Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

Exclusion Criteria

• •1. Documented hypoglycemia occurring in the fasting state (\> 12 hours fast);
• •2. Chronic kidney disease stage 4 or 5 (including end-stage renal disease);
• •3. Hepatic disease, including serum alanine transaminase (ALT) or aspartate aminotransferase (AST) 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;
• •4. Congestive heart failure, New York Heart Association (NYHA )class II, III or IV;
• •5. History of myocardial infarction, unstable angina or revascularization within the past 6 months or 2 or more risk factors for coronary artery disease including diabetes, uncontrolled hypertension, uncontrolled hyperlipidemia, and active tobacco use;
• •6. History of cardiac arrhythmia or arrhythmia detected by EKG during the screening visit;
• •7. History of syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
• •8. Concurrent administration of β-blocker therapy;
• •9. History of a cerebrovascular accident;
• •10. Seizure disorder (other than with suspect or documented hypoglycemia);
• •11. Active treatment with any diabetes medications except for acarbose;
• •12. Active malignancy, except basal cell or squamous cell skin cancers;
• •13. Personal or family history of pheochromocytoma or disorder with increased risk of pheochromocytoma (MEN 2, neurofibromatosis, or Von Hippel-Lindau disease);
• •14. Known insulinoma or glucagonoma;
• •15. Major surgical operation within 30 days prior to screening;
• •16. Hematocrit \< 33%;
• •17. Bleeding disorder, treatment with warfarin, or platelet count \<50,000;
• •18. Blood donation (1 pint of whole blood) within the past 2 months;
• •19. Active alcohol abuse or substance abuse;
• •20. Current administration of oral or parenteral corticosteroids;
• •21. 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. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an intrauterine device (IUD), the double barrier method (the woman uses a diaphragm and spermicide and the man uses a condom), or abstinence;
• •22. Use of an investigational drug within 30 days prior to screening;
• •23. Current use of anticholinergic medications;
• •24. Allergy to a component of the study drug.