Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome (iCan3 Dumping)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dumping Syndrome; Post-bariatric Hypoglycemia
• Intervention / Treatment: Device: Can i3 Continuous Glucose Monitoring System

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Luiz Kaiser Junior, PhD; Phone Number: + 55 17 3302-4781; Email: kaiserjr@kaiserclinica.com.br

Study Locations

• Brazil
  • São Paulo
    • São José do Rio Preto, São Paulo, Brazil, 15015-110
      • Recruiting
      • Kaiser Clínica Hospital Dia
      • Contact: Roberto Luiz Kaiser Junior, PhD; Phone Number: + 55 17 3302-4781; Email: kaiserjr@kaiserclinica.com.br
      • Contact: Flavio Pirozzi, PhD; Phone Number: + 55 17 3302-4781; Email: cepkaiser@kaiserclinica.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1 - Experimental; Continuous Glucose Monitoring (iCan i3)	Device: Can 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
Active Comparator: Arm 2 - Active Comparator; Capillary Glucose Monitoring (fingerstick using glucometer)	Device: Can 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	60 days
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.	60 days
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.	60 days

Collaborators and Investigators

• Sponsor: Kaiser Clinic and Hospital

Publications and helpful links

General Publications

• 3. Carpentieri GB, Gonçalves SEAB, Mourad WM, et al. Hipoglicemia pós-cirurgia bariátrica: medicamentos com diferentes mecanismos de ação para tratar um distúrbio único. Arch Endocrinol Metab. 2023;67(3):442-9.
• 2. Scarpelini E, Arts J, Karamanolis G, et al. Consenso internacional sobre o diagnóstico e manejo da síndrome de dumping. Nat Rev Endocrinol. 2020;16(8):448-66.
• D'hoedt A, Vanuytsel T. Síndrome de dumping após cirurgia bariátrica: prevalência, fisiopatologia e papel na redução de peso: uma revisão sistemática. Acta Gastroenterol Belg. 2023;83(3):417-27.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Hypoglycemia; Continuous Glucose Monitoring; Post-Bariatric Hypoglycemia; Roux-en-Y Gastric Bypass; Late Dumping Syndrome
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Metabolic Diseases; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Glucose Metabolism Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Postgastrectomy Syndromes; Hypoglycemia; Dumping Syndrome
• Other Study ID Numbers: iCan3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No