RecruitingNCT07470593

Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.

Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.

Sponsor

University Hospital, Strasbourg, France

Enrollment

36 participants

Start Date

Dec 15, 2025

Study Type

OBSERVATIONAL

Conditions

Type 1 Diabetes (T1D)

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

Min Age: 18 Years

Inclusion Criteria7

≥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 Criteria5

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