Standardization of C-Peptide and HbA1C Measurements Program

C 肽和 HbA1C 测量程序标准化

• 批准号: 10662554
• 负责人: Randie Little
• 金额: $ 47.74万
• 依托单位: UNIVERSITY OF MISSOURI-COLUMBIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2027-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10662554
• 关键词: Affect; American; Beta Cell; Biological; Biological Assay; Blood Glucose; Blood Vessels; Blood specimen; C-Peptide; Calibration; Capillary Electrophoresis; Caring; Cell physiology; Certification; Chronic; Chronic Disease; Clinical; Clinical Chemistry; Clinical Research; Complications of Diabetes Mellitus; Data; Data Analyses; Development; Diabetes Mellitus; Diagnosis; Diagnostic; Disease; Disease Progression; Evaluation; Eye; Fostering; Freezing; Glycosylated hemoglobin A; Goals; Heart; Hemoglobin; Hyperglycemia; Insulin deficiency; Insulin-Dependent Diabetes Mellitus; International; Kidney; Laboratories; Manufacturer; Measurement; Methods; Monitor; Pathologist; Performance; Peripheral Nerves; Persons; Publishing; Recommendation; Reporting; Research; Research Project Grants; Risk; Scheme; Site; Specific qualifier value; Specificity; Standardization; Testing; Therapeutic Intervention; United States National Institutes of Health; Update; Variant; Whole Blood; college; diabetes control; diagnostic tool; effectiveness evaluation; glycemic control; high risk; improved; meetings; member; preservation; programs; web site

Project Summary Diabetes mellitus is a chronic disorder characterized by insulin deficiency, hyperglycemia and high risk for development of complications of the eyes, kidneys, peripheral nerves, heart and blood vessels. The disease is highly prevalent, affecting more than 30 million people in the U.S. Monitoring of glycemic control has traditionally been considered a cornerstone of diabetes care. The importance of monitoring glycemia has been established by studies proving a direct relationship between mean blood glucose and the development and progression of the chronic complications of diabetes. The landmark Diabetes Control and Complications Trial (DCCT), completed in 1993, showed that risks for development and/or progression of the chronic complications of type 1 diabetes is closely related to the degree of glycemic control, as assessed by HbA1c determinations. The importance of HbA1c as a marker of glycemic control in diabetes mellitus, and more recently as a diagnostic tool, is now well established. This proposed project will improve the measurement of HbA1c for optimal clinical and diagnostic use. This will be done through an established standardization program by continuously tightening criteria for method and laboratory certification, monitoring performance of laboratory methods and laboratories, and testing and publishing data on HbA1c analytical and biological interferences. Preservation of beta cell function in type 1 diabetes has been identified as an important goal in delaying progression of the disease at onset and also for therapeutic intervention. Accurate, standardized measurement of C-peptide will aid in this goal and is also the subject of this proposal. Standardization will be accomplished by implementation of a traceability scheme with re-calibration of C- peptide methods by each manufacturer and monitoring the effects of re-calibration by evaluation of proficiency testing data. In addition, criteria will be formulated for acceptable accuracy, precision and specificity of C-peptide assays.

项目总结