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

Post-bariatric Hypoglycemia Clinical Trial

Official title: Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

A control system for sensor-guided delivery was previously developed and tested in a Proof-of-Concept (POC) study in a clinical research setting during 9 mixed meal tolerance tests in 8 unique patients with severe hypoglycemia following bariatric surgery. This optimized algorithm will now be implemented to deliver stable glucagon in a closed-loop system. A randomized, placebo-controlled, masked trial will be conducted to assess the efficacy of the closed loop system to prevent and treat hypoglycemia occurring in patients with PBH in response to meals (part 1). Part 2 will test whether the closed loop system can also prevent and treat hypoglycemia in patients with PBH in response to exercise. A manufacturing program from our collaborating team at Xeris Pharmaceuticals will continue to produce supplies of glucagon for the clinical trial in a current good manufacturing practice (cGMP) facility, with continued shelf-life stability testing. ;

Related Conditions & MeSH terms

• Hypoglycemia
• Post-bariatric Hypoglycemia

• NCT number: NCT03255629
• Study type: Interventional
• Source: Joslin Diabetes Center
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: September 19, 2017
• Completion date: August 22, 2018