NCT07470593 Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
| NCT ID | NCT07470593 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Type 1 Diabetes (T1D) |
| Study Type | OBSERVATIONAL |
| Enrollment | 36 participants |
| Start Date | 2025-12-15 |
| Primary Completion | 2029-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 36 participants in total. It began in 2025-12-15 with a primary completion date of 2029-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Islet transplantation is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. Currently, there is no standardized method to detect early dysfunction of the transplanted islets. This study aims to determine whether a parameter derived from continuous glucose monitoring (CGM), Time in Tight Range (70-140 mg/dL), is associated with pancreatic islet grafts function. The study hypothesis is that a decrease in Time in Tight Range reflects early loss of islet graft function.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old * Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis) * Patient who has completed a full cycle of pancreatic islet transplantation, either: * Islet Transplantation Alone (ITA), or * Islet After Kidney (IAK), or * Simultaneous Islet Kidney (SIK), with \>10,000 IEQ/kg of recipient body weight, or \<10,000 IEQ/kg but having achieved insulin independence * Patient who has provided consent for reuse of their data for this research Exclusion Criteria: * Patient refusal to wear continuous glucose monitoring device * Pancreatic islet autotransplantation * Inability to provide informed consent (e.g., difficulties understanding study information) * Patient under judicial protection (safeguard of justice) * Patient under guardianship or curatorship
Contact & Investigator
Luc RAKOTOARISOA, Dr
PRINCIPAL INVESTIGATOR
HOPITAUX UNIVERSITAIRES DE STRASBOURG
Frequently Asked Questions
Who can join the NCT07470593 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes (T1D). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07470593 currently recruiting?
Yes, NCT07470593 is actively recruiting participants. Contact the research team at pargol.zandyazdi@chru-strasbourg.fr for enrollment information.
Where is the NCT07470593 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT07470593 clinical trial?
NCT07470593 is sponsored by University Hospital, Strasbourg, France. The principal investigator is Luc RAKOTOARISOA, Dr at HOPITAUX UNIVERSITAIRES DE STRASBOURG. The trial plans to enroll 36 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.