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

Recruitingn/aAges 18 Years - anyAllUniversity Hospital, Strasbourg, France
NCT07470593 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Continuous glucose monitoring (CGM) with TITR measurement
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Where

1 site
Hopitaux Universitaires de Strasbourg
Strasbourg, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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