Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous glucose monitor (Dexcom® G7).
- Who it may be relevant to
- Registry conditions: Hypoglycemia Non-Diabetic, Gastric Bypass Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery: The HypoSurge Randomized Clinical Trial
Overview
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.
Interventions
- Device Continuous glucose monitor (Dexcom® G7)
Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
Primary outcome measures
- • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.0 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. [Time frame: Screening (week 0) and week 6]
Secondary outcome measures (3)
- • Difference between the two treatment arms in change in weekly diurnal time spent with hypoglycaemia (interstitial glucose <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. [Time frame: Screening (week 0) and week 6]
- • Difference between the two treatment arms in change in weekly time (total and nocturnal) spent with hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the screening week to week 6, measured with a continuous glucose monitor. [Time frame: Screening (week 0) and week 6]
- • Difference between the two treatment arms in change in weekly events (diurnal, total and nocturnal) of hypoglycaemia (interstitial glucose <3.0 mmol/L and <3.9 mmol/L) from the sceening week to week 6, measured with a continuous glucose monitor. [Time frame: Screening (week 0) and week 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust — Tønsberg
Identifiers
NCT: NCT06468865 · 596343