NCT07440706 Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
| NCT ID | NCT07440706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaiser Clinic and Hospital |
| Condition | Dumping Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-10-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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