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

Abstract

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 A clinical pattern emerged where four participants randomized to the DPIP treatment arm were withdrawn early as the DPIP did not work well for the purpose studied.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.

Human regular U‐500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study

“…Use of U‐500 insulin in a U‐100 pump requires mathematical conversion and could be confusing; for example, 10 U of bolus insulin displayed on a U‐100 pump would in fact deliver 50 U, or 5‐fold more, if using U‐500 insulin. Previous studies of U‐500R in CSII therapy lacked controls, were mostly retrospective, or included a small number of subjects . Therefore, the use of U‐500R by CSII needed to be studied in a larger, prospective, randomized clinical trial.…”

“…Previous studies of U-500R in CSII therapy lacked controls, were mostly retrospective, or included a small number of subjects. 2,9 Therefore, the use of U-500R by CSII needed to be studied in a larger, prospective, randomized clinical trial.…”