Clinical Trial: Human Islet Transplantation in Brittle Type 1 Diabetes Mellitus. The GRAGIL 2 Study.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Transplantation d'Ilots Pancreatiques Allogeniques Adultes Pour le Traitement du Diabete Insulino-dependant: Etude GRAGIL 2.
Brief Summary: This research project is supported by a multicentric network of collaborators whose goal is to assess the efficacy of transplanting allogenic pancreas islets to restore insulin secretion in patients with brittle type 1, insulin-dependent diabetes mellitus and to improve their metabolic control.
Detailed Summary: The general objective is to demonstrate the beneficial effect of islet allotransplantation in patients with brittle type 1 diabetes with no endogenous insulin secretion, for whom the risk of the spontaneous course of the disease is judged to be worse than the transplantation-related risk. The specific objective is to establish reference data for islet transplantation in non-uremic patients with brittle diabetes, in a multicentric network setting, using the Edmonton protocol.
Sponsor: University Hospital, Grenoble
Current Primary Outcome:
- The rate of insulin-independence, judged upon the following criteria : HbA1c < 6.1%,
- post-prandial blood glucose < 180 mg/dl, mean amplitude of glycemic excursion (MAGE index)
- < 60 mg/dl, basal C-peptide > 0.5 ng/ml. This insulin independent rate will be assessed 6 months
- and 12 months following transplantation.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The rate of success according to the DiaCell composite score defined by the following 4 items : functional islet graft, defined by a basal C-peptide > 0.5 ng/ml;
- good metabolic control, defined by HbA1c ≤ 6.5%; disappearance of hypoglycemic events; reduction in exogenous insulin needs ≥ 30%.
- Morbidity and quality of life will also be assessed.
Original Secondary Outcome: Same as current
Information By: University Hospital, Grenoble
Dates:
Date Received: May 2, 2006
Date Started: July 2003
Date Completion:
Last Updated: March 1, 2012
Last Verified: March 2012