Three Way Crossover Closed Loop Study With Xeris Glucagon

PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

May 17, 2019

Study Completion Date

May 17, 2019

Conditions
Type1diabetes
Interventions
DEVICE

Artificial Pancreas Controller in Dual Hormone Mode

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The algorithm has 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to two Omnipod insulin pumps, one filled with insulin and one with glucagon.

DEVICE

Artificial Pancreas Controller in Single Hormone Mode

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod pump filled with insulin.

DEVICE

Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode

The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod insulin pump filled with insulin.

DRUG

XeriSol glucagon

XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.

Trial Locations (1)

97239

Oregon Health and Science University, Portland

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Xeris Pharmaceuticals

INDUSTRY

lead

Oregon Health and Science University

OTHER