Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients

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 warfarin, or platelet count \<50,000;
• •blood donation (1 pint of whole blood) within the past 2 months;
• •active alcohol abuse or substance abuse;
• •current administration of oral or parenteral corticosteroids;
• •pregnancy and/ or Lactation: For women of childbearing potential: there is a requirement for a negative urine pregnancy test and for agreement to use contraception during the study and for at least 1 month after participating in the study.
• •use of an investigational drug within 30 days prior to screening.
• •there will be no involvement of special vulnerable populations such as pregnant women, prisoners, institutionalized or incarcerated individuals, or others who may be considered vulnerable populations.