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The Department of Veterans Affairs Implanted Insulin Pump Study

The Department of Veterans Affairs Cooperative Studies Center has initiated a randomized controlled study (cooperative studies protocol [CSP] 344A) comparing implanted insulin pump (IIP) therapy with multipledose insulin (MDI) in non-insulindependent diabetes mellitus (N1DDM) in seven Department of Veterans Affairs Medical Centers. This report presents the study's rationale, protocol issues, and anticipated outcomes. The IIP study was designed to determine not only whether implanted insulin pumps are an alternative to multiple-dose subcutaneous insulin delivery in patients who require intensive insulin treatment, but whether there are relative advantages or disadvantages to IIP therapy versus MDI. The study offers Veterans Affairs investigators the chance to become familiar with this new therapy, using it in a population quite different from the carefully selected patients with insulin-dependent diabetes mellitus (IDDM) in whom most pump work has been accomplished. It is also a chance to determine whether IIP can be used in future long-term treatment trials of NIDDM. The IIP study is ancillary to a Veterans Affairs cooperative study titled, Glycemic Control and Complications in Non-Insulin-Dependent Diabetes: A Feasibility Study (CSP 344). Initiated in 1990, CSP 344 is a randomized comparison of intensive glycemic control versus standard diabetes care in NIDDM chaired by Carlos Abraira, MD, of The Edward Hines Jr Hospital and Stritch School of Medicine, Chicago, IL. The intention is to proceed with a long-term control and complications trial in NIDDM if feasibility is demonstrated.