Survival assessment of the extended-wear insulin infusion set featuring lantern technology in adults with type 1 diabetes by the glucose clamp technique

Diabetes Obes Metab. 2021 Jun;23(6):1402-1408. doi: 10.1111/dom.14337. Epub 2021 Mar 4.

Abstract

Maintaining good glycaemic control with the same infusion set for longer than 3 days may improve the quality of life of insulin pump users. The aim of the current study was to assess the efficacy and safety of the novel, extended-wear infusion set over 7 days of wear in adults with type 1 diabetes. Sixteen participants completed three identical 8-hour euglycaemic clamp experiments on Days 1, 4 and 7 of infusion set wear. Between the experiments, the participants were discharged home for routine diabetes management while wearing the same extended-wear infusion set throughout the study. Time to reach the maximum glucose infusion rate (TGIRmax ) on Day 7 was reduced by 67% compared with Day 1 (p < .001). The corresponding area under the glucose infusion rate curve (AUCGIR ) was comparable for the first 2 h of the clamp (p = .891) but decreased by 28% over time (p < .008). While the extent of insulin absorption decreased with prolonged wear, it was accompanied by an increase in insulin absorption rate. The infusion set survival rate was 100% without leakages, occlusion alarms, severe hypoglycaemia or ketoacidosis. The extended-wear infusion set proved safe and effective during prolonged wear in real-life conditions.

Keywords: CSII; clinical trial; insulin pump therapy; pharmacodynamics; pharmacokinetics; type 1 diabetes.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Blood Glucose
  • Diabetes Mellitus, Type 1* / drug therapy
  • Glucose Clamp Technique
  • Humans
  • Hypoglycemic Agents / therapeutic use
  • Insulin / therapeutic use
  • Insulin Infusion Systems
  • Quality of Life
  • Technology

Substances

  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin