Human Islet Transplantation in Brittle Type 1 Diabetes Mellitus. The GRAGIL 2 Study.

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT00321256
• Lead Sponsor: University Hospital, Grenoble

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 Description

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.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2006-05-02
• Study First Submitted QC: 2006-05-02
• Study First Posted: 2006-05-03
• Study Completion: 2007-07
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-01
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

University Hospital, Department of Surgery; 🇨🇭 Geneva, Switzerland

University Hospital, Department of Endocrinology; 🇫🇷 Strasbourg, France