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

NCT07470593 | Recruiting

• 1 other identifier: RC25-0034
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 1 Diabetes (T1D)

Outcome Measures

Primary Outcomes (1)

• Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.

  1 year post-transplant

Study Arms (1)

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

Interventions

Continuous glucose monitoring (CGM) with TITR measurement OTHER

Continuous glucose monitoring (CGM) with TITR measurement

Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hopitaux Universitaires de Strasbourg

Strasbourg, 67200, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Luc RAKOTOARISOA, Dr

  HOPITAUX UNIVERSITAIRES DE STRASBOURG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pargol ZANDYAZDI

CONTACT

0033 3 88 11 54 30; pargol.zandyazdi@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: December 15, 2025
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): December 15, 2029
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)