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Trial record 4 of 30 for:    Recruiting, Not yet recruiting, Available Studies | islet cell transplantation

Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes (STABILOT)

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ClinicalTrials.gov Identifier: NCT02854696
Recruitment Status : Recruiting
First Posted : August 3, 2016
Last Update Posted : March 17, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented pump therapy) for patients with brittle type1 diabetes.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Procedure: Islet graft Drug: best medical care Phase 3

Detailed Description:
The main goal is to perform a cost-utility analysis to compare islet cell transplantation versus best medical treatment (defined as Sensor augmented insulin pump therapy) for patients with brittle type1 diabetes.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes
Study Start Date : July 2016
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Islet graft
Patients who receive islet graft Intervention : Procedure/Surgery
Procedure: Islet graft
Patients will be transplanted with pancreatic islet cells
Other Name: islet cell transplantation

Active Comparator: Best medical care
Patients who continue their optimal medical treatment (insulin pump therapy coupled with real time continuous glucose monitoring) Intervention : insulin treatment
Drug: best medical care
Patients will continue their insulin treatment
Other Name: insulin treatment




Primary Outcome Measures :
  1. Incremental cost- utility ratio at 1 year [ Time Frame: 1 year ]
    The primary endpoint will be the incremental cost-effectiveness ratio at one year for islet transplantation versus Best Medical Treatment of brittle type 1 diabetes.The effectiveness will be expressed as quality adjusted life years (QALYs) in a cost-utility analysis. QALYs are a composite measure of outcomes where utilities for health states (on 0-1 scale, where 0 corresponds to death and 1 to full health) act as qualitative weights to combine quantity and quality of life. The number of QALYs in each group will be assessed with the EuroQol 5 Dimensions questionnaire (EQ5D). The EQ-5D measures health status in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression.


Secondary Outcome Measures :
  1. Cost-effectiveness ratio at 1 year [ Time Frame: 1 year ]
    Assessment of the cost-effectiveness ratio at 1 year between islet cell transplantation versus best medical treatment (SAP therapy) for patients with brittle type 1 diabetes without impairment of vital prognosis. Two criteria of effectiveness will be used : the life years gained and the number of hypoglycemia

  2. Assessment of individual medical benefit of quality of life [ Time Frame: 6 months and 1year ]
    Evaluate with DQOL questionnaire

  3. Assessment of individual medical benefit in terms of metabolic efficacy [ Time Frame: 6 months and 1 year ]
    measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability

  4. Assessment and comparison of individual medical benefit in terms of complications of islet cell transplantation between the two groups [ Time Frame: 6 months and 1 year ]
    measured from in insulin independence, hospitalizations

  5. Assessment and comparison of clinical benefit for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation [ Time Frame: 1 year ]
    measured from DQOL, insulin independence, complications of islet cell transplantation

  6. Assessment and comparison of costs for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation [ Time Frame: 1 year ]
    measured from hospitalizations

  7. Assessment of total cost of islet cell transplantation [ Time Frame: 1 year ]
    Assessment of total cost of islet cell transplantation for patients with type 1 diabetes without impairment of vital prognosis, from pre-transplant period until 1 year after the last injection. Two perspectives will be used: French health care system and hospital.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria :

  • Suffering from diabetes since more than 5 years
  • Patient with brittle type 1 diabetes despite an optimized insulin treatment and educational training will be included. A patient will be considered as experiencing a brittle type 1 diabetes if at least two criteria are present among: persistence of severe hypoglycemia, occurrence of ketoacidosis events without obvious etiology, diagnosis of unaware hypoglycemic episodes < 3 mmol/l based on CGM or self-monitoring blood glucose data, a mean blood glucose standard deviation>50%, MAGE index (Mean amplitude of glucose excursions)>60 mg/dl, LBGI index (low blood glucose index)>5, Clarke score≥4 or HYPOSCORE>800.
  • Insulin needs < 0,85 U/kg/day
  • HbA1c < 12% ;
  • No residual insulin secretion (plasmatic basal and stimulated C-peptide < 0.3 ng/ml)
  • Social Security membership or benefit from Social Security
  • Patients who signed the consent form

Exclusion Criteria :

Exclusion criteria related to islet infusion:

  • Hemostatic disorders, pre-existing liver disease (PAL, Gamma-GT, ASAT-ALAT >2N) or vesicular lithiasis.

Exclusion criteria related to diabetic complications:

  • Evolutive proliferative retinopathy, evolutive nephropathy (Glomerular filtration rate <30 ml/min/1.73m2 and/or proteinuria >0.5g/day), evolutive cardiopathy or obliterative arteriopathy with trophic cutaneous lesions.

Exclusion criteria related to immunosuppressant use:

  • Hemoglobin < 110mg/dL in women and < 120 mg/dL in men, leuconeutropenia, thrombopenia, systemic infection including chronic hepatitis B, C and VIH, neoplasia disease and hypertension>160/100 mmHg.
  • Corticoid treatment (except for patient that benefited from a kidney graft with maintenance steroid therapy)
  • Presence of anti-HLA antibody directed against the donor
  • Positive B or T cells crossmatch

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854696


Contacts
Contact: Sandra DAVID TCHOUDA, MD, PhD +33 476767186 SDavidTchouda@chu‐grenoble.fr
Contact: Sandrine MASSICOT +33 476768860 SMassicot@chu‐grenoble.fr

Locations
France
University Hospital of Besançon Recruiting
Besancon, France
Contact: Sophie BOROT, MD, PhD    +33 3 81 66 82 29    sophie.borot@univ-fcomte.fr   
Principal Investigator: Sophie BOROT, MD, PhD         
university hospital of Clermont Ferrand Not yet recruiting
Clermont Ferrand, France
Contact: Igor TAUVERON, MD, PhD    +33 4 73 75 15 29    itauveron@chu-clermontferrand.fr   
Principal Investigator: Igor TAUVERON, MD, PhD         
Sub-Investigator: Béatrice ROCHE, MD, PhD         
Grenoble University Hospital Recruiting
Grenoble, France, 38000
Contact: Sandrine LABLANCHE, MD, PhD    +33 4 76 63 54 26    slablanche@chu-grenoble.fr   
Contact: Myriam HADDOUCHE       mhaddouche@chu-grenoble.fr   
Sub-Investigator: Sandrine LABLANCHE, MD, PhD         
Principal Investigator: Pierre-Yves BENHAMOU, MD, PhD         
Sub-Investigator: Rachel TETAZ, MD, PhD         
University hospital of Lille Recruiting
Lille, France, 59000
Contact: Marie-Christine VANTYGHEM, MD, PhD    +33 3.20.44.45.35    Marie-Christine.VANTYGHEM@CHRU-LILLE.FR   
Principal Investigator: Marie-Christine VANTYGHEM, MD, PhD         
Sub-Investigator: François PATTOU, MD, PhD         
Sub-Investigator: Noel NOEL, MD, PhD         
Sub-Investigator: Kristell LE MAPIHAN, MD         
University Hospital of Lyon Recruiting
Lyon, France, 69000
Contact: Charles THIVOLET, MDPHD    +33 4 78 86 14 87    charles.thivolet@chu-lyon.fr   
Principal Investigator: Charles THIVOLET, MD, PhD         
Sub-Investigator: Emmanuel MORELON, MD, PhD         
Sub-Investigator: Lionel BADET, MD, PhD         
Sub-Investigator: Fanny BURON, MD         
University Hospital of Montpellier Recruiting
Montpellier, France, 34000
Contact: Anne WOJTUSCISZYN, MD, PhD    +33 4 67 33 83 86    a-wojtusciszyn@chu-montpellier.fr   
Principal Investigator: Anne WOJTUSCISZYN, MD, PhD         
Sub-Investigator: Eric RENARD, MD, PhD         
University hospital of Nancy Not yet recruiting
Nancy, France, 54511
Contact: Sophie GIRERD, MD, PhD    +33 3.83.15.31.69    s.girerd@chu-nancy.fr   
Principal Investigator: Luc FRIMAT, MD, PhD         
Sub-Investigator: Sophie GIRERD, MD, PhD         
Sub-Investigator: Bruno GUERCI, MD, PhD         
university hospital of Nantes Recruiting
Nantes, France, 44093
Contact: Lucy CHAILLOUS, MD, PhD    +33 2 53 48 27 01    lucy.chaillous@chu-nantes.fr   
Principal Investigator: Lucy CHAILLOUS, MD, PhD         
Sub-Investigator: Diego CANTAROVICH, MD, PhD         
APHP Recruiting
Paris, France, 75010
Contact: Jean-Pierre RIVELINE, MD, PhD    +33 1 49 95 83 79    jeanpierre.riveline@lrb.aphp.fr   
Contact: Nahima Geblaoui    +33 1 49 95 87 04    nahima.gueblaoui@aphp.fr   
Principal Investigator: Jean-Pierre RIVELINE, MD, PhD         
Sub-Investigator: Pierre CATTAN, MD, PhD         
Sub-Investigator: Marie-Noelle PERALDI, MD, PhD         
Sub-Investigator: Antoine DURRBACH, MD, PhD         
University hospital of Strasbourg Recruiting
Strasbourg, France, 67000
Contact: Laurence KESSLER, MD, PhD    +33 3 88 11 62 67    laurence.kessler@chru-strasbourg.fr   
Principal Investigator: Laurence KESSLER, MD, PhD         
Switzerland
University Hospital of Geneva Active, not recruiting
Geneva, Switzerland, CH-1211
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre-Yves BENHAMOU, MD, PhD University Hospital, Grenoble

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02854696     History of Changes
Other Study ID Numbers: 38RC14.453
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University Hospital, Grenoble:
Islet cell Transplantation
cost-effectiveness analysis
Cost-utility analysis
Type 1 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs