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Feasibility of Outpatient Fully Integrated Closed-Loop Control

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Featured Article :. Feasibility of Outpatient Fully Integrated Closed-Loop Control First studies of wearable artificial pancreas. - PowerPoint PPT Presentation

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Feasibility of Outpatient FullyIntegrated Closed-Loop Control

First studies of wearable artificial pancreasFeatured Article:Boris P. Kovatchev, Ph.D., Eric Renard, M.D., Ph.D., Claudio Cobelli, Ph.D., Howard C. Zisser, M.D., Patrick Keith-Hynes, Ph.D., Stacey M. Anderson, M.D., Sue A. Brown, M.D., Daniel R. Chernavvsky, M.D., Marc D. Breton, Ph.D., Anne Farret, M.D., Ph.D., Marie-Jose Pelletier, M.D., Jrme Place, M.S.C., Daniela Bruttomesso, M.D., Ph.D., Simone del Favero, Ph.D., Roberto Visentin, M.S.C., Alessio Filippi, M.D., Rachele Scotton, M.D., Angelo Avogaro, M.D., Ph.D., Francis J. Doyle III, Ph.D.Diabetes Care Volume 36: 1851-1858July, 2013STUDY OBJECTIVETo evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs)

System uses a smart phone as a closed-loop control platform

Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858STUDY DESIGN AND METHODS20 patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at the Sansum Diabetes Research InstituteU.S. studies were conducted entirely in an outpatient settingStudies in Italy and France were hybrid hospitalhotel admissionsA continuous glucose monitoring/pump system was placed on the subject and was connected to DiAsPatient operated the system via the DiAs user interface in open-loop mode (first 14 h of study), switching to closed-loop for the remaining 28 hStudy personnel monitored remotely via 3G or WiFi connection to DiAs and were available onsite for assistance

Kovatchev B. P. et al. Diabetes Care 2013;36:1851-18583Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858

Figure 1- Protocol design in European (A) and United States (B) investigation centers.4RESULTSTotal duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop)

97.7% of the total possible time from admission to discharge represented

Predetermined primary end point of 80% system functionality was exceeded

Kovatchev B. P. et al. Diabetes Care 2013;36:1851-18585Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858

Figure 2- A: Photos of the DiAs smart phone displaying CGM and insulin delivery traces (left) and the entire system worn by a study subject (right). B: Screenshot of the remote monitoring system operation during the trials at Sansum. Each of the five subjects participating simultaneously in these trials is represented by an icon on the computer screen. HYPER, hyperglycemia; HYPO, hypoglycemia.6CONCLUSIONSContemporary smart phones are capable of running outpatient closed-loop control

Future steps should include equipping insulin pumps and sensors with wireless capabilities, as well as studies focusing on control efficacy and patient-oriented clinical outcomes

Kovatchev B. P. et al. Diabetes Care 2013;36:1851-18587Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858

Table 1- Performance metrics for the functioning of the artificial pancreas system used in these studies and of its primary components

Data presented separately for the two communication boxes used throughout the study.8Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858

Table 1 Continued- Performance metrics for the functioning of the artificial pancreas system used in these studies and of its primary components

Data presented separately for the two communication boxes used throughout the study.

9Kovatchev B. P. et al. Diabetes Care 2013;36:1851-1858

Table 2- Performance of the control algorithm10