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Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring
- Source :
- Diabetes Technol Ther
- Publication Year :
- 2019
- Publisher :
- Mary Ann Liebert, Inc., publishers, 2019.
-
Abstract
- 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.
- Subjects :
- 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
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Journal :
- Diabetes Technol Ther
- Accession number :
- edsair.doi.dedup.....b5f2c2dd364539a043430bfa6bf5fed2