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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Continuous glucose monitors measures glucose levels in the interstitial fluid every 5 minutes
1Department of Endocrinology, Obesity and Nutrition, Vestfold Hospital Trust
Tønsberg, Vestfold, Norway
RECRUITING• 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 6
• 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 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.
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.
Interstitial glucose is measured for one week during the screening week and one week during week 6.
Time frame: Screening (week 0) and week 6
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