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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Patients will be transplanted with pancreatic islet cells
Patients will continue their insulin treatment
University Hospital of Besançon
Besançon, France
university hospital of Clermont Ferrand
Clermont-Ferrand, France
Grenoble University Hospital
Grenoble, France
University hospital of Lille
Incremental cost- utility ratio at 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.
Time frame: 1 year
Cost-effectiveness ratio at 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
Time frame: 1 year
Assessment of individual medical benefit of quality of life
Evaluate with DQOL questionnaire
Time frame: 6 months and 1year
Assessment of individual medical benefit in terms of metabolic efficacy
measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability
Time frame: 6 months and 1 year
Assessment and comparison of individual medical benefit in terms of complications of islet cell transplantation between the two groups
measured from in insulin independence, hospitalizations
Time frame: 6 months and 1 year
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Lille, France
University Hospital of Lyon
Lyon, France
University Hospital of Montpellier
Montpellier, France
University hospital of Nancy
Nancy, France
university hospital of Nantes
Nantes, France
APHP
Paris, France
University hospital of Strasbourg
Strasbourg, France
...and 1 more locations
Assessment and comparison of clinical benefit for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation
measured from DQOL, insulin independence, complications of islet cell transplantation
Time frame: 1 year
Assessment and comparison of costs for patients with brittle type 1 diabetes with impairment of vital prognosis before and after islet cell transplantation
measured from hospitalizations
Time frame: 1 year
Assessment of total cost of islet cell transplantation
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.
Time frame: 1 year