Using continuous glucose monitoring to spot early loss of pancreatic islet transplant function
Official title: Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
Run by University Hospital, Strasbourg, France · NCT07470593 · Data updated 2026-11-12
This project will see if a CGM measure called Time in Tight Range (70–140 mg/dL) can detect early loss of islet transplant function in adults with insulin-dependent diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | December 15, 2029 |
| Study ends | December 15, 2029 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07470593 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with insulin-dependent diabetes who have completed a full cycle of pancreatic islet transplantation (ITA, IAK, or SIK) meeting the specified IEQ/kg criteria or who achieved insulin independence and who consent to reuse of their data.
✕Probably not a fit
Patients without an islet transplant, those who had islet autotransplantation, people unable or unwilling to wear a CGM, or those under guardianship or judicial protection are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational protocol follows adult recipients of pancreatic islet transplants and collects continuous glucose monitoring (CGM) data over time. The primary metric of interest is Time in Tight Range (TITR, 70–140 mg/dL) derived from CGM recordings. Investigators will relate changes in TITR to clinical indicators of graft function such as insulin requirement, C-peptide, HbA1c, and hypoglycemia events. The aim is to see whether declines in TITR precede clinical signs of graft failure and could serve as an early warning signal.
Why it matters
Potential benefit: If successful, this approach could give patients and clinicians an early warning of islet graft decline so interventions might be started sooner to preserve function and reduce return of severe hypoglycemia.
How similar studies have gone: CGM-derived metrics like time-in-range are well established for diabetes management, but applying TITR specifically to detect early islet graft failure is relatively novel with limited prior validation.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Hopitaux Universitaires de Strasbourg
Strasbourg, France Recruiting
Study contacts
- Principal investigator: Luc RAKOTOARISOA, Dr — Hopitaux Universitaires de Strasbourg
- Study coordinator: Pargol ZANDYAZDI
- Email: pargol.zandyazdi@chru-strasbourg.fr
- Phone: 0033 3 88 11 54 30
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.