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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Type 1 diabetic patients describing:
Exclusion Criteria:
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Patients aged of minimum 18 years with Type 1 unstable diabetes, eligible to both Islet Transplant of Closed Loop treatement.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myriam HADDOUCHE | Contact | +33476765509 | mhaddouche@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Sandrine LABLANCHE, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HCL - Edouard Herriot Hospital | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69437 | France |
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| 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 (%) | 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) | glucose variability for CL & IG patients : - MAGE index | 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) | Data sensor Glycaemia variability for CL & IG patients: - CV (%) | 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) | Level of blood glucose for CL & IG patients :
| 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 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 | Before CL initiation or quarterly pre-transplant follow-up, then every 3 months for 1 year then every 6 months for 3 years |
| 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 | 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 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) | 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 stability in patients treated with Closed Loop (CL) or Islet Graft (IG) | Glycaemia stability for CL & IG patients : - HbA1c (%) | 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. |
| 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) | 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 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 | 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 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) | 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 quality of the Islet Graft (IG) | Quality of islet graft in IG patients : - Graft function assessed by IGLS 2.0 score | 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 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). | 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. |
| 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 | Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG. |
| 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 | Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG. |
| 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 | Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG. |
| 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 | Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG. |
| 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 | Before CL/1st IG, and at 6, 12 and 24 months after CL/1st IG. |
| 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 | 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) |
| 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 | 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) |
| 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). | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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 | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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 | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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 | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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 | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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 | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| Describe the frequency of occurrence of severe hypoglycaemia with third-party assistance | Incidence rate of severe hypoglycaemia with assistance of a third party | Throughout the follow-up period (from 2 to 4 years depending on the date of inclusion in the cohort) |
| 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. | At 2 years post-equipment or post-transplant |
| Hospices Civils de Lyon - Lyon Sud | Recruiting | Pierre-Bénite | Auvergne-Rhône-Alpes | 69310 | France |
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| Strasbourg Civil Hospital | Recruiting | Strasbourg | Grand Est | 67000 | France |
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| Grenoble University Hospital | Recruiting | La Tronche | ISERE | 38700 | France |
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| Montpellier University Hospital - Lapeyronnie Hospital | Recruiting | Montpellier | Occitanie | 34295 | France |
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| Toulouse University Hospital - Hôpital Rangueil | Recruiting | Toulouse | Occitanie | 31059 | France |
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| APH Paris - LARIBOISIERE Hospital | Not yet recruiting | Paris | Île-de-France Region | 75010 | France |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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