Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
Launched by UNIVERSITY HOSPITAL, GRENOBLE · May 27, 2025
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called the STABILOOP study, is looking at two treatment options for people with unstable Type 1 Diabetes (T1D): closed-loop therapy, which automatically adjusts insulin delivery, and islet transplantation, where healthy insulin-producing cells are transplanted into the body. The goal is to see if closed-loop therapy can be a good option for patients who are potential candidates for islet transplantation but have ongoing challenges managing their blood sugar levels.
To be eligible for this study, participants must have Type 1 Diabetes with significant and persistent blood sugar fluctuations despite receiving optimal care from a healthcare team. This includes having severe low blood sugar episodes that have affected their quality of life. Participants will be closely monitored for 12 months to see how well the closed-loop therapy works for them. It’s important to note that the study is not yet recruiting participants, and individuals who have already received certain treatments, like a kidney transplant or closed-loop therapy, cannot participate. This study aims to provide valuable insights into managing difficult-to-treat diabetes, potentially improving the lives of many patients.
Gender
ALL
Eligibility 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
About University Hospital, Grenoble
The University Hospital of Grenoble is a leading academic medical center dedicated to advancing healthcare through innovative clinical research and comprehensive patient care. As a prominent sponsor of clinical trials, the hospital leverages its expertise in various medical disciplines to facilitate cutting-edge studies that aim to improve treatment outcomes and enhance patient safety. With a strong commitment to collaboration, the University Hospital of Grenoble engages in partnerships with academic institutions, industry leaders, and regulatory bodies to drive scientific discovery and translate research findings into clinical practice. Its state-of-the-art facilities and multidisciplinary teams ensure rigorous adherence to ethical standards and regulatory guidelines, fostering an environment where groundbreaking research can thrive.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Tronche, Isere, France
Lyon, Auvergne Rhône Alpes, France
Pierre Benite, Auvergne Rhône Alpes, France
Strasbourg, Grand Est, France
Paris, Ile De France, France
Montpellier, Occitanie, France
Toulouse, Occitanie, France
Lyon, , France
Pierre Benite, , France
Patients applied
Trial Officials
Sandrine LABLANCHE, MD, PhD
Principal Investigator
University Hospital, Grenoble
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported