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Title: Feasibility study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes.
Austin Authors: 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
Affiliation: Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia..
Department of Medicine, University of Melbourne, Department of Medicine, St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia..
The Artificial Pancreas Center, Department of Anesthesiology, Thomas Jefferson University, Philadelphia, Pennsylvania, USA..
Capillary Biomedical Inc., Irvine, California, USA..
Department of Endocrinology and Diabetes, The Royal Melbourne Hospital, Parkville, Victoria, Australia..
Medicine (University of Melbourne)
Integrated Medical Development, LLC, Princeton Junction, New Jersey, USA..
Issue Date: Jun-2022
Date: 2022-03-18
Publication information: Diabetes, Obesity & Metabolism 2022; 24(6): 1143-1149
Abstract: 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.
DOI: 10.1111/dom.14685
Journal: Diabetes, obesity & metabolism
PubMed URL: 35257468
PubMed URL:
Type: Journal Article
Subjects: CSII
insulin pump therapy
phase I-II study
type 1 diabetes
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