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

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.

This is a prospective, single-center, randomized, open-label clinical study evaluating the performance of a continuous glucose monitoring system (iCan i3) compared to conventional capillary glucose monitoring in post-bariatric patients diagnosed with late dumping syndrome.

Sixty participants will be randomly assigned (1:1) to either continuous glucose monitoring or capillary glucose monitoring for a period of 60 days. Data collected will include glycemic variability, hypoglycemic episodes, symptom correlation, and patient-reported outcomes such as fear of hypoglycemia (HFS-II) and quality of life (SF-36).

Continuous glucose data will be recorded every 3 minutes in the intervention group, while the control group will perform up to three capillary measurements per day based on symptoms.

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