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NCT Number: NCT07470593

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67200, France

Location status: Recruiting

Location contact

Luc RAKOTOARISOA

CONTACT

[email protected]

033 3 88 12 75 76

Luc RAKOTOARISOA, Dr

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring (CGM) with TITR measurement

Other

Continuous glucose monitoring (CGM) with TITR measurement

Primary outcomes

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

Time frame: 1 year post-transplant

Study contacts

Contact information is provided by the study sponsor or research team.

Pargol ZANDYAZDI

CONTACT

[email protected]

0033 3 88 11 54 30

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Acronym: ISLET-TITR

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Mar 13, 2026
Registry last updated: Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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