Feasibility of Outpatient Fully Integrated Closed-Loop Control

• DOI: 10.2337/dc12-1965
• Publication Date: 2013-06-25T19:50:34Z
• Authors: Boris P. Kovatchev; Eric Renard; Claudio Cobelli; Howard C. Zisser; Patrick Keith-Hynes; Stacey M. Anderson; Sue A. Brown; Daniel R. Chernav...; Marc D. Breton; Anne Farret; Marie-Josée Pelle...; Jérôme Place; Daniela Bruttomesso; Simone Del Favero; Roberto Visentin; Alessio Filippi; Rachele Scotton; Angelo Avogaro; Francis J. Doyle
• Keywords: Adult; Blood Glucose; Male; Pancreas, Artificial; Blood Glucose Self-Monitoring; Middle Aged; 3. Good health; Young Adult; 03 medical and health sciences; Diabetes Mellitus, Type 1; 0302 clinical medicine; Italy; Diabetes Care Symposium; Outpatients; Humans; Hypoglycemic Agents; Insulin; Female; France; Algorithms; Cell Phone; Aged

OBJECTIVE To evaluate the feasibility of a wearable artificial pancreas system, Diabetes Assistant (DiAs), which uses smart phone as closed-loop control platform. RESEARCH DESIGN AND METHODS Twenty patients with type 1 diabetes were enrolled at Universities Padova, Montpellier, and Virginia Sansum Research Institute. Each trial continued for 42 h. The United States studies conducted entirely in outpatient setting (e.g., hotel or guest house); Italy France hybrid hospital–hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on subject connected to DiAs. patient operated via DiAs user interface open-loop mode (first 14 h study), switching remaining 28 Study personnel monitored remotely 3G WiFi connection available site assistance. RESULTS total duration proper communication functioning 807.5 (274 533.5 closed-loop), represented 97.7% possible time from admission discharge. This exceeded predetermined primary end point 80% functionality. CONCLUSIONS study demonstrated that contemporary is capable running introduced prototype (DiAs) further investigation. Following this proof concept, future steps should include equipping insulin pumps sensors wireless capabilities, well focusing efficacy patient-oriented clinical outcomes.