Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Condition: Hypoglycemia; Complications of Bariatric Procedures
MeSH terms: Hypoglycemia
Intervention: G-Pump™ (glucagon infusion)
Intervention description: 0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: hypoglycemia; glucagon; glucose metabolism disorders; hormones; gastrointestinal agents; bariatric surgery; incretins

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.
    

Eligibility criteria:

        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 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.