A Study Evaluating the iCan i3 Continuous Glucose Monitoring System Compared to Capillary Glucose Monitoring in Post-Bariatric Patients With Late Dumping Syndrome

What this Trial Is About

Researchers are studying late dumping syndrome, a common complication after Roux-en-Y gastric bypass surgery that causes low blood sugar after meals and affects patient safety and quality of life. This study compares the iCan i3 continuous glucose monitoring (CGM) system with traditional fingerstick glucose monitoring to see which better detects low blood sugar episodes. It is a prospective, randomized clinical study involving post-bariatric patients diagnosed with late dumping syndrome. Participants will be randomly assigned to one of two groups for 60 days. One group will use the iCan i3 CGM device, which measures glucose levels every 3 minutes via a sensor placed on the abdomen and connected to a mobile app. Sensors will be changed every 15 days. The other group will monitor glucose using a glucometer with up to three fingerstick measurements daily, mainly when symptoms appear. Both groups will record symptoms and meal times. During the study, participants will be monitored for episodes of low blood sugar, time spent in low glucose, and severity of these events. Researchers will assess clinical outcomes, symptom correlation, and quality of life using questionnaires about fear of hypoglycemia and general well-being. Data collection includes continuous glucose readings or capillary measurements, symptom diaries, and patient-reported outcomes, with follow-up lasting 60 days.

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