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Three Way Crossover Closed Loop Study With Xeris Glucagon

NCT03424044 PHASE1 COMPLETED Results posted

Closed-loop systems are an emerging technology that automate hormone delivery. They are quickly paving the way to revolutionize the treatment of type 1 diabetes. Several categories have emerged: dual-hormone (insulin and glucagon) closed-loop systems and closed-loop systems with insulin only, one variety of which is the low glucose suspend safety feature now available from Medtronic (MiniMed640G with SmartGuard). The study described within this protocol is designed to test the efficacy of a new closed-loop algorithm for managing blood glucose in people with type 1 diabetes before and after exercise. The new algorithm will have 3 modes: a single hormone insulin only mode, a dual-hormone insulin and glucagon mode and an insulin only mode with predictive low glucose suspend, all with an exercise detection algorithm. The purpose of this study is to determine whether a dual hormone AP using a stable investigational glucagon with an exercise detection algorithm outperforms both single hormone AP and a low glucose suspend algorithm.

Details

Lead sponsorOregon Health and Science University
PhasePHASE1
StatusCOMPLETED
Enrolment23
Start dateThu Mar 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionFri May 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States