Comparative Effectiveness and Safety of Methods of Insulin Delivery and Glucose Monitoring for Diabetes Mellitus: A Systematic Review and Meta-analysis.
ABSTRACT 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.
- SourceAvailable from: Fernando Gomez-Peralta[Show abstract] [Hide abstract]
ABSTRACT: Objective To provide practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus. Participants Members of the Diabetes Mellitus Working Group of the Spanish Society of Endocrinology and Nutrition. Methods Recommendations were formulated according to the Grading of Recommendations, Assessment, Development, and Evaluation system to describe both the strength of recommendations and the quality of evidence. A systematic search was made in MEDLINE (PubMed). Papers in English and Spanish with publication date before 15 February 2013 were included. For recommendations about drugs only those approved by the European Medicines Agency were included. After formulation of recommendations, they were discussed by the Working Group. Conclusions The document provides evidence-based practical recommendations for evaluation and management of hypoglycemia in patients with diabetes mellitus.Endocrinología y Nutrición 01/2013; 60(9):517.e1–517.e18.
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ABSTRACT: When we are interested in making decisions about best use, comparative therapeutic efficacy, or cost-effectiveness of diabetes technologies such as insulin pump therapy [continuous subcutaneous insulin infusion (CSII)] or continuous glucose monitoring, meta-analysis for the purpose of literature summary is inappropriate and may be misleading. Instead, "decision-making meta-analysis" is more appropriate and should involve either preselection of trials based on intended use [e.g., elevated baseline hemoglobin A1c or hypoglycemia rate for trials of multiple daily injections (MDI) versus CSII] or metaregression of summary effect sizes in different trials against potential effect-modifying covariates such as baseline risk, or models of the covariates that determine effect size using individual patient data. Appropriate meta-analysis should also only include trials that are of sufficient duration to accurately measure outcomes such as severe hypoglycemia, and they should not use obsolete technology that is of proven inferiority to current technology. The use of appropriate decision-making meta-analysis is illustrated by the change in the rate ratio for severe hypoglycemia in randomized controlled trials of MDI versus CSII in type 1 diabetes from 1.56 (95% confidence interval 0.96-2.55; p = .074) for literature-summary meta-analysis to 2.0 (1.08-3.69; p = .027) for decision-making meta-analysis of all patients and 3.91 (1.35-11.36; p = .01) for trials in children.Journal of diabetes science and technology 11/2013; 7(6):1567-74. DOI:10.1177/193229681300700617
- Journal of diabetes science and technology 01/2013; 7(6):1650-1.