Implantable insulin pumps: the Veterans Administration Study, a decade later

Abstract

The Veterans Administration Cooperative Study (VACS) on implanted pumps was a pioneering experience which produced relevant information worthy of reconsideration even 10 years later. It was the first, and still the only, multicenter, randomized clinical trial of implantable insulin pump (IIP) therapy accomplished independent of industry. In a cohort of 121 type 2 diabetics already treated with insulin the study demonstrated a significant benefit of IIP in terms of stability of glycaemic control, reduction of hypoglycaemic events, reduced weight increase and improved quality of life. Furthermore the study was important in introducing a group of important academic centres to the use of IIP therapy. A series of sub-studies contributed productively. Altered production of pump insulin during the study, the short period of observation (one year), unavoidable biases introduced by the unblinded and unprotocolized insulin adjustments were limitations. Neverthless, the VACS, as an independent, rigorous multicenter trial, was successful in demonstrating certain benefits of IIP therapy and raising its profile in the U.S.A.