Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
A Prospective Randomized Study Evaluating the Efficacy and Safety of the iCan i3 Continuous Glucose Monitoring System in Post-Bariatric Patients With Late Dumping Syndrome
Kaiser Clinic and Hospital
60 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria8
- 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
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Interventions
Intervention 1 - Experimental Arm Device: iCan i3 Continuous Glucose Monitoring System Participants assigned to the experimental group will use the iCan i3 continuous glucose monitoring (CGM) system for 60 days. The sensor will be inserted in the abdominal region and will provide real-time interstitial glucose readings every 3 minutes via Bluetooth connection to a mobile application. Sensors will be replaced every 15 days, totaling four cycles during the study period. Data will be continuously recorded and stored for subsequent analysis. Participants will also record hypoglycemic symptoms and meal timing in a study diary. Intervention 2 - Active Comparator Arm Device: Capillary Glucose Monitoring (Glucometer - Sinocare) Participants assigned to the control group will perform capillary blood glucose monitoring using a glucometer (Sinocare). Measurements will be performed up to three times per day, preferably in the presence of hypoglycemic symptoms, using fingerstick sampling with
Locations(1)
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NCT07440706