Dumping SyndromeiCan3 DumpingNCT07440706
Continuous Glucose Monitoring With iCan i3 in Post-Bariatric Patients With Late Dumping Syndrome
A study testing Can i3 Continuous Glucose Monitoring System in people with Dumping Syndrome and Post-bariatric Hypoglycemia, run by Kaiser Clinic and Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dumping Syndrome, Post-bariatric Hypoglycemia
- What is being tested?
- Can i3 Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Oct 2025to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Kaiser Clínica Hospital Dia
São José do Rio Preto, São Paulo, 15015-110
Roberto Luiz Kaiser Junior, PhD, + 55 17 3302-4781, kaiserjr@kaiserclinica.com.br
Flavio Pirozzi, PhD, + 55 17 3302-4781, cepkaiser@kaiserclinica.com.br
About this study
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
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.
Read the 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.
- Conditions
- Dumping Syndrome, Post-bariatric Hypoglycemia
- Being tested
- Can i3 Continuous Glucose Monitoring System
- Keywords
- Late Dumping Syndrome, Post-Bariatric Hypoglycemia, Continuous Glucose Monitoring, Roux-en-Y Gastric Bypass, Hypoglycemia
- Medical subject headings
- Dumping Syndrome, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Can i3 Continuous Glucose Monitoring SystemDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Experimental | Experimental | Continuous Glucose Monitoring (iCan i3) Receives: Device: Can i3 Continuous Glucose Monitoring System |
| Arm 2 - Active Comparator | Active comparator | Capillary Glucose Monitoring (fingerstick using glucometer) Receives: Device: Can i3 Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start15 Oct 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dumping SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Clinic and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440706
- Sponsor's protocol ID
- iCan3
- Acronym
- iCan3 Dumping
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36748934Scarpellini 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.
PubMed 32457534D'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.