Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Recruiting now · Not applicable
Conditions studied: Dumping Syndrome, Post-bariatric Hypoglycemia
In brief
Late dumping syndrome is a common complication following Roux-en-Y gastric bypass, characterized by postprandial hypoglycemia with significant impact on patient safety and quality of life. Traditional capillary glucose monitoring has limited ability to detect rapid glycemic fluctuations. This prospective randomized study aims to evaluate the efficacy and safety of the iCan i3 continuous glucose monitoring (CGM) system compared to conventional capillary glucose monitoring in detecting hypoglycemic events in post-bariatric patients with late dumping syndrome. Participants will be randomized into two groups: one using CGM and one using standard fingerstick monitoring, and followed for 60 days. Clinical outcomes, hypoglycemia frequency, symptom correlation, and quality of life will be assessed.
Key facts
- Study ID
- NCT07440706
- Run by
- Kaiser Clinic and Hospital
- People needed
- 60
- Starts
- 2025-10-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-02-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18-65 years
- History of Roux-en-Y gastric bypass ≥12 months
- Clinical diagnosis of late dumping syndrome
- Stable body weight (<5% variation in last 3 months)
- Ability to provide informed consent
You may not qualify if…
- Diagnosis of diabetes mellitus under treatment
- Use of antidiabetic medications (except acarbose)
- Pregnancy or breastfeeding
- Cognitive impairment affecting study participation
- Known hypersensitivity to CGM adhesives
- Conditions increasing risk of hypoglycemia (e.g., prolonged fasting)
- Active or prior malignancy
- Need for imaging procedures during study period
Where it is running
- Kaiser Clínica Hospital Dia — São José do Rio Preto, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
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