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

NCT07440706 | Recruiting

• 1 other identifier: iCan3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dumping Syndrome; Post-bariatric Hypoglycemia

Keywords

Late Dumping Syndrome; Post-Bariatric Hypoglycemia; Continuous Glucose Monitoring; Roux-en-Y Gastric Bypass; Hypoglycemia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Arm 1 - Experimental

EXPERIMENTAL

Continuous Glucose Monitoring (iCan i3)

Device: Can i3 Continuous Glucose Monitoring System

Arm 2 - Active Comparator

ACTIVE COMPARATOR

Capillary Glucose Monitoring (fingerstick using glucometer)

Device: Can i3 Continuous Glucose Monitoring System

Interventions

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

Arm 1 - Experimental; Arm 2 - Active Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Clinic and Hospital: lead

Study Sites (1)

Kaiser Clínica Hospital Dia

São José do Rio Preto, São Paulo, 15015-110, Brazil

RECRUITING

Related Publications (3)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Dumping Syndrome; Hypoglycemia

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Roberto Luiz Kaiser Junior, PhD

CONTACT

+ 55 17 3302-4781; kaiserjr@kaiserclinica.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)