Feasibility study of a prototype extended‐wear insulin infusion set in adults with type 1 diabetes. Issue 6 (18th March 2022)

• Record Type: Journal Article
• Authors: Kastner, Jasmin R.; Venkatesh, Nisha; Brown, Katie; Muchmore, Douglas B.; Ekinci, Elif; Fourlanos, Spiros; Joseph, Jeffrey I; Shafeeq, Miami; Shi, Leon; Strange, Poul; Strasma, Paul J.; O'Neal, David N.
• Is Part Of: Diabetes, obesity & metabolism. Volume 24:Issue 6(2022)
• Page Start: 1143
• Page End: 1149
• Publication Date: 2022-03-18
• Subjects: CSII -- insulin pump therapy -- phase I‐II study -- type 1 diabetes; Diabetes -- Periodicals; Obesity -- Periodicals; Metabolism -- Disorders -- Periodicals; Clinical pharmacology -- Periodicals; 616.462
• DOI: 10.1111/dom.14685
• Languages: English
• ISSNs: 1462-8902

Abstract

Abstract: Aim: To assess the 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 IIS (CBX IIS) incorporates a soft, flexible, reinforced kink‐resistant angled nylon‐derivative cannula with one distal and three proximal ports to optimize insulin delivery. Twenty adult participants with type 1 diabetes 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 of 41) of sets were worn for 7 days. No serious adverse events were reported. Five infusion sets failed prematurely because of: unresolvable hyperglycaemia (three); hyperglycaemia with elevated ketones (one); or infection (one). 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 < .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.