Refining the role of closed-loop insulin therapy versus islet transplantation for unstable type 1 diabetes
Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
This prospective project will follow people with unstable type 1 diabetes who are candidates for islet transplantation to see how often closed-loop insulin systems fail over 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 7 sites (Lyon, Auvergne-Rhône-Alpes and 6 other locations) |
| Trial ID | NCT07006272 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: People with type 1 diabetes who have persistent, significant glycaemic variability for more than 12 months despite optimized multidisciplinary care with pump and continuous glucose monitoring and who are being considered for islet transplantation.
Not a fit: Patients with well-controlled type 1 diabetes, those who have not received optimized pump/sensor-based care, or those not considered transplant candidates are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help clinicians match patients to closed-loop systems or islet transplantation more accurately, potentially reducing severe hypoglycaemia and glucose variability.
How similar studies have performed: Previous randomized trials have shown closed-loop systems reduce hypoglycaemia and improve time-in-range, but directly positioning closed-loop therapy versus islet transplantation in real-world referral cohorts is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lyon, Auvergne-Rhône-Alpes and 6 other locations
- 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)
- APH Paris - LARIBOISIERE Hospital — Paris, Île-de-France Region, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Sandrine LABLANCHE, MD, PhD — University Hospital, Grenoble
- Study coordinator: Myriam HADDOUCHE
- Email: mhaddouche@chu-grenoble.fr
- Phone: +33476765509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.