NCT07440706 Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
| NCT ID | NCT07440706 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kaiser Clinic and Hospital |
| Condition | Dumping Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-15 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07440706 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Dumping Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07440706 currently recruiting?
Yes, NCT07440706 is actively recruiting participants. Contact the research team at kaiserjr@kaiserclinica.com.br for enrollment information.
Where is the NCT07440706 trial being conducted?
This trial is being conducted at São José do Rio Preto, Brazil.
Who is sponsoring the NCT07440706 clinical trial?
NCT07440706 is sponsored by Kaiser Clinic and Hospital. The trial plans to enroll 60 participants.