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A study presented during a poster session at the American Diabetes Association Virtual 81st Scientific Sessions evaluated performance, safety, and satisfaction of an extended-wear insulin infusion set in patients with type 1 diabetes.
Individuals with type 1 diabetes reported greater satisfaction with extended-wear infusion sets (EWIS) compared with shorter-wear insulin ISs, according to the results of a late-breaking poster presented at the American Diabetes Association Virtual 81st Scientific Sessions.1
Standard insulin ISs are labeled for 2 or 3 days of use. Few studies have investigated issues often encountered with standard IS use. The Medtronic EWIS evaluated in the study is designed to increase wear time up to 7 days.
The pivotal trial of this EWIS overall has demonstrated a failure rate due to unexplained hyperglycemia of <1%, and met all primary safety end points and no increase in A1c or a total daily dose of insulin. The present study, which was presented on June 25, 2021, during the virtual poster session, reported on patient satisfaction during the trial’s EWIS use.
This multi-center, single-arm, nonrandomized, noninferiority trial included 259 adult participants with type 1 diabetes using the MiniMed 670G system (with Humalog or Novolog insulin). Study participants wore a 2- or 3-day IS for 2 weeks followed by 12 consecutive EWIS wears of 174 hours or until set failure.
For the study, participants completed a Medtronic Likert-based questionnaire, once at baseline and once at the end of the study period. According to the findings, participants reported improved ease and convenience of use, comfort, wear, duration, and time required to change a set with EWIS (P< 0.001) compared with the 2- or 3-day use IS. Compared with standard IS use, 97%, 92%, and 96% of participants using EWIS reported satisfaction scores ranging from satisfied to extremely satisfied for comfort and duration of wear, and convenience of use, respectively.
Based on the results, the authors concluded greater satisfaction with the EWIS among participants, which could lead to reduced care burden and improved adherence.
“The strong overall satisfaction with and preference for the 7-days EWIS, in addition to the <1% unexplained hyperglycemia failure rate and safety profile, indicate a potential reduction in diabetes management burden with EWIS,” the authors concluded.
EWIS also demonstrated a 74.8% survival rate (77.8% excluding inadvertent early removal) in patients with type 1 diabetes on insulin pump therapy with continuous glucose monitoring. In the safety results, which were also presented during the meeting, glycemic control outcomes were improved during EWIS use and there were no episodes of EWIS-related severe hypoglycemia or diabetic ketoacidosis. Overall, the 7-day EWIS was safe and its performance proved to be superior at ≥174 hours compared with the performance observed for 2- or 3-day ISs.2
1. Brazg RL, Bailey TS, Kudva YC, Garg SK, et al. 101-LB: Reported patient satisfaction during the Medtronic extended-wear infusion set (EWIS) pivotal trial. Presented at: American Diabetes Association Virtual 81st Scientific Sessions; June 25-29, 2021; online.
2. Buckingham BA, Brazg RL, Bailey TS, Kudva YC, et al. 100-LB – Infusion set survival and performance during the Medtronic extended-wear infusion set (EWIS) pivotal trial. Presented at: American Diabetes Association Virtual 81st Scientific Sessions; June 25-29, 2021; online.