Health TrialsbyHealthPanel

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

ConditionsDumping SyndromePost-bariatric Hypoglycemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Can i3 Continuous Glucose Monitoring System

    Device

    Intervention 1 - Experimental Arm Device: iCan i3 Continuous Glucose Monitoring System Participants assigned to the experimental group will use the iCan i3 continuous glucose monitoring (CGM) system for 60 days. The sensor will be inserted in the abdominal region and will provide real-time interstitial glucose readings every 3 minutes via Bluetooth connection to a mobile application. Sensors will be replaced every 15 days, totaling four cycles during the study period. Data will be continuously recorded and stored for subsequent analysis. Participants will also record hypoglycemic symptoms and meal timing in a study diary. Intervention 2 - Active Comparator Arm Device: Capillary Glucose Monitoring (Glucometer - Sinocare) Participants assigned to the control group will perform capillary blood glucose monitoring using a glucometer (Sinocare). Measurements will be performed up to three times per day, preferably in the presence of hypoglycemic symptoms, using fingerstick sampling with

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm 1 - ExperimentalExperimental treatment 1 intervention
Group B: Arm 2 - Active ComparatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of hypoglycemic episodes (<70 mg/dL)

Mean number of hypoglycemic episodes per participant, defined as glucose levels \<70 mg/dL, measured using continuous glucose monitoring or capillary glucose monitoring over the study period.

Time frame
60 days
2

Time Spent in Hypoglycemia

Percentage of time with glucose levels below 70 mg/dL, assessed continuously in the CGM group and estimated based on recorded measurements in the capillary monitoring group.

Time frame
60 days
3

Clinical Severity of Hypoglycemic Events

Proportion of hypoglycemic episodes classified as mild (self-managed) or severe (requiring external assistance), based on participant-reported symptoms and clinical evaluation.

Time frame
60 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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Kaiser Clinic and Hospital

Lead sponsor

Source ClinicalTrials.gov
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