At a glance
ClinicalIndex Comparison Record- ✓Post-bariatric hypoglycemia with prior episodes of neuroglycopenia, unresponsive to dietary intervention and trial of acarbose at maximum tolerated dose
- ✓Age 18–65 years
- ✕Hypoglycemia occurring only in fasting state (>12 hours fast)
- ✕Chronic kidney disease stage 4 or 5 or end-stage renal disease
- ✕Hepatic disease: ALT or AST ≥3× upper limit of normal, serum albumin <3.0 g/dL, or serum bilirubin >2.0
- ✕Congestive heart failure NYHA class II, III, or IV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia
In Brief
A Phase 2 clinical trial evaluating glucagon and Closed loop glucagon pump for Post-bariatric Hypoglycemia. Completed, enrolled 18 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals
a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.