Expectations and strategies regarding islet transplantation: Metabolic data from the GRAGIL 2 trial

Details

Serval ID
serval:BIB_CB63AE85A6BC
Type
Article: article from journal or magazin.
Collection
Publications
Title
Expectations and strategies regarding islet transplantation: Metabolic data from the GRAGIL 2 trial
Journal
Transplantation
Author(s)
Badet L., Benhamou P. Y., Wojtusciszyn A., Baertschiger R., Milliat-Guittard L., Kessler L., Penfornis A., Thivolet C., Renard E., Bosco D., Morel P., Morelon E., Bayle F., Colin C., Berney T., GRAGIL Grp
ISSN
0041-1337
Publication state
Published
Issued date
2007
Volume
84
Number
1
Pages
89-96
Language
english
Notes
191bj
Times Cited:44
Cited References Count:29
Abstract
Background. Whether islet transplantation should be aimed at restoring insulin independence or providing adequate metabolic control is still debated. The GRAGIL2 trial was designed as a phase 1-2 study where primary outcome was the rate of insulin independence, and secondary outcome was the success rate defined by a composite score based upon basal C-peptide, HbA1c, hypoglycemic events, and exogenous insulin needs.
Methods. C-peptide negative type I brittle diabetic patients experiencing severe hypoglycemia were eligible to receive a maximum of two islet preparations totalizing 10,000 IE/kg or more, with a threshold of 5,000 IE/kg for the first infusion, according to the Edmonton protocol, within the Swiss-French GRAGIL multicentric network. A sequential analysis with a triangular test was performed in every five patients after 6- and 12-month follow-up. Maximal inefficiency was set at 40% and minimal efficiency at 66%.
Results. From September 2003 to October 2005, 10 patients were included. Median waiting time was 6.7 months (first injection) and 9 weeks (second injection). All but one patient received 11,089 +/- 505 IE/kg: one received a single graft of 5398 IE/kg. At 6 months, insulin independence and composite success rates were 6 of 10 and 6 of 10, respectively. At 12 months, insulin independence was observed in 3 of 10 patients and success in 5 of 10 patients.
Conclusion. Based upon our sequential analysis settings, islet transplantation failed to achieve the primary goal, insulin independence, but tended to succeed in reaching the secondary goal, successful metabolic control. Currently it appears to be a successful biological closed-loop glucose control method for brittle diabetes.
Keywords
pancreatic islet transplantation, type 1 diabetes mellitus, multicentric network, brittle diabetes, type-1 diabetic-patients, beta-cell function, insulin independence, allotransplantation, normoglycemia, network
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Create date
14/06/2021 8:58
Last modification date
18/09/2021 5:38
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