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08-04-2022 | Diabetes | News | Article

Pivotal study shows feasibility of extended-wear insulin infusion set

Author: Laura Cowen

medwireNews: An extended-wear insulin infusion set, worn for up to 7 days, is more satisfactory to users than standard insulin infusion sets and does not adversely affect glycemic control, shows a study in people with type 1 diabetes.

The trial, by Bruce Buckingham (Stanford University School of Medicine, Palo Alto, California, USA) and colleagues, included 259 adults (mean age 45 years, 48% men) with type 1 diabetes, who used the Medtronic extended-wear insulin infusion set for up to 7 days, across 12 consecutive wears in combination with their own MiniMed™ 670G system with insulin lispro or insulin aspart.

Buckingham and team observed no serious adverse device effects, unanticipated adverse device effects, or diabetic ketoacidosis events during a total of 3041 device wears.

The serious adverse event rate was 3.8 cases per 100 participant–years, but none of the three events that occurred were related to the device or study procedure.

The rates of severe hypoglycemia and severe hyperglycemia were 2.5 and 104.1 cases per 100 participant–years, respectively, while skin infection at the infusion set insertion site occurred at a rate of 20.1 events per 100 participant–years.

The authors report in Diabetes Technology & Therapeutics that the overall infusion set survival rate at the end of day 7 was 77.8%.

The device failure rate due to unexplained hyperglycemia during the 7 days of wear was 0.1% with insulin lispro and 0.4% with insulin aspart.

And the researchers note that all of these outcomes occurred at rates that were similar to or lower than those reported in studies among standard insulin infusion set users.

In addition, glycemic control remained stable throughout the study, and participants reported significantly greater satisfaction with the extended-wear set than with standard sets worn before the study in terms of ease of insertion, comfort of wear, duration of wear, time required to change the set, and convenience of use.

“Opportunities for [insulin infusion set] technology advancement have not only included extending the duration of [insulin infusion set] wear but also maintaining glycemic control, while mitigating adverse events across wear duration,” Buckingham et al remark.

They conclude: “The Medtronic extended infusion set described in this study was safely worn for up to 7 days by adults without adversely affecting glycemic control and with favorable user satisfaction.”

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Diabetes Technol Ther 2022; doi:10.1089/dia.2021.0540