This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The main goal of this multi-center observational study is to establish the relationship between Mean Blood Glucose (MBG) concentration and glycohemoglobin (HbA1c) values according to the Diabetes Control and Complications Trial (DCCT) and the International Federation of Clinical Chemistry (IFCC) method over a wide range of glycemic control in both Type 1 and Type 2 Diabetes. The ultimate goal, when the relationship has been confirmed, is to implement the calculated MBG as the means of expressing HbA1c results and use the IFCC-HbA1c to standardize HbA1c assays. The main hypothesis to be tested is that standardized measurements of HbA1c can be used to accurately estimate mean blood glucose concentrations during the preceding two to three months over a wide range of DCCT HbA1c values (4-6.5%, 6.6-8.5% and > 8.5%) in subjects with either Type 1 or Type 2, normal glucose tolerance and of various racial and/or ethnic backgrounds. A secondary aim is to develop predictive formulas from the calibration data that are generated from this study that will allow HbA1c data to be expressed in terms of MBG values in clinical practice.
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