About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis)
Islet Transplantation Alone (ITA), or
Islet After Kidney (IAK), or
Disqualifiers
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)
Trial population
Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis).
Trial design
Case-control
Prospective
Treatments tested in this trial
Continuous glucose monitoring (CGM) with TITR measurement
Other interventionContinuous glucose monitoring (CGM) with TITR measurement
Treatment groups
Trial outcomes
Primary outcomes
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
Sponsors and contacts
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