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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
Other Locations
France
Hopitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Contact Information
Primary
Pargol ZANDYAZDI
pargol.zandyazdi@chru-strasbourg.fr
0033 3 88 11 54 30
Time Frame
Start Date: 2025-12-15
Estimated Completion Date: 2029-12-15
Participants
Target number of participants: 36
Treatments
Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation
Continuous glucose monitoring (CGM) with TITR measurement
Sponsors
Leads: University Hospital, Strasbourg, France

This content was sourced from clinicaltrials.gov