1. Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas.
- Author
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Kovatchev BP, Renard E, Cobelli C, Zisser HC, Keith-Hynes P, Anderson SM, Brown SA, Chernavvsky DR, Breton MD, Mize LB, Farret A, Place J, Bruttomesso D, Del Favero S, Boscari F, Galasso S, Avogaro A, Magni L, Di Palma F, Toffanin C, Messori M, Dassau E, and Doyle FJ 3rd
- Subjects
- Adult, Blood Glucose drug effects, Blood Glucose Self-Monitoring, Cell Phone, Cross-Over Studies, Diabetes Mellitus, Type 1 blood, Female, Humans, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Hypoglycemic Agents therapeutic use, Insulin adverse effects, Insulin therapeutic use, Insulin Infusion Systems, Male, Middle Aged, Outpatients, Treatment Outcome, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Pancreas, Artificial adverse effects
- Abstract
Objective: We estimate the effect size of hypoglycemia risk reduction on closed-loop control (CLC) versus open-loop (OL) sensor-augmented insulin pump therapy in supervised outpatient setting., Research Design and Methods: Twenty patients with type 1 diabetes initiated the study at the Universities of Virginia, Padova, and Montpellier and Sansum Diabetes Research Institute; 18 completed the entire protocol. Each patient participated in two 40-h outpatient sessions, CLC versus OL, in randomized order. Sensor (Dexcom G4) and insulin pump (Tandem t:slim) were connected to Diabetes Assistant (DiAs)-a smartphone artificial pancreas platform. The patient operated the system through the DiAs user interface during both CLC and OL; study personnel supervised on site and monitored DiAs remotely. There were no dietary restrictions; 45-min walks in town and restaurant dinners were included in both CLC and OL; alcohol was permitted., Results: The primary outcome-reduction in risk for hypoglycemia as measured by the low blood glucose (BG) index (LGBI)-resulted in an effect size of 0.64, P = 0.003, with a twofold reduction of hypoglycemia requiring carbohydrate treatment: 1.2 vs. 2.4 episodes/session on CLC versus OL (P = 0.02). This was accompanied by a slight decrease in percentage of time in the target range of 3.9-10 mmol/L (66.1 vs. 70.7%) and increase in mean BG (8.9 vs. 8.4 mmol/L; P = 0.04) on CLC versus OL., Conclusions: CLC running on a smartphone (DiAs) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy. This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety., (© 2014 by the American Diabetes Association.)
- Published
- 2014
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