Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
NCT02733588 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2018-10-30
Summary
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe hypoglycemia following bariatric surgery.
Conditions
- Hypoglycemia
- Complications of Bariatric Procedures
Interventions
- DRUG
-
G-Pump™ (glucagon infusion)
0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
collaborator NIH -
Xeris Pharmaceuticals
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-03-31
- Primary Completion
- 2017-04-05
- Completion
- 2017-06-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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