Three Way Crossover Closed Loop Study With Xeris Glucagon
Status:
Completed
Trial end date:
2019-05-17
Target enrollment:
Participant gender:
Summary
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.