Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
NCT ID: NCT07006272
Last Updated: 2025-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
35 participants
OBSERVATIONAL
2025-06-04
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Closed Loop
Patients who choose te be treated by Closed-Loop in routine care
No interventions assigned to this group
Islet Graft
Patients who choose te be treated by Islet Graft in routine care
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Sandrine LABLANCHE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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HCL - Edouard Herriot Hospital
Lyon, Auvergne-Rhône-Alpes, France
Hospices Civils de Lyon - Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
Strasbourg Civil Hospital
Strasbourg, Grand Est, France
Grenoble University Hospital
La Tronche, ISERE, France
Montpellier University Hospital - Lapeyronnie Hospital
Montpellier, Occitanie, France
Toulouse University Hospital - Hôpital Rangueil
Toulouse, Occitanie, France
APH Paris - LARIBOISIERE Hospital
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Haddouche
Role: backup
Haddouche
Role: backup
Other Identifiers
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38RC24.0169
Identifier Type: -
Identifier Source: org_study_id
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