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 ]
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