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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07470593

Acronym

ISLET-TITR

Enrollment

Registered

2026-03-13

Start date

2025-12-15

Completion date

2029-12-15

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes (T1D)

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.

Interventions

OTHERContinuous glucose monitoring (CGM) with TITR measurement

Continuous glucose monitoring (CGM) with TITR measurement

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

CONTACTPargol ZANDYAZDI

pargol.zandyazdi@chru-strasbourg.fr0033 3 88 11 54 30

PRINCIPAL_INVESTIGATORLuc RAKOTOARISOA, Dr

HOPITAUX UNIVERSITAIRES DE STRASBOURG

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026