Longevity of the novel ConvaTec infusion set with Lantern technology

Abstract

Current insulin infusion sets are approved for only 2-3 days. The novel ConvaTec infusion set with Lantern technology is designed to extend infusion set wear time. The goal of this pilot study was to evaluate the duration of wear for this set. This was a pilot safety study in adults with type 1 diabetes using tethered insulin pumps. Participants inserted the set and wore it for 10 days or until failure. Among 24 participants, two were excluded. Forty-five per cent of the sets lasted 10 days. Median wear time was 9.1 (7.1, 10.0) days. Among 12 premature failures, six (50%) involved adhesive failures, four (33%) hyperglycaemia unresponsive to correction, one (8%) hyperglycaemia with ketones and one (8%) infection. Average CGM glucose per day of infusion set wear showed a statistically significant increase over time, while total daily insulin over the same period did not change. In this pilot study, the duration of wear for the novel infusion set exceeded previously reported commercial sets (P < .001). This extended wear technology may eventually allow for a combined glucose sensor and infusion set.

Keywords: CSII; insulin pump therapy; insulin therapy; type 1 diabetes.

Conflict of interest statement

CONFLICT OF INTEREST

RAL has consulted for GlySens Incorporated, Abbott Diabetes Care, Biolinq, Capillary Biomedical, Morgan Stanley and Tidepool. LH has no conflicts of interest or disclosures to declare. JZ has no conflicts of interest or disclosures to declare. PKS and MH are employees of ConvaTec. BB is on medical advisory boards for ConvaTec, Medtronic, Capillary Biomedical and Tidepool.

© 2021 John Wiley & Sons Ltd.

Figures

FIGURE 1

ConvaTec infusion set with Lantern technology. A, Distal tip of novel ConvaTec infusion set with Lantern technology cannula (left), demonstration of increased surface area of distribution in unkinked state (middle) and catheter being kinked by underlying muscle with continued flow through side openings (right). B, Infusion set with no site failure at day 10 (top). Infusion set failure at day 8, with leakage (bottom)

FIGURE 2

Performance of the novel ConvaTec infusion set. A, Survival curve by day for the novel ConvaTec infusion set with Lantern technology worn for a maximum of 10 days. Survival at 7 days is highlighted with a dotted line for comparison with prior studies, in which infusion sets were worn for a week. B, Average glucose on continuous glucose monitor (CGM) and total daily insulin (TDI) dosage by day of infusion set wear. At the bottom of each bar is the number of participants providing data. For CGM, participants had to provide sufficient CGM data and partial data for the last day of wear is included (when values may be higher with a failing infusion set). TDI was included on the final day only with more than 22 hours of insulin data. *P < .05 compared with mean glucose on day 1, all other comparisons in an ANOVA were insignificant