Clinical trial NCT07006272: Cohort Study to Refine the Positioning of Closed-loop Therapy Versus Islet Transplantation in the Management of Patients With Unstable Type 1 Diabetes
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Type 1 Diabetes (T1D)
Keywords: islet transplantation
closed loop
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2025-06-05
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

* 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

Primary outcomes:
measure: Describe Closed Loop (CL) failures at 12 months in patients referred to an expert center for management of unstable diabetes.
timeFrame: 12 months
Secondary outcomes:
measure: Assess quality of glycaemic control in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess the variation of the glycaemia management index in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess glucose variability in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess glycaemia variability in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess the level of mean glucose in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess hypoglycemia awareness in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months for 1 year then every 6 months for 3 years
measure: Assess balance between hypoglycaemia and hyperglycaemia in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess the evolution of insulin requirement in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess glycaemia stability in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years 1st IG, depending on the date of inclusion in the study.
measure: Assess renal function in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess occurence of sever diabetic related events in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: 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.
measure: Assess the level of endogenous production of insulin in patients treated with Islet Graft (IG)
timeFrame: 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.
measure: Assess the quality of the Islet Graft (IG)
timeFrame: 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.
measure: Assess the antidiabetic management in patients treated with Islet Graft (IG)
timeFrame: Quarterly pre-transplant follow-up, then every 3 months during 2 to 4 follow-up years after 1st IG, depending on the date of inclusion in the study.
measure: Assessing quality of life related to diabetes disease in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.
measure: Assessing global quality of life in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.
measure: Assessing diabetes burden (diabetes-related emotional distress) in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.
measure: Assessing diabetes burden (fear of hypoglycemia) in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.
measure: Assessing diabetes burden (impact and severity of fatigue) in patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.
measure: Assess overall patient satisfaction of patients treated with Closed Loop (CL) or Islet Graft (IG)
timeFrame: Before CL/1st IG, then at 6, 12, 24 months post-CL or post 1st IG (or just before a change in treatment modality such as failure of CL or IG)
measure: Assess overall patient satisfaction of patients treated with Closed Loop (CL)
timeFrame: Before CL/1st IG, then at 6, 12, 24 months post-CL or post 1st IG (or just before a change in treatment modality such as failure of CL or IG)
measure: Evaluate the clinical course of diabetes treated with Closed Loop (CL) Islet Graft (IG).
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Identify the factors associated with Closed Loop (CL) treatment failures (hypoglycaemia)
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Identify the factors associated with Closed Loop (CL) treatment failures (diabetes-related emotional distress)
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Identify the factors associated with Closed Loop (CL) treatment failures (fear of hypoglycemia)
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Identify the factors associated with Closed Loop (CL) treatment failures (HbA1c)
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Identify the factors associated with Closed Loop (CL) treatment failures (TBR)
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Describe the frequency of occurrence of severe hypoglycaemia with third-party assistance
timeFrame: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)
measure: Assess the medico-economic impact at 2 years of islet transplantation compared with Closed Loop (CL) therapy from the perspective of the French healthcare system.
timeFrame: At 2 years post-equipment or post-transplant
Other outcomes:
Locations:
city: Lyon
country: France
facility: HCL - Edouard Herriot Hospital
state: Auvergne-Rhône-Alpes
city: Pierre Benite
country: France
facility: Hospices Civils de Lyon - Lyon Sud
state: Auvergne-Rhône-Alpes
city: Strasbourg
country: France
facility: Strasbourg Civil Hospital
state: Grand Est
city: Paris
country: France
facility: APH Paris - LARIBOISIERE Hospital
state: Ile de France
city: La Tronche
country: France
facility: Grenoble University Hospital
state: Isere
city: Montpellier
country: France
facility: Montpellier University Hospital - Lapeyronnie Hospital
state: Occitanie
city: Toulouse
country: France
facility: Toulouse University Hospital - Hôpital Rangueil
state: Occitanie
Study officials:
affiliation: University Hospital, Grenoble
name: Sandrine LABLANCHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: