Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02733588 | Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients | PHASE2 | COMPLETED | 8 | — | — | Mar 1, 2016 | Jun 1, 2017 | Oct 30, 2018 | 1 | United States |
Frequency with which the device controller software correctly identifies impending hypoglycemia (glucose \< 75 mg/dl) and notifies the investigator to initiate treatment. Reported as the number of successful identifications.
| Arm | Type | Description |
|---|---|---|
| G-Pump™ (glucagon infusion) | EXPERIMENTAL | 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump |
| Name | Type | Description |
|---|---|---|
| G-Pump™ (glucagon infusion) | DRUG | 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump |
Inclusion Criteria: * diagnosed with ongoing post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention (low glycemic index, controlled carbohydrate portions) and trial of acarbose therapy at the maximally tolerated dose. * willingness to provide inform...