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Research Letter
October 4, 2016

Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes

Author Affiliations
  • 1International Diabetes Center, Minneapolis, Minnesota
  • 2Barbara Davis Center for Diabetes, University of Colorado Denver, Aurora
  • 3Yale University, New Haven, Connecticut
  • 4Stanford University, Stanford, California
  • 5Atlanta Diabetes Associates, Atlanta, Georgia
  • 6Medtronic, Northridge, California
JAMA. 2016;316(13):1407-1408. doi:10.1001/jama.2016.11708

Closed-loop artificial pancreas technology uses a control algorithm to automatically adjust insulin delivery based on subcutaneous sensor data to improve diabetes management. Currently available systems stop insulin in response to existing1 or predicted2 low sensor glucose values, whereas hybrid closed-loop systems combine user-delivered premeal boluses with automatic interprandial insulin delivery.3 This study investigated the safety of a hybrid closed-loop system in patients with type 1 diabetes.

Patients aged 14 to 75 years with type 1 diabetes for at least 2 years, glycated hemoglobin (HbA1c) less than 10%, and more than 6 months of insulin pump use were recruited from 10 centers (9 in the United States, 1 in Israel) between June 2, 2015, and November 11, 2015. This before and after study had a 2-week run-in period (baseline) for patients to learn the devices without the automated features followed by a 3-month study period with the initial 6 days used to collect insulin and sensor glucose data for the hybrid closed-loop algorithm. In the study period, there was a 6-day hotel stay during which 1 day was used for frequent sampling of venous blood glucose to verify the accuracy of the system. The last patient visit was March 7, 2016. Two central and 4 local institutional review boards approved the study. Written informed consent was obtained from adults and parents, and written assent from minors.

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