Comparative Effectiveness and Safety of Methods of Insulin Delivery and Glucose Monitoring for Diabetes Mellitus: A Systematic Review and Meta-analysis.
Case Western Reserve University, Cleveland, Ohio, United States Annals of internal medicine
(Impact Factor: 17.81).
07/2012; 157(5):E-508. DOI: 10.7326/0003-4819-157-5-201209040-00508
BACKGROUND: Patients with diabetes mellitus need information about the effectiveness of innovations in insulin delivery and glucose monitoring. PURPOSE: To review how intensive insulin therapy (multiple daily injections [MDI] vs. rapid-acting analogue -based continuous subcutaneous insulin infusion [CSII]) or method of monitoring (self-monitoring of blood glucose [SMBG] vs. real-time continuous glucose monitoring [rt-CGM]) affects outcomes in type 1 and 2 diabetes mellitus. DATA SOURCES: MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials through February 2012 without language restrictions. STUDY SELECTION: 33 randomized, controlled trials in children or adults that compared CSII with MDI (n = 19), rt-CGM with SMBG (n = 10), or sensor-augmented insulin pump use with MDI and SMBG (n = 4). DATA EXTRACTION: 2 reviewers independently evaluated studies for eligibility and quality and serially abstracted data. DATA SYNTHESIS: In randomized, controlled trials, MDI and CSII showed similar effects on hemoglobin A1c (HbA1c) levels and severe hypoglycemia in children or adults with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. In adults with type 1 diabetes mellitus, HbA1c levels decreased more with CSII than with MDI, but 1 study heavily influenced these results. Compared with SMBG, rt-CGM achieved a lower HbA1c level (between-group difference of change, -0.26% [95% CI, -0.33% to -0.19%]) without any difference in severe hypoglycemia. Sensor-augmented insulin pump use decreased HbA1c levels more than MDI and SMBG did in persons with type 1 diabetes mellitus (between-group difference of change, -0.68% [CI, -0.81% to -0.54%]). Little evidence was available on other outcomes. LIMITATION: Many studies were small, of short duration, and limited to white persons with type 1 diabetes mellitus. CONCLUSION: Continuous subcutaneous insulin infusion and MDI have similar effects on glycemic control and hypoglycemia, except CSII has a favorable effect on glycemic control in adults with type 1 diabetes mellitus. For glycemic control, rt-CGM is superior to SMBG and sensor-augmented insulin pumps are superior to MDI and SMBG without increasing the risk for hypoglycemia. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.
Available from: PubMed Central
- "This study showed a difference in insulin regimen between insurance types, and HbA1c and several cardiovascular disease risk factors were no longer significant after insulin regimen was controlled for. A recent meta-analysis looking at differences in HbA1c between children on continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) showed no significant difference, although there was a trend toward better glycemic control in children on CSII and more data are needed on this topic . Previous studies show those with a higher parental education level and those with private insurance are more likely to be on insulin pump therapy . "
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Adult studies have shown a correlation between low socioeconomic status and Type 1 Diabetes complications, but studies have not been done in children to examine the effect of socioeconomic status on risk for future complications. This study investigates the relationship between insurance status and parental education and both glycemic control and cardiovascular disease (CVD) risk factors in youth with type 1 diabetes.
A cross-sectional study of 295 youth with established type 1 diabetes who underwent examination with fasting blood draw and reported insurance status and parental education.
Youth with type 1 diabetes and public insurance had higher hemoglobin A1c (HbA1c), body mass index, hs-CRP, and blood pressure (p < 0.05) than those with private insurance. Insulin regimen varied between insurance groups, and differences in HbA1c and CVD risk factors, except for diastolic blood pressure (DBP), were no longer evident after controlling for insulin regimen. Parental education was not associated with HbA1c or CVD risk factors.
Youth with type 1 diabetes and public insurance have worse glycemic control and elevated CVD risk factors compared to those with private insurance, but this was no longer seen when insulin regimen was controlled for. Further research is needed to look at differences between those with public insurance and private insurance that contribute to differences in type 1 diabetes outcomes, and to identify modifiable risk factors in pediatric patients in order to focus earlier interventions to decrease and prevent future diabetes complications.
Available from: Irene Darmadi Blackberry
- "Use of these devices thus may increase the timeliness and safety of insulin initiation and up-titration among people with T2D, particularly by identifying asymptomatic nocturnal hypoglycemia and unrecognized post-prandial glucose elevations [16,17]. This technology has been used widely in type 1 diabetes (T1D) in specialist centers, however evidence regarding the utility and efficacy of this technology in primary care is lacking [18-20]. While attention needs to be paid to the technical evidence relating to insulin introduction, addressing barriers to the initiation of insulin and tailoring the interventions at the levels of patient, health professional and health system will ensure the interventions are widely acceptable and sustainable in primary care [21-23]. "
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Insulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care.
The study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a “basal plus” regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia.
This article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial.
Available from: Teresa Montiel
- "During the last decades, the intensive use of insulin or other drugs that stimulate insulin secretion as the main treatment to prevent hyperglycemia and its long-term vascular associated complications has resulted in an increase in the incidence of hypoglycemia in diabetic patients (Diabetes Control and Complications Trial (DDCT), 2006; Steil et al., 2006). Devices to continuously monitor glucose blood levels and to optimize the delivery of insulin or insulin analogues have not succeeded in completely preventing the occurrence of repeated episodes of hypoglycemia, despite their success in reducing hyperglycemia (Fatourechi et al., 2009; Yeh et al., 2012, see Section 5 in the present review). Therefore, nowadays hypoglycemia remains to be major a complication of insulin therapy. "
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ABSTRACT: The aim of the present review is to offer a current perspective about the consequences of hypoglycemia and its impact on the diabetic disorder due to the increasing incidence of diabetes around the world. The main consequence of insulin treatment in type 1 diabetic patients is the occurrence of repetitive periods of hypoglycemia and even episodes of severe hypoglycemia leading to coma. In the latter, selective neuronal death is observed in brain vulnerable regions both in humans and animal models, such as the cortex and the hippocampus. Cognitive damage subsequent to hypoglycemic coma has been associated with neuronal death in the hippocampus. The mechanisms implicated in selective damage are not completely understood but many factors have been identified including excitotoxicity, oxidative stress, zinc release, PARP-1 activation and mitochondrial dysfunction. Importantly, the diabetic condition aggravates neuronal damage and cognitive failure induced by hypoglycemia. In the absence of coma prolonged and severe hypoglycemia leads to increased oxidative stress and discrete neuronal death mainly in the cerebral cortex. The mechanisms responsible for cell damage in this condition are still unknown. Recurrent moderate hypoglycemia is far more common in diabetic patients than severe hypoglycemia and currently important efforts are being done in order to elucidate the relationship between cognitive deficits and recurrent hypoglycemia in diabetics. Human studies suggest impaired performance mainly in memory and attention tasks in healthy and diabetic individuals under the hypoglycemic condition. Only scarce neuronal death has been observed under moderate repetitive hypoglycemia but studies suggest that impaired hippocampal synaptic function might be one of the causes of cognitive failure. Recent studies have also implicated altered mitochondrial function and mitochondrial oxidative stress.
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