NCT06468865

Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sykehuset i Vestfold HF · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn if continuous glucose monitoring works to treat postprandial hypoglycaemia in patients who have undergone gastric bypass surgery. The main question it aims to answer is: • Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after gastric bypass surgery? Researchers will compare continuous glucose monitoring to usual care to see if continuous glucose monitoring works to treat postprandial hypoglycaemia. Participants will: * Use a continuous glucose monitor for 6 weeks or use no continuous glucose monitor for 5 weeks and wear a blinded continuous glucose monitor for 1 week. * Visit the clinic 2-3 times and have 2-3 phone consultations. * Register symptoms of hypoglycaemia, answer questionnaires, undergo a 24-hour dietary recall interview conducted by a registered dietitian, measure weight and body composition and take blood samples.

Conditions

• Hypoglycemia Non-Diabetic
• Gastric Bypass Surgery

Interventions

Type	Name	Description
DEVICE	Continuous glucose monitor (Dexcom® G7)	Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes

Timeline

• Start date: 2024-11-12
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2024-06-21
• Last updated: 2024-11-05

Locations

1 site across 1 country: Norway

Regulatory

• FDA-regulated device study