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Islet Transplantation in Patients with Type 1 Diabetes Mellitus
Evidence Reports/Technology Assessments, No. 98
Investigators: Margaret Piper, PhD, MPH, Principal Investigator, Jerome Seidenfeld, PhD, and Naomi Aronson, PhD, EPC Director.
Structured Abstract
Context:
Pancreas transplantation is used selectively for labile type 1 diabetes to achieve physiologic insulin regulation. Infusing pancreatic islets into the liver via catheter (“islet transplant”) may offer similar benefit with less surgical risk.
Objectives:
Systematic evidence review on the outcomes of islet transplantation, particularly using the Edmonton or a subsequently developed islet transplant protocol.
Data Sources:
MEDLINE searched through October 2003. Primary evidence from published papers and registries, supplemented with evidence from recent meeting abstracts and presentations.
Study Selection:
Selected studies were prospective trials of allogeneic islet transplant for treatment of type 1 diabetes 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.
Data Extraction:
A single reviewer selected studies and abstracted data. A second reviewer fact-checked the evidence tables.
Data Synthesis:
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.
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 NIH-funded Collaborative Islet Transplant Registry.) 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. 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.
Contents
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-02-0026. Prepared by: Blue Cross and Blue Shield Association, Technology Evaluation Center Evidence-based Practice Center (EPC), Chicago, Illinois.
Suggested citation:
Piper M, Seidenfeld J, Aronson N. Islet Transplantation in Patients with Type 1 Diabetes Mellitus. Evidence Report/Technology Assessment No. 98 (Prepared by Blue Cross and Blue Shield Association Technology Evaluation Center Evidence-based Practice Center under Contract No. 290-02-0026). AHRQ Publication 04-E017-2. Rockville, MD: Agency for Healthcare Research and Quality. August 2004
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers - patients and clinicians, health system leaders, and policymakers - make more informed decisions and improve the quality of health care services.
The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.
- 1
540 Gaither Road, Rockville, MD 20850. www
.ahrq.gov
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- Islet Transplantation in Patients with Type 1 Diabetes MellitusIslet Transplantation in Patients with Type 1 Diabetes Mellitus
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