Combining an Electrochemical Continuous Glucose Sensor With an Insulin Delivery Cannula: A Feasibility Study

作者：Cheng Yi Yuan, Bella Halim, Yee Wen Kong, Jean Lu, Ralph Dutt‐Ballerstadt, Peter Eckenberg, Ken Hillen, A. Koski, Vlad Milenkowic, Emma Netzer, Varuni Obeyesekere, Solomon Reid, Catriona M. Sims, Sara Vogrin, Huanping Wu, Thomas L. Seidl, David N. O’Neal · 发表于：Journal of Diabetes Science and Technology · 年份：2024 · DOI：10.1177/19322968241236771 · 被引用次数：4 · 研究领域：Diabetes Management and Research、Hyperglycemia and glycemic control in critically ill and hospitalized patients、Spectroscopy Techniques in Biomedical and Chemical Research

Background: Combining a continuous glucose monitor with an insulin delivery cannula (CGM-IS) could benefit clinical outcomes. We evaluated the feasibility of a single-needle insertion electrochemical investigational CGM-IS (Pacific Diabetes Technologies, Portland, Oregon) in type 1 diabetes adults. Methods: Following 48 hours run-in using a Medtronic 780G in manual mode with a commercial insulin set, 12 participants commenced insulin delivery using the CGM-IS. A standardized test meal was eaten on the mornings of days 1 and 4. Venous samples were collected every 10 minutes one hour prior to and 15 minutes post-meal for four hours. CGM-IS glucose measurements were post-processed with a single capillary blood calibration during warm-up and benchmarked against YSI. A Dexcom G6 sensor was worn post-consent to study end. Results: Mean absolute relative difference (MARD) for the CGM-IS glucose measurements was 9.2% (484 paired data points). Consensus error grid revealed 88.6% within zone A and 100% in A + B. Mean (SD) % bias was −3.5 (11.7) %. There were 35 paired YSI readings <100 mg/dL cutoff and 449 ≥100 mg/dL with 81.4% within ±15 mg/dL or ±15%, and 89.9% within ±20 mg/dL or ±20%. Two cannula occlusions required discontinuation of insulin delivery: one at 70 hours post insertion and another during the day 4 meal test. Mean (SD) Dexcom glucose measurements during run-in and between meal tests was respectively 161.3 ± 27.3 mg/dL versus 158.0 ± 25.6 mg/dL; P = .39 and correspon...