Comparing closed-loop insulin therapy and islet transplantation for unstable type 1 diabetes
Observes adults with unstable type 1 diabetes to compare closed-loop insulin therapy with islet transplantation.
Plain-language title generated from the registry record
Registry title: Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
Key facts
- Where
- La Tronche, Lyon, Montpellier, Paris, Pierre-Bénite, Strasbourg, and Toulouse, FranceSee the 7 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 1 diabetes whose blood sugar swings strongly and stays unstable despite expert care, with severe low blood sugar episodes or ketoacidosis.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Type 1 diabetes with strong blood sugar swings lasting more than 12 months despite optimal care by an expert team. The swings must be severe: at least 2 severe lows needing help from another person in the last 12 months, or at least 1 life-threatening low (coma, convulsions or injury), or ketosis or ketoacidosis.
- Earlier treatment
- Must have had optimal diabetes care for more than 12 months: an expert team, training in insulin therapy and blood sugar monitoring, and an insulin pump with a glucose sensor that stops insulin before lows.
- Biomarker or test result
- Blood sugar variability: standard deviation above 50% of the mean glucose or MAGE above 60 mg/dL (3.3 mmol/L); or coefficient of variation above 36%; or LBGI above 5 or HYPOSCORE above 800.
Main reasons for not taking part
- Type 1 diabetes that does not meet the criteria for islet transplantation
- Already using a closed-loop system
- Kidney transplant
- Protected persons under the French law articles L1121-5 to L1121-8
- Opposed to taking part in research
Read by machine on 12 November 2026.
Where in France
- Grenoble University HospitalLa Tronche, FranceContact: Myriam HADDOUCHETaking people
- HCL - Edouard Herriot HospitalLyon, FranceContact: Céline DAGOTTaking people
- Montpellier University Hospital - Lapeyronnie HospitalMontpellier, FranceContact: Oriane ORVILLARD, MDTaking people
- APH Paris - LARIBOISIERE HospitalParis, FranceContact: Djamila BELLILI, MDNot yet recruiting
- Hospices Civils de Lyon -Lyon SudPierre-Bénite, FranceContact: Stéphanie AUBUSSIERTaking people
- Strasbourg Civil HospitalStrasbourg, FranceContact: Leila BOUNYARTaking people
- Toulouse University Hospital - Hôpital RangueilToulouse, FranceContact: Marie-Blanche ARHAINX, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- University Hospital, Grenoble
- Trial code
- NCT07006272
- Record updated
- 28 July 2025
- Original description
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.Read full original descriptionShow less
Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
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.
Inclusion: 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: Kidney transplant patients; Patients with type 1 diabetes who do not meet the criteria for islet transplantation; Patients already fitted with a closed loop; Persons covered by articles L1121-5 to L1121-8 of the CSP (corresponding to all protected persons); Persons opposed to participation in research.