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.
Study Type
OBSERVATIONAL
Enrollment
35
HCL - Edouard Herriot Hospital
Lyon, Auvergne-Rhône-Alpes, France
RECRUITINGHospices Civils de Lyon - Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
RECRUITINGStrasbourg Civil Hospital
Strasbourg, Grand Est, France
RECRUITINGGrenoble University Hospital
La Tronche, ISERE, France
RECRUITINGMontpellier University Hospital - Lapeyronnie Hospital
Montpellier, Occitanie, France
RECRUITINGToulouse University Hospital - Hôpital Rangueil
Toulouse, Occitanie, France
RECRUITINGAPH Paris - LARIBOISIERE Hospital
Paris, Île-de-France Region, France
NOT_YET_RECRUITINGDescribe 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)
Time frame: 12 months
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.
Time frame: 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)
Variation of glycaemia management index for CL \& IG patients : \- Data sensor GMI (%)
Time frame: 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
Time frame: 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 (%)
Time frame: 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 : * Data sensor average daily blood glucose
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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 (%)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: At 2 years post-equipment or post-transplant
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