학술논문

Rationale and Design for a GRADE Substudy of Continuous Glucose Monitoring
Document Type
article
Author
Larkin, Mary ENathan, David MBebu, IonutKrause-Steinrauf, HeidiHerman, William HHiggins, John MTiktin, MargaretCohen, Robert MLund, ClaireBergenstal, Richard MJohnson, Mary LArends, ValerieCrandall, Jill PMcKee, Melissa DianeBrown-Friday, JanetXhori, EntilaBallentine-Cargill, KeishaDuran, SallyLukin, JenniferBeringher, Stephaniede la torre, Susana GonzalezPhillips, LawrenceBurgess, ElizabethOlson, DarinRhee, MaryWilson, PeterRaines, Tasha StephanieCostello, JulieGullett, ChonaMaher-Albertelli, MaxineMorehead, FolayanMungara, RadhikaPerson, SaranjitSavoye, LouiseSibymon, MabilTanukonda, SridharWhite, Carol AnnHolloway, LeahAdams, CynthiaRoss, AprilBalasubramanyam, AshokGonzalez, EricaWright, CharlyneHollander, PriscillaRoe, ErinUy, AnalynBurt, PollyEstrada, LorieChionh, KrisIsmail-Beigi, FaramarzFalck-Ytter, CorinnaKassem, Laure SayyedSood, AjayCramer, BethanyIacoboni, JacalynKononets, Maria VKulow, TanyaNewman, CynthiaStancil, Katherine ASanders, CristinaTucker, LisaWerner, AmandaKrol, AdrienneMcPhee, GloriaPatel, ChristineColosimo, LindaGoland, RobinPring, JamesKringas, PatriciaTejada, JessicaHausheer, CamilleSchneier, HarveyGumpel, KellyKirpitch, AmandaGreen, Jennifer BAbouAssi, HibaChatterjee, RaneeFeinglos, Mark NJones, Jennifer EnglishKhan, Shubi AKimpel, Jeanne BZimmer, Ronna PFurst, MarySatterwhite, Barbara MThacker, Connie RKreider, Kathryn EvansMather, Kieren JLteif, AmaleHamilton, TonyaPatel, NickRiera, GabrielaJackson, MarciaPirics, VivianHoward, DevinAguillar, DanielleHurt, SloanBergenstal, RichardCarlson, AndersMartens, ThomasJohnson, Mary
Source
Diabetes Technology & Therapeutics. 21(12)
Subject
Diabetes
Clinical Research
Metabolic and endocrine
Black or African American
Blood Glucose
Blood Glucose Self-Monitoring
Diabetes Mellitus
Type 2
Glycated Hemoglobin
Hispanic or Latino
Humans
Hypoglycemic Agents
Randomized Controlled Trials as Topic
Research Design
White People
Type 2 diabetes
Glycated hemoglobin
Interracial differences
Continuous glucose monitoring
Average glucose
GRADE Research Group
Clinical Sciences
Medical Physiology
Endocrinology & Metabolism
Language
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.