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

NCT07006272 | Recruiting

• 1 other identifier: 38RC24.0169
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 7

Brief Summary

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

Type 1 Diabetes (T1D)

Keywords

islet transplantation; closed loop

Outcome Measures

Primary Outcomes (1)

• Describe Closed Loop (CL) failures at 12 months in patients referred to an expert center for management of unstable diabetes.

  Proportion of patients on CL who have had in the year following the introduction of CL therapy : at least 2 severe hypoglycaemias (HS) with assistance from a third party or 1 life-threatening HS (coma or convulsion)

  12 months

Secondary Outcomes (29)

• Assess quality of glycaemic control in patients treated with Closed Loop (CL) or Islet Graft (IG)

  Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.

• Assess the variation of the glycaemia management index in patients treated with Closed Loop (CL) or Islet Graft (IG)

  Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.

• Assess glucose variability in patients treated with Closed Loop (CL) or Islet Graft (IG)

  Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.

• Assess glycaemia variability in patients treated with Closed Loop (CL) or Islet Graft (IG)

  Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.

• Assess the level of mean glucose in patients treated with Closed Loop (CL) or Islet Graft (IG)

  Before CL initiation or quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after CL initiation or 1st IG, depending on the date of inclusion in the study.

Study Arms (2)

Closed Loop

Patients who choose te be treated by Closed-Loop in routine care

Islet Graft

Patients who choose te be treated by Islet Graft in routine care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged of minimum 18 years with Type 1 unstable diabetes, eligible to both Islet Transplant of Closed Loop treatement.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (7)

HCL - Edouard Herriot Hospital

Lyon, Auvergne-Rhône-Alpes, 69437, France

RECRUITING

Hospices Civils de Lyon - Lyon Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69310, France

RECRUITING

Strasbourg Civil Hospital

Strasbourg, Grand Est, 67000, France

RECRUITING

Grenoble University Hospital

La Tronche, ISERE, 38700, France

RECRUITING

Montpellier University Hospital - Lapeyronnie Hospital

Montpellier, Occitanie, 34295, France

RECRUITING

Toulouse University Hospital - Hôpital Rangueil

Toulouse, Occitanie, 31059, France

RECRUITING

APH Paris - LARIBOISIERE Hospital

Paris, Île-de-France Region, 75010, France

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sandrine LABLANCHE, MD, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myriam HADDOUCHE

CONTACT

+33476765509; mhaddouche@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 5, 2025
• Study Start: June 4, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): June 30, 2031
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)