Refining the role of closed-loop insulin therapy versus islet transplantation for unstable type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

STABILOOP is a prospective, multicenter descriptive cohort (RIPH3) enrolling patients with persistent severe glycaemic variability despite optimized pump, sensor and education-based care. Participants referred to expert French centers will use closed-loop systems under real-world conditions and be monitored for closed-loop failures at 12 months. The study aims to describe which patients who are theoretically eligible for islet transplantation might instead be managed effectively with closed-loop therapy. There are no assigned interventions; data collection is observational to inform clinical decision-making between device therapy and transplantation.

Why it matters

Who can join: the full rules

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

Where it's running

• HCL - Edouard Herriot Hospital
  Lyon, Auvergne-Rhône-Alpes, France Recruiting
• Hospices Civils de Lyon - Lyon Sud
  Pierre-Bénite, Auvergne-Rhône-Alpes, France Recruiting
• Strasbourg Civil Hospital
  Strasbourg, Grand Est, France Recruiting
• Grenoble University Hospital
  La Tronche, Isere, France Recruiting
• Montpellier University Hospital - Lapeyronnie Hospital
  Montpellier, Occitanie, France Recruiting
• Toulouse University Hospital - Hôpital Rangueil
  Toulouse, Occitanie, France Recruiting

Study contacts

• Principal investigator: Sandrine LABLANCHE, MD, PhD — University Hospital, Grenoble
• Study coordinator: Myriam HADDOUCHE
• Email: mhaddouche@chu-grenoble.fr
• Phone: +33476765509

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.