Continuous Glucose Monitoring to Reduce Hypoglycemia and Improve Safety After Gastric Surgery

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, Ill 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 syncope (unrelated to hypoglycemia) or diagnosed cardiac arrhythmia
• •7. Concurrent administration of beta-blocker therapy;
• •8. History of a cerebrovascular accident;
• •9. Seizure disorder (other than with suspect or documented hypoglycemia);
• •10. Active treatment with any diabetes medications except for acarbose;
• •11. Active treatment with octreotide or diazoxide;
• •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 (multiple endocrine neoplasia (MEN) 2, neurofibromatosis, or Von Hippel-Lindau disease);
• •14. Known insulinoma;
• •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 I 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.