Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function. (ISLET-TITR)

March 13, 2026 updated by: University Hospital, Strasbourg, France

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67200
        • Recruiting
        • Hôpitaux Universitaires de Strasbourg
        • Contact:
        • Principal Investigator:
          • Luc RAKOTOARISOA, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation
Continuous glucose monitoring (CGM) with TITR measurement
Other: Continuous glucose monitoring (CGM) with TITR measurement
Continuous glucose monitoring (CGM) with TITR measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
Time Frame: 1 year post-transplant
1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Luc RAKOTOARISOA, Dr, Hôpitaux Universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2025

Primary Completion (Estimated)

December 15, 2029

Study Completion (Estimated)

December 15, 2029

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC25-0034

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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