ArticleJournal of diabetes science and technology2026
First in Human Feasibility Study of an Insulin Patch Pump Combined With CGM-Insulin Delivery Cannula.
Article in Journal of diabetes science and technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
19 authors.
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Abstract
aimsCombining a patch pump (PP) with a single-insertion glucose-sensing cannula (continuous glucose monitor with an insulin set [CGM-IS]) may reduce user burden compared with tethered insulin pumps or multiple daily injections. We aimed to determine feasibility of a combined device.
methodsThis feasibility study evaluated a PP with a CGM-IS (PP-CGM-IS) with manual bolus insulin dosing in T1D adults with insulin pump and CGM experience. The pilot phase involved 3 participants undergoing a mixed meal test (MMT) for 12 hours. In the second phase, 15 participants were studied for 72 hours, including day 1 and day 3 MMTs and one supervised free-living day at a hotel. Primary outcome was accuracy of the CGM device, assessed by mean absolute relative difference (MARD). Secondary outcomes included number of insulin delivery failures and device survival duration.
resultsTwenty-six devices were inserted in 18 participants. Mean age was 51 years, 14 were female. Nine device (sensor) failures occurred immediately post-insertion requiring re-insertion. Mean absolute relative difference against Yellow Springs Instruments (YSI) in 17 devices was 11.6%. Consensus error grid analysis against YSI analyser showed 83.16% of readings fell within zone A and 100% within zones A and B. Mean glucose, time in range, and total daily insulin dose on day 2 of the main phase compared with baseline did not suggest compromise of insulin delivery. There were no serious adverse events.
conclusionThis first-in-human study confirms feasibility of integrating CGM-IS with PP. A PP-CGM-IS system warrants further research, including improved insertion process, greater sensor accuracy and ultimately real-time algorithm implementation.
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