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Clinical Trials in France / NCT07470593
Recruiting Observational

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

NCT07470593 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Strasbourg, France
Phase
Observational
Started
2025-12-15
Last updated
2026-03-17

Condition(s) studied

Type 1 Diabetes (T1D)

Investigational drug(s) / intervention(s)

Continuous glucose monitoring (CGM) with TITR measurement

Continuous glucose monitoring (CGM) with TITR measurement: Continuous glucose monitoring (CGM) with TITR measurement

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year. — 1 year post-transplant

Trial sites (1)

FacilityCityRegionStatus
Hopitaux Universitaires de Strasbourg Strasbourg France Recruiting

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Other trials for the same condition

Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation Starting soon
Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes Starting soon
Efficacy of Islet Re-transplantation After Failure of Beta-cell Replacement Recruiting
Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07470593 on ClinicalTrials.gov ↗ ← All trials in France