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NCT07006272Recruiting

Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes

Source: ClinicalTrials.gov · Last updated 28 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
35 (estimated)
First submitted
13 May 2025
Start date
4 Jun 2025
Primary completion date
31 Dec 2030
Lead sponsor
University Hospital, Grenoble
NCT number
NCT07006272

What you commit to

  • Study type: Observational
  • Planned participants: 35
  • From 4 Jun 2025 to the primary completion date, 31 Dec 2030
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Kidney transplant patients

Other illness

  • Patients with type 1 diabetes who do not meet the criteria for islet transplantation

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Grenoble University Hospital
Coordinator of this site? Confirm its status
La TroncheFranceRecruiting
HCL - Edouard Herriot Hospital
Coordinator of this site? Confirm its status
LyonFranceRecruiting
Montpellier University Hospital - Lapeyronnie Hospital
Coordinator of this site? Confirm its status
MontpellierFranceRecruiting
APH Paris - LARIBOISIERE Hospital
Coordinator of this site? Confirm its status
ParisFranceNot yet recruiting
Hospices Civils de Lyon -Lyon Sud
Coordinator of this site? Confirm its status
Pierre-BéniteFranceRecruiting
Strasbourg Civil Hospital
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting
Toulouse University Hospital - Hôpital Rangueil
Coordinator of this site? Confirm its status
ToulouseFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.