1. Feasibility study of a prototype extended‐wear insulin infusion set in adults with type 1 diabetes.
- Author
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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., and O'Neal, David N.
- Subjects
TYPE 1 diabetes ,INSULIN pumps ,INSULIN ,INSULIN therapy ,PROTOTYPES ,FEASIBILITY studies - 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. [ABSTRACT FROM AUTHOR]
- Published
- 2022
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