Abstract
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 corresponding mean total daily insulin delivered by the pump was 58.0 ± 25.4 Units versus 57.1 ± 28.8 Units; P = .47. CONCLUSIONS: Insulin delivery and glucose sensing with the investigational CGM-IS was feasible. Longer duration studies are needed.