Continuous glucose monitoring with iCan i3 for late dumping after Roux-en-Y gastric bypass

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

This trial will test whether the iCan i3 continuous glucose monitor can detect low blood sugar better than fingerstick checks in adults with late dumping syndrome after Roux-en-Y gastric bypass.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Kaiser Clinic and Hospital (Academic / other)
• Locations: 1 site (São José do Rio Preto, São Paulo)
• Trial ID: NCT07440706 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center, randomized, open-label study comparing the iCan i3 continuous glucose monitoring (CGM) system to conventional capillary (fingerstick) glucose monitoring in adults with late dumping syndrome after Roux-en-Y gastric bypass. Sixty participants will be randomized 1:1 to wear the CGM (recording glucose every 3 minutes) or to perform up to three symptom-driven capillary checks per day and will be followed for 60 days. Outcomes include frequency and timing of hypoglycemic episodes, glycemic variability, correlation of symptoms with measured glucose, and patient-reported outcomes including HFS-II and SF-36. The study is conducted at Kaiser Clínica Hospital Dia in São José do Rio Preto, São Paulo.

Who should consider this trial

Good fit: Adults aged 18–65 with a history of Roux-en-Y gastric bypass at least 12 months earlier, a clinical diagnosis of late dumping syndrome, stable weight, and ability to consent are ideal candidates.

Not a fit: People with treated diabetes, current use of antidiabetic drugs (except acarbose), pregnancy or breastfeeding, cognitive impairment, known CGM adhesive allergy, or other conditions that increase hypoglycemia risk are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, CGM could improve detection of postprandial hypoglycemia and allow earlier corrective actions, reducing safety risks and improving quality of life.

How similar studies have performed: Prior studies have shown CGM can improve detection of postprandial hypoglycemia after bariatric surgery, though device types and study designs have varied.

Eligibility criteria

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

Where this trial is running

São José do Rio Preto, São Paulo

• Kaiser Clínica Hospital Dia — São José do Rio Preto, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Roberto Luiz Kaiser Junior, PhD

Conditions Dumping Syndrome; Post-bariatric Hypoglycemia; Late Dumping Syndrome; Post-Bariatric Hypoglycemia; Continuous Glucose Monitoring; Roux-en-Y Gastric Bypass; Hypoglycemia