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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

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

Qualifiers

≥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 design

Treatments tested in this trial

  • Continuous glucose monitoring (CGM) with TITR measurement

Treatment groups

36 Participants
are divided into 1 treatment group