Clinical Trial: Health Economic Analysis of Islet Cell Transplantation for the Stabilization of the Severe Forms of Type 1 Diabetes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Health Economic Analysis of Islet Cell Transplantation for Patients With Severe Forms of Brittle Type 1 Diabetes

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.

Detailed Summary: 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.
Sponsor: University Hospital, Grenoble

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Grenoble

Dates:
Date Received: March 4, 2016
Date Started: July 2016
Date Completion: December 2023
Last Updated: March 16, 2017
Last Verified: March 2017