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Article: Mitra M. Fatourechi, Yogish C. Kudva, M. Hassan Murad, Mohamed B. Elamin, Claudia C. Tabini, and Victor M. Montori Hypoglycemia with intensive insulin therapy. A systematic review and meta-analyses of randomized trials of continuous subcutaneous insulin infusion versus multiple daily injections J Clin Endocrinol Metab 2008; 0: jc.2008-1415v1 [Abstract]

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Re: Insulin pump therapy reduces severe hypoglycemia

Victor M. Montori   (8 June 2009)

Insulin pump therapy reduces severe hypoglycemia

J. Hans DeVries   (9 April 2009)

Re: Insulin pump therapy reduces severe hypoglycemia 8 June 2009
Victor M. Montori, Professor of Medicine Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN Send letter to journal: Re: Re: Insulin pump therapy reduces severe hypoglycemia montori.victor{at}mayo.edu Victor M. Montori	Dr. DeVries indicates that our results would have changed had we only included the trial he and colleagues published in 2002, a trial he believed we missed. As can be verified in our reported methods, the trial to which he refers was not missed but rather fell outside the scope of our review, which by protocol, only considered trials published after 2002. The arbitrary addition of one or another trial can affect the results of the review, which is the fundamental reason why systematic reviews use a protocol to avoid selection bias and why we believe our findings to be inconclusive.
Insulin pump therapy reduces severe hypoglycemia 9 April 2009
J. Hans DeVries, endocrinologist University of Amsterdam Send letter to journal: Re: Insulin pump therapy reduces severe hypoglycemia j.h.devries{at}amc.uva.nl J. Hans DeVries	In their meta analysis of trials of insulin pump therapy versus injection therapy (1), Fatourechi et al. missed a trial, which if included might have altered the conclusions of the paper. This trial presented HbA1c data from 79 patients with 0.84% lower HbA1c concentration in the pump group. More importantly, in the missed trial, the number of patients with severe hypoglycemia was larger in the injection group – 6 of 32 completers – than in the pump group – 3 of 39 completers. While this difference was not significant on its own, in their meta analysis, these data would have changed of the rates of severe hypoglycemia substantially. They calculated an OR for severe hypoglycemia of 0.48 (95% CI 0.23 to 1.00) on the basis of 25 patients with severe hypoglycemia among 492 patients treated with an insulin pump vs. 47 among 487 treated with multiple daily injections. With the additional data from the missed trial, 28/532 vs. 53/519, using the Cochrane software tool for meta analysis (RevMan), in a random effects model, the OR becomes 0.52 (95% CI 0.32 to 0.85, P = 0.009, with no indication of heterogeneity, I2 = 0%). Thus, with inclusion of these data, one can conclude that insulin pump therapy is associated with a statistically significant nearly 50% reduction in severe hypoglycemia. References 1. Fatourechi MM, Kudva YC, Murad MH, Elamin MB, Tabini CC, Montori VM 2009 Hypoglycemia with Intensive Insulin Therapy: A Systematic Review and Meta-Analyses of Randomized Trials of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections J Clin Endocrinol Metab 94:729-740 2. DeVries JH, Snoek FJ, Kostense PJ, Masurel N, Heine RJ. 2002 A Randomized Trial of Continuous Subcutaneous Insulin Infusion and Intensive Injection Therapy in Type 1 Diabetes for Patients With Long- Standing Poor Glycemic Control. Diabetes Care 25:2074-2080. 3. Retnakaran R., Hochman J., DeVries J.H., Hanaire-Broutin H., Heine R.J., Melki V. et al. 2004 Continuous Subcutaneous Insulin Infusion vs Multiple Daily Injections: The Impact of Baseline A1c. Diabetes Care 27:2590-2596. (2) Retnakaran R., Hochman J., DeVries J.H., Hanaire-Broutin H., Heine R.J., Melki V. et al. Continuous Subcutaneous Insulin Infusion vs Multiple Daily Injections: The Impact of Baseline A1c. Diabetes Care 2004; 27:2590-2596.