Open AccessRationale and Design for a GRADE Substudy of Continuous Glucose Monitoring
Author(s) -
Mary Larkin,
David M. Nathan,
Ionut Bebu,
Heidi KrauseSteinrauf,
William H. Herman,
John M. Higgins,
Margaret Tiktin,
Robert M. Cohen,
Claire Lund,
Richard M. Bergenstal,
Mary L. Johnson,
Valerie Arends,
Jill P. Crandall,
M. Diane McKee,
Janet Brown-Friday,
Entila Xhori,
Keisha Ballentine-Cargill,
Sally Duran,
Jennifer Lukin,
Stephanie Beringher,
Susana Gonzalez de la torre,
Lawrence S. Phillips,
Elizabeth Burgess,
Darin E. Olson,
Mary K. Rhee,
Peter Wilson,
Tasha Stephanie Raines,
Julie Costello,
Chona Gullett,
Maxine Maher-Albertelli,
Folayan Morehead,
Radhika Mungara,
Saranjit Person,
Louise Savoye,
Mabil Sibymon,
Sridhar Tanukonda,
Carol Ann White,
Leah Holloway,
Cynthia Adams,
April Ross,
Ashok Balasubramanyam,
Erica Gonzalez,
C. Wright,
Priscilla Hollander,
Erin Roe,
Analyn Uy,
Polly Burt,
Lorie Estrada,
Kris Chionh,
Faramarz IsmailBeigi,
Corinna Falck-Ytter,
Laure Sayyed Kassem,
A. K. Sood,
Bethany Cramer,
Jacalyn Iacoboni,
Maria V. Kots,
Tanya Kulow,
Cynthia Newman,
Katherine A. Stancil,
Cristina Sanders,
Lisa Tucker,
Amanda Werner,
Adrienne Krol,
Gloria McPhee,
Christine Patel,
Linda Colosimo,
Robin Goland,
James Pring,
P. Kringas,
Jéssica Tejada,
Camille Hausheer,
Harvey Schneier,
Kelly Gumpel,
Amanda Kirpitch,
Jennifer B. Green,
Hiba AbouAssi,
Ranee Chatterjee,
Mark N. Feinglos,
Jennifer English Jones,
Shubi A. Khan,
J.B. Kimpel,
Ronna P. Zimmer,
Mary Furst,
B.M. Satterwhite,
Connie R. Thacker,
Kathryn Evans Kreider,
Kieren J. Mather,
Amale Lteif,
T. Hamilton,
Nick C. Patel,
G. Riera,
Marcia Jackson,
Vivian Pirics,
D. Howard,
Danielle Aguillar,
S. Hurt,
Anders L. Carlson,
Thomas Martens,
R. Hill,
Jamie Hyatt,
C. Jensen,
M. Madden,
Dianna C. Martin,
Holly Willis,
Wanda Konerza,
Rebecca Passi,
K. Kleeberger,
Stephen P. Fortmann,
M. Herson,
Karen Mularski,
Harry Glauber,
J. Prihoda,
Britt Ash,
Christina Carlson,
P.A. Ramey,
E. Schield,
Britta Torgrimson-Ojerio,
Kathy Arnold,
Bryan Kauffman,
E. Panos,
S. Sahnow,
K. Bays,
Jennifer Cook,
J. Gluth,
Debra Sasaki,
K. Schell,
Jennifer Criscola,
C. Friason,
Suzi Jones,
С. А. Назаров,
Joshua I. Barzilay,
N. Rassouli,
Rachel Puttnam,
Michelle Curtis,
K. Stokes,
B. Hollis,
C. Sanders-Jones,
R. Nelson,
Z. El-Haqq,
A. Kolli,
Tú-Anh Tran,
Deborah J. Wexler,
James B. Meigs,
Amy Dushkin,
Gianna Rocchio,
Brittany D. Chambers,
Mike Yepes,
Barbara Steiner,
H. Dulin,
M. Cayford,
A. DeManbey,
Lindsey Gurry,
Mallory Hillard,
Kimberly Martin,
Christine Stevens,
Nopporn Thangthaeng,
R. Kochis,
Elyse Raymond,
Valerie Ripley,
Jean Park,
Vanita R. Aroda,
Adline Ghazi,
Amy Loveland,
Maria D. Hurtado,
Alexander Kuhn,
Florence Mofor,
Hermes Flórez,
Willy Marcos Valencia,
Jennifer B. Marks,
Lisset Oropesa-Gonzalez,
A.K. Riccio Veliz,
Ramfis NietoMartínez,
Miriam Gutt,
Andrew Ahmann,
Diana Aby-Daniel,
Farahnaz Joarder,
Victoria Morimoto,
C. Sprague,
Daisuke Yamashita,
Nancy Cady,
P. Kirchhoff,
N. Rivera-Eschright,
Joseph Adducci,
B. Morales Gomez,
Аліна Гончарова,
Sophia H. Hox,
Helen Petrovitch,
M. Matwichyna,
Victoria Jenkins,
N.O. Bermudez,
R.R. Ishii,
Daniel S. Hsia,
William T. Cefalu,
Frank L. Greenway,
C. Waguespack,
Erin King,
Natalie Haynes,
A. Thomassie,
Brandi Bourgeois,
C. Hazlett,
Robert R. Henry,
Sunder Mudaliar,
Schafer Boeder,
Jeremy Pettus,
Elsa Diaz,
Catherine DeLue,
Erick Castro,
Sylvia Hernandez,
Jonathan Krakoff,
Jeffrey M. Curtis,
Tina Killean,
E. Joshevama,
E. Diaz,
Denelle Martin,
T. Karshner,
Jeanine Albu,
F. Xavier PiSunyer,
Sylvaine Frances,
Carol A. Maggio,
Emily Ellis,
Joseph Bastawrose,
Xiuqun Gong,
Mary Ann Banerji,
Phyllis August,
Daniel Lorber,
N.M. Brown,
D.H. Josephson,
Lorraine L. Thomas,
M. Tsovian,
A. Cherian,
Marlo H. Jacobson,
M.M. Mishko,
M. Sue Kirkman,
Katherine Bergamo,
John B. Buse,
Jean M. Dostou,
Laura Young,
April Goley,
J. B. Kerr,
Joseph F. Largay,
S. Guarda,
J. Cuffee,
D. Culmer,
Rachael Fraser,
Hope Almeida,
Samantha Coffer,
E. Debnam,
L. Kiker,
Sarah U. Morton,
K. Josey,
Gail Fuller,
W. Timothy Garvey,
Andrea Cherrington,
Dana Golson,
O. Griffith,
Mary Catherine Robertson,
April A. Agne,
S. McCullars,
Jacqueline Craig,
K. Kersey,
M.C. Rogge,
Carla Wilson,
Kathryn Burton,
Sonia Lipp,
Mary Beth Vonder Meulen,
Neda Rasouli,
Emily B. Schroeder,
Stephanie Steiner,
Chelsea Baker,
Chantal Underkofler,
Sara Douglass,
William I. Sivitz,
Erin Cline,
L.K. Knosp,
Jennifer McConnell,
T. Lowe,
Rodica PopBusui,
Meng H. Tan,
Catherine L. Martin,
Andrea Waltje,
L. Goodhall,
Rebecca Eggleston,
Shihchen Kuo,
Stephanie Bule,
N. Kessler,
Elizabeth LaSalle,
Elizabeth R. Seaquist,
A. Bantle,
Anjali Kumar,
J. Bruce Redmon,
John P. Bantle,
Tasma Harindhanavudhi,
M. Coe,
M. Mech,
Abdisa Taddese,
Lesia Lesne,
Shan D. Smith,
Cyrus Desouza,
Lisa Kuechenmeister,
Vijay Shivaswamy,
A.L. Morales,
M.G. Rodriguez,
K. Seipel,
Alissa Alfred,
J. Eggert,
G. Lord,
William Taylor,
R. Tillson,
David S. Schade,
Allen Adolphe,
Mark R. Burge,
Elizabeth Duran-Valdez,
Janae Martinez,
D. Hernandez McGinnis,
B. Pucchetti,
E. Scripsick,
Ralph A. DeFronzo,
Eugênio Cersósimo,
Muhammad AbdulGhani,
Curtis Triplitt,
H. Verastiqui,
Rosa Irene Garza,
K. Wright,
Curtiss Puckett,
Philip Raskin,
Chanhaeng Rhee,
S. Abraham,
L.F. Jordan,
S. Sao,
L. Morton,
Oralenda Smith,
Laura Osornio Walker,
Laura Schnurr-Breen,
Rosa Ayala,
Robert Brian Kraymer,
D. Sturgess,
Kristina M. Utzschneider,
Steven E. Kahn,
Lorena Alarcon-Casas Wright,
Edward J. Boyko,
Elaine C. Tsai,
Dace Trence,
Basma N. Fattaleh,
Brenda K. Montgomery,
Karen M. Atkinson,
Tessa Concepcion,
Alexandra Kozedub,
C. Moak,
S. Rhothisen,
Tom A. Elasy,
Stéphanie Martin,
Laura Shackelford,
R. Goidel,
Nina Hinkle,
J. Lipps Hogan,
C. Lovell,
Janet Myers,
Janet B. McGill,
Maamoun Salam,
Sarah Kissel,
Toni Schweiger,
Carol Recklein,
William V. Tamborlane,
P. Gatcomb,
Anne Camp,
Barbara Gulanski,
Silvio E. Inzucchi,
Kim Pham,
Michele Alguard,
Katarzyna Lessard,
Magalys Perez,
Elizabeth Magenheimer,
Abmaridel Montoza,
Henry B. Burch,
Andrew A. Bremer,
Barbara Linder,
Judith Fradkin,
John M. Lachin,
Naji Younes,
Michael Backman,
C.J. Buys,
Anna Fagan Murphy,
Yuping Gao,
M.R. Gramzinski,
Stephanie V. Hall,
Elizabeth Legowski,
A. Arey,
Joel Bethepu,
P. Mangat Dhaliwal,
Paula McGee,
E. Mesimer,
Lisa Ngo,
Michael W. Steffes,
Jesse C. Seegmiller,
Amy K. Saenger,
Deanna Gabrielson,
T. Conner,
Stuart Warren,
Jolene Day,
Alexandra Scrymgeour,
Elsayed Z. Soliman,
ZhuMing Zhang,
Charles Campbell,
Julie Hu,
Lisa Keasler,
Susan Hensley,
Yabing Li,
Rada Mihalcea,
Verónica PérezRosas,
Lisa A. Prosser,
Ken Resnicow,
Wen Ye,
Hui Shao,
Ping Zhang,
José A. Luchsinger,
Danurys Sanchez,
Erik J. Groessl,
Helen Chong,
Naomi Hillery,
I. Abdouch,
P. Brantley,
Frances E. Broyles,
G. Canaris,
Paul M. Copeland,
J.J. Craine,
W.L. Fein,
Melissa S. Lee,
R. Meiners,
Vaughn Meiners,
Hollis R. O’Neal,
James E. Park,
E. Sledge,
Jeanne Steppel-Resnick,
Alexander Turchin
Publication year - 2019
Publication title -
diabetes technology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.142
H-Index - 88
eISSN - 1557-8593
pISSN - 1520-9156
DOI - 10.1089/dia.2019.0202
Subject(s) - medicine , glycemic , diabetes mellitus , glycated hemoglobin , hypoglycemia , population , ethnic group , type 2 diabetes , observational study , research design , endocrinology , environmental health , social science , sociology , anthropology
Background: The G lycemia R eduction A pproaches in D iabetes: A Comparative E ffectiveness (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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