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

Description

To assess the efficacy of a closed loop glucagon system to prevent and treat hypoglycemia occurring in patients with Post-Bariatric Hypoglycemia (PBH) in response to meals and exercise.

Study Start Date

August, 18 2017

Estimated Completion Date

August 2018

Interventions

  • Drug: glucagon
  • Device: Closed loop glucagon pump

Study ID

Joslin Diabetes Center -- 2016-27

Status

Recruiting

Trial ID

NCT03255629

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

40

Sponsor

Joslin Diabetes Center

Inclusion Criteria

    1. Males or females 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. 2. Age 18-65 years of age, inclusive, at screening. 3. Willingness to provide informed consent and follow all study procedures, including attending all scheduled visits.

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 ALT or 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, 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 ?-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 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.

Gender

All

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Mary E Patti MD 617-309-1966 mary.elizabeth.patti@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Mary E Patti MD 617-309-1966 mary.elizabeth.patti@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Mary E Patti MD 617-309-1966 mary.elizabeth.patti@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Mary E Patti MD 617-309-1966 mary.elizabeth.patti@joslin.harvard.edu
Joslin Diabetes Center - Boston, Massachusetts 2.4 miles Mary E Patti MD 617-309-1966 mary.elizabeth.patti@joslin.harvard.edu

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.