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

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