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Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.

Publication ,  Journal Article
Larkin, ME; Nathan, DM; Bebu, I; Krause-Steinrauf, H; Herman, WH; Higgins, JM; Tiktin, M; Cohen, RM; Lund, C; Bergenstal, RM; Johnson, ML ...
Published in: Diabetes Technol Ther
December 2019

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.

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Published In

Diabetes Technol Ther

DOI

EISSN

1557-8593

Publication Date

December 2019

Volume

21

Issue

12

Start / End Page

682 / 690

Location

United States

Related Subject Headings

  • White People
  • Research Design
  • Randomized Controlled Trials as Topic
  • Hypoglycemic Agents
  • Humans
  • Hispanic or Latino
  • Glycated Hemoglobin
  • Endocrinology & Metabolism
  • Diabetes Mellitus, Type 2
  • Blood Glucose Self-Monitoring
 

Citation

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Chicago
ICMJE
MLA
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Larkin, M. E., Nathan, D. M., Bebu, I., Krause-Steinrauf, H., Herman, W. H., Higgins, J. M., … GRADE Research Group, . (2019). Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring. Diabetes Technol Ther, 21(12), 682–690. https://doi.org/10.1089/dia.2019.0202
Larkin, Mary E., David M. Nathan, Ionut Bebu, Heidi Krause-Steinrauf, William H. Herman, John M. Higgins, Margaret Tiktin, et al. “Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.Diabetes Technol Ther 21, no. 12 (December 2019): 682–90. https://doi.org/10.1089/dia.2019.0202.
Larkin ME, Nathan DM, Bebu I, Krause-Steinrauf H, Herman WH, Higgins JM, et al. Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring. Diabetes Technol Ther. 2019 Dec;21(12):682–90.
Larkin, Mary E., et al. “Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring.Diabetes Technol Ther, vol. 21, no. 12, Dec. 2019, pp. 682–90. Pubmed, doi:10.1089/dia.2019.0202.
Larkin ME, Nathan DM, Bebu I, Krause-Steinrauf H, Herman WH, Higgins JM, Tiktin M, Cohen RM, Lund C, Bergenstal RM, Johnson ML, Arends V, GRADE Research Group. Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring. Diabetes Technol Ther. 2019 Dec;21(12):682–690.
Journal cover image

Published In

Diabetes Technol Ther

DOI

EISSN

1557-8593

Publication Date

December 2019

Volume

21

Issue

12

Start / End Page

682 / 690

Location

United States

Related Subject Headings

  • White People
  • Research Design
  • Randomized Controlled Trials as Topic
  • Hypoglycemic Agents
  • Humans
  • Hispanic or Latino
  • Glycated Hemoglobin
  • Endocrinology & Metabolism
  • Diabetes Mellitus, Type 2
  • Blood Glucose Self-Monitoring