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

RecruitingNAAges 18 Years - 65 YearsAllKaiser Clinic and Hospital
NCT07440706 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Can i3 Continuous Glucose Monitoring System
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Where

1 site
Kaiser Clínica Hospital Dia
São José do Rio Preto, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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