n = 30 (42.9%) suffered from ED. The presence of ED was associated with higher glycated hemoglobin level (OR, 95% CI; 1.62, 1.02–2.60; p = 0.043), presence of at least one diabetic complication (3.49, 1.10–11.03; p = 0.03), and skin AF (9.20, 1.60–52.94; p = 0.01), but not with IR (0.78, 0.57–2.60; p = 0.12). Skin AF values ≥ 2.2 indicates presence of ED with a sensitivity of 70.0% and a specificity of 77.5%. Area under the curve was equal to 0.72 (95% CI: 0.60–0.85). Conclusions The presence of ED in individuals with T1DM is associated with HbA1c, the presence of at least one diabetic complication, and skin AF.
... The T1D diagnosis was based on national guidelines, which correspond to those published by international society for pediatric and adolescendt diabetes (ISPAD). 5,6 The studied group was comprised by 194 patients, 95 (49%) girls and 99 (51%) boys. A detailed characteristic of the studied patients is shown in Table 1. ...
... The percentage of patients with pH <7.1 at onset was more than two times lower among remitters (13% [12] vs 5% [6]). Children with another Regarding the anthropometric parameters, remitters did not differ from non-remitters regarding height, but they had significantly higher weight as well as BMI SDS (at T1D onset) than those that did not achieve PR (Table 1.). ...
... In the pediatric diabetes center where this study was performed all children, even youngest ones, achieve from the beginning intensive insulin treatment aiming at normoglycemia (HbA1c ≤ 6.5%; 42.1 mmol/mol), according to the national guidelines published annually by Diabetes Poland. 6 Most of these young patients are using insulin pumps. It may be that such an intensive, aggressive approach results in higher remission rates, regardless of age. ...
Article
Aim The study aimed to analyze the frequency of partial remission (PR) and its association with chosen clinical and laboratory factors among pediatric patients with newly diagnosed type 1 diabetes (T1D). The long‐term effect of PR on chosen parameters was also investigated. Methods In 194 patients (95 girls) aged 8.1&pm;4.3 years we analyzed data at T1D onset: glycaemia, pH, C‐peptide, antibodies, weight, concomitant autoimmune diseases. Anthropometric parameters, daily insulin requirement (DIR), and HbA1c 2 and 4 years after T1D diagnosis were also analyzed. We determined PR based on HbA1c and DIR measurements at least every 3 months. Results PR occurred in 59% of patients. Remitters had significantly higher pH (7.33 vs 7.28, p=0.03), weight standard deviation score (SDS) (0.25 vs ‐0.24, p= 0.002) and body mass index SDS (0.19 vs ‐0.66, p=0.02) compared with non‐remitters. Concomitant diseases correlated negatively with PR. Multivariate analysis indicated only pH at onset was an independent predictor of PR. pH was the most important factor associated with the beginning of PR. There was a positive correlation between the start and duration of PR. Four years after T1D onset remitters had lower HbA1c (7.24 vs 8.05%, 53 vs 63.9 mmol/mol, p<0.001) and DIR (0.81 vs 1.08, p=0.005). Conclusions PR occurred quite often and developed more frequently in children with higher: weight and BMI SDS, but the main factor influencing PR presence and duration was higher pH at T1D onset. There was a beneficial impact of PR on HbA1c and DIR after 4 years of treatment. This article is protected by copyright. All rights reserved.
... Clinical manifestations of LADA do not always allow a definite diagnosis, presenting diagnostic challenges when differentiating with T2DM. A definite diagnosis of LADA requires identification of auto-antibodies typical for T1DM, mostly antiGAD65, and/or a low serum peptide C level [13]. ...
... A definite diagnosis of monogenic diabetes is a result of genetic testing. The most common form of MODY is associated with HNF1A and glucokinase gene mutations [13]. ...
... Typical clinical presentation of MODY due to an HNF1Agene mutation includes: (1) Early onset of diabetes (typically before 25 years of age; (2) No insulin dependence and keto acidosis, low insulin requirement, detectable peptide C levels despite the disease being present for several years or even longer; (3) Diabetic family history over at least 2 generations, with early-onset diabetes in at least two family members. OGTT performed at an early stage of diabetes usually shows high postprandial glucose level elevation with often normal fasting blood glucose; (4) Absence of auto antibodies typical for T1DM;and (5) Glycosuria higher than expected based on blood glucose levels [13]. ...
... Physical activity improves insulin sensitivity [1], the lipid profile [2], quality of life [3], and body weight and prevents cardiovascular dis-eases [4]. It is uniformly recommended by the American Diabetes Association [5], the International Society for Pediatric and Adolescent Diabetes (ISPAD) [6], and the Diabetes Poland [7] for patients with diabetes. The biggest concerns regarding the practice of sports by children with type 1 diabetes (T1DM) are fear of hypogly-Nighttime Hypoglycemia in Children with Type 1 Diabetes after one Day of Football Tournament ...
... Children were requested to sleep at approximately 10:00 P.M. and to wake up at 7:00 A.M. Nighttime blood glucose levels were measured by the children and/ or their parents using their own glucose meters (self-monitoring of blood glucose [SMBG]) at 10:00 P.M., 01:00 A.M., 03:00 A.M. and 07:00 A.M. Children with additional monitoring (FGM, CGM) were allowed to use it freely, however, these measurements and related clinical decisions were not recorded, and blood glucose was still measured with glucose meter at protocol-derived time-points. Decisions were made by the children and/or parents based on general standards of care [6,7]. If during the night, the blood glucose level was < 5.6 mmol/L, the parents were advised to administer 10-25 g of carbohydrates to the patients, depending on body weight. ...
Article
The aim of the study was to investigate factors related to the occurrence of nighttime hypoglycemia after a football tournament in children with type 1 diabetes mellitus. The multicenter study (GoalDiab study) included 189 children and adolescents with type 1 diabetes mellitus, from 11 diabetes care centers in Poland. Hypoglycemia was defined according to the International Hypoglycemia Study Group Statement. We analyzed the data of 95 participants with completed protocols with regards to nighttime hypoglycemia (82% male), aged 11.6 (9.8–14.2) years, diabetes duration 5.0 (2.0–8.0) years. There were 47 episodes of nighttime Level 1 hypoglycemia (≤3.9 mmol/L). Occurrence of clinically important Level 2 hypoglycemia (<3.0 mmol/L) during a game period was positively associated with nighttime hypoglycemia (≤3.9 mmol/L) incident (Odds Ratio=10.7; 95% Confidence Interval: 1.1–100.2; p=0.04). Using Continuous Glucose Monitoring was negatively associated with the occurrence of nighttime hypoglycemia (≤3.9 mmol/L) compared with using glucose meters or Flash Glucose Monitoring (Odds Ratio=0.31; 95% Confidence Interval: 0.12–0.83; p=0.02). The occurrence of clinically important hypoglycemia related to physical activity is associated with the occurrence of hypoglycemia during the night. Continuous Glucose Monitoring is negatively associated with nighttime hypoglycemia after a day of competition.
... oraz u osób młodszych obciążonych czynnikami ryzyka rozwoju cukrzycy (np. otyłością lub dodatnim wywiadem rodzinnym w kierunku cukrzycy) [14]. Zespół ekspertów PTD podkreśla, że powtarzanie porad dotyczących zmiany dotychczasowego stylu życia w aspekcie diety czy aktywności fizycznej, ma kluczowe znaczenie w efektywnej prewencji cukrzycy typu 2 [14]. ...
... otyłością lub dodatnim wywiadem rodzinnym w kierunku cukrzycy) [14]. Zespół ekspertów PTD podkreśla, że powtarzanie porad dotyczących zmiany dotychczasowego stylu życia w aspekcie diety czy aktywności fizycznej, ma kluczowe znaczenie w efektywnej prewencji cukrzycy typu 2 [14]. Wykonanie oznaczeń stężenia glukozy i lipidogramu w osoczu krwi żylnej pobranej na czczo (najlepiej co najmniej 9 godz. ...
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Background Every year in Poland almost 5 million prophylactic examinations (PEs) are carried out by occupational medicine specialists (OMPs) among workers, for the purposes envisaged in the Polish Labour Code. The aim of this study was to collect workers’ opinions on the possible extension of these check-ups in the field of prophylaxis and prevention of civilization diseases (CivDs), focusing also on the “healthy lifestyle” recommendations. Material and Methods The study group comprised 325 employees who filled out an anonymous questionnaire containing questions about the possible extension of the PE scope for CivD and cancer prophylaxis. During medical check-ups, evaluation of the incidental glucose (IG) and total cholesterol (TCh) levels, waist circumference measurement and electrocardiography (ECG) were proposed. The respondents were asked about the most interesting issues for discussing with OMPs. Results Screening tests for some cancers (69.5%) and risk factors for CivDs (61.5%) were indicated as the most interesting topics to discuss with OMPs. The possibility for evaluating the levels of IG and TCh during PEs was approved by approx. 94.8% and 95.3% of the respondents, respectively. Almost 96% accepted having ECG and 80% agreed to waist circumference measurement. As many as 89.5% of the respondents supported the idea of organizing physical activities at their workplaces, and 77.8% were eager to learn about “healthy lifestyles” during training sessions conducted at their workplaces. Conclusions Restricting the aim of PEs just to certifying the ability to work, or identifying certain medical contraindications, means losing a chance for implementing the prophylaxis and prevention of diseases’ development among active working subjects. The kinds of activities proposed by the authors of this publication have been approved by the employees. Med Pr. 2019;70(4):425–33
... Procedures for the treatment of patients with previously diagnosed autoimmune diabetes mellitus (type 1 diabetes, type LADA diabetes), in which the basis of treatment is intensive insulin therapy, are strictly defined [15][16][17]. In these patients, continuous subcutaneous insulin infusion (CSII) with continuous monitoring of glucose (CGM) is most commonly used. ...
... The subject of discussion is the treatment of patients with type 2 diabetes and patients with hyperglycaemia without previously diagnosed diabetes. According to current recommendations, these patients should be treated with insulin therapy [15]. This applies to patients with type 2 diabetes treated with oral hypoglycaemic agents. ...
Article
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Hyperglycemia is frequently occurring in critically ill patients and the incidence is particularly high in patients receiving nutrition support. One of the forms of such nutrition is enteral nutrition, which is used particularly often. There are patients with type 1 diabetes, type 2 diabetes and other forms of diabetes as well as patients who have not previously been diagnosed with diabetes in this group of patients. The basis of pharmacotherapy in this case is an insulin therapy. The principles of such a therapy in patients with previously diagnosed diabetes are regulated by PTD guidelines. According to literature data, hyperglycemic patients with no previously diagnosed diabetes require special attention. The pathomechanism of these disorders is very complex and these patients require special care in determining the insulin therapy program. So far, there are no unambiguous guidelines in this area.
... Additionally, adequate interpretation of the HbA1c measurement, that is routinely performed during diabetes control visits, requires also to know the patient's serum iron concentration, because the presence of iron deficiency anemia correlates with higher HbA1c values [7]. It is interesting that even though the value of a performed blood count is well known as well as the multiplicity of information it gives, there are no recommendations whether and when it should be carried out in T1D patients-neither in the guidelines published by Diabetes Poland (2018) nor those of the International Society for Pediatric and Adolescent Diabetes [8,9]. Until present, there have been a few publications assessing the blood count, iron metabolism parameters, and vitamin B12 levels in children with T1D, which most often use other T1D individuals as a control group. ...
... In all patients, physical examination with auxological assessment was performed. Routine laboratory tests (screening for autoimmune concomitant diseases and complications) were performed according to recent Diabetes Poland and ISPAD guidelines [8,9]. ...
Article
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Aim: The aim of the study was to assess markers of anemia in type 1 diabetes (T1D) children, compare them to results obtained in the control group, and estimate their relation to BMI SDS. Methods: 94 (59% ♀) T1D children without other autoimmune disorders, aged 12.5 ± 4.1 years, T1D duration: 4.2 ± 3.6 years, HbA1c 7.3 ± 1.5% (57 ± 12.6 mmol/mol). Sex- and age-matched controls (43 children). In all children, anthropometric measurements, the blood count, iron turnover parameters, and vitamin B12 concentration were taken. Results: T1DM children had significantly higher red cell distribution width (RDW) (13.6 versus 12.6%; p < 0.001), hepcidin (0.25 versus 0.12 ng/ml; p < 0.001), and vitamin B12 concentrations (459 versus 397 pg/ml; p < 0.01) and lower TIBC (59.09 versus 68.15 μmol/l; p < 0.001) than in the control group. Logistic regression revealed that RDW, TIBC (both p < 0.001), and hepcidin (p < 0.05) significantly differentiated both groups. In T1DM children, BMI SDS negatively correlated with vitamin B12 (p < 0.01) concentration and mean corpuscular hemoglobin concentration (p < 0.05) and positively with TIBC (p < 0.01) and HbA1c (p < 0.001). Conclusions: Patients and controls differed especially in terms of RDW and TIBC. In studied T1DM children, BMI SDS was associated to iron metabolism parameters and vitamin B12 concentration.
... When properly treated, T1DM in many patients is asymptomatic; however, the management of the disease and treatment methods are the main factors that might impact the QoL. There are many rules to follow for T1DM patients, such as: lifelong insulin therapy-most patients usually require at least 4 injections of insulin daily and frequent self-monitoring of blood glucose levels-up to 6-10 times daily and diet control-including education about how to adjust the timing, size, frequency, and composition of meals [5,9]. ...
... According to studies by Costa L et al. [39] and Anderson BJ et al. [8], the QoL of patients with T1DM is worsening with the time since diagnosis and with the increase in glycated hemoglobin (HbA1c), which proves insufficient glycemic control [8,39]. The problems for patients suffering from T1DM change over time, at first, they are bound to treatment regimens and the necessity of self-control, and after years of the disease when complications may occur, in addition to the everyday treatment, they may also have to deal with disease complications [9,39,44,45]. It may also be supposed that the impairment of the QoL seen in married T1DM patients might be related to sexual dysfunction, which tends to be of a greater extent in patients with a long-lasting disease [46,47]. ...
Article
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Background and aims: Chronic spontaneous urticaria (CSU) and diabetes mellitus type 1 (T1DM) may compromise the quality of life (QoL). We decided to compare the QoL of T1DM patients to those suffering from CSU. Materials and methods: Sixty-six patients with well-controlled T1DM (male 52%) in the mean age of (SD) 36.3 (11.09) years and 51 patients with CSU (male 33%) in the mean age of (SD) 35.8 (8.53) years were enrolled in this observational study. All the participants completed a Short-Form 36 (SF-36) QoL. Results: The QoL related to social functioning was significantly worse among CSU patients. There were differences related to gender found in the group of patients with T1DM-where men tended to declare a better quality of life than women (p = 0.015)-especially in the area of energy/fatigue and pain. It appeared that due to physical and emotional problems occurring in married patients, the QoL is lower in T1DM group in comparison to the CSU one. Conclusions: The patients with CSU presented significantly worse social functioning compared to the ones with T1DM. This fact proves the QoL impairment level is not always related to the level of health danger. The differences in the QoL related to gender and marital status found among T1DM patients point to the necessity for further exploration in a larger group of patients. Due to the fact that optimal disease management should ensure patient's good emotional well-being, there is a need for additional psychological and social care for patients from those two groups.
... The blood test revealed a blood glucose level of 26.8 mmol/L (482 mg/dl), pH 6.902, base excess (BE) of − 29.3 mmol/L, HbA1c of 12.9%, sodium level of 142 mEq/L, potassium level of 4.11 mEq/L and ketone level of 6.1 mmol/L. The patient was treated according to the recommendations of the International Society of Pediatric and Adolescent Diabetes and the Polish Diabetes Association [1,15]. ...
... Many authors [1,2,5,15] have reported that administration of phosphates in DKA does not improve prognosis, and indeed increases the risk of hypocalcaemia. In our case, hypocalcaemia occurred on the fifth day of treatment, and the patient was treated with calcium supplementation. ...
Article
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Background Hypophosphatemia has many causes, and is often encountered during DKA (Diabetic Ketoacidosis) treatment. However, it rarely requires clinical intervention. Case presentation Ventricular arrhythmia was observed in a 10-year-old girl with newly diagnosed type 1 diabetes mellitus and hypophosphatemia while undergoing treatment for ketoacidosis. Oral phosphate supplementation ceased ventricular arrhythmia almost completely. Conclusions The clinical signs of hypophosphatemia are potentially life-threatening. Therefore, physicians should be vigilant when treating patients who are at risk of hypophosphatemia. Severe hypophosphatemia accompanied by clinical symptoms requires oral or intravenous supplementation of phosphate.
... Diabetes is classified as a disease of civilization; therefore, it is very important to improve public knowledge about its risk factors, symptoms and complications, especially considering that a significant percentage of people with diabetes is not aware of their illness. According to the recommendations of Diabetes Poland, people over 45 years of age should undergo screening for type 2 diabetes at least once every three years, and those with risk factors for diabetes should be examined annually regardless of age [14]. According to our knowledge, no study evaluating knowledge about type 2 diabetes among people from the general population has been published in Poland. ...
... As mentioned in the introduction, in accordance with the recommendations of the Diabetes Poland, every person over 45 years of age should undergo screening for type 2 diabetes at least once every three years, and in those with risk factors for diabetes such examination should be performed annually regardless of age [14]. It should be noted, that our study showed that people over 45 years of age were characterized by the lowest score in the test of knowledge about diabetes and, what is more, in nearly 1% of respondents random glycemia was > 300 mg/dL and overt diabetes was suspected. ...
Article
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Introduction. Type 2 diabetes mellitus is a non-infectious epidemic of the 21st century; therefore, it is essential to focus on prophylaxis, early detection and proper treatment in order to avoid its complications. The aim of this study was to evaluate diabetes-related knowledge among visitors of two shopping centers in Upper Silesia in Poland. The study was conducted by medical students from Medical University of Silesia in cooperation with the International Federation of Medical Students’ Associations in Poland under supervision of doctors from the Department of Internal Diseases, Diabetology and Nephrology in Zabrze. Material and methods. People were invited to fulfill a 12-item questionnaire evaluating the basic diabetes-related knowledge (among others symptoms of hyperglycemia, risk factors, complications and treatment of diabetes mellitus). They had their weight and height measurement performed as well as glycemia measured with the use of glucometer. Results. 401 out of 1500 invited shopping-center visitors agreed to take part in the study (27%) and their mean score of the diabetes knowledge test was 54.7 ± 18.7% of the correct answers. It turned out that there is an association of knowledge about diabetes with person’s age and gender — younger people and women had a better knowledge about diabetes. Conclusions. There should be a great attention paid to different forms of education in order to improve the level of diabetes-related knowledge among the general public as a way to improve early diagnosis and a proper treatment.
... Testing FGL and the lipid profile in venous blood, preferably at least 9 h after the last meal, is difficult or even impossible if the prophylactic medical check-up of a worker is carried out in the afternoon or evening. However, nonfasting levels can be used for screening and general risk estimation [20,44,45]. What is more, in the Polish legislation, the employer is burdened with the total financial cost of employee examinations [10]. ...
... The Polish Diabetes Association recommends testing the FGL in venous blood every 3 years among all people aged >45 years and in younger individuals with risk factors for diabetes (e.g., obesity, a family history of diabetes) [43,44]. The ESC and the European Atherosclerosis Society recommend performing screening tests for dyslipidemia among men aged ≥40 years and women aged ≥50 years [20]. ...
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Objectives: Cardiovascular and metabolic disorders constitute major health problems in the working populations in Europe. The aim of this project was to evaluate the health condition of workers employed in a Polish research and medical institution, and then to establish the necessary preventive actions by creating a modern model of occupational healthcare integrated with civilization disease (CivD) prevention. Material and methods: Overall, 100 workers voluntarily participated in a health program for CivD prevention during mandatory prophylactic examinations. Data from these examinations was collected in a system of electronic documentation to enable the analysis of the workers' health condition and risk factors of CivDs. Results: Women accounted for 72% of the employees who voluntarily participated in the prevention program, and 80% of the subjects had university education. As regards the health condition, 27% of the patients had elevated systolic, and 23% diastolic, blood pressure, and 21% had an abnormal fasting glucose level. Stressful job was an important factor correlated with an excessive body mass index, diastolic blood pressure, as well as total and low-density lipoprotein cholesterol levels. Smoking, sedentary work and a lack of physical activity were significant factors for abdominal obesity. Generally, 94% of the program participants required some further interventions in lifestyle, diagnostics or treatment. Conclusions: Civilization disease prevention should focus on increasing physical activity both in leisure time and at the workplace as far as practicable. There is a need for implementing projects leading to occupational stress reduction and smoking cessation. Men as well as workers with vocational and elementary education need to be recruited for prevention programs dedicated to employees.
... This may swing between hyperglycemia and hypoglycemia incidents. According to the recommendation of Polish Diabetes Association (PTD), ADA therapeutic targets vary depending on clinical status and compliance, the actual presence of macroangiopathic damages, the diabetes duration time, and life expectancy (ADA, 2017;Diabetology, 2018). ...
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By 2015, diabetes has affected more than 415 million people over the world. It is anticipated that 640 million adults will suffer from diabetes in 2040. The elongation of the life expectancy, as the result of better general health care, extends also the time when diabetic complications may develop together with other senility-specific problems. The Giant Geriatric Syndromes (Geriatric Giants) have been qualified by the original Nascher’s criteria defined more than 100 years ago, but they are becoming more and more relevant in connection with the aging of societies. The criteria comprise the older age, commonness of the health problem, multifactorial etiology, functional or cognitive impairment, worsened outcome, and increased morbidity and mortality. We described the impact of diabetes on Geriatric Giants including cognitive dysfunction, depression, malnutrition, incontinence, falls and fractures, chronic pain, and the loss of senses. The association of diabetes with Geriatric Giants reveals as a vicious circle with the background of neurovascular complications. However, diabetes influence on the incidence of cancer in elderly was also discussed, since neoplastic diseases associate with Geriatric Giants, for example, chronic pain and depression. The knowledge about these aspects of functional decline in geriatric population is crucial to improve patient care.
... 27% of the GDM subjects were treated with intensive insulin therapy, while 73% of them were controlled with only one basal insulin injection per day. Diagnostic criteria for GDM were based on the OGTT at 24-28 weeks of gestation: fasting glucose ≥5.1 mmol/L (92 mg/dL), or one hour plasma glucose result of ≥10.0 mmol/L (180 mg/dL), or a two-hour plasma glucose result of ≥8.5 mmol/L (153 mg/dL) [26,27]. This subgroup had no concomitant diseases and received only vitamin-iron supplementation and anti-diabetic treatment. ...
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The exact roles of adipokines in the pathogenesis of type 2 diabetes and obesity are still unclear. The aim of the study was to evaluate fatty acid binding protein 4 (FABP4) concentrations in the serum and urine of women with excessive gestational weight gain (EGWG) and gestational diabetes mellitus (GDM) in the early post-partum period, with reference to their laboratory test results, body composition, and hydration status. The study subjects were divided into three groups: 24 healthy controls, 24 mothers with EGWG, and 22 GDM patients. Maternal body composition and hydration status were evaluated by the bioelectrical impedance analysis (BIA) method. Concentrations of FABP4, leptin, and ghrelin were determined via enzyme-linked immunosorbent assay (ELISA). Healthy women were characterized by the lowest serum leptin concentrations and by a negative correlation between the serum and urine FABP4 levels. Serum FABP4 levels were the highest in the GDM group. Serum FABP4 and leptin concentrations correlated positively in the GDM group. The EGWG group had the highest degree of BIA disturbances in the early puerperium and positive correlations between the urine FABP4 and serum leptin and ghrelin concentrations. The physiological and pathological significance of these findings requires further elucidation.
... Moreover, the patients or their parents may be afraid of exercise-induced hypogly-cemia [30] and such fear is often aggravated by insufficient knowledge about diabetes among school staff [11]. Finally, competitive athletes with T1DM must prove they have a good understanding and control of their disease before receiving clearance from sports medicine specialists [7]. All of these may discourage young people with T1DM from exercise and affect their fitness level. ...
Article
Regular physical activity increases lifespan for those with type 1 diabetes. However, disease-related barriers may deter children from exercise and affect their fitness. This study examined the safety of the Cooper test concerning diabetes-related acute complications in children with type 1 diabetes and their fitness. Blood glucose was recorded before and 0, 30, 60 min after the test. The covered distances were transformed to z-scores based on the national charts. Body mass index, body fat percentage and glycated hemoglobin were measured. The run was completed by 80 individuals (45% boys, age 13.6±2.1 years; diabetes duration 6.3±3.5 years). During the follow-up 11 children reached glucose alert values (3–3.9 mmol/L), 3 presented clinically significant hypoglycemia (<3 mmol/L), none experienced severe hypoglycemia. The covered distance was 1914±298 m, not significantly different from the reference population (z-score −0.12±0.71 vs 0, p=0.12). The study participants were more overweight than general pediatric population in terms of body mass index (z-score 0.48±0.94 vs 0, p<0.001) and body fat percentage (z-score: 0.37±0.85 vs 0, p<0.001). In conclusion, the Cooper test can be safely used in children with diabetes to assess their physical capacity. Youth with type 1 diabetes present fitness similar to healthy children but exhibit increased body mass index and adiposity.
... All the study subjects included in this study were Caucasian. The study included women receiving only vitamin-iron supplementation during pregnancy, without any exclusion criteria given below, with normal pre-pregnancy BMI values and three normal results of the two-hour, 75 g oral glucose tolerance test at 24-28 weeks of gestation [55,56]. Depending on the achieved gestational weight gain, two groups were strictly selected: ...
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Among the new adipokines, secreted frizzled-related protein 5 (SFRP5) is considered to prevent obesity and insulin resistance. The umbilical cord SFRP5 levels have not yet been investigated. The main aim of the study was to investigate whether the umbilical cord SFRP5 concentrations are altered in term neonates born to mothers with excessive gestational weight gain (EGWG). Two groups of subjects were selected depending on their gestational weight gain, i.e. 28 controls and 38 patients with EGWG. Umbilical cord and maternal serum SFRP5 levels were lower in the EGWG group. Umbilical cord SFRP5 concentrations were directly associated with the maternal serum SFRP5, hemoglobin A1c and lean tissue index, umbilical cord leptin levels, as well as newborns’ anthropometric measurements in the EGWG subjects. In multiple linear regression models performed in all the study participants, umbilical cord SFRP5 concentrations depended positively on the maternal serum SFRP5, ghrelin, and leptin levels and negatively on the umbilical cord ghrelin levels, low-density lipoprotein cholesterol, pre-pregnancy body mass index, and gestational weight gain. EGWG is associated with disturbances in SFRP5 concentrations. Obstetricians and midwives should pay attention to nutrition and weight management during pregnancy.
... Of the subjects, 60% of those with GDM were treated by the intensive insulin therapy and 40% of them were controlled with only one basal insulin injection per day. The diagnostic criteria for GDM were based on the OGTT at 24-28 weeks of gestation, as follows: fasting glucose ≥5.1 mmol/L (92 mg/dL), or one hour plasma glucose result of ≥10.0 mmol/L (180 mg/dL), or a two-hour plasma glucose result of ≥8.5 mmol/L (153 mg/dL) [49,50]. ...
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Women with a previous history of gestational diabetes mellitus (GDM) have a significantly increased risk of developing type 2 diabetes, obesity, and cardiovascular diseases in the future. The aim of the study was to evaluate ghrelin concentrations in serum and urine in the GDM group in the early post-partum period, with reference to laboratory results, body composition, and hydration status. The study subjects were divided into two groups, that is, 28 healthy controls and 26 patients with diagnosed GDM. The maternal body composition and hydration status were evaluated by the bioelectrical impedance analysis (BIA) method. The concentrations of ghrelin in the maternal serum and urine were determined via enzyme-linked immunosorbent assay (ELISA). The laboratory and BIA results of the mothers with GDM were different from those without GDM. Urine ghrelin positively correlated with serum ghrelin and high-density lipoprotein cholesterol (HDL) levels in healthy mothers. There were direct correlations between urine ghrelin and HDL as well as triglycerides levels in the GDM group. Neither the lean tissue index nor body cell mass index were related to the serum ghrelin concentrations in this group. Only the urine ghrelin of healthy mothers correlated with the fat tissue index. Our results draw attention to urine as an easily available and appropriable biological material for further studies.
... Of the GDM subjects, 60% were undergoing intensive insulin therapy, while 40% of them received a single basal insulin injection per day. The diagnostic criteria for GDM were based on the OGTT at 24-28 weeks of gestation: fasting glucose ≥5.1 mmol/L (92 mg/dL), a one-hour plasma glucose result of ≥10.0 mmol/L (180 mg/dL), or a two-hour plasma glucose result of ≥8.5 mmol/L (153 mg/dL) [27,28]. ...
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Fetuses exposed to gestational diabetes mellitus (GDM) have a higher risk of abnormal glucose homeostasis in later life. The molecular mechanisms of this phenomenon are still not fully understood. Fatty acid binding protein 4 (FABP4) appears to be one of the most probable candidates involved in the pathophysiology of GDM. The main aim of the study was to investigate whether umbilical cord serum FABP4 concentrations are altered in term neonates born to GDM mothers. Two groups of subjects were selected—28 healthy controls and 26 patients with GDM. FABP4, leptin, and ghrelin concentrations in the umbilical cord serum, maternal serum, and maternal urine were determined via an enzyme-linked immunosorbent assay. The umbilical cord serum FABP4 levels were higher in the GDM offspring and were directly associated with the maternal serum FABP4 and leptin levels, as well as the prepregnancy body mass index (BMI) and the BMI at and after delivery; however, they correlated negatively with birth weight and lipid parameters. In the multiple linear regression models, the umbilical cord serum FABP4 concentrations depended positively on the maternal serum FABP4 and negatively on the umbilical cord serum ghrelin levels and the high-density lipoprotein cholesterol. There are many maternal variables that can affect the level of FABP4 in the umbilical cord serum, thus, their evaluation requires further investigation.
... However, the Austrian Society of Nephrology has endorsed the KDIGO guidelines and the Austrian Diabetes Association 15 issued a statement that also closely follows the ADA/KDIGO suggestions. The situation is similar in Scotland, 16 Poland 17 and Hungary. 18,19 Guidelines in the Netherlands also mostly follow KDIGO and ADA but suggest even lower blood pressure goals. ...
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Background: The number of patients with type 2 diabetes mellitus and diabetes mellitus-associated chronic kidney disease varies considerably between countries. Next to differences in genetic as well as life style risk factors, varying practices in medical care delivery might cause this diversity. Method: The PROVALID study recruited 4000 patients with type 2 diabetes mellitus at the primary level of healthcare in five European countries (Austria, Hungary, The Netherlands, Poland and Scotland). Baseline data were used to describe patient characteristics and compare the adherence to ADA (American Diabetes Association) and KDIGO (Kidney Disease: Improving Global Outcomes) guidelines with respect to metabolic and blood pressure control, use of renin-angiotensin system-blocking agents, statins and acetylsalicylic acid between the countries. Results: About 34.8% of the population had evidence of diabetes mellitus-associated chronic kidney disease. The median HbA1c level of the cohort was 6.8% (ranging from 6.5 in Poland to 7.0% in Scotland). Mean blood pressure was 136/79 (±17/10) and significantly higher in subjects with elevated albuminuria. These individuals also were more often treated with renin-angiotensin system-blocking agents (74.1% vs 84.6%), whereas the use of statins was driven by cardiovascular comorbidity. Acetylsalicylic acid was used in only 28.9% subjects. Despite similar cardiovascular comorbidities and renal function, the use of renin-angiotensin system-blocking agents varied significantly between the countries from 66.7% to 87.4%. An even higher variability was observed for patients >40 years of age using statins (39.8%-82.7%) and administration of acetylsalicylic acid in patients older than 50 years (5.2%-43.8%). Conclusion: Our study shows that medical practice in type 2 diabetes mellitus patients with and without renal disease is different in European countries. Longitudinal follow-up will reveal if this diversity affects clinical endpoints.
... The enrolled subjects were on vitamin-iron supplementation only, during the whole pregnancy. They presented normal pre-pregnancy BMI and showed no carbohydrate metabolism disorders, as documented in three normal results of the two-hour, 75 g oral glucose tolerance test performed at 24-28 weeks of gestation [30,31]. Two groups were selected based on the gestational weight gain: ...
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Background and objectives: Data concerning vaspin in obstetric aspects are limited and conflicting. The aim of the study was to evaluate vaspin concentrations in the serum and urine of women with excessive gestational weight gain (EGWG) in the early post-partum period (i.e., 48 h after delivery), when placental function no longer influences the results. Materials and Methods: The study subjects were divided into two groups of 28 healthy controls and 38 mothers with EGWG. Maternal body composition and hydration status were evaluated by the bioelectrical impedance analysis (BIA) method. Concentrations of vaspin, fatty acid-binding protein 4 (FABP4), leptin, and ghrelin were determined via enzyme-linked immunosorbent assay (ELISA). Results: Serum vaspin levels were lower in the EGWG group, whereas no significant differences were noted between the groups, with regard to the urine vaspin concentrations. In both studied groups, the serum vaspin concentrations correlated positively with the urine FABP4 levels and negatively with gestational weight gain, body mass index gain in the period from pre-pregnancy to 48 h after delivery (ΔBMI), and fat tissue index (FTI). In the multiple linear regression models, the serum vaspin concentrations were positively dependent on the serum FABP4 levels, as well as negatively dependent on triglycerides, FTI, and ΔBMI. Conclusions: Our study revealed that the EGWG mothers were characterized by significantly lower serum vaspin concentrations in the early post-partum period compared with the subjects that had appropriate gestational weight gain. Our observation supports previous hypotheses that vaspin might be used as a marker of lipid metabolism in pregnancy and maternal adipose tissue. Considering the fact that FABP4 is widely referred to as a pro-inflammatory adipokine, further research on the protective role of vaspin seems crucial, especially in the context of its relationship to FABP4.
... T1D was diagnosed according to the recommendations of the ISPAD [11,20], and CD according to the ESPGHAN criteria [10]. Routine serological tests necessary to perform a diagnosis were performed in Department of Biochemistry, Radioimmunology and Experimental Medicine, and Department of Pathomorphology at The Children's Memorial Health Institute (for T1D: anti-glutamic decarboxylase (anti-GAD), anti-tyrosine phosphatase (anti-IA2), anti-islet cell (ICA) antibodies, and for CD: serum anti-tissue transglutaminase antibody (anti-tTg Ab)). ...
Article
Patients with type 1 diabetes (T1D) are at higher risk of celiac disease (CD). Recently, intestinal fatty acid binding protein (I-FABP) has been shown to be a serological biomarker of impaired intestinal barrier in CD. Thus, the aim of this study was to verify whether I-FABP could be an early marker of CD in pediatric T1D patients. I-FABP was measured in sera of patients with T1D (n = 156), active CD (n = 38), T1D with active CD (T1D-CD, n= 51), and age-matched healthy children (n = 55). Additionally, I-FABP was determined in T1D patients with negative CD serology at least one year before CD diagnosis (T1D-CD-1, n = 22), in CD patients on a gluten-free diet (CD-GFD, n = 36), and T1D-CD patients on GFD (T1D-CD-GFD, n = 39). Sera were tested using immunoenzymatic assay. Significantly increased levels of I-FABP were found in the T1D, active CD, and T1D-CD groups (1153 ± 665, 1104 ± 916, and 1208 ± 878, respectively) in comparison to healthy with controls (485 ± 416, p < 0.05). GFD induced a significant decrease in I-FABP levels in CD and T1D-CD groups (510 ± 492 and 548 ± 439, respectively). Interestingly, in T1D-CD-1 and T1D, I-FABP levels were comparable (833 ± 369 vs. 1153 ± 665), and significantly increased in relation to healthy controls and T1D-CD values on GFD. The results indicate that the epithelial barrier is disrupted in T1D patients independently of CD development; therefore, I-FABP cannot serve as an early marker of CD in T1D patients. Although GFD can improve epithelial recovery, the question remains as to whether GFD could exert beneficial effects on the intestinal barrier in early stages of T1D.
... Characteristics of the study subjects also included: normal pre-pregnancy BMI values and three consecutive correct/normal results of 2 h-75 g-oral glucose tolerance test performed at 24-28 weeks of pregnancy [52,53], no concomitant diseases, and only vitamin-iron supplementation. ...
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Two-thirds of pregnant women exceed gestational weight gain recommendations. Excessive gestational weight gain (EGWG) appears to be associated with offspring’s complications induced by mechanisms that are still unclear. The aim of this study was to investigate whether umbilical cord leptin (UCL) and ghrelin (UCG) concentrations are altered in full-term neonates born to EGWG mothers and whether neonatal anthropometric measurements correlate with UCL and UCG levels and maternal serum ghrelin and leptin as well as urine ghrelin concentrations. The study subjects were divided into two groups, 28 healthy controls and 38 patients with EGWG. Lower UCL and UCG levels were observed in neonates born to healthy mothers but only in male newborns. In the control group UCG concentrations correlated positively with neonatal birth weight, body length and head circumference. In the control group maternal serum ghrelin levels correlated negatively with neonatal birth weight, body length and head circumference as well as positively with chest circumference. In the EGWG group UCG concentrations correlated negatively with neonatal birth weight and birth body length. UCL correlated positively with birth body length in EGWG group and negatively with head circumference in the control group. In conclusion, EGWG is associated with disturbances in UCL and UCG concentrations.
... A positive answer to one of the questions has a sensitivity of 97% and a specificity of 67% for the recognize of depression. In case of suspected depression, the patient should be referred for psychiatric consultation [4,5]. ...
Article
Depression and diabetes belong to the most common diseases in the human population. Mood disorders are often diagnosed in patients with chronic diseases, including type 1 and type 2 diabetes. Patients suffering from both diseases have been observed to have poorer blood glucose control, an increased risk of complications and mortality compared to the group with diabetes alone. The association between diabetes and depression is complex. Their frequent cooccurrence may be influenced by psychological factors, hormonal and immunological disorders. In depression, hypothalamo-pituitary-adrenal axis dysregulation is observed, which causes peripheral hypercortisolemia. The excess of cortisol leads to hepatic glycogenolysis and reduction in insulin sensitivity of peripheral tissues. It has been proven that depression is accompanied by chronic subclinical inflammation. In this review we present the data regarding the relation between hypercortisolemia, subclinical inflammation and depression in patients with type 1 and type 2 diabetes.
... Gliflozins are used at every stage of diabetes treatment [1]. The most important feature of these drugs is their beneficial effect on the reduction of cardiovascular risk. ...
Article
We present a 62-year-old obese male patient with a 12-year history of type 2 diabetes and poor glycemic control: HbA1c 12% (108 mmol/mol). Patient was admitted to Diabetology Department to optimize diabetes treatment. After diabetes treatment modification (among others an SGLT -2 inhibitor adding) we observed excess weight loss - 21 kg within 180 days. In our opinion, progressive weight loss can not be associated with the change in lifestyle or the increase in physical activity but with the mechanism of drug action. Does it result from the hyper-reactivity of SGLT-2 or the mechanism of drug action that has not been discovered yet?
... An outpatient healthcare team includes a child diabetologist or endocrinologist, nurse, dietician, and psychologist. One of the tasks of the healthcare team is to educate school staff on diabetes management (Diabetology Clinical, 2018). The healthcare team should ensure a good cooperation between the child's family, school nurses, and teachers. ...
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Background: In general, school nurses are aware that it is important to have knowledge of type 1 diabetes to give adequate care to children with the disease. Many studies assessing diabetes knowledge have found different deficits among nurses. To our knowledge, however, no study has assessed the knowledge of type 1 diabetes among school nurses. Objective: To assess actual and perceived diabetes knowledge among school nurses. Design: Cross-sectional studies. Settings: Seventeen primary care facilities in Warsaw that employed school nurses. Participants: Two hundred and thirty school nurses. Methods: With the Diabetes Knowledge Questionnaire (DKQ), we assessed actual diabetes knowledge. With the Self-Assessed Diabetes Knowledge (SADK), we assessed perceived diabetes knowledge. Both the DKQ and SADK assessed seven domains of diabetes knowledge: general diabetes knowledge; insulin and glucagon; insulin pumps; diabetes complications; nutrition; physical activity, stress, and comorbidities; and glycemia measurements. We related DKQ and SADK scores to each other and to sociodemographic and work-related factors. Results: The rate of correct responses in the DKQ was 46.7%, with the lowest rate regarding knowledge of insulin pumps (36.5%), nutrition (37.4%), and insulin and glucagon (37.9%). Actual and perceived diabetes knowledge were moderately positively correlated (rho = 0.18, p =.009). In six of the seven knowledge domains examined, school nurses perceived their diabetes knowledge better compared with their actual knowledge. DKQ scores were higher in nurses with higher education (p = .024), those who had relatives or friends with diabetes (p = .032), and those who had prior diabetes training (p = .050). Interestingly, DKQ scores were higher among nurses with fewer years of experience (rho = - 0.18, p = .011). Conclusions: There is a need for additional diabetes training among nursing students and practicing nurses to provide safe and effective care for children with type 1 diabetes.
... Chronic hyperglycemia is associated with failure of various organs. One of the complications of diabetes that is a major cause of premature mortality in type 2 diabetes is cardiovascular disease [1]. ...
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Background: This study assessed the influence of the haptoglobin phenotype on markers regulating inflammation in patients with type 2 diabetes. Methods: The haptoglobin phenotypes, soluble form of CD163 receptor (sCD163), p53 concentrations and high mobility group box protein 1 (HMGB1), interleukin 10 (IL-10) secretion in serum were assayed via ELISA tests. In the first part of the project, patients were divided into three groups which differed by the haptoglobin phenotype, and afterwards into two groups according to the criterion of the presence or absence of cardiovascular disease. Results: Diabetic patients with haptoglobin phenotype 1-1 (Hp1-1) had a significantly higher concentration of IL-10 and sCD163 compared to haptoglobin phenotype 2-1 (Hp2-1) and haptoglobin phenotype 2-2 (Hp2-2). Moreover, diabetic patients with Hp1-1 had a significantly lower concentration of p53 and HMGB1 compared to diabetic patients with Hp2-1 and Hp2-2. The results have shown that diabetics with Hp2-1 had a significantly lower postprandial glucose level compared to diabetics with Hp2-2. Apart from that, there were no differences in the occurrence of haptoglobin variants between patients with or without cardiovascular disease. Conclusions: Our study provides new data for a relationship between the type of haptoglobin in patients with type 2 diabetes and the concentration of factors that regulate the body's inflammation. We have shown that the Hp1-1 can serve as a genetic marker of inflammatory processes.
... Polskie Towarzystwo Diabetologiczne [Gumprecht 2018] w celach dietoterapii cukrzycy typu 2 zaleca opieranie diety osób chorych przede wszystkim na produktach o niskim indeksie glikemicznym (IG < 55). Można do nich zaliczyć nasiona roślin strączkowych, które dodatkowo charakteryzują się wysoką zawartością włókna pokarmowego, którego jedną z funkcji jest obniżenie poposiłkowego stężenia glukozy we krwi i/lub obniżenie poziomu insuliny [Jarosz 2017]. ...
... Digital technology provides access to educational content, information, and general support for those with diabetes, the most challenging chronic disease with complex clinical care and management (16,17). Educational programs are the basis for the treatment and prevention of diabetes (18). Furthermore, technologybased education can support regular diabetes selfmanagement activities including continuous glucose monitoring, physical exercise, healthy nutrition, taking medication, management of complications, and problemsolving (19). ...
Article
Background: Nowadays, digital games are not just entertainment, but beside routine treatments, they are used in patient care, especially in patients with diabetes. Application of digital games in patient's education can improve self-management of diabetes. The aim of the present study was to evaluate the effect of a mobile game (Amoo) implementation on enhancing dietary information in patients with type 2 diabetes. Methods: A mobile game (called Amoo), which was developed by researchers of this study, was applied to assess the self-education of patients with diabetes. Sixty patients with type 2 diabetes participated in the study. The participants took part in a pre-intervention test to determine their dietary information. The participants were randomly divided into one of two groups, including the intervention group: played the game for 15 minutes daily for 6 weeks, and the control group: did not involve in the game. A post-intervention test was run to show a possible improvement in dietary information. Data were analyzed using paired t test and suitable non-parametric testes including Mann-Whitney and Wilcoxon signed rank tests as well as Spearman and Pearson correlation coefficients via IBM SPSS statistics version 21 (SPSS, v 21.0, IBM, Armonk, NY, USA). A P-value less than 0.05 was considered as a significant level. Results: The results indicated a statistically significant difference between the pre and post test scores in the intervention group (p<0.001). However, there was no significant difference in fasting blood sugar (p=0.125). Conclusion: The mobile game (Amoo) could enhance the knowledge of patients with type 2 diabetes about food calories and glycemic index. This means that mobile games may serve as an educational aid to these patients.
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Objective: The aim of this study was to check the hypothesis concerning the crucial role of DNA methylation (one of the epigenetic mechanisms) within selected genes related to the destruction and regeneration of neural cells and its input in the pathogenesis of diabetic neuropathy, using a model of the DNA in peripheral blood cells. Methods: A cross-sectional, case-control study was conducted, consisting of 24 adult Type 1 Diabetes Melitus (T1DM) patients with autonomic neuropathy (CAN), 25 T1DM patients without neuropathy and 25 matched, healthy adults acting as a control (Ctrl). The Ewing's tests, using the ProSciCard apparatus (Mewicon CATEEM-Tec GmbH), was employed to assess the severity of the patients' symptoms of autonomic neuropathy. For DNA methylation analysis, DNA material of each sample DNA after bisulfite conversion was used for the hybridization of BeadChips (Infinium Methylation EPIC Kit, Illumina), and imaged on the Illumina HiScan. The changes in the expression of selected genes were examined using real-time PCR. Probes were labeled using fluorescein amidite, FAM (Thermo Fisher Scientific). Amplification was performed using the continuous fluorescence detection 7900 HT Fast Real-Time PCR system (Thermo Fisher Scientific). The expression ratio of the target mRNA was normalized to the level of 18s RNA and compared with the control. Statistical analysis was performed using Statistica version 13.1. The statistically significant results were recognized, with a value of p < 0.05. Results: Clinical analysis of the investigated groups revealed a significantly higher percentage of personal insulin pump users in the group without neuropathy. The glucose metabolic control, based on the HbA1c level analysis, was also significantly better in T1DM patients without CAN. The Bumphunter method for DNA methylation analysis showed statistically significant regions related to the genes involved in nerve regeneration ninjurin 2 (NINJ2) and functionality (BR serine/threonine kinase 2 BRSK2, claudin 4 CLDN4). When compared with T1DM patients without neuropathy, T1DM patients with neuropathy showed significantly increased methylation in the first NINJ2 axon, and a lower level of DNA methylation in the region of the first intron of BRSK2, as well as the CLDN4 5'UTR regions. The qRT-PCR results confirmed the decreased expression of NINJ2 and CLDN4 genes in patients with T1DM with CAN. Conclusions: The different DNA methylation profiles, correlating with the expression of genes related to nervous tissue development and regeneration in patients with T1DM with autonomic neuropathy provide evidence for the role of epigenetic mechanisms promoting the development of CAN, a chronic complication of T1DM.
Article
Aims To evaluate the prevalence of diabetes and impaired fasting glucose in Poland in 2013–2014 and to determine the temporal trends between 2003–2005 and 2013–2014. Methods A questionnaire survey was conducted in a representative sample of Polish adults, complemented by anthropometric and fasting plasma glucose measurements. The research was part of the national cross‐sectional WOBASZ study. Diabetes was assessed as self‐reported or screened (fasting plasma glucose level ≥ 7 mmol/l, based on one blood sample). Results In the years 2013–2014 among 5694 participants aged 20–74 years, 6.0% (95% CI 5.4–6.6) reported a previous diagnosis of diabetes (5.8% in women and 6.2% in men). In addition, 2.4% of the participants (95% CI 2.0–2.8) without a previous diagnosis of diabetes (1.8% of women and 3.1% of men) had a fasting blood glucose level ≥7.0 mmol/l in a single measurement. In a single measurement, 18.4% of the participants (95% CI 17.4–19.4; 13.2% of women and 23.8% of men) had impaired fasting glucose. The prevalence of dysglycaemia in the WOBASZ II study was significantly higher compared to the WOBASZ I study findings from 2003–2005, increased from 6.6% to 8.4% for diabetes and from 9.3% to 18.4% for impaired fasting glucose (after age and sex standardization to the 2013 Polish population). Conclusions The prevalence of diabetes in Poland is similar to that observed in other European populations and has increased significantly over the last decade.
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Due to a global increase in the prevalence of type 2 diabetes mellitus (T2DM), there is an urgent need for early identification of prediabetes, as these people have the highest risk of developing diabetes. Circulating miRNAs have shown potential as progression biomarkers in other diseases. This study aimed to conduct a baseline comparison of serum-circulating miRNAs in prediabetic individuals, with the distinction between those who later progressed to T2DM and those who did not. The expression levels of 798 miRNAs using NanoString technology were examined. Spearman correlation, receiver operating characteristic (ROC) curve analysis, and logistic regression modeling were performed. Gene ontology (GO) and canonical pathway analysis were used to explore the biological functions of the miRNA target genes. The study revealed that three miRNAs were upregulated in the serum samples of patients who later progressed to T2DM. Pathway analysis showed that the miRNA target genes were mainly significantly enriched in neuronal NO synthase (nNOS) signaling in neurons, amyloid processing, and hepatic cholestasis. ROC analysis demonstrated that miR-491-5p, miR-1307-3p, and miR-298 can be introduced as a diagnostic tool for the prediction of T2DM (area under the curve (AUC) = 94.0%, 88.0%, and 84.0%, respectively). Validation by real-time quantitative polymerase chain reaction (qRT-PCR) confirmed our findings. The results suggest that circulating miRNAs can potentially be used as predictive biomarkers of T2DM in prediabetic patients.
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Introduction. The history of recommendations by the Polish Federation for Education in Diabetology dates back to 2006, when guidelines for nurses/midwifes working with diabetic patients were first drawn up. However, the development of nurses and midwifes? competences requires stronger actions that foster a transition from experience-based towards evidence-based practice. Aim. The aim of this publication is to present a set of procedures describing nursing interventions in diabetes care, including currently available scientific evidence and clinical experience of specialists involved in the care of diabetic patients. Material and methods. The study involved a literature review of selected areas of nursing practice in diabetes care. When compiling the material, the priority was to use data from (in order of significance): randomized controlled clinical trials and their meta-analyses, observational studies and other studies with an adequate scientific status. Results. This joint study yielded 11 procedures describing selected aspects of nursing interventions in diabetic patients. Each of the procedures details key recommendations on diabetes care, arranged in accordance of the significance ascribed to the scientific evidence analyzed. Conclusions. The 2020 PFED guidelines on nursing and midwifery diabetes care are the effect of the evaluation of the previous versions and comprise a considerably more extensive, comprehensive and evidence-based set of practices. The major asset of these guidelines is their interdisciplinarity, reflected in the fact that the final version of the publication was approved by consultants in numerous nursing fields, a consultant in diabetology, and the President of the Polish Federation for Education in Diabetology, who all represent the medical community. The authors experience gained during work on international recommendations (New Insulin Delivery Recommendations) played an important role when formulating the present guidelines.
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Aim To investigate whether physical activity is associated with the occurrence of remission in adults with type 1 diabetes. Methods 99 adult participants with newly diagnosed type 1 diabetes were enrolled into a prospective, observational study. The participants were advised to exercise 2-3 times a week with moderate intensity for a one-year period. Physical activity was assessed by a self-administrated questionnaire on every fourth visit. We counted the months in which participants fulfilled a partial-remission criteria: HbA1c <6.5%, C-peptide >0.5 ng/ml, and daily dose of insulin <0.3 U/kg/day. We assigned the participants to two groups: MORE EFFORT and LESS EFFORT, depending on the median value of physical activity in the studied population. Results The occurrence of the remission achieved statistical significance at 6th month with a greater prevalence in MORE EFFORT group (55% vs. 35% p=0.047). In multivariate logistic regression analysis for the occurrence of remission at 12th month, physical activity before the diagnosis was the only variable that influences the occurrence of the remission [AOR=3.32 (95%CI 1.25-8.80); p=0.02]. Conclusion In adults with newly diagnosed type 1 diabetes physical activity before the diagnosis is associated with higher occurrence of remission. This article is protected by copyright. All rights reserved.
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Objective Reporting Items for Clinical Practice Guidelines (CPGs) in HealThcare (RIGHT) checklist was used as a tool to assess the reporting quality of 2014–2018 CPGs on diabetes treatment, aiming to promote the application of RIGHT and improve the reporting quality of future guidelines. Methods We searched Chinese Biomedical Literature Service System (CBM), China National Knowledge Infrastructure (CNKI), Wanfang Data, VIP database, Medline, Embase, Allied, and Complementary MEdicine Database (AMED), and Medlive and Google Scholar (Google academics), and collected published CPGs on diabetes with published date during 1st January, 2014 and 7th November, 2018. CPGs on diabetes issued since 2014 were included and filtered by two reviewers independently. Then the basic information extraction and RIGHT evaluation of the included CPG are carried out. Results A total of 34 guidelines were included, out of which 7 are for Chinese and 27 for other countries. Overall, basic information (domain 1) got the highest (64.66%) reporting rate, while financing and conflict-of-interest statements and management (domain 6) got the lowest (8.1%). For all guidelines, classification of guidelines (item 1c) was sufficiently reported, and description of the specific sources of funding for all stages of guideline development (item 18a) was not reported. For Chinese CPGs, financing and conflict-of-interest statements and management (domain 6) was most insufficiently reported, and only identification of guideline in the title (item 1a), corresponding information of the developer or author (item 4), description of basic epidemiology (item 5), and subgroup description (item 7b) out of 22 items were better reported than foreign guidelines. Conclusions Overall, the CPGs on diabetes during 2014–2018 adhered to ~41% RIGHT checklist, of which Chinese CPGs adhered less than that of foreign guidelines. It is suggested that the RIGHT reporting checklist should be endorsed and used by CPG developers to ensure higher quality and adequate use of guidelines.
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Background: Gestational diabetes mellitus (GDM) is associated with short- and long-term complications for the mother and her infant. Women who are unable to maintain their blood glucose concentration within pre-specified treatment targets with diet and lifestyle interventions will require anti-diabetic pharmacological therapies. This review explores the safety and effectiveness of insulin compared with oral anti-diabetic pharmacological therapies, non-pharmacological interventions and insulin regimens. Objectives: To evaluate the effects of insulin in treating women with gestational diabetes. Search methods: We searched Pregnancy and Childbirth's Trials Register (1 May 2017), ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP) (1 May 2017) and reference lists of retrieved studies. Selection criteria: We included randomised controlled trials (including those published in abstract form) comparing:a) insulin with an oral anti-diabetic pharmacological therapy;b) with a non-pharmacological intervention;c) different insulin analogues;d) different insulin regimens for treating women with diagnosed with GDM.We excluded quasi-randomised and trials including women with pre-existing type 1 or type 2 diabetes. Cross-over trials were not eligible for inclusion. Data collection and analysis: Two review authors independently assessed study eligibility, risk of bias, and extracted data. Data were checked for accuracy. Main results: We included 53 relevant studies (103 publications), reporting data for 7381 women. Forty-six of these studies reported data for 6435 infants but our analyses were based on fewer number of studies/participants.Overall, the risk of bias was unclear; 40 of the 53 included trials were not blinded. Overall, the quality of the evidence ranged from moderate to very low quality. The primary reasons for downgrading evidence were imprecision, risk of bias and inconsistency. We report the results for our maternal and infant GRADE outcomes for the main comparison. Insulin versus oral anti-diabetic pharmacological therapyFor the mother, insulin was associated with an increased risk for hypertensive disorders of pregnancy (not defined) compared to oral anti-diabetic pharmacological therapy (risk ratio (RR) 1.89, 95% confidence interval (CI) 1.14 to 3.12; four studies, 1214 women; moderate-quality evidence). There was no clear evidence of a difference between those who had been treated with insulin and those who had been treated with an oral anti-diabetic pharmacological therapy for the risk of pre-eclampsia (RR 1.14, 95% CI 0.86 to 1.52; 10 studies, 2060 women; moderate-quality evidence); the risk of birth by caesarean section (RR 1.03, 95% CI 0.93 to 1.14; 17 studies, 1988 women; moderate-quality evidence); or the risk of developing type 2 diabetes (metformin only) (RR 1.39, 95% CI 0.80 to 2.44; two studies, 754 women; moderate-quality evidence). The risk of undergoing induction of labour for those treated with insulin compared with oral anti-diabetic pharmacological therapy may possibly be increased, although the evidence was not clear (average RR 1.30, 95% CI 0.96 to 1.75; three studies, 348 women; I² = 32%; moderate-quality of evidence). There was no clear evidence of difference in postnatal weight retention between women treated with insulin and those treated with oral anti-diabetic pharmacological therapy (metformin) at six to eight weeks postpartum (MD -1.60 kg, 95% CI -6.34 to 3.14; one study, 167 women; low-quality evidence) or one year postpartum (MD -3.70, 95% CI -8.50 to 1.10; one study, 176 women; low-quality evidence). The outcomes of perineal trauma/tearing or postnatal depression were not reported in the included studies.For the infant, there was no evidence of a clear difference between those whose mothers had been treated with insulin and those treated with oral anti-diabetic pharmacological therapies for the risk of being born large-for-gestational age (average RR 1.01, 95% CI 0.76 to 1.35; 13 studies, 2352 infants; moderate-quality evidence); the risk of perinatal (fetal and neonatal death) mortality (RR 0.85; 95% CI 0.29 to 2.49; 10 studies, 1463 infants; low-quality evidence);, for the risk of death or serious morbidity composite (RR 1.03, 95% CI 0.84 to 1.26; two studies, 760 infants; moderate-quality evidence); the risk of neonatal hypoglycaemia (average RR 1.14, 95% CI 0.85 to 1.52; 24 studies, 3892 infants; low-quality evidence); neonatal adiposity at birth (% fat mass) (mean difference (MD) 1.6%, 95% CI -3.77 to 0.57; one study, 82 infants; moderate-quality evidence); neonatal adiposity at birth (skinfold sum/mm) (MD 0.8 mm, 95% CI -2.33 to 0.73; random-effects; one study, 82 infants; very low-quality evidence); or childhood adiposity (total percentage fat mass) (MD 0.5%; 95% CI -0.49 to 1.49; one study, 318 children; low-quality evidence). Low-quality evidence also found no clear differences between groups for rates of neurosensory disabilities in later childhood: hearing impairment (RR 0.31, 95% CI 0.01 to 7.49; one study, 93 children), visual impairment (RR 0.31, 95% CI 0.03 to 2.90; one study, 93 children), or any mild developmental delay (RR 1.07, 95% CI 0.33 to 3.44; one study, 93 children). Later infant mortality, and childhood diabetes were not reported as outcomes in the included studies.We also looked at comparisons for regular human insulin versus other insulin analogues, insulin versus diet/standard care, insulin versus exercise and comparisons of insulin regimens, however there was insufficient evidence to determine any differences for many of the key health outcomes. Please refer to the main results for more information about these comparisons. Authors' conclusions: The main comparison in this review is insulin versus oral anti-diabetic pharmacological therapies. Insulin and oral anti-diabetic pharmacological therapies have similar effects on key health outcomes. The quality of the evidence ranged from very low to moderate, with downgrading decisions due to imprecision, risk of bias and inconsistency.For the other comparisons of this review (insulin compared with non-pharmacological interventions, different insulin analogies or different insulin regimens), there is insufficient volume of high-quality evidence to determine differences for key health outcomes.Long-term maternal and neonatal outcomes were poorly reported for all comparisons.The evidence suggests that there are minimal harms associated with the effects of treatment with either insulin or oral anti-diabetic pharmacological therapies. The choice to use one or the other may be down to physician or maternal preference, availability or severity of GDM. Further research is needed to explore optimal insulin regimens. Further research could aim to report data for standardised GDM outcomes.
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Background: Pregnant women with type 1 diabetes are a high-risk population who are recommended to strive for optimal glucose control, but neonatal outcomes attributed to maternal hyperglycaemia remain suboptimal. Our aim was to examine the effectiveness of continuous glucose monitoring (CGM) on maternal glucose control and obstetric and neonatal health outcomes. Methods: In this multicentre, open-label, randomised controlled trial, we recruited women aged 18-40 years with type 1 diabetes for a minimum of 12 months who were receiving intensive insulin therapy. Participants were pregnant (≤13 weeks and 6 days' gestation) or planning pregnancy from 31 hospitals in Canada, England, Scotland, Spain, Italy, Ireland, and the USA. We ran two trials in parallel for pregnant participants and for participants planning pregnancy. In both trials, participants were randomly assigned to either CGM in addition to capillary glucose monitoring or capillary glucose monitoring alone. Randomisation was stratified by insulin delivery (pump or injections) and baseline glycated haemoglobin (HbA1c). The primary outcome was change in HbA1c from randomisation to 34 weeks' gestation in pregnant women and to 24 weeks or conception in women planning pregnancy, and was assessed in all randomised participants with baseline assessments. Secondary outcomes included obstetric and neonatal health outcomes, assessed with all available data without imputation. This trial is registered with ClinicalTrials.gov, number NCT01788527. Findings: Between March 25, 2013, and March 22, 2016, we randomly assigned 325 women (215 pregnant, 110 planning pregnancy) to capillary glucose monitoring with CGM (108 pregnant and 53 planning pregnancy) or without (107 pregnant and 57 planning pregnancy). We found a small difference in HbA1c in pregnant women using CGM (mean difference -0·19%; 95% CI -0·34 to -0·03; p=0·0207). Pregnant CGM users spent more time in target (68% vs 61%; p=0·0034) and less time hyperglycaemic (27% vs 32%; p=0·0279) than did pregnant control participants, with comparable severe hypoglycaemia episodes (18 CGM and 21 control) and time spent hypoglycaemic (3% vs 4%; p=0·10). Neonatal health outcomes were significantly improved, with lower incidence of large for gestational age (odds ratio 0·51, 95% CI 0·28 to 0·90; p=0·0210), fewer neonatal intensive care admissions lasting more than 24 h (0·48; 0·26 to 0·86; p=0·0157), fewer incidences of neonatal hypoglycaemia (0·45; 0·22 to 0·89; p=0·0250), and 1-day shorter length of hospital stay (p=0·0091). We found no apparent benefit of CGM in women planning pregnancy. Adverse events occurred in 51 (48%) of CGM participants and 43 (40%) of control participants in the pregnancy trial, and in 12 (27%) of CGM participants and 21 (37%) of control participants in the planning pregnancy trial. Serious adverse events occurred in 13 (6%) participants in the pregnancy trial (eight [7%] CGM, five [5%] control) and in three (3%) participants in the planning pregnancy trial (two [4%] CGM and one [2%] control). The most common adverse events were skin reactions occurring in 49 (48%) of 103 CGM participants and eight (8%) of 104 control participants during pregnancy and in 23 (44%) of 52 CGM participants and five (9%) of 57 control participants in the planning pregnancy trial. The most common serious adverse events were gastrointestinal (nausea and vomiting in four participants during pregnancy and three participants planning pregnancy). Interpretation: Use of CGM during pregnancy in patients with type 1 diabetes is associated with improved neonatal outcomes, which are likely to be attributed to reduced exposure to maternal hyperglycaemia. CGM should be offered to all pregnant women with type 1 diabetes using intensive insulin therapy. This study is the first to indicate potential for improvements in non-glycaemic health outcomes from CGM use. Funding: Juvenile Diabetes Research Foundation, Canadian Clinical Trials Network, and National Institute for Health Research.
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Purpose of Review Diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS) are diabetic emergencies that cause high morbidity and mortality. Their treatment differs in the UK and USA. This review delineates the differences in diagnosis and treatment between the two countries. Recent Findings Large-scale studies to determine optimal management of DKA and HHS are lacking. The diagnosis of DKA is based on disease severity in the USA, which differs from the UK. The diagnosis of HHS in the USA is based on total rather than effective osmolality. Unlike the USA, the UK has separate guidelines for DKA and HHS. Treatment of DKA and HHS also differs with respect to timing of fluid and insulin initiation. Summary There is considerable overlap but important differences between the UK and USA guidelines for the management of DKA and HHS. Further research needs to be done to delineate a unifying diagnostic and treatment protocol.
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Potential benefits of carbohydrate counting for glycemic control in patients with type 1 diabetes mellitus (T1DM) remain inconclusive. Our aim is to systematically assess the efficacy of carbohydrate counting in patients with T1DM. We searched PubMed, Embase, Web of Science, Cochrane Library and the Chinese Biology Medicine (CBM) up to December 2015. Randomized controlled trials (RCTs) with at least 3 months follow-up that evaluated carbohydrate counting compared with usual or other diabetes dietary education in patients with T1DM were included. Overall meta-analysis identified a significant decrease in HbA1c concentration with carbohydrate counting versus other diabetes diet method or usual diabetes dietary education (SMD: −0.35, 95%CI: −0.65 to −0.05, P = 0.023). Subgroup analysis restricted to trials which compared carbohydrate counting with usual diabetes dietary found a significant decrease in HbA1c in carbohydrate counting group (SMD: −0.68, 95%CI: −0.98 to −0.38, P = 0.000), and a similar result has emerged from six studies in adults (SMD: −0.40, 95%CI: −0.78 to −0.02, P = 0.037). Carbohydrate counting may confer positive impact on glucose control. Larger clinical trials are warranted to validate this positive impact.
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Objective: The Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Released Controlled Evaluation (ADVANCE) trial reported that intensive glucose control prevents end-stage kidney disease (ESKD) in patients with type 2 diabetes, but uncertainty about the balance between risks and benefits exists. Here, we examine the long-term effects of intensive glucose control on risk of ESKD and other outcomes. Research design and methods: Survivors, previously randomized to intensive or standard glucose control, were invited to participate in post-trial follow-up. ESKD, defined as the need for dialysis or kidney transplantation, or death due to kidney disease, was documented overall and by baseline CKD stage, along with hypoglycemic episodes, major cardiovascular events, and death from other causes. Results: A total of 8,494 ADVANCE participants were followed for a median of 5.4 additional years. In-trial HbA1c differences disappeared by the first post-trial visit. The in-trial reductions in the risk of ESKD (7 vs. 20 events, hazard ratio [HR] 0.35, P = 0.02) persisted after 9.9 years of overall follow-up (29 vs. 53 events, HR 0.54, P < 0.01). These effects were greater in earlier-stage CKD (P = 0.04) and at lower baseline systolic blood pressure levels (P = 0.01). The effects of glucose lowering on the risks of death, cardiovascular death, or major cardiovascular events did not differ by levels of kidney function (P > 0.26). Conclusions: Intensive glucose control was associated with a long-term reduction in ESKD, without evidence of any increased risk of cardiovascular events or death. These benefits were greater with preserved kidney function and with well-controlled blood pressure.
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Objective To assess the effect of antihypertensive treatment on mortality and cardiovascular morbidity in people with diabetes mellitus, at different blood pressure levels. Design Systematic review and meta-analyses of randomised controlled trials. Data sources CENTRAL, Medline, Embase, and BIOSIS were searched using highly sensitive search strategies. When data required according to the protocol were missing but trials were potentially eligible, we contacted researchers, pharmaceutical companies, and authorities. Eligibility criteria Randomised controlled trials including 100 or more people with diabetes mellitus, treated for 12 months or more, comparing any antihypertensive agent against placebo, two agents against one, or different blood pressure targets. Results 49 trials, including 73 738 participants, were included in the meta-analyses. Most of the participants had type 2 diabetes. If baseline systolic blood pressure was greater than 150 mm Hg, antihypertensive treatment reduced the risk of all cause mortality (relative risk 0.89, 95% confidence interval 0.80 to 0.99), cardiovascular mortality (0.75, 0.57 to 0.99), myocardial infarction (0.74, 0.63 to 0.87), stroke (0.77, 0.65 to 0.91), and end stage renal disease (0.82, 0.71 to 0.94). If baseline systolic blood pressure was 140-150 mm Hg, additional treatment reduced the risk of all cause mortality (0.87, 0.78 to 0.98), myocardial infarction (0.84, 0.76 to 0.93), and heart failure (0.80, 0.66 to 0.97). If baseline systolic blood pressure was less than 140 mm Hg, however, further treatment increased the risk of cardiovascular mortality (1.15, 1.00 to 1.32), with a tendency towards an increased risk of all cause mortality (1.05, 0.95 to 1.16). Metaregression analyses showed a worse treatment effect with lower baseline systolic blood pressures for cardiovascular mortality (1.15, 1.03 to 1.29 for each 10 mm Hg lower systolic blood pressure) and myocardial infarction (1.12, 1.03 to 1.22 for each 10 mm Hg lower systolic blood pressure). Patterns were similar for attained systolic blood pressure. Conclusions Antihypertensive treatment reduces the risk of mortality and cardiovascular morbidity in people with diabetes mellitus and a systolic blood pressure more than 140 mm Hg. If systolic blood pressure is less than 140 mm Hg, however, further treatment is associated with an increased risk of cardiovascular death, with no observed benefit.
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Background Increased plantar foot pressure is one of several key factors that lead to diabetic foot ulcers. Multiple methods have been proposed to relieve this pressure and thus enhance wound healing and potentially prevent relapse. We aimed in this systematic review to find the best available evidence for off-loading methods. Methods We searched MEDLINE, Embase, Cochrane CENTRAL, Web of Science, and Scopus through October 2011. Pairs of independent reviewers selected studies and extracted data. Predefined outcomes of interest included complete wound healing, time to complete wound healing, amputation, infection, and relapse rates. Results We identified 19 interventional studies, of which 13 were randomized controlled trials, including data from 1605 patients with diabetic foot ulcers using an off-loading method. The risk of bias in the included studies was moderate. This analysis demonstrated improved wound healing with total contact casting over removable cast walker, therapeutic shoes, and conventional therapy. There was no advantage of irremovable cast walkers over total contact casting. There was improved healing with half-shoe compared with conventional wound care. Therapeutic shoes and insoles reduced relapse rate in comparison with regular footwear. Data were sparse regarding other off-loading methods. Conclusions Although based on low-quality evidence (ie, evidence warranting lower certainty), benefits are demonstrated for use of total contact casting and irremovable cast walkers in the treatment of diabetic foot ulcers. Reduced relapse rate is demonstrated with various therapeutic shoes and insoles in comparison with regular footwear.
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Background: The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain. Methods: We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. Results: At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P=0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group. Conclusions: Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.).
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Objective: Assess effect of diabetes self-management education and support methods, providers, duration, and contact time on glycemic control in adults with type 2 diabetes. Method: We searched MEDLINE, CINAHL, EMBASE, ERIC, and PsycINFO to December 2013 for interventions which included elements to improve participants' knowledge, skills, and ability to perform self-management activities as well as informed decision-making around goal setting. Results: This review included 118 unique interventions, with 61.9% reporting significant changes in A1C. Overall mean reduction in A1C was 0.74 and 0.17 for intervention and control groups; an average absolute reduction in A1C of 0.57. A combination of group and individual engagement results in the largest decreases in A1C (0.88). Contact hours ≥10 were associated with a greater proportion of interventions with significant reduction in A1C (70.3%). In patients with persistently elevated glycemic values (A1C>9), a greater proportion of studies reported statistically significant reduction in A1C (83.9%). Conclusions: This systematic review found robust data demonstrating that engagement in diabetes self-management education results in a statistically significant decrease in A1C levels. Practice implications: The data suggest mode of delivery, hours of engagement, and baseline A1C can affect the likelihood of achieving statistically significant and clinically meaningful improvement in A1C.
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Importance Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME).Objective To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy.Design, Setting, and Participants Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015.Interventions Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n = 203 eyes), or ranibizumab, 0.5 mg, by intravitreous injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n = 191 eyes). Eyes in both treatment groups could receive ranibizumab for DME.Main Outcomes and Measures The primary outcome was mean visual acuity change at 2 years (5-letter noninferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization.Results Mean visual acuity letter improvement at 2 years was +2.8 in the ranibizumab group vs +0.2 in the PRP group (difference, +2.2; 95% CI, −0.5 to +5.0; P < .001 for noninferiority). The mean treatment group difference in visual acuity area under the curve over 2 years was +4.2 (95% CI, +3.0 to +5.4; P < .001). Mean peripheral visual field sensitivity loss was worse (−23 dB vs −422 dB; difference, 372 dB; 95% CI, 213-531 dB; P < .001), vitrectomy was more frequent (15% vs 4%; difference, 9%; 95% CI, 4%-15%; P < .001), and DME development was more frequent (28% vs 9%; difference, 19%; 95% CI, 10%-28%; P < .001) in the PRP group vs the ranibizumab group, respectively. Eyes without active or regressed neovascularization at 2 years were not significantly different (35% in the ranibizumab group vs 30% in the PRP group; difference, 3%; 95% CI, −7% to 12%; P = .58). One eye in the ranibizumab group developed endophthalmitis. No significant differences between groups in rates of major cardiovascular events were identified.Conclusions and Relevance Among eyes with proliferative diabetic retinopathy, treatment with ranibizumab resulted in visual acuity that was noninferior to (not worse than) PRP treatment at 2 years. Although longer-term follow-up is needed, ranibizumab may be a reasonable treatment alternative, at least through 2 years, for patients with proliferative diabetic retinopathy.Trial Registration clinicaltrials.gov Identifier: NCT01489189
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Background: Traditional genetic testing focusses on analysis of one or a few genes according to clinical features; this approach is changing as improved sequencing methods enable simultaneous analysis of several genes. Neonatal diabetes is the presenting feature of many discrete clinical phenotypes defined by different genetic causes. Genetic subtype defines treatment, with improved glycaemic control on sulfonylurea treatment for most patients with potassium channel mutations. We investigated the effect of early, comprehensive testing of all known genetic causes of neonatal diabetes. Methods: In this large, international, cohort study, we studied patients with neonatal diabetes diagnosed with diabetes before 6 months of age who were referred from 79 countries. We identified mutations by comprehensive genetic testing including Sanger sequencing, 6q24 methylation analysis, and targeted next-generation sequencing of all known neonatal diabetes genes. Findings: Between January, 2000, and August, 2013, genetic testing was done in 1020 patients (571 boys, 449 girls). Mutations in the potassium channel genes were the most common cause (n=390) of neonatal diabetes, but were identified less frequently in consanguineous families (12% in consanguineous families vs 46% in non-consanguineous families; p<0·0001). Median duration of diabetes at the time of genetic testing decreased from more than 4 years before 2005 to less than 3 months after 2012. Earlier referral for genetic testing affected the clinical phenotype. In patients with genetically diagnosed Wolcott-Rallison syndrome, 23 (88%) of 26 patients tested within 3 months from diagnosis had isolated diabetes, compared with three (17%) of 18 patients referred later (>4 years; p<0·0001), in whom skeletal and liver involvement was common. Similarly, for patients with genetically diagnosed transient neonatal diabetes, the diabetes had remitted in only ten (10%) of 101 patients tested early (<3 months) compared with 60 (100%) of the 60 later referrals (p<0·0001). Interpretation: Patients are now referred for genetic testing closer to their presentation with neonatal diabetes. Comprehensive testing of all causes identified causal mutations in more than 80% of cases. The genetic result predicts the best diabetes treatment and development of related features. This model represents a new framework for clinical care with genetic diagnosis preceding development of clinical features and guiding clinical management. Funding: Wellcome Trust and Diabetes UK.
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Background: The relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown. Methods: At 89 clinical sites, we randomly assigned 660 adults (mean age, 61±10 years) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg (224 participants), bevacizumab at a dose of 1.25 mg (218 participants), or ranibizumab at a dose of 0.3 mg (218 participants). The study drugs were administered as often as every 4 weeks, according to a protocol-specified algorithm. The primary outcome was the mean change in visual acuity at 1 year. Results: From baseline to 1 year, the mean visual-acuity letter score (range, 0 to 100, with higher scores indicating better visual acuity; a score of 85 is approximately 20/20) improved by 13.3 with aflibercept, by 9.7 with bevacizumab, and by 11.2 with ranibizumab. Although the improvement was greater with aflibercept than with the other two drugs (P<0.001 for aflibercept vs. bevacizumab and P=0.03 for aflibercept vs. ranibizumab), it was not clinically meaningful, because the difference was driven by the eyes with worse visual acuity at baseline (P<0.001 for interaction). When the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with aflibercept, 7.5 with bevacizumab, and 8.3 with ranibizumab (P>0.50 for each pairwise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with aflibercept, 11.8 with bevacizumab, and 14.2 with ranibizumab (P<0.001 for aflibercept vs. bevacizumab, P=0.003 for aflibercept vs. ranibizumab, and P=0.21 for ranibizumab vs. bevacizumab). There were no significant differences among the study groups in the rates of serious adverse events (P=0.40), hospitalization (P=0.51), death (P=0.72), or major cardiovascular events (P=0.56). Conclusions: Intravitreous aflibercept, bevacizumab, or ranibizumab improved vision in eyes with center-involved diabetic macular edema, but the relative effect depended on baseline visual acuity. When the initial visual-acuity loss was mild, there were no apparent differences, on average, among study groups. At worse levels of initial visual acuity, aflibercept was more effective at improving vision. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01627249.).
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BACKGROUND: Continuous glucose monitoring highlights the complexity of postprandial glucose patterns present in type 1 diabetes and points to the limitations of current approaches to mealtime insulin dosing based primarily on carbohydrate counting. METHODS: A systematic review of all relevant biomedical databases, including MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials, was conducted to identify research on the effects of dietary fat, protein, and glycemic index (GI) on acute postprandial glucose control in type 1 diabetes and prandial insulin dosing strategies for these dietary factors. RESULTS: All studies examining the effect of fat (n = 7), protein (n = 7), and GI (n = 7) indicated that these dietary factors modify postprandial glycemia. Late postprandial hyperglycemia was the predominant effect of dietary fat; however, in some studies, glucose concentrations were reduced in the first 2–3 h, possibly due to delayed gastric emptying. Ten studies examining insulin bolus dose and delivery patterns required for high-fat and/or high-protein meals were identified. Because of methodological differences and limitations in experimental design, study findings were inconsistent regarding optimal bolus delivery pattern; however, the studies indicated that high-fat/protein meals require more insulin than lower-fat/protein meals with identical carbohydrate content. CONCLUSIONS: These studies have important implications for clinical practice and patient education and point to the need for research focused on the development of new insulin dosing algorithms based on meal composition rather than on carbohydrate content alone.
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To examine the teratogenic potential of statins. Cohort study. United States. A cohort of 886 996 completed pregnancies linked to liveborn infants of women enrolled in Medicaid from 2000 to 2007. We examined the risk of major congenital malformations and organ specific malformations in offspring associated with maternal use of a statin in the first trimester. Propensity score based methods were used to control for potential confounders, including maternal demographic characteristics, obstetric and medical conditions, and use of other drugs. 1152 (0.13%) women used a statin during the first trimester. In unadjusted analyses, the prevalence of malformations in the offspring of these women was 6.34% compared with 3.55% in those of women who did not use a statin in the first trimester (relative risk 1.79, 95% confidence interval 1.43 to 2.23). Controlling for confounders, particularly pre-existing diabetes, accounted for this increase in risk (1.07, 0.85 to 1.37). There were also no statistically significant increases in any of the organ specific malformations assessed after accounting for confounders. Results were similar across a range of sensitivity analyses. Our analysis did not find a significant teratogenic effect from maternal use of statins in the first trimester. However, these findings need to be replicated in other large studies, and the long term effects of in utero exposure to statins needs to be assessed, before use of statins in pregnancy can be considered safe. © Bateman et al 2015.
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Lowering blood pressure (BP) is widely used to reduce vascular risk in individuals with diabetes. To determine the associations between BP-lowering treatment and vascular disease in type 2 diabetes. We searched MEDLINE for large-scale randomized controlled trials of BP-lowering treatment including patients with diabetes, published between January 1966 and October 2014. Two reviewers independently extracted study characteristics and vascular outcome data. Estimates were stratified by baseline BP and achieved BP, and pooled using fixed-effects meta-analysis. All-cause mortality, cardiovascular events, coronary heart disease events, stroke, heart failure, retinopathy, new or worsening albuminuria, and renal failure. Forty trials judged to be of low risk of bias (100,354 participants) were included. Each 10-mm Hg lower systolic BP was associated with a significantly lower risk of mortality (relative risk [RR], 0.87; 95% CI, 0.78-0.96); absolute risk reduction (ARR) in events per 1000 patient-years (3.16; 95% CI, 0.90-5.22), cardiovascular events (RR, 0.89 [95% CI, 0.83-0.95]; ARR, 3.90 [95% CI, 1.57-6.06]), coronary heart disease (RR, 0.88 [95% CI, 0.80-0.98]; ARR, 1.81 [95% CI, 0.35-3.11]), stroke (RR, 0.73 [95% CI, 0.64-0.83]; ARR, 4.06 [95% CI, 2.53-5.40]), albuminuria (RR, 0.83 [95% CI, 0.79-0.87]; ARR, 9.33 [95% CI, 7.13-11.37]), and retinopathy (RR, 0.87 [95% CI, 0.76-0.99]; ARR, 2.23 [95% CI, 0.15-4.04]). When trials were stratified by mean baseline systolic BP at greater than or less than 140 mm Hg, RRs for outcomes other than stroke, retinopathy, and renal failure were lower in studies with greater baseline systolic BP (P interaction <0.1). The associations between BP-lowering treatments and outcomes were not significantly different, irrespective of drug class, except for stroke and heart failure. Estimates were similar when all trials, regardless of risk of bias, were included. Among patients with type 2 diabetes, BP lowering was associated with improved mortality and other clinical outcomes with lower RRs observed among those with baseline BP of 140 mm Hg and greater. These findings support the use of medications for BP lowering in these patients.
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Accumulating evidence suggests that bariatric surgery improves survival among patients with severe obesity, but research among veterans has shown no evidence of benefit. To examine long-term survival in a large multisite cohort of patients who underwent bariatric surgery compared with matched control patients. In a retrospective cohort study, we identified 2500 patients (74% men) who underwent bariatric surgery in Veterans Affairs (VA) bariatric centers from 2000-2011 and matched them to 7462 control patients using sequential stratification and an algorithm that included age, sex, geographic region, body mass index, diabetes, and Diagnostic Cost Group. Survival was compared across patients who underwent bariatric surgery and matched controls using Kaplan-Meier estimators and stratified, adjusted Cox regression analyses. Bariatric procedures, which included 74% gastric bypass, 15% sleeve gastrectomy, 10% adjustable gastric banding, and 1% other. All-cause mortality through December 2013. Surgical patients (n = 2500) had a mean age of 52 years and a mean BMI of 47. Matched control patients (n = 7462) had a mean age of 53 years and a mean BMI of 46. At the end of the 14-year study period, there were a total of 263 deaths in the surgical group (mean follow-up, 6.9 years) and 1277 deaths in the matched control group (mean follow-up, 6.6 years). Kaplan-Meier estimated mortality rates were 2.4% at 1 year, 6.4% at 5 years, and 13.8% at 10 years for surgical patients; for matched control patients, 1.7% at 1 year, 10.4% at 5 years, and 23.9% at 10 years. Adjusted analysis showed no significant association between bariatric surgery and all-cause mortality in the first year of follow-up (adjusted hazard ratio [HR], 1.28 [95% CI, 0.98-1.68]), but significantly lower mortality after 1 to 5 years (HR, 0.45 [95% CI, 0.36-0.56]) and 5 to 14 years (HR, 0.47 [95% CI, 0.39-0.58]). The midterm (>1-5 years) and long-term (>5 years) relationships between surgery and survival were not significantly different across subgroups defined by diabetes diagnosis, sex, and period of surgery. Among obese patients receiving care in the VA health system, those who underwent bariatric surgery compared with matched control patients who did not have surgery had lower all-cause mortality at 5 years and up to 10 years following the procedure. These results provide further evidence for the beneficial relationship between surgery and survival that has been demonstrated in younger, predominantly female populations.
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Importance Little evidence exists on which exercise modality is optimal for obese adolescents.Objective To determine the effects of aerobic training, resistance training, and combined training on percentage body fat in overweight and obese adolescents.Design, Setting, and Participants Randomized, parallel-group clinical trial at community-based exercise facilities in Ottawa (Ontario) and Gatineau (Quebec), Canada, among previously inactive postpubertal adolescents aged 14 to 18 years (Tanner stage IV or V) with body mass index at or above the 95th percentile for age and sex or at or above the 85th percentile plus an additional diabetes mellitus or cardiovascular risk factor.Interventions After a 4-week run-in period, 304 participants were randomized to the following 4 groups for 22 weeks: aerobic training (n = 75), resistance training (n = 78), combined aerobic and resistance training (n = 75), or nonexercising control (n = 76). All participants received dietary counseling, with a daily energy deficit of 250 kcal.Main Outcomes and Measures The primary outcome was percentage body fat measured by magnetic resonance imaging at baseline and 6 months. We hypothesized that aerobic training and resistance training would each yield greater decreases than the control and that combined training would cause greater decreases than aerobic or resistance training alone.Results Decreases in percentage body fat were −0.3 (95% CI, −0.9 to 0.3) in the control group, −1.1 (95% CI, −1.7 to −0.5) in the aerobic training group (P = .06 vs controls), and −1.6 (95% CI, −2.2 to −1.0) in the resistance training group (P = .002 vs controls). The −1.4 (95% CI, −2.0 to −0.8) decrease in the combined training group did not differ significantly from that in the aerobic or resistance training group. Waist circumference changes were −0.2 (95% CI, −1.7 to 1.2) cm in the control group, −3.0 (95% CI, −4.4 to −1.6) cm in the aerobic group (P = .006 vs controls), −2.2 (95% CI −3.7 to −0.8) cm in the resistance training group (P = .048 vs controls), and −4.1 (95% CI, −5.5 to −2.7) cm in the combined training group. In per-protocol analyses (≥70% adherence), the combined training group had greater changes in percentage body fat (−2.4, 95% CI, −3.2 to −1.6) vs the aerobic group (−1.2; 95% CI, −2.0 to −0.5; P = .04 vs the combined group) but not the resistance group (−1.6; 95% CI, −2.5 to −0.8).Conclusions and Relevance Aerobic, resistance, and combined training reduced total body fat and waist circumference in obese adolescents. In more adherent participants, combined training may cause greater decreases than aerobic or resistance training alone.Trial Registration clinicaltrials.gov Identifier: NCT00195858
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Background In the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) factorial trial, the combination of perindopril and indapamide reduced mortality among patients with type 2 diabetes, but intensive glucose control, targeting a glycated hemoglobin level of less than 6.5%, did not. We now report results of the 6-year post-trial follow-up. Methods We invited surviving participants, who had previously been assigned to perindopril–indapamide or placebo and to intensive or standard glucose control (with the glucose-control comparison extending for an additional 6 months), to participate in a post-trial follow-up evaluation. The primary end points were death from any cause and major macrovascular events. Results The baseline characteristics were similar among the 11,140 patients who originally underwent randomization and the 8494 patients who participated in the post-trial follow-up for a median of 5.9 years (blood-pressure–lowering comparison) or 5.4 years (glucose-control comparison). Between-group differences in blood pressure and glycated hemoglobin levels during the trial were no longer evident by the first post-trial visit. The reductions in the risk of death from any cause and of death from cardiovascular causes that had been observed in the group receiving active blood-pressure–lowering treatment during the trial were attenuated but significant at the end of the post-trial follow-up; the hazard ratios were 0.91 (95% confidence interval [CI], 0.84 to 0.99; P=0.03) and 0.88 (95% CI, 0.77 to 0.99; P=0.04), respectively. No differences were observed during follow-up in the risk of death from any cause or major macrovascular events between the intensive-glucose-control group and the standard-glucose-control group; the hazard ratios were 1.00 (95% CI, 0.92 to 1.08) and 1.00 (95% CI, 0.92 to 1.08), respectively. Conclusions The benefits with respect to mortality that had been observed among patients originally assigned to blood-pressure–lowering therapy were attenuated but still evident at the end of follow-up. There was no evidence that intensive glucose control during the trial led to long-term benefits with respect to mortality or macrovascular events. (Funded by the National Health and Medical Research Council of Australia and others; ADVANCE-ON ClinicalTrials.gov number, NCT00949286.)
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Objective: Effective treatment algorithms are needed to guide diabetes care at hospital discharge in general medicine and surgery patients with type 2 diabetes. Research design and methods: This was a prospective, multicenter open-label study aimed to determine the safety and efficacy of a hospital discharge algorithm based on admission HbA1c. Patients with HbA1c <7% (53.0 mmol/mol) were discharged on their preadmission diabetes therapy, HbA1c between 7 and 9% (53.0-74.9 mmol/mol) were discharged on a preadmission regimen plus glargine at 50% of hospital daily dose, and HbA1c >9% were discharged on oral antidiabetes agents (OADs) plus glargine or basal bolus regimen at 80% of inpatient dose. The primary outcome was HbA1c concentration at 12 weeks after hospital discharge. Results: A total of 224 patients were discharged on OAD (36%), combination of OAD and glargine (27%), basal bolus (24%), glargine alone (9%), and diet (4%). The admission HbA1c was 8.7 ± 2.5% (71.6 mmol/mol) and decreased to 7.3 ± 1.5% (56 mmol/mol) at 12 weeks of follow-up (P < 0.001). The change of HbA1c from baseline at 12 weeks after discharge was -0.1 ± 0.6, -0.8 ± 1.0, and -3.2 ± 2.4 in patients with HbA1c <7%, 7-9%, and >9%, respectively (P < 0.001). Hypoglycemia (<70 mg/dL) was reported in 22% of patients discharged on OAD only, 30% on OAD plus glargine, 44% on basal bolus, and 25% on glargine alone and was similar in patients with admission HbA1c ≤7% (26%) compared with those with HbA1c >7% (31%, P = 0.54). Conclusions: Measurement of HbA1c on admission is beneficial in tailoring treatment regimens at discharge in general medicine and surgery patients with type 2 diabetes.
Article
Importance Insulin pump therapy may improve metabolic control in young patients with type 1 diabetes, but the association with short-term diabetes complications is unclear. Objective To determine whether rates of severe hypoglycemia and diabetic ketoacidosis are lower with insulin pump therapy compared with insulin injection therapy in children, adolescents, and young adults with type 1 diabetes. Design, Setting, and Participants Population-based cohort study conducted between January 2011 and December 2015 in 446 diabetes centers participating in the Diabetes Prospective Follow-up Initiative in Germany, Austria, and Luxembourg. Patients with type 1 diabetes younger than 20 years and diabetes duration of more than 1 year were identified. Propensity score matching and inverse probability of treatment weighting analyses with age, sex, diabetes duration, migration background (defined as place of birth outside of Germany or Austria), body mass index, and glycated hemoglobin as covariates were used to account for relevant confounders. Exposures Type 1 diabetes treated with insulin pump therapy or with multiple (≥4) daily insulin injections. Main Outcomes and Measures Primary outcomes were rates of severe hypoglycemia and diabetic ketoacidosis during the most recent treatment year. Secondary outcomes included glycated hemoglobin levels, insulin dose, and body mass index. Results Of 30 579 patients (mean age, 14.1 years [SD, 4.0]; 53% male), 14 119 used pump therapy (median duration, 3.7 years) and 16 460 used insulin injections (median duration, 3.6 years). Patients using pump therapy (n = 9814) were matched with 9814 patients using injection therapy. Pump therapy, compared with injection therapy, was associated with lower rates of severe hypoglycemia (9.55 vs 13.97 per 100 patient-years; difference, −4.42 [95% CI, −6.15 to −2.69]; P < .001) and diabetic ketoacidosis (3.64 vs 4.26 per 100 patient-years; difference, −0.63 [95% CI, −1.24 to −0.02]; P = .04). Glycated hemoglobin levels were lower with pump therapy than with injection therapy (8.04% vs 8.22%; difference, −0.18 [95% CI, −0.22 to −0.13], P < .001). Total daily insulin doses were lower for pump therapy compared with injection therapy (0.84 U/kg vs 0.98 U/kg; difference, −0.14 [−0.15 to −0.13], P < .001). There was no significant difference in body mass index between both treatment regimens. Similar results were obtained after propensity score inverse probability of treatment weighting analyses in the entire cohort. Conclusions and Relevance Among young patients with type 1 diabetes, insulin pump therapy, compared with insulin injection therapy, was associated with lower risks of severe hypoglycemia and diabetic ketoacidosis and with better glycemic control during the most recent year of therapy. These findings provide evidence for improved clinical outcomes associated with insulin pump therapy compared with injection therapy in children, adolescents, and young adults with type 1 diabetes.
Article
BACKGROUND The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338.)
Article
Background Evolocumab is a monoclonal antibody that inhibits proprotein convertase subtilisin–kexin type 9 (PCSK9) and lowers low-density lipoprotein (LDL) cholesterol levels by approximately 60%. Whether it prevents cardiovascular events is uncertain. Methods We conducted a randomized, double-blind, placebo-controlled trial involving 27,564 patients with atherosclerotic cardiovascular disease and LDL cholesterol levels of 70 mg per deciliter (1.8 mmol per liter) or higher who were receiving statin therapy. Patients were randomly assigned to receive evolocumab (either 140 mg every 2 weeks or 420 mg monthly) or matching placebo as subcutaneous injections. The primary efficacy end point was the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization. The key secondary efficacy end point was the composite of cardiovascular death, myocardial infarction, or stroke. The median duration of follow-up was 2.2 years. Results At 48 weeks, the least-squares mean percentage reduction in LDL cholesterol levels with evolocumab, as compared with placebo, was 59%, from a median baseline value of 92 mg per deciliter (2.4 mmol per liter) to 30 mg per deciliter (0.78 mmol per liter) (P<0.001). Relative to placebo, evolocumab treatment significantly reduced the risk of the primary end point (1344 patients [9.8%] vs. 1563 patients [11.3%]; hazard ratio, 0.85; 95% confidence interval [CI], 0.79 to 0.92; P<0.001) and the key secondary end point (816 [5.9%] vs. 1013 [7.4%]; hazard ratio, 0.80; 95% CI, 0.73 to 0.88; P<0.001). The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL cholesterol levels (median, 74 mg per deciliter [1.9 mmol per liter]). There was no significant difference between the study groups with regard to adverse events (including new-onset diabetes and neurocognitive events), with the exception of injection-site reactions, which were more common with evolocumab (2.1% vs. 1.6%). Conclusions In our trial, inhibition of PCSK9 with evolocumab on a background of statin therapy lowered LDL cholesterol levels to a median of 30 mg per deciliter (0.78 mmol per liter) and reduced the risk of cardiovascular events. These findings show that patients with atherosclerotic cardiovascular disease benefit from lowering of LDL cholesterol levels below current targets. (Funded by Amgen; FOURIER ClinicalTrials.gov number, NCT01764633.)
Article
Background: Ezetimibe improves cardiovascular (CV) outcomes in patients stabilized after acute coronary syndrome (ACS) when added to statin therapy. After ACS, patients vary considerably in their risk for recurrent CV events. Objectives: This study tested the hypothesis that atherothrombotic risk stratification may be useful to identify post-ACS patients who have the greatest potential for benefit from the addition of ezetimibe to statin therapy. Methods: The TIMI (Thrombolysis In Myocardial Infarction) Risk Score for Secondary Prevention (TRS 2°P) is a simple 9-point risk stratification tool, previously developed in a large population with atherothrombosis to predict CV death, myocardial infarction (MI), and ischemic stroke (CV death/MI/ischemic cerebrovascular accident [iCVA]). The current study applied this tool prospectively to 17,717 post-ACS patients randomized either to ezetimibe and simvastatin or to placebo and simvastatin in IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial). Treatment efficacy was assessed by baseline risk for CV death/MI/iCVA, the IMPROVE-IT composite endpoints (CE), and individual component endpoints at 7 years. Results: All 9 clinical variables in the TRS 2°P were independent risk indicators for CV death/MI/iCVA (p < 0.001). The integer-based scheme showed a strong graded relationship with the rate of CV death/MI/iCVA, the trial CE, and the individual components (p trend <0.0001 for each). High-risk patients (n = 4,393; 25%), defined by ≥3 risk indicators, had a 6.3% (95% confidence interval: 2.9% to 9.7%) absolute risk reduction in CV death/MI/iCVA at 7 years with ezetimibe/simvastatin, thus translating to a number-needed-to-treat of 16. Intermediate-risk patients (2 risk indicators; n = 5,292; 30%) had a 2.2% (95% confidence interval: -0.3% to 4.6%) absolute risk reduction. Low-risk patients (0 to 1 risk indicators; n = 8,032; 45%) did not appear to derive benefit from the addition of ezetimibe (p interaction = 0.010). Similar findings were observed for the IMPROVE-IT primary CE. Conclusions: Atherothrombotic risk stratification using the TRS 2°P identifies high-risk patients who derive greatest benefit from the addition of ezetimibe to statin therapy for secondary prevention after ACS. (Improved Reduction of Outcomes: Vytorin Efficacy International Trial [IMPROVE-IT]; NCT00202878).
Article
Type 1 diabetes is a challenging condition to manage for various physiological and behavioural reasons. Regular exercise is important, but management of different forms of physical activity is particularly difficult for both the individual with type 1 diabetes and the health-care provider. People with type 1 diabetes tend to be at least as inactive as the general population, with a large percentage of individuals not maintaining a healthy body mass nor achieving the minimum amount of moderate to vigorous aerobic activity per week. Regular exercise can improve health and wellbeing, and can help individuals to achieve their target lipid profile, body composition, and fitness and glycaemic goals. However, several additional barriers to exercise can exist for a person with diabetes, including fear of hypoglycaemia, loss of glycaemic control, and inadequate knowledge around exercise management. This Review provides an up-to-date consensus on exercise management for individuals with type 1 diabetes who exercise regularly, including glucose targets for safe and effective exercise, and nutritional and insulin dose adjustments to protect against exercise-related glucose excursions.
Article
Background: Diabetic patients receiving insulin should have periodic intraoperative glucose measurement. The authors conducted a care redesign effort to improve intraoperative glucose monitoring. Methods: With approval from Vanderbilt University Human Research Protection Program (Nashville, Tennessee), the authors created an automatic system to identify diabetic patients, detect insulin administration, check for recent glucose measurement, and remind clinicians to check intraoperative glucose. Interrupted time series and propensity score matching were used to quantify pre- and postintervention impact on outcomes. Chi-square/likelihood ratio tests were used to compare surgical site infections at patient follow-up. Results: The authors analyzed 15,895 cases (3,994 preintervention and 11,901 postintervention; similar patient characteristics between groups). Intraoperative glucose monitoring rose from 61.6 to 87.3% in cases after intervention (P = 0.0001). Recovery room entry hyperglycemia (fraction of initial postoperative glucose readings greater than 250) fell from 11.0 to 7.2% after intervention (P = 0.0019), while hypoglycemia (fraction of initial postoperative glucose readings less than 75) was unchanged (0.6 vs. 0.9%; P = 0.2155). Eighty-seven percent of patients had follow-up care. After intervention the unadjusted surgical site infection rate fell from 1.5 to 1.0% (P = 0.0061), a 55.4% relative risk reduction. Interrupted time series analysis confirmed a statistically significant surgical site infection rate reduction (P = 0.01). Propensity score matching to adjust for confounders generated a cohort of 7,604 well-matched patients and confirmed a statistically significant surgical site infection rate reduction (P = 0.02). Conclusions: Anesthesiologists add healthcare value by improving perioperative systems. The authors leveraged the one-time cost of programming to improve reliability of intraoperative glucose management and observed improved glucose monitoring, increased insulin administration, reduced recovery room hyperglycemia, and fewer surgical site infections. Their analysis is limited by its applied quasiexperimental design.
Article
Background: Tight control of blood glucose in type 1 diabetes delays onset of macrovascular and microvascular diabetic complications; however, glucose levels need to be closely monitored to prevent hypoglycaemia. We aimed to assess whether a factory-calibrated, sensor-based, flash glucose-monitoring system compared with self-monitored glucose testing reduced exposure to hypoglycaemia in patients with type 1 diabetes. Method: In this multicentre, prospective, non-masked, randomised controlled trial, we enrolled adult patients with well controlled type 1 diabetes (HbA1c ≤58 mmol/mol [7·5%]) from 23 European diabetes centres. After 2 weeks of all participants wearing the blinded sensor, those with readings for at least 50% of the period were randomly assigned (1:1) to flash sensor-based glucose monitoring (intervention group) or to self-monitoring of blood glucose with capillary strips (control group). Randomisation was done centrally using the biased-coin minimisation method dependent on study centre and type of insulin administration. Participants, investigators, and study staff were not masked to group allocation. The primary outcome was change in time in hypoglycaemia (<3·9 mmol/L [70 mg/dL]) between baseline and 6 months in the full analysis set (all participants randomised; excluding those who had a positive pregnancy test during the study). This trial was registered with ClinicalTrials.gov, number NCT02232698. Findings: Between Sept 4, 2014, and Feb 12, 2015, we enrolled 328 participants. After the screening and baseline phase, 120 participants were randomly assigned to the intervention group and 121 to the control group, with outcomes being evaluated in 119 and 120, respectively. Mean time in hypoglycaemia changed from 3·38 h/day at baseline to 2·03 h/day at 6 months (baseline adjusted mean change -1·39) in the intervention group, and from 3·44 h/day to 3·27 h/day in the control group (-0·14); with the between-group difference of -1·24 (SE 0·239; p<0·0001), equating to a 38% reduction in time in hypoglycaemia in the intervention group. No device-related hypoglycaemia or safety issues were reported. 13 adverse events were reported by ten participants related to the sensor-four of allergy events (one severe, three moderate); one itching (mild); one rash (mild); four insertion-site symptom (severe); two erythema (one severe, one mild); and one oedema (moderate). There were ten serious adverse events (five in each group) reported by nine participants; none were related to the device. Interpretation: Novel flash glucose testing reduced the time adults with well controlled type 1 diabetes spent in hypoglycaemia. Future studies are needed to assess the effectiveness of this technology in patients with less well controlled diabetes and in younger age groups. Funding: Abbott Diabetes Care.
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Background: Diabetes results in a rise in blood glucose above normal physiological levels; if untreated this may cause damage to many systems including the cardiovascular and renal systems. Pregnancy increases resistance to insulin action; for those women who have pre-gestational diabetes, this results in an increasing insulin requirement. There are several methods of administering insulin. Conventionally, insulin has been administered subcutaneously, formally referred to as intensive conventional treatment, but now more usually referred to as multiple daily injections (MDI). An alternative method of insulin administration is the continuous subcutaneous insulin infusion pump (CSII). Objectives: To compare CSII with MDI of insulin for pregnant women with pre-existing and gestational diabetes. Search methods: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 March 2016) and reference lists of retrieved studies. Selection criteria: Randomised trials comparing CSII with MDI for pregnant women with diabetes. Data collection and analysis: Three review authors independently assessed studies and two review authors extracted data. Disagreements were resolved through discussion with the third author. We assessed the quality of the evidence using the GRADE approach. Main results: We included five single-centre trials (undertaken in Italy) with 153 women and 154 pregnancies in this review.There were no clear differences in the primary outcomes reported between CSII and MDI in the included trials: caesarean section (risk ratio (RR) 1.09, 95% confidence interval (CI) 0.66 to 1.77; three trials, 71 women, evidence graded very low), large-for-gestational age (RR 4.15, 95% CI 0.49 to 34.95; three trials, 73 infants; evidence graded very low), and perinatal mortality (RR 2.33, 95% CI 0.38 to 14.32; four trials, 83 infants, evidence graded very low). Other primary outcomes were not reported in these trials (hypertensive disorders of pregnancy, development of type 2 diabetes, composite outcome of serious neonatal outcomes, and neurosensory disability).There was no clear evidence of differences in the maternal secondary outcomes: maternal weight gain during pregnancy, 24 hour mean blood glucose in each trimester, mean maternal HbA1c in each trimester, maternal hypoglycaemia, and maternal hyperglycaemia. The included studies did not report several GRADE outcomes: perineal trauma, return to pre-pregnancy weight, postnatal depression, induction of labour. Many maternal secondary outcomes were also not reported.In two trials, including a total of 61 infants, CSII was associated with an increase in mean birthweight compared with MDI (mean difference (MD) 220.56 g, 95% CI -2.09 g to 443.20 g; P = 0.05). However, the large CI including anything from a small reduction to an increase in mean birthweight and the lack of a difference in macrosomia rate (RR 3.20, CI 0.14 to 72.62; two trials, 61 infants) suggests uncertainty. Large-for-gestational age (see above), andsmall-for-gestational age also suggests uncertainty of effect. No significant differences were found in: gestation at delivery, preterm birth < 37 weeks' gestation, preterm birth < 32 weeks' gestation, neonatal hypoglycaemia (evidence graded very low), respiratory distress syndrome, neonatal hyperbilirubinaemia, and fetal anomaly. There were no data reported on many important infant outcomes, including the GRADE outcomes adiposity and diabetes. There was no follow-up of infants in childhood or adulthood, so longer-term outcomes were not reported.The only outcome reported for use of health service resources wasmaternal days hospitalised, which did not show a difference between groups in the small number of women included (MD 9.40, CI -6.04 to 24.84; one trial, 10 women).The methods used by the trials were poorly reported, for example although blinding of participants and clinicians regarding intervention allocation is impossible, it is possible to blind assessors and this along with other aspects of trial methods was not reported, which means that the trials are at an unclear or high risk of bias. We do not know if the women who participated were representative, and therefore if the results can be generalised. Most GRADE outcomes were not reported. For the GRADE outcomes that were reported, our assessment was that the evidence is very low quality (caesarean section, large-for-gestational age, perinatal mortality, andneonatal hypoglycaemia). This was due to design limitations in the included trials, small sample sizes in the trials contributing data, wide CIs crossing both the line of no effect and the line of appreciable benefit and/or harm, and often few events. We are therefore uncertain whether CSII or MDI improves outcomes for pregnant women with diabetes and their infants, and the results of further studies may differ substantially from those presented in this review. Authors' conclusions: There is no evidence to support the use of one particular form of insulin administration over another for pregnant women with diabetes. There are only a small number of trials appropriate for meta-analysis, a small number of women included and questionable generalisability of the trial population.Pump technology has progressed since these trials were undertaken. Well-designed randomised trials are required to evaluate comparisons such as patch pumps against MDI and more conventional CSII against MDI. These trials should be adequately powered to assess the effect of interventions, and report the core set of outcomes used in Cochrane reviews of diabetes in pregnancy. Trials to assess the effects of pumps on birthweight and macrosomia rates are needed. It would be beneficial for future trials to undertake longer-term follow-up of participants and their infants, assess women's preferences, and conduct an economic evaluation.
Article
Defining chronic kidney disease (CKD) is the subject of intense debate in the current nephrology literature. The debate concerns the threshold value of estimated glomerular filtration rate (eGFR) used to make the diagnosis of CKD. Current recommendations argue that a universal threshold of 60 mL/min/1.73m(2) should be used. This threshold has been defended by epidemiological studies showing that the risk of mortality or end-stage renal disease increases with an eGFR below 60 mL/min/1.73m(2). However, a universal threshold does not take into account the physiologic decline in GFR with ageing nor does it account for the risk of mortality and end-stage renal disease being trivial with isolated eGFR levels just below 60 mL/min/1.73m(2) in older subjects and significantly increased with eGFR levels just above 60 mL/min/1.73m(2) among younger patients. Overestimation of the CKD prevalence in the elderly (medicalisation of senescence) and underestimation of CKD (potentially from treatable primary nephrologic diseases) in younger patients is of primary concern. An age-calibrated definition of CKD has been proposed to distinguish age-related from disease-related changes in eGFR. For patients younger than 40 years, CKD is defined by eGFR below 75 mL/min/1.73m(2). For patients with ages between 40 and 65 years, CKD is defined by 60 mL/min/1.73m(2). For subjects older than 65 years without albuminuria or proteinuria, CKD is defined by eGFR below 45 mL/min/1.73m(2).