Ignite Creation Date:
2024-07-17 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468865
Status:
RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-14
Brief Title:
Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Bariatric Surgery
Sponsor:
Sykehuset i Vestfold HF
Organization:
Sykehuset i Vestfold HF
Study Overview
Official Title:
Continuous Glucose Monitoring in Treatment of Postprandial Hypoglycemia After Bariatric Surgery The HypoBar Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HypoBar
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 bariatric 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 bariatric 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 5 weeks or use no continuous glucose monitor for 5 weeks During week 6 both groups will wear a continuous glucose monitor but the patients who have not been wearing a continuous glucose monitor will wear a blinded continuous glucose monitor
Visit the clinic 3 times
Register symptoms of hypoglycaemia answer questionnaires keep a food diary measure weight and body composition and take blood samples
Is continuous glucose monitoring superior to usual care for prevention of postprandial hypoglycaemia in patients with verified postprandial hypoglycaemia after bariatric 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 5 weeks or use no continuous glucose monitor for 5 weeks During week 6 both groups will wear a continuous glucose monitor but the patients who have not been wearing a continuous glucose monitor will wear a blinded continuous glucose monitor
Visit the clinic 3 times
Register symptoms of hypoglycaemia answer questionnaires keep a food diary measure weight and body composition and take blood samples
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None