Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery

NCT06468865 | Recruiting FDA Device

• 1 other identifier: 596343
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• • 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.

  Interstitial glucose is measured for one week during the screening week and for one week during week 6.

  Screening (week 0) and week 6

Secondary Outcomes (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.

  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.

  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.

  Screening (week 0) and week 6

Study Arms (2)

Continuous glucose monitor

EXPERIMENTAL

The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week. After the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will also use a continuous glucose monitor and receiver which displays real-time glucose levels, for 6 weeks, to learn how to avoid hypoglycaemia.

Device: Continuous glucose monitor (Dexcom® G7)

No continuous glucose monitor

NO INTERVENTION

The participants will wear a blinded (i.e. glucose levels are not displayed) Dexcom® G7 continuous glucose monitor for one week during the screening week. After the screening week, the patients will be given dietary guidance on how to avoid hypoglycaemia and be given a capillary glucometer (standard treatment procedure). The patients will not use a continuous glucose monitor during the following 5 weeks, but during week 6 the patient will wear a blinded continuous glucose monitor.

Interventions

Continuous glucose monitor (Dexcom® G7) DEVICE

Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes

Continuous glucose monitor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sykehuset i Vestfold HF: lead

Study Sites (1)

1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust

Tønsberg, Vestfold, 3103, Norway

RECRUITING

Central Study Contacts

Heidi Borgeraas, PhD

CONTACT

004746707000; heibor@siv.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 21, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Locations

NO (1)