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Recruiting Observational

Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes

NCT07006272 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-06-04
Last updated
2025-07-28

Condition(s) studied

Type 1 Diabetes (T1D)

Study summary

Prospective, multicenter, descriptive cohort (RIPH3 study under the Jardé Act), STABILOOP study aims to describe whether BF may be an appropriate therapeutic option for the cohort of patients who are theoretically candidates for Islet transplantation, by describing Closed-Loop failures at 12 months in patients referred to an expert center for management of unstable diabetes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: Type 1 diabetic patients describing: * Significant glycaemic variability defined by the presence of one of these 3 criteria: - Standard deviation \> 50% of the glycaemic mean or a MAGE index \> 60 mg/dL * Coefficient of glycaemic variation \> 36% * LBGI index \> 5 or HYPOSCORE \> 800 * This glycaemic variability must be persistent, i.e. persist for more than 12 months despite optimal diabetes management by a multi-professional team. Optimum management involves : * Monitoring by a team with expertise in insulin pump and glucose sensor technologies * Training patients in functional insulin therapy, intensive self-monitoring of blood glucose levels, and prevention and management of situations where there is a risk of hypoglycaemia * Use of pump and glucose sensor therapy, with interruption before hypoglycaemia * Reinforced multi-professional support and monitoring, possibly combined with support via telemedicine. * This glycaemic variability must be considered as severe, i.e. causing unpredictable clinical and metabolic events that impair quality of life, such as severe, disabling and frequent hypoglycaemia (at least 2 Severe Hypoglycaemia with assistance from a third party in the last 12 months or at least 1 Severe Hypoglycaemia with life-threatening consequences in the last 12 months (coma, convulsions or trauma)) or ketosis ketoacidosis. Exclusion Criteria: * Patients with type 1 diabetes who do not meet the criteria for islet transplantation * Patients already fitted with a closed loop * Kidney transplant patients * Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons) * Persons opposed to participation in research

Primary outcome measure(s)

  • Describe Closed Loop (CL) failures at 12 months in patients referred to an expert center for management of unstable diabetes. — 12 months
    Proportion of patients on CL who have had in the year following the introduction of CL therapy : at least 2 severe hypoglycaemias (HS) with assistance from a third party or 1 life-threatening HS (coma or convulsion)

Trial sites (7)

FacilityCityRegionStatus
HCL - Edouard Herriot Hospital Lyon Auvergne-Rhône-Alpes Recruiting
Hospices Civils de Lyon - Lyon Sud Pierre-Bénite Auvergne-Rhône-Alpes Recruiting
Strasbourg Civil Hospital Strasbourg Grand Est Recruiting
Grenoble University Hospital La Tronche ISERE Recruiting
Montpellier University Hospital - Lapeyronnie Hospital Montpellier Occitanie Recruiting
Toulouse University Hospital - Hôpital Rangueil Toulouse Occitanie Recruiting
APH Paris - LARIBOISIERE Hospital Paris Île-de-France Region Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07006272 on ClinicalTrials.gov ↗ ← All trials in France