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Type 1 Diabetes (T1D)STABILOOPNCT07006272

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

An observational study of Type 1 Diabetes (T1D), run by University Hospital, Grenoble at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes (T1D)
How many people
35 participants
Where
7 sitesFrance
Study dates
4 Jun 2025to 30 Jun 2031
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Myriam HADDOUCHE contact

+33476765509

mhaddouche@chu-grenoble.fr

7 sites in 1 country

France7 sites, 7 recruiting

  • Grenoble University Hospital

    La Tronche, ISERE, 38700

    Myriam HADDOUCHE, +33663218329, MHaddouche@chu-grenoble.fr

    Haddouche

    Recruiting

  • HCL - Edouard Herriot Hospital

    Lyon, Auvergne-Rhône-Alpes, 69437

    Céline DAGOT, +33472116220, celine.dagot@chu-lyon.fr

    Fanny BURON, MD

    Recruiting

  • Montpellier University Hospital - Lapeyronnie Hospital

    Montpellier, Occitanie, 34295

    Oriane ORVILLARD, MD, +33467338431, o-villard@chu-montpellier.fr

    Eric RENARD, MD, PhD

    Recruiting

  • APH Paris - LARIBOISIERE Hospital

    Paris, Île-de-France Region, 75010

    Djamila BELLILI, MD, +33149959015, djamila.bellili@aphp.fr

    Jean-Pierre RIVELINE, MD, PhD

    Not yet recruiting

  • Hospices Civils de Lyon - Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69310

    Stéphanie AUBUSSIER, +33478861940, stephanie.auboussier@chu-lyon.fr

    Amal LEMOINE, MD

    Recruiting

  • Strasbourg Civil Hospital

    Strasbourg, Grand Est, 67000

    Leila BOUNYAR, +33388116267, leila.bounyar@chru-strasbourg.fr

    Haddouche

    Recruiting

  • Toulouse University Hospital - Hôpital Rangueil

    Toulouse, Occitanie, 31059

    Marie-Blanche ARHAINX, MD, +33561323361, arhainx.mb@chu-toulouse.fr

    Hélène HANAIRE, MD, PhD

    Recruiting

Other trials in France

About this study

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.

Keywords
islet transplantation, closed loop
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07006272
Study groupRoleWhat they receive
Closed LoopPatients who choose te be treated by Closed-Loop in routine care
Islet GraftPatients who choose te be treated by Islet Graft in routine care

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 12 months

Secondary outcomes (29)

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

    Quality of glycaemic control for CL \& IG patients :

    • Data sensor (TIR-TBR-TAR > Glycaemic Target 70-140 \& 70-180), reported as percentage of time.

    Measured: 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.

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

    Variation of glycaemia management index for CL \& IG patients :

    • Data sensor GMI (%)

    Measured: 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.

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

    glucose variability for CL \& IG patients :

    • MAGE index

    Measured: 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.

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

    Data sensor Glycaemia variability for CL \& IG patients:

    • CV (%)

    Measured: 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.

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

    Level of blood glucose for CL \& IG patients :

    • Data sensor average daily blood glucose

    Measured: 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.

  6. Assess hypoglycemia awareness in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Hypoglycemia awareness for CL \& IG patients :

    • Clarke score every 3 months for 1 year then every 6 months for 3 years

    Measured: Before CL initiation or quarterly pre-transplant follow-up, then every 3 months for 1 year then every 6 months for 3 years

  7. Assess balance between hypoglycaemia and hyperglycaemia in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Balance between hypoglycaemia and hyperglycaemia for CL \& IG patients :

    • GRI glycaemic risk index

    Measured: 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.

  8. Assess the evolution of insulin requirement in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Insulin requirement for CL \& IG patients :

    • insulin doses (IU/kg/day)

    Measured: 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.

  9. Assess glycaemia stability in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Glycaemia stability for CL \& IG patients :

    • HbA1c (%)

    Measured: 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.

  10. Assess renal function in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Quality of renal function for CL \& IG patients :

    • Creatininaemia (µmol/L) to estimate the glomerular filtration rate (mL/min/1.73m²)

    Measured: 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.

  11. Assess occurence of sever diabetic related events in patients treated with Closed Loop (CL) or Islet Graft (IG)

    For CL \& IG patients :

    • sever hypoglycaemia (with assistance from a third party) / ketosis or ketoacidosis

    Measured: 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.

  12. Assess the level of endogenous production of insulin in patients treated with Islet Graft (IG)

    Level of C-peptide for IG patients :

    • Fasting and stimulated C-peptide (nmol/L)

    Measured: 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.

  13. Assess the quality of the Islet Graft (IG)

    Quality of islet graft in IG patients :

    • Graft function assessed by IGLS 2.0 score

    Measured: 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.

  14. Assess the antidiabetic management in patients treated with Islet Graft (IG)

    Antidiabetic drug used in IG patients :

    • Presence of antidiabetic drugs other than insulin (metformin, SLGT-2 inhibitor, GLP-1 analogues, DPP4 inhibitor, hypoglycaemic sulphonamides, glinides).

    Measured: 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.

  15. Assessing quality of life related to diabetes disease in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describing quality of life questionnaires :

    DQOL (Diabetes Quality of Life Measure), score (0-100), higher scores = better quality of life

    Measured: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.

  16. Assessing global quality of life in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describing quality of life questionnaires :

    EQ-5D-5L (auto assessed health status questionnaire), score (0-1), higher scores = better health status

    Measured: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.

  17. Assessing diabetes burden (diabetes-related emotional distress) in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describing the burden of diabetes/questionnaires :

    T1-DDS (type 1 diabetes distress scale), score (28-168), higher scores = worse outcome

    Measured: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.

  18. Assessing diabetes burden (fear of hypoglycemia) in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describing the burden of diabetes:

    HFS (hypoglycemia fear score), score (0-132), higher scores = worse outcome

    Measured: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.

  19. Assessing diabetes burden (impact and severity of fatigue) in patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describing the burden of diabetes/questionnaires :

    FSS (fatigue severity scale), score (9-63), higher scores = worse outcome

    Measured: Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG.

  20. Assess overall patient satisfaction of patients treated with Closed Loop (CL) or Islet Graft (IG)

    Describe patients' overall experience of their treatment modality(ies):

    • DTSQ (diabetes treatment satisfaction questionnaire), score (0-36), higher scores = better treatment satisfaction

    Measured: 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)

  21. Assess overall patient satisfaction of patients treated with Closed Loop (CL)

    Describe patients' overall experience of their treatment modality(ies):

    • INSPIRE questionnaire (insulin dosing systems: perceptions, ideas, reflections, and expectations), score (0-80), higher scores = more positive attitudes or greater perceived benefit/support

    Measured: 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)

  22. Evaluate the clinical course of diabetes treated with Closed Loop (CL) Islet Graft (IG).

    Clinical evolution criteria to be reported (first occurence):

    HS with assistance of a third party, hypoglycaemic comas, convulsions, cardiovascular events (acute coronary syndrome (ACS), stroke, transient ischaemic attack (TIA), amputations, haemorrhage, thrombosis) cancers, ketosis, ketoacidosis, hospitalisations, infections.

    The data collected will be reported according to the CTCAE v6 classification (classification terminology criteria for adverse events).

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  23. Identify the factors associated with Closed Loop (CL) treatment failures (hypoglycaemia)

    Identification if the "initial number of HS with assistance from a third party" prior to BF therapy is associated with the failure of BF therapy

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  24. Identify the factors associated with Closed Loop (CL) treatment failures (diabetes-related emotional distress)

    Identification if the "initial level of depression/anxiety or distress related to type 1 diabetes (T1-DDS questionnaire)" is associated with the failure of BF therapy

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  25. Identify the factors associated with Closed Loop (CL) treatment failures (fear of hypoglycemia)

    Identification if the "initial level of fear of hypoglycaemia (HSF questionnaire)" is associated with the failure of BF therapy

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  26. Identify the factors associated with Closed Loop (CL) treatment failures (HbA1c)

    Identification if the "initial level of HbA1 (%)" si associated with the failure of BF therapy

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  27. Identify the factors associated with Closed Loop (CL) treatment failures (TBR)

    Identification if the "initial level of % time below 70mg/dL" is associated with the failure of BF therapy

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  28. Describe the frequency of occurrence of severe hypoglycaemia with third-party assistance

    Incidence rate of severe hypoglycaemia with assistance of a third party

    Measured: Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort)

  29. 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.

    The cost differential and the incremental cost-utility ratio (ICUR) will be analysed and expressed as the additional cost per healthy life-year gained with islet transplantation compared with CL therapy.

    Measured: At 2 years post-equipment or post-transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2025
  2. Study start4 Jun 2025
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion30 Jun 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07006272
Sponsor's protocol ID
38RC24.0169
Acronym
STABILOOP
Status last verified
Jul 2025
First submitted
13 May 2025
Last updated
28 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes (T1D), run by University Hospital, Grenoble at 7 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Myriam HADDOUCHE (+33476765509, mhaddouche@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Describe Closed Loop (CL) failures at 12 months in patients referred to an expert center for management of unstable diabetes. (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07006272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.

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