Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Gastric Bypass Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSykehuset i Vestfold HF
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Not able to give informed consent
Reduced compliance due to severe mental and psychiatric conditions
Use of insulin or sulfonylureas
Use of systemic corticosteroids
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous glucose monitor (Dexcom® G7)
DeviceContinuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Continuous glucose monitorExperimental treatment 1 intervention
Group B: No continuous glucose monitorNo intervention 0 interventions
Trial outcomes
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.
Time frame
Screening (week 0) and week 6Secondary outcomes
1
• 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.
Time frame
Screening (week 0) and week 62
• 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.
Time frame
Screening (week 0) and week 63
• 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.
Time frame
Screening (week 0) and week 6Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov