Hybrid Closed-Loop Insulin Delivery in Type 1 Diabetes During Supervised Outpatient Conditions. (May 2016)

• Record Type: Journal Article
• Authors: Grosman, Benyamin; Ilany, Jacob; Roy, Anirban; Kurtz, Natalie; Wu, Di; Parikh, Neha; Voskanyan, Gayane; Konvalina, Noa; Mylonas, Chrystaleni; Gottlieb, Rebecca; Kaufman, Francine; Cohen, Ohad
• Is Part Of: Journal of diabetes science and technology. Volume 10:Number 3(2016:May)
• Page Start: 708
• Page End: 713
• Publication Date: 2016-05
• Subjects: artificial pancreas -- diabetes -- insulin pump therapy -- human trials; Diabetes -- Periodicals; Medical technology -- Periodicals; Diabetes Mellitus -- Periodicals; 616.462005
• DOI: 10.1177/1932296816631568
• Languages: English
• ISSNs: 1932-2968

Abstract

Background: Efficacy and safety of the Medtronic Hybrid Closed-Loop (HCL) system were tested in subjects with type 1 diabetes in a supervised outpatient setting. Methods: The HCL system is a prototype research platform that includes a sensor-augmented insulin pump in communication with a control algorithm housed on an Android-based cellular device. Nine subjects with type 1 diabetes (5 female, mean age 53.3 years, mean A1C 7.2%) underwent 9 studies totaling 571 hours of closed-loop control using either default or personalized parameters. The system required meal announcements with estimates of carbohydrate (CHO) intake that were based on metabolic kitchen quantification (MK), dietician estimates (D), or subject estimates (Control). Postprandial glycemia was compared for MK, D, and Control meals. Results: The overall sensor glucose mean was 145 ± 43, the overall percentage time in the range 70-180 mg/dL was 80%, the overall percentage time <70 mg/dL was 0.79%. Compared to intervals of default parameter use (225 hours), intervals of personalized parameter use (346 hours), sensor glucose mean was 158 ± 49 and 137 ± 37 mg/dL ( P < .001), respectively, and included more time in range (87% vs 68%) and less time below range (0.54% vs 1.18%). Most subjects underestimated the CHO content of meals, but postprandial glycemia was not significantly different between MK and matched Control meals ( P = .16) or between D and matched Control meals ( P = .76). There were no episodes of severe hypoglycemia. Conclusions: The HCL system was efficacious and safe during this study. Personally adapted HCL parameters were associated with more time in range and less time below range than default parameters. Accurate estimates of meal CHO did not contribute to improved postprandial glycemia.