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Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness
Comparative Effectiveness Reviews, No. 57
Investigators: Sherita Hill Golden, MD, MHS, Todd Brown, MD, PhD, Hsin-Chieh Yeh, PhD, Nisa Maruthur, MD, MHS, Padmini Ranasinghe, MD, MPH, Zack Berger, MD, PhD, Yong Suh, MBA, MSc, Lisa M Wilson, ScM, Elisabeth B Haberl, BA, and Eric B Bass, MD, MPH.
Author Information and AffiliationsStructured Abstract
Objectives:
To systematically review whether the mode of intensive insulin therapy (continuous subcutaneous insulin infusion [CSII] vs. multiple daily injections [MDI]) and/or the mode of blood glucose monitoring (real time-continuous glucose monitoring [rt-CGM] vs. self-monitoring of blood glucose [SMBG]) results in better glycemic control, less hypoglycemia, improved quality of life, and improved clinical outcomes in individuals with type 1 diabetes, type 2 diabetes, and pre-existing diabetes in pregnancy.
Data Sources:
MEDLINE®, Embase®, and the Cochrane Central Register of Controlled Trials from inception to July 2011. Additional studies were identified from reference lists and technical experts.
Review Methods:
We included randomized controlled trials (RCTs) for all outcomes and observational studies for selected clinical outcomes that compared the effects of CSII with MDI or rt-CGM with SMBG among children, adolescents, or adults with either type 1 or type 2 diabetes, or pregnant women with pre-existing diabetes. We excluded studies that used regular insulin in the CSII arms. Two reviewers evaluated studies for eligibility, serially abstracted data using standardized forms, and independently evaluated study quality. We conducted meta-analyses when there were sufficient data and studies were sufficiently homogeneous.
Results:
We included 41 studies (44 publications). RCTs showed no difference in the effect of CSII and MDI on HbA1c (moderate strength of evidence [SOE]) or severe hypoglycemia (low SOE) for children or adolescents with type 1 diabetes, or for adults with type 2 diabetes. In adults with type 1 diabetes, HbA1c decreased more with CSII than with MDI (low SOE), but results were heavily influenced by one study. There was no difference in severe hypoglycemia (low SOE). In children and adults with type 1 diabetes, CSII use was associated with improved quality of life compared with MDI (low SOE). There was insufficient evidence about quality of life for adults with type 2 diabetes. The SOE regarding pregnant women with pre-existing diabetes was either low or insufficient on all outcomes. We found studies of the comparative effectiveness of rt-CGM versus SMBG in individuals with type 1 diabetes only. Compared with SMBG, rt-CGM achieved a lower HbA1c, with greater reductions occurring where sensor compliance was 60 percent or greater (high SOE). There was no difference in the rate of severe hypoglycemia (low SOE) or quality of life (low SOE). Sensor-augmented pump use was associated with a significantly greater reduction in HbA1c compared with MDI/SMBG use in nonpregnant individuals with type 1 diabetes (moderate SOE). The evidence for other outcomes was low or insufficient.
Conclusions:
The approach to intensive insulin therapy can be individualized to patient preference that will maximize their quality of life, as both CSII and MDI have similar effectiveness on glycemic control and severe hypoglycemia, except in adults with type 1 diabetes where CSII had a favorable effect on HbA1c. These data also indicate that rt-CGM is superior to SMBG in lowering HbA1c, without affecting the risk of severe hypoglycemia, in nonpregnant individuals with type 1 diabetes, particularly when compliance is high. Sensor-augmented pumps are superior to MDI/SMBG in lowering HbA1c.
Contents
- Preface
- Acknowledgments
- Key Informants and Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Burden of Diabetes and Its Classification
- Importance of Tight Glycemic Control and Associated Risks in Diabetes
- Methods To Achieve Tight Glycemic Control and Minimize Risk: Advances in Insulin Delivery (Conventional Vs. Intensive Insulin Therapy)
- Methods To Achieve Tight Glycemic Control and Minimize Risk: Advances in Glucose Monitoring
- Knowledge Gaps: Comparative Effectiveness of Insulin Delivery and Glucose Monitoring in Specific Diabetic Populations
- Scope of the Review
- Key Questions
- Methods
- Results
- Search Results
- Key Question 1 In patients receiving intensive insulin therapy, does mode of delivery (CSII vs. MDI) have a differential effect on process measures, intermediate outcomes, and clinical outcomes in patients with diabetes mellitus?
- Key Question 2 In patients receiving intensive insulin therapy (MDI or CSII), does the type of glucose monitoring (rt-CGM vs. SMBG) have a differential effect on process measures, intermediate outcomes, and clinical outcomes in patients with diabetes mellitus?
- Discussion
- References
- Abbreviations
- Appendix A Detailed Electronic Database Search Strategies
- Appendix B Forms
- Appendix C List of Devices
- Appendix D List of Excluded Articles
- Appendix E Evidence Tables
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10061-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
Suggested citation:
Golden SH, Brown T, Yeh HC, Maruthur N, Ranasinghe P, Berger Z, Suh Y, Wilson LM, Haberl EB, Bass EB. Methods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness. Comparative Effectiveness Review No. 57. (Prepared by Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 12-EHC036-EF. Rockville, MD: Agency for Healthcare Research and Quality. July 2012. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the author(s), who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
- Review Methods for insulin delivery and glucose monitoring in diabetes: summary of a comparative effectiveness review.[J Manag Care Pharm. 2012]Review Methods for insulin delivery and glucose monitoring in diabetes: summary of a comparative effectiveness review.Golden SH, Sapir T. J Manag Care Pharm. 2012 Aug; 18(6 Suppl):S1-17.
- Review Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis.[Ann Intern Med. 2012]Review Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis.Yeh HC, Brown TT, Maruthur N, Ranasinghe P, Berger Z, Suh YD, Wilson LM, Haberl EB, Brick J, Bass EB, et al. Ann Intern Med. 2012 Sep 4; 157(5):336-47.
- Continuous Subcutaneous Insulin Infusion (CSII) Pumps for Type 1 and Type 2 Adult Diabetic Populations: An Evidence-Based Analysis.[Ont Health Technol Assess Ser....]Continuous Subcutaneous Insulin Infusion (CSII) Pumps for Type 1 and Type 2 Adult Diabetic Populations: An Evidence-Based Analysis.Medical Advisory Secretariat. Ont Health Technol Assess Ser. 2009; 9(20):1-58. Epub 2009 Oct 1.
- Optimizing type 1 diabetes after multiple daily injections and capillary blood monitoring: Pump or sensor first? A meta-analysis using pooled differences in outcome measures.[Diabetes Obes Metab. 2021]Optimizing type 1 diabetes after multiple daily injections and capillary blood monitoring: Pump or sensor first? A meta-analysis using pooled differences in outcome measures.Thomas MG, Avari P, Godsland IF, Lett AM, Reddy M, Oliver N. Diabetes Obes Metab. 2021 Nov; 23(11):2521-2528. Epub 2021 Aug 12.
- Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.[Acta Diabetol. 2021]Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials.Dicembrini I, Cosentino C, Monami M, Mannucci E, Pala L. Acta Diabetol. 2021 Apr; 58(4):401-410. Epub 2020 Aug 13.
- Methods for Insulin Delivery and Glucose Monitoring: Comparative EffectivenessMethods for Insulin Delivery and Glucose Monitoring: Comparative Effectiveness
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