Actively Recruiting
Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
Led by University Hospital, Grenoble · Updated on 2025-07-28
35
Participants Needed
7
Research Sites
316 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with type 1 diabetes
- Significant glycemic variability defined by one of these: standard deviation > 50% of glycemic mean, MAGE index > 60 mg/dL, coefficient of variation > 36%, LBGI index > 5, or HYPOSCORE > 800
- Persistent glycemic variability lasting more than 12 months despite optimal diabetes management by a specialized team
- Optimal management includes expertise in insulin pump and glucose sensor technologies, training in functional insulin therapy and hypoglycemia prevention, use of pump and sensor therapy, and reinforced multi-professional support possibly including telemedicine
- Severe glycemic variability causing unpredictable clinical and metabolic events that impair quality of life, such as at least 2 severe hypoglycemia events needing assistance or 1 severe event with life-threatening consequences in the last 12 months, or ketoacidosis
You will not qualify if you...
- Patients with type 1 diabetes not meeting criteria for islet transplantation
- Patients already using a closed-loop system
- Kidney transplant recipients
- Persons protected by articles L1121-5 to L1121-8 of the CSP
- Persons opposed to participation in research
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
HCL - Edouard Herriot Hospital
Lyon, Auvergne-Rhône-Alpes, France, 69437
Actively Recruiting
2
Hospices Civils de Lyon - Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69310
Actively Recruiting
3
Strasbourg Civil Hospital
Strasbourg, Grand Est, France, 67000
Actively Recruiting
4
Grenoble University Hospital
La Tronche, ISERE, France, 38700
Actively Recruiting
5
Montpellier University Hospital - Lapeyronnie Hospital
Montpellier, Occitanie, France, 34295
Actively Recruiting
6
Toulouse University Hospital - Hôpital Rangueil
Toulouse, Occitanie, France, 31059
Actively Recruiting
7
APH Paris - LARIBOISIERE Hospital
Paris, Île-de-France Region, France, 75010
Not Yet Recruiting
Research Team
M
Myriam HADDOUCHE
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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