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Full Title: Islet Transplantation in Patients with Type 1 Diabetes Mellitus
View or download Summary/Report
Objectives: To systematically review the evidence on the outcomes of contemporary islet transplantation procedures (that used the Edmonton or subsequently developed protocols) that aim at achieving physiologic insulin regulation in patients with labile type 1 diabetes.
Data Sources: MEDLINE®, through October 2003. Primary evidence from published papers and registries, supplemented with evidence from recent meeting abstracts and presentations.
Review Methods: Prospective trials of allogeneic islet transplant for treatment of type 1 diabetes were selected that reported glycemic outcomes and/or adverse events at least 3 months post-procedure, and used the Edmonton or a subsequently developed islet transplant protocol.
Results: Twelve published articles reporting efficacy and adverse outcomes, and two others reporting only adverse outcomes, constituted the available primary evidence. Supplemental sources provided preliminary results of studies in progress. Outcomes of interest were summarized in tables and synthesized across studies. Of 37 patients from three centers, 28 (76 percent) maintained insulin independence at 1 year (published evidence); similarly, 50 to 90 percent of 104 patients from four centers were insulin independent (supplemental evidence). Serious adverse events, including portal vein thrombosis and hemorrhage, occur infrequently.
Conclusions: Evidence on outcomes of islet transplant is limited by small patient numbers, short followup, and lack of standardized reporting. (These issues are being addressed by the National Institute of Health (NIH) funded Collaborative Islet Transplant Registry.) Data are lacking on long-term durability of the procedure, effects on diabetic complications, or long-term consequences of immunosuppression. Evidence is insufficient for comparison with whole-organ pancreas transplant.
Islet Transplantation in Patients with Type 1 Diabetes Mellitus
Evidence-based Practice Center: Blue Cross and Blue Shield Association Technology Evaluation Center
Topic Nominator: PacifiCare
Current as of August 2004