Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous glucose monitoring (CGM) with TITR measurement.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Overview
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.
Interventions
- Other Continuous glucose monitoring (CGM) with TITR measurement
Continuous glucose monitoring (CGM) with TITR measurement
Primary outcome measures
- Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year. [Time frame: 1 year post-transplant]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Hopitaux Universitaires de Strasbourg — Strasbourg
Identifiers
NCT: NCT07470593 · RC25-0034