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

Diabetes Care. 2013 Jul;36(7):1851-8. doi: 10.2337/dc12-1965.


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.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Algorithms
  • Blood Glucose / drug effects
  • Blood Glucose Self-Monitoring
  • Cell Phone
  • Diabetes Mellitus, Type 1 / drug therapy
  • Female
  • France
  • Humans
  • Hypoglycemic Agents / administration & dosage
  • Hypoglycemic Agents / therapeutic use
  • Insulin / administration & dosage
  • Insulin / therapeutic use
  • Italy
  • Male
  • Middle Aged
  • Outpatients
  • Pancreas, Artificial*
  • Young Adult


  • Blood Glucose
  • Hypoglycemic Agents
  • Insulin

Associated data

  • ClinicalTrials.gov/NCT01447979
  • ClinicalTrials.gov/NCT01447992
  • ClinicalTrials.gov/NCT01578980