Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring
Autor: | John M. Higgins, Richard M. Bergenstal, Ionut Bebu, Claire Lund, Valerie L. Arends, Mary E. Larkin, Heidi Krause-Steinrauf, Robert M. Cohen, Mary L. Johnson, Margaret Tiktin, David M. Nathan, William H. Herman |
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Jazyk: | angličtina |
Rok vydání: | 2019 |
Předmět: |
Blood Glucose
medicine.medical_specialty endocrine system diseases Endocrinology Diabetes and Metabolism Population 030209 endocrinology & metabolism Type 2 diabetes Hypoglycemia White People 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Endocrinology Blood Glucose Self-Monitoring Internal medicine Diabetes mellitus Medicine Humans Hypoglycemic Agents 030212 general & internal medicine education Glycemic Randomized Controlled Trials as Topic Glycated Hemoglobin education.field_of_study business.industry nutritional and metabolic diseases Original Articles Hispanic or Latino medicine.disease Black or African American Medical Laboratory Technology chemistry Diabetes Mellitus Type 2 Research Design Observational study Glycated hemoglobin business |
Zdroj: | Diabetes Technol Ther |
Popis: | Background: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness (GRADE) study has enrolled a racially and ethnically diverse population with type 2 diabetes, performed extensive phenotyping, and randomly assigned the participants to one of four second-line diabetes medications. The continuous glucose monitoring (CGM) substudy has been added to determine whether there are racial/ethnic differences in the relationship between average glucose (AG) and hemoglobin A1c (HbA1c). CGM will also be used to compare time in target range, glucose variability, and the frequency and duration of hypoglycemia across study groups. Methods: The observational CGM substudy will enroll up to 1800 of the 5047 GRADE study participants from the four treatment groups, including as many as 450 participants from each of 4 racial/ethnic minority groups to be compared: Hispanic White, non-Hispanic White, non-Hispanic African American, and non-Hispanic Other. CGM will be performed for 2 weeks in proximity to a GRADE annual visit, during which an oral glucose tolerance test will be performed and HbA1c and glycated albumin measured. Indicators of interindividual variation in red blood cell turnover, based on specialized erythrocyte measurements, will also be measured to explore the potential causes of interindividual HbA1c variations. Conclusions: The GRADE CGM substudy will provide new insights into whether differences exist in the relationship between HbA1c and AG among different racial/ethnic groups and whether glycemic profiles differ among frequently used diabetes medications and their potential clinical implications. Understanding such differences is important for clinical care and adjustment of diabetes medications in patients of different races or ethnicities. |
Databáze: | OpenAIRE |
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