Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatri… (NCT02733588) | Clinical Trial Compass
CompletedPhase 2
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
United States8 participantsStarted 2016-03
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 informed consent and follow all study procedures, including attending all scheduled visits.
Exclusion Criteria:
* documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
* chronic kidney disease stage 4 or 5;
* hepatic disease, including serum alanine aminotransferase or aspartate aminotransferase greater than or equal to 3 times the upper limit of normal; hepatic synthetic insufficiency as defined as serum albumin \< 3.0 g/dL; or serum bilirubin \> 2.0;
* congestive heart failure, New York Heart Association class II, III or IV;
* history of myocardial infarction, unstable angina or revascularization within the past 6 months;
* history of a cerebrovascular accident;
* seizure disorder (other than with suspect or documented hypoglycemia);
* active treatment with any diabetes medications except for acarbose;
* active malignancy, except basal cell or squamous cell skin cancers;
* personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
* known insulinoma;
* major surgical operation within 30 days prior to screening;
* hematocrit ≤ 33%;
* bleeding disorder, treatment with …