Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Can i3 Continuous Glucose Monitoring System.
- Who it may be relevant to
- Registry conditions: Dumping Syndrome, Post-bariatric Hypoglycemia. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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
- 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
Primary outcome measures
- Frequency of hypoglycemic episodes (<70 mg/dL) [Time frame: 60 days]
- Time Spent in Hypoglycemia [Time frame: 60 days]
- Clinical Severity of Hypoglycemic Events [Time frame: 60 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Brazil · 1 center
- Kaiser Clínica Hospital Dia — São José do Rio Preto
Publications
- Carpentieri GB, Goncalves SEAB, Mourad WM, Pinto LGC, Zanella MT. Hypoglycemia post bariatric surgery: drugs with different mechanisms of action to treat a unique disorder. Arch Endocrinol Metab. 2023 Mar 30;67(3):442-449. doi: 10.20945/2359-3997000000598. Epub 2023 Feb 7. PMID 36748934
- Scarpellini E, Arts J, Karamanolis G, Laurenius A, Siquini W, Suzuki H, Ukleja A, Van Beek A, Vanuytsel T, Bor S, Ceppa E, Di Lorenzo C, Emous M, Hammer H, Hellstrom P, Laville M, Lundell L, Masclee A, Ritz P, Tack J. International consensus on the diagnosis and management of dumping syndrome. Nat Rev Endocrinol. 2020 Aug;16(8):448-466. doi: 10.1038/s41574-020-0357-5. Epub 2020 May 26. PMID 32457534
- 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.
Identifiers
NCT: NCT07440706 · iCan3