Continuous glucose monitoring with iCan i3 for late dumping after Roux-en-Y gastric bypass
Official title: 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
Run by Kaiser Clinic and Hospital · NCT07440706 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Kaiser Clinic and Hospital Academic / other |
| Locations | 1 site (São José do Rio Preto, São Paulo) |
| Status | Recruiting |
| Started | October 15, 2025 |
| Main results expected | October 15, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 27, 2026 |
| Trial ID | NCT07440706 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Prior studies have shown CGM can improve detection of postprandial hypoglycemia after bariatric surgery, though device types and study designs have varied.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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Kaiser Clínica Hospital Dia
São José do Rio Preto, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Roberto Luiz Kaiser Junior, PhD
- Email: kaiserjr@kaiserclinica.com.br
- Phone: + 55 17 3302-4781
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.