NCT07440706

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Kaiser Clinic and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Dumping Syndrome
• Post-bariatric Hypoglycemia

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2025-10-15
• Primary completion: 2026-10-15
• Completion: 2026-12-31
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Brazil