Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
XeriSol glucagon · 1 trial · 1 indication
Assess the percent of time that the Dexcom G5 or G6 reported sensor glucose values less than 70 mg/dl using Dexcom sensor across all three arms.
| Arm | Type | Description |
|---|---|---|
| Dual Hormone Closed-loop Arm | EXPERIMENTAL | Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in dual hormone mode and XeriSol glucagon to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery and an increase in glucagon delivery upon detection. |
| Single Hormone Closed-loop Arm | EXPERIMENTAL | Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in single hormone mode to manage blood sugar that includes an exercise detection component that includes a reduction in insulin delivery upon detection. |
| Predictive Low Glucose Suspend Arm | EXPERIMENTAL | Subjects will undergo a 76 hour study with 9 hours inpatient and 67 hours outpatient using the closed-loop artificial pancreas controller in predictive low glucose suspend mode. The system will run through the closed-loop system but will utilize the patient's optimized basal rates, correction factors and carb ratios as they would normally run on their own insulin pump. But the mode will have the additional safety net of the pump suspending insulin when it predicts a hypoglycemic event. |
| Name | Type | Description |
|---|---|---|
| Artificial Pancreas Controller in Dual Hormone Mode | DEVICE | 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. |
| Artificial Pancreas Controller in Single Hormone Mode | DEVICE | 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. |
| Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode | DEVICE | 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. |
| XeriSol glucagon | DRUG | 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. |
Inclusion Criteria: * Diagnosis of type 1 diabetes mellitus for at least 1 year. * Male or female subjects 21-50 years of age. * Physically willing and able to perform 45 min of exercise. * Current use of an insulin pump. * Lives with another person age 18 or older who will be present while subject...
XeriSol glucagon is an investigational small molecule developed by Xeris Biopharma Holdings, Inc. for type 1 diabetes. It has been studied in a Phase 1 closed loop crossover trial in adults with type 1 diabetes, evaluating its use with a closed loop system. It is not approved and remains in clinical development.
XeriSol glucagon is being developed by Xeris Biopharma Holdings, Inc., which trades on the Nasdaq under the ticker XERS. The company is the sponsor of the Phase 1 clinical program for this investigational small molecule in type 1 diabetes.
XeriSol glucagon is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational product and has not been approved by the FDA for any indication.
XeriSol glucagon has been studied in one completed Phase 1 trial, NCT03424044, titled Three Way Crossover Closed Loop Study With Xeris Glucagon. The trial enrolled 23 adults aged 21 years and older with type 1 diabetes in the United States and used a controlled, randomized design.
No. XeriSol glucagon is an investigational small molecule in Phase 1 clinical development for type 1 diabetes and has not been approved by the FDA. Its only listed trial, NCT03424044, is completed, and no active trials are ongoing.