Using continuous glucose monitoring to treat low blood sugar after gastric bypass surgery
Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
This study is testing if using a continuous glucose monitor can help people who had gastric bypass surgery avoid low blood sugar after meals compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sykehuset i Vestfold HF Academic / other |
| Locations | 1 site (Tønsberg, Vestfold) |
| Trial ID | NCT06468865 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine the effectiveness of continuous glucose monitoring in preventing postprandial hypoglycemia in patients who have undergone gastric bypass surgery. Participants will either use a continuous glucose monitor for six weeks or follow usual care for five weeks before wearing a blinded monitor for one week. The study will involve clinic visits, phone consultations, and assessments of symptoms, dietary habits, and blood samples. The primary goal is to compare the outcomes of continuous glucose monitoring against standard care in managing hypoglycemia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone gastric bypass surgery at least one year prior and experience symptomatic postprandial hypoglycemia.
Not a fit: Patients with severe medical conditions, those on specific medications like insulin or sulfonylureas, or those who have undergone revisional bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of postprandial hypoglycemia in patients who have had gastric bypass surgery.
How similar studies have performed: While continuous glucose monitoring is a well-established tool in diabetes management, its application for treating postprandial hypoglycemia in this specific population is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gastric bypass surgery at least 1 year ago * Age ≥18 years * Symptomatic postprandial hypoglycaemia; capillary glucose level \<3.0 mmol/L 1-4 hours after meals Exclusion Criteria: * Not able to give informed consent * Reduced compliance due to severe mental and psychiatric conditions * Use of insulin or sulfonylureas * Use of systemic corticosteroids * Primary or secondary adrenal insufficiency * Insulinoma * Severe heart-, lung, liver- or kidney disease, cancer, malnutrition and other medical conditions causing fragility * Performed bariatric revisional surgery * Drug- or alcohol abuse * Pregnancy * Use of acarbose or octreotide in the treatment of postprandial hypoglycemia * Use of continuous glucose monitor
Where this trial is running
Tønsberg, Vestfold
- 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust — Tønsberg, Vestfold, Norway (Recruiting)
Study contacts
- Study coordinator: Heidi Borgeraas, PhD
- Email: heibor@siv.no
- Phone: 004746707000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.