Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome

Condition(s) studied

Investigational drug(s) / intervention(s)

Can i3 Continuous Glucose Monitoring System: 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

Study 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

Primary outcome measure(s)

• Frequency of hypoglycemic episodes (<70 mg/dL) — 60 days
  Mean number of hypoglycemic episodes per participant, defined as glucose levels \<70 mg/dL, measured using continuous glucose monitoring or capillary glucose monitoring over the study period.
• Time Spent in Hypoglycemia — 60 days
  Percentage of time with glucose levels below 70 mg/dL, assessed continuously in the CGM group and estimated based on recorded measurements in the capillary monitoring group.
• Clinical Severity of Hypoglycemic Events — 60 days
  Proportion of hypoglycemic episodes classified as mild (self-managed) or severe (requiring external assistance), based on participant-reported symptoms and clinical evaluation.

Trial sites (1)

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