U500 Disposable Patch Insulin Pump: Results and Discussion of a Veterans Affairs Pilot Study

We present a Veterans Affairs–sponsored pilot study of U500 concentrated insulin administered via disposable patch insulin pump (DPIP) vs twice-daily (BID) injections with an insulin pen in a case series format. We conducted a prospective, single-center, randomized, intent-to-treat pilot study. Ten participants were enrolled with poorly controlled diabetes, defined as hemoglobin A1C >8.0 and severe insulin resistance defined as total daily dose >200 units. Participants were randomized in a 1:1 ratio to either U500 DPIP or U500 BID insulin titration protocols for 14 weeks. A clinical pattern emerged where four participants randomized to the DPIP treatment arm were withdrawn early as the DPIP did not work well for the purpose studied. There was not a statistically significant difference in the rate of hypoglycemia between treatment arms. Based on our clinical experience and results, we argue against the general use of U500 DPIP in clinical practice.