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

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.

Feasibility study of a prototype extended‐wear insulin infusion set in adults with type 1 diabetes

“…In conjunction with the fall in TIR, there was a reciprocal increase in time in hyperglycaemia suggesting a deterioration in glucose control when the set is worn beyond 72 h. In keeping with the aforementioned, TDD of insulin also increased with time. The increase in glucose levels with duration of IIS wear reflect the observations described in reports of other extended‐wear infusion set studies 11,12 …”

“…7 days of wear time with reduced failures and increased patient satisfaction although some have reported an increase in average glucose per day of infusion set wear. [11][12][13][14][15] We suggest that there is room and a need for improvement in current IIS technology to increase the reliability of insulin delivery, reduce patient burden and minimize waste.…”

The improved survival rate and cost-effectiveness of a 7-day continuous subcutaneous insulin infusion set

“…Due to varying needs and behaviors, residual, unusable, insulin (e.g. dead volume) will be localized in three key areas as shown in The Extended Infusion Set (EIS, see Figure 1) can be worn up to 7 days, providing more reliable insulin delivery and decreasing the frequency of adverse effects while minimizing the amount of insulin wastage [37][38][39]. In particular, by reducing inflammatory-inducing insulin aggregates and improving the adhesives used in the infusion sets, the EIS survival rate reached 80% over seven days in a clinical trial [40].…”

Improving the Patient Experience With Longer Wear Infusion Sets Symposium Report

“…Nevertheless, many PwD prefer to use their IISs and insertion sites longer than the manufacturer-recommended duration to minimize pain with insertion procedures and reduce costs. 3 IIS reactions can include occlusion, kinking, and insertion site reactions, such as irritation, infections, lipohypertrophy, and variable insulin absorption, all of which could interfere with metabolic control. 4 Because of problems associated with prolonged IIS wear, until this year, all U.S. Food and Drug Administration (FDA)-cleared IISs have been indicated for a maximal usage time of two to three days.…”

“…Nevertheless, many PwD prefer to use their IISs and insertion sites longer than the manufacturer-recommended duration to minimize pain with insertion procedures and reduce costs. 3…”