Feasibility of outpatient fully integrated closed-loop control: first studies of wearable artificial pancreas

Boris P Kovatchev, Eric Renard, Claudio Cobelli, Howard C Zisser, Patrick Keith-Hynes, Stacey M Anderson, Sue A Brown, Daniel R Chernavvsky, Marc D Breton, Anne Farret, Marie-Josée Pelletier, Jérôme Place, Daniela Bruttomesso, Simone Del Favero, Roberto Visentin, Alessio Filippi, Rachele Scotton, Angelo Avogaro, Francis J Doyle 3rd, Boris P Kovatchev, Eric Renard, Claudio Cobelli, Howard C Zisser, Patrick Keith-Hynes, Stacey M Anderson, Sue A Brown, Daniel R Chernavvsky, Marc D Breton, Anne Farret, Marie-Josée Pelletier, Jérôme Place, Daniela Bruttomesso, Simone Del Favero, Roberto Visentin, Alessio Filippi, Rachele Scotton, Angelo Avogaro, Francis J Doyle 3rd

Abstract

Objective: To evaluate the feasibility of a wearable artificial pancreas system, the Diabetes Assistant (DiAs), which uses a smart phone as a closed-loop control platform.

Research design and methods: Twenty patients with type 1 diabetes were enrolled at the Universities of Padova, Montpellier, and Virginia and at Sansum Diabetes Research Institute. Each trial continued for 42 h. The United States studies were conducted entirely in outpatient setting (e.g., hotel or guest house); studies in Italy and France were hybrid hospital-hotel admissions. A continuous glucose monitoring/pump system (Dexcom Seven Plus/Omnipod) was placed on the subject and was connected to DiAs. The patient 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 h. Study personnel monitored remotely via 3G or WiFi connection to DiAs and were available on site for assistance.

Results: The total duration of proper system communication functioning was 807.5 h (274 h in open-loop and 533.5 h in closed-loop), which represented 97.7% of the total possible time from admission to discharge. This exceeded the predetermined primary end point of 80% system functionality.

Conclusions: This study demonstrated that a contemporary smart phone is capable of running outpatient closed-loop control and introduced a prototype system (DiAs) for further investigation. Following this proof of concept, 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.

Trial registration: ClinicalTrials.gov NCT01447979 NCT01447992 NCT01578980.

Figures

Figure 1
Figure 1
Protocol design in European (A) and United States (B) investigation centers.
Figure 2
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.

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Source: PubMed

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