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

2022-06

Kastner, Jasmin R

Venkatesh, Nisha

Brown, Katie

Muchmore, Douglas B

Ekinci, Elif I

Fourlanos, Spiros

Joseph, Jeffrey I

Shafeeq, Miami

Shi, Leon

Strange, Poul

Strasma, Paul J

O'Neal, David N

CSII

insulin pump therapy

phase I-II study

type 1 diabetes

Journal Article

https://orcid.org/0000-0002-0821-3778

https://orcid.org/0000-0003-2372-395X

https://orcid.org/0000-0002-0870-4032

10.1111/dom.14685

To assess the feasibility of a prototype insulin infusion set (IIS) for extended wear in adults with type 1 diabetes. 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. 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). 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.

link

Diabetes, Obesity & Metabolism 2022; 24(6): 1143-1149

Diabetes, obesity & metabolism