Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKaiser Clinic and Hospital
About this trial
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
Qualifiers
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)
Disqualifiers
Diagnosis of diabetes mellitus under treatment
Use of antidiabetic medications (except acarbose)
Pregnancy or breastfeeding
Cognitive impairment affecting study participation
Trial design
Treatments tested in this trial
- Can i3 Continuous Glucose Monitoring System
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov