Status:
COMPLETED
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
Lead Sponsor:
Xeris Pharmaceuticals
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hypoglycemia
Complications of Bariatric Procedures
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 pat...
Detailed Description
This is a Phase 2a, single-center, open-label, proof-of-concept study designed to test the ability of the control algorithm to detect and direct timing of G-Pump™ glucagon infused from an OmniPod® pum...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT02733588
Start Date
March 1 2016
End Date
June 1 2017
Last Update
October 30 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215