Dumping Syndrome, Post-bariatric Hypoglycemia
Conditions
Keywords
Late Dumping Syndrome, Post-Bariatric Hypoglycemia, Continuous Glucose Monitoring, Roux-en-Y Gastric Bypass, Hypoglycemia
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.
Detailed description
This is a prospective, single-center, randomized, open-label clinical study evaluating the performance of a continuous glucose monitoring system (iCan i3) compared to conventional capillary glucose monitoring in post-bariatric patients diagnosed with late dumping syndrome. Sixty participants will be randomly assigned (1:1) to either continuous glucose monitoring or capillary glucose monitoring for a period of 60 days. Data collected will include glycemic variability, hypoglycemic episodes, symptom correlation, and patient-reported outcomes such as fear of hypoglycemia (HFS-II) and quality of life (SF-36). Continuous glucose data will be recorded every 3 minutes in the intervention group, while the control group will perform up to three capillary measurements per day based on symptoms.
Interventions
DEVICECan i3 Continuous Glucose Monitoring System
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
Sponsors
Kaiser Clinic and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of hypoglycemic episodes (<70 mg/dL) | 60 days | 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 Spent in Hypoglycemia | 60 days | 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. |
| Clinical Severity of Hypoglycemic Events | 60 days | Proportion of hypoglycemic episodes classified as mild (self-managed) or severe (requiring external assistance), based on participant-reported symptoms and clinical evaluation. |
Countries
Brazil
Contacts
CONTACTRoberto Luiz Kaiser Junior, PhD
Outcome results
None listed