Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery (HypoSurge)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastric Bypass Surgery; Hypoglycemia Non-Diabetic
• Intervention / Treatment: Device: Continuous glucose monitor (Dexcom® G7)

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Borgeraas, PhD; Phone Number: 004746707000; Email: heibor@siv.no

Study Locations

• Norway
  • Vestfold
    • Tønsberg, Vestfold, Norway, 3103
      • Recruiting
      • 1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust
      • Contact: Heidi Borgeraas, PhD; Phone Number: +47 46707000; Email: heibor@siv.no
      • Contact: Dag Hofsø, MD, PhD; Phone Number: +47 90591666; Email: dag.hofso@siv.no
      • Principal Investigator: Heidi Borgeraas, PhD
      • Sub-Investigator: Dag Hofsø, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous glucose monitor; 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); Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
No Intervention: No continuous glucose monitor; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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.	Interstitial glucose is measured for one week during the screening week and one week during week 6.	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.	Interstitial glucose is measured for one week during the screening week and one week during week 6.	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.	Interstitial glucose is measured for one week during the screening week and one week during week 6.	Screening (week 0) and week 6

Collaborators and Investigators

• Sponsor: Sykehuset i Vestfold HF

Study record dates

Study Major Dates

• Study Start (Estimated): November 12, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 14, 2024
• First Submitted That Met QC Criteria: June 20, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 1, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Hypoglycemia
• Other Study ID Numbers: 596343

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes