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

Recruiting now

Conditions studied: Type 1 Diabetes (T1D)

In brief

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.

Key facts

Study ID

NCT07006272

Run by

University Hospital, Grenoble

People needed

35

Starts

2025-06-04

Expected to finish

2031-06-30

Last updated by the study team

2025-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• HCL - Edouard Herriot Hospital — Lyon, Auvergne-Rhône-Alpes, France (enrolling)
• Hospices Civils de Lyon - Lyon Sud — Pierre-Bénite, Auvergne-Rhône-Alpes, France (enrolling)
• Strasbourg Civil Hospital — Strasbourg, Grand Est, France (enrolling)
• Grenoble University Hospital — La Tronche, ISERE, France (enrolling)
• Montpellier University Hospital - Lapeyronnie Hospital — Montpellier, Occitanie, France (enrolling)
• Toulouse University Hospital - Hôpital Rangueil — Toulouse, Occitanie, France (enrolling)
• APH Paris - LARIBOISIERE Hospital — Paris, Île-de-France Region, France

Full record on ClinicalTrials.gov

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