Diabetes Obes Metab. 2022 Mar 8. doi: 10.1111/dom.14685. Online ahead of print.
ABSTRACT
AIM: To assess feasibility of a prototype insulin infusion set (IIS) for extended wear in adults with type 1 diabetes.
MATERIALS AND METHODS: The prototype Capillary Biomedical investigational extended-wear insulin infusion set (CBX IIS) incorporates a soft, flexible, reinforced kink-resistant angled nylon-derivative cannula with 1 distal and 3 proximal ports to optimise insulin delivery. Twenty type 1 diabetes adult participants established on insulin pump therapy used the CBX IIS for two 7-day test periods while wearing a Dexcom G5 continuous glucose monitor.
RESULTS: Participants were able to wear the CBX IIS for an average of 6.6±1.4 days. Eighty-eight percent (36/41) of sets were worn for 7 days. No serious adverse events were reported. Five infusion sets failed prematurely due to: unresolvable hyperglycaemia (3); hyperglycaemia with elevated ketones (1); or infection (1). Median time in range (3.9-10.0 mmol/L) was 62% [54–76]. Average glucose levels per day of infusion set wear showed a statistically significant increase over time (p<0.001).
CONCLUSIONS: Our preliminary observations confirm the tolerability of the prototype CBX IIS for extended wear, albeit with a deterioration in glucose control after the third day. This article is protected by copyright. All rights reserved.
PMID:35257468 | DOI:10.1111/dom.14685
