Updates are available Correction dated 2025-04-22
Click to view Correction: https://doi.org/10.1007/s00125-025-06433-3
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Authors
Ehrmann, Dominic https://orcid.org/0000-0002-5794-5596
Krause-Steinrauf, Heidi https://orcid.org/0000-0001-6894-4110
Uschner, Diane https://orcid.org/0000-0002-7858-796X
Wen, Hui https://orcid.org/0000-0002-0597-7596
Hoogendoorn, Claire J. https://orcid.org/0000-0003-4526-1952
Crespo-Ramos, Gladys https://orcid.org/0000-0001-8781-1858
Presley, Caroline https://orcid.org/0000-0001-6492-9941
Arends, Valerie L.
Cohen, Robert M.
Garvey, W. Timothy
Martens, Thomas https://orcid.org/0000-0002-9858-2138
Willis, Holly J. https://orcid.org/0000-0002-2404-5751
Cherrington, Andrea
Gonzalez, Jeffrey S.
,
Crandall, J. P.
McKee, M. D.
Behringer-Massera, S.
Brown-Friday, J.
Xhori, E.
Ballentine-Cargill, K.
Duran, S.
Estrella, H.
Gonzalez de la Torre, S.
Lukin, J.
Phillips, L. S.
Burgess, E.
Olson, D.
Rhee, M.
Wilson, P.
Raines, T. S.
Boers, J.
Costello, J.
Maher-Albertelli, M.
Mungara, R.
Savoye, L.
White, C. A.
Gullett, C.
Holloway, L.
Morehead, F.
Person, S.
Sibymon, M.
Tanukonda, S.
Adams, C.
Ross, A.
Balasubramanyam, A.
Gaba, R.
Gonzalez Hattery, E.
Ideozu, A.
Jimenez, J.
Montes, G.
Wright, C.
Ismail-Beigi, F.
Falck-Ytter, C.
Sayyed Kassem, L.
Sood, A.
Tiktin, M.
Kulow, T.
Newman, C.
Stancil, K. A.
Cramer, B.
Iacoboni, J.
Kononets, M. V.
Sanders, C.
Tucker, L.
Werner, A.
Maxwell, A.
McPhee, G.
Patel, C.
Colosimo, L.
Krol, A.
Goland, R.
Pring, J.
Alfano, L.
Kringas, P.
Hausheer, C.
Tejada, J.
Gumpel, K.
Kirpitch, A.
Schneier, H.
Mariash, C. N.
Mather, K. J.
Ismail, H. M.
Lteif, A.
Mullen, M.
Hamilton, T.
Patel, N.
Riera, G.
Jackson, M.
Pirics, V.
Aguillar, D.
Howard, D.
Hurt, S.
Bergenstal, R.
Carlson, A.
Johnson, M.
Hill, R.
Hyatt, J.
Jensen, C.
Madden, M.
Martin, D.
Konerza, W.
Yang, S.
Kleeberger, K.
Passi, R.
Fortmann, S.
Herson, M.
Mularski, K.
Glauber, H.
Prihoda, J.
Ash, B.
Carlson, C.
Ramey, P. A.
Schield, E.
Torgrimson-Ojerio, B.
Arnold, K.
Kauffman, B.
Panos, E.
Sahnow, S.
Bays, K.
Berame, K.
Cook, J.
Ghioni, D.
Gluth, J.
Schell, K.
Criscola, J.
Friason, C.
Jones, S.
Nazarov, S.
Wexler, D.
Larkin, M. E.
Meigs, J.
Chambers, B.
Dushkin, A.
Rocchio, G.
Yepes, M.
Steiner, B.
Dulin, H.
Cayford, M.
Chu, K.
DeManbey, A.
Hillard, M.
Martin, K.
Thangthaeng, N.
Gurry, L.
Kochis, R.
Raymond, E.
Ripley, V.
Stevens, C.
Park, J.
Aroda, V.
Ghazi, A.
Magee, M.
Ressing, Ann
Loveland, A.
Hamm, M.
Hurtado, M.
Kuhn, A.
Leger, J.
Manandhar, L.
Mwicigi, F.
Sanchez, O.
Young, T.
Garg, R.
Lagari-Libhaber, V.
Florez, H. J.
Valencia, W. M.
Marks, J.
Casula, S.
Oropesa-Gonzalez, L.
Hue, L.
Cuadot, A.
Nieto-Martinez, R.
Riccio Veliz, A. K.
Gutt, M.
Kendal, Y. J.
Veciana, B.
Hox, S. H.
Petrovitch, H.
Matwichyna, M.
Jenkins, V.
Broadwater, L.
Ishii, R. R.
Bermudez, N. O.
Hsia, D. S.
Cefalu, W. T.
Greenway, F. L.
Waguespack, C.
King, E.
Fry, G.
Dragg, A.
Gildersleeve, B.
Arceneaux, J.
Haynes, N.
Thomassie, A.
Pavlionis, M.
Bourgeois, B.
Hazlett, C.
Krakoff, J.
Curtis, J. M.
Killean, T.
Khalid, M.
Joshevama, E.
Diaz, E.
Tsingine, K.
Karshner, T.
Banerji, M. A.
August, P.
Lee, M.
Lorber, D.
Brown, N. M.
Josephson, D. H.
Thomas, L. L.
Tsovian, M.
Cherian, A.
Jacobson, M. H.
Mishko, M. M.
Dyer, D.
Lawson, M. C. R.
Griffith, O.
Agne, A.
McCullars, S.
Craig, J.
Rogge, M. C.
Burton, K.
Kersey, K.
Wilson, C.
Lipp, S.
Vonder Meulen, M. B.
Adkins, C.
Onadeko, T.
Rasouli, N.
Baker, C.
Schroeder, E.
Razzaghi, M.
Lyon, C.
Penaloza, R.
Underkofler, C.
Lorch, R.
Douglass, S.
Steiner, S.
Sivitz, W. I.
Cline, E.
Knosp, L. K.
McConnell, J.
Lowe, T.
Herman, W. H.
Pop-Busui, R.
Tan, M. H.
Martin, C.
Waltje, A.
Katona, A.
Goodhall, L.
Eggleston, R.
Kuo, S.
Bojescu, S.
Bule, S.
Kessler, N.
LaSalle, E.
Whitley, K.
Seaquist, E. R.
Bantle, A.
Harindhanavudhi, T.
Kumar, A.
Redmon, B.
Bantle, J.
Coe, M.
Mech, M.
Taddese, A.
Lesne, L.
Smith, S.
Desouza, C.
Kuechenmeister, L.
Shivaswamy, V.
Burbach, S.
Rodriguez, M. G.
Seipel, K.
Alfred, A.
Morales, A. L.
Eggert, J.
Lord, G.
Taylor, W.
Tillson, R.
Schade, D. S.
Adolphe, A.
Burge, M.
Duran-Valdez, E.
Martinez, J.
Bancroft, A.
Kunkel, S.
Ali Jamaleddin Ahmad, F.
Hernandez McGinnis, D.
Pucchetti, B.
Scripsick, E.
Zamorano, A.
Raskin, P.
Rhee, C.
Abraham, S.
Jordan, L. F.
Sao, S.
Morton, L.
Smith, O.
Osornio Walker, L.
Schnurr-Breen, L.
Ayala, R.
Kreymer, R. B.
Sturgess, D.
Utzschneider, K. M.
Kahn, S. E.
Alarcon-Casas Wright, L.
Boyko, E. J.
Tsai, E. C.
Trence, D. L.
Trikudanathan, S.
Fattaleh, B. N.
Montgomery, B. K.
Atkinson, K. M.
Kozedub, A.
Concepcion, T.
Moak, C.
Prikhodko, N.
Rhothisen, S.
Tamborlane, W.
Camp, A.
Gulanski, B.
Inzucchi, S. E.
Pham, K.
Alguard, M.
Gatcomb, P.
Lessard, K.
Perez, M.
Iannone, L.
Magenheimer, E.
Montosa, A.
Fradkin, J.
Burch, H. B.
Bremer, A. A.
Nathan, D. M.
Lachin, J. M.
Buse, J. B.
Younes, N.
Bebu, I.
Butera, N.
Buys, C. J.
Fagan, A.
Gao, Y.
Ghosh, A.
Gramzinski, M. R.
Hall, S. D.
Kazemi, E.
Legowski, E.
Liu, H.
Suratt, C.
Tripputi, M.
Arey, A.
Backman, M.
Bethepu, J.
Lund, C.
Mangat Dhaliwal, P.
McGee, P.
Mesimer, E.
Ngo, L.
Steffes, M.
Seegmiller, J.
Saenger, A.
Gabrielson, D.
Conner, T.
Warren, S.
Day, J.
Huminik, J.
Scrymgeour, A.
Abdouch, Ivan
Bahtiyar, Gul
Brantley, Paula
Broyles, Frances E.
Canaris, Gay
Copeland, Paul
Craine, Jeri J.
Fein, Warren L.
Gliwa, Agnieska
Hope, Lisel M.
Lee, Melissa S.
Meiners, Rebecca
Meiners, Vaughan
O’Neal, Hollis
Park, James E.
Sacerdote, Alan
Sledge, Edward Jr.
Soni, Lisa
Steppel-Reznik, Jeanne
Turchin, Alexander
Golden, Sherita H.
Naik, Aanand D.
Walker, Elizabeth A.
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Funding
Funding for this research was provided by:
National Heart, Lung, and Blood Institute
Centers for Disease Control and Prevention
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (U01DK098246, U34-DK-088043)
Otto-Friedrich-Universität Bamberg
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More Information
Article History
Received: 19 July 2024
Accepted: 3 January 2025
First Online: 14 February 2025
Change Date: 22 April 2025
Change Type: Correction
Change Details: A Correction to this paper has been published:
Change Details: https://doi.org/10.1007/s00125-025-06433-3
Acknowledgements
: The following GRADE Research Group investigators were collaborators in this work:GRADE Emotional Distress Substudy Research Group (April 30, 2021)Designations: Principal Investigator (PI); Co-Principal Investigator (Co-PI); Co-Investigator (Co-I); Study Coordinator (SC); Recruitment/Retention Coordinator (RC); Research Staff (RS)Co-Principal Investigators of the Emotional Distress Substudy: Cherrington, AL (Co-Chair, University of Alabama Birmingham, Birmingham, AL, USA); Gonzalez, Jeffrey S. (Co-Chair, Yeshiva University, Bronx, NY, USA; Albert Einstein College of Medicine Bronx, NY, USA);Krause-Steinrauf, H (Coordinating Center, The George Washington University Biostatistics Center, Rockville, MD, USA)Current Clinical CentersAlbert Einstein College of Medicine, Bronx, New York, USA: Crandall, JP (PI); McKee, MD (Co-PI, past); Behringer-Massera, S (Co-I, past); Brown-Friday, J (SC); Xhori, E (RC, past); Ballentine-Cargill, K (RS); Duran, S (RS); Estrella, H (RS); Gonzalez de la torre, S (RS, past); Lukin, J (RS, past)Atlanta VA Medical Center, Decatur, GA, USA: Phillips, LS (PI); Burgess, E (Co-I); Olson, D (Co-I); Rhee, M (Co-I); Wilson, P (Co-I); Raines, TS (SC); Boers, J (SC); Costello, J (SC); Maher-Albertelli, M (SC); Mungara, R (SC); Savoye, L (SC, past); White, CA (SC); Gullett, C (SC; past); Holloway, L (SC, past); Morehead, F (SC, past); Person, S (SC, past); Sibymon, M (SC, past); Tanukonda, S (SC, past); Adams, C (RC, past); Ross, A (RC, past)Baylor College of Medicine, Houston, Texas, USA: Balasubramanyam, A (PI); Gaba, R (Co-I); Gonzalez Hattery, E (SC); Ideozu, A (SC); Jimenez, J (SC); Montes, G (RC); Wright, C (RS, past)Case Western Reserve University/Cleveland VA/MetroHealth Medical Center, Cleveland, OH, USA: Ismail-Beigi, F (PI); Falck-Ytter, C (Co-PI); Sayyed Kassem, L (Co-PI); Sood, A (Co-PI, past); Tiktin, M (Co-I, SC); Kulow, T (SC); Newman, C (SC); Stancil, KA (SC); Cramer, B (SC, past); Iacoboni, J (SC, past); Kononets, MV (SC, past); Sanders, C (SC, past); Tucker, L (SC, past); Werner, A (SC, past); Maxwell, A (RS); McPhee, G (RS); Patel, C (RS); Colosimo, L (RS, past); Krol, A (RS, past)Columbia University Medical Center, New York, NY, USA: Goland, R (PI); Pring, J (SC); Alfano, L (SC); Kringas, P (SC, past); Hausheer, C (RC, past); Tejada, J (RC, past); Gumpel, K (RS, past); Kirpitch, A (RS, past); Schneier, H (RS, past)Indiana University, Bloomington, IN, USA: Mariash, CN (PI); Mather, KJ (PI, past); Ismail, HM (Co-I); Lteif, A (Co-I, past); Mullen, M (SC); Hamilton, T (SC, past); Patel, N (SC, past); Riera, G (RC); Jackson, M (RC, past); Pirics, V (RC, past); Aguillar, D (RS, past); Howard, D (RS, past); Hurt, S (RS, past)International Diabetes Center, Minneapolis, MN, USA: Bergenstal, R (PI); Carlson, A (Co-I); Martens, T (Co-I); Johnson, M (SC); Hill, R (SC); Hyatt, J (SC); Jensen, C (SC); Madden, M (SC); Martin, D (SC); Willis, H (SC); Konerza, W (RS); Yang, S (RS); Kleeberger, K (RS, past); Passi, R (RS, past)Kaiser Permanente Northwest, Portland, OR, USA: Fortmann, S (PI); Herson, M (Co-I); Mularski, K (Co-I); Glauber, H (Co-I, past); Prihoda, J (Co-I, past); Ash, B (SC); Carlson, C (SC); Ramey, PA (SC); Schield, E (SC); Torgrimson-Ojerio, B (SC); Arnold, K (SC, past); Kauffman, B (SC, past); Panos, E (SC, past); Sahnow, S (RC); Bays, K (RS); Berame, K (RS); Cook, J (RS); Ghioni, D (RS); Gluth, J (RS); Schell, K (RS); Criscola, J (RS, past); Friason, C (RS, past); Jones, S (RS, past); Nazarov, S (RS, past)Massachusetts General Hospital, Boston, MA, USA: Wexler, D (PI); Larkin, ME (Co-I, SC); Meigs, J (Co-I); Chambers, B (SC, past); Dushkin, A (SC, past); Rocchio, G (SC, past); Yepes, M (SC, past); Steiner, B (RC); Dulin, H (RC, past); Cayford, M (RS); Chu, K (RS); DeManbey, A (RS); Hillard, M (RS); Martin, K (RS); Thangthaeng, N (RS); Gurry, L (RS, past); Kochis, R (RS, past); Raymond, E (RS, past); Ripley, V (RS, past); Stevens, C (RS, past)MedStar Health Research Institute/ MedStar Baltimore, Hyattsville, MD, USA: Park, J (PI); Aroda, V (PI, past); Ghazi, A (Co-PI); Magee, M (Co-I); Ressing, Ann (Co-I); Loveland, A (SC); Hamm, M (SC); Hurtado, M (SC); Kuhn, A (SC); Leger, J (SC); Manandhar, L (SC); Mwicigi, F (SC); Sanchez, O (SC); Young, T (SC)Miami VA Healthcare System/University of Miami, Miami, FL, USA: Garg, R (PI), Lagari-Libhaber, V (PI); Florez, HJ (PI, past); Valencia, WM (PI, past); Marks, J (Co-PI, past); Casula, S (Co-I); Oropesa-Gonzalez, L (SC); Hue, L (SC, past); Cuadot, A (SC, past); Nieto-Martinez, R (SC, past); Riccio Veliz, AK (SC, past); Gutt, M (RC, past); Kendal, YJ (RS, past); Veciana, B. (RS, past)Pacific Health Research and Education Institute/VA Pacific Islands, Honolulu, HI, USA: Hox, SH (PI); Petrovitch, H (Co-PI); Matwichyna, M (SC); Jenkins, V (SC, past); Broadwater, L (RS); Ishii, RR (RS); Bermudez, NO (RS; past)Pennington Biomedical Research Center, Baton Rouge, LA, USA: Hsia, DS (PI); Cefalu, WT (PI, past); Greenway, FL (Co-I); Waguespack, C (Co-I); King, E (SC); Fry, G (SC); Dragg, A (SC); Gildersleeve, B (SC); Arceneaux, J (SC); Haynes, N (SC, past); Thomassie, A (SC, past); Pavlionis, M (SC, past); Bourgeois, B (RC, past); Hazlett, C (RS)Southwestern American Indian Center, Phoenix, AZ, USA: Krakoff, J (PI); Curtis, JM (Co-I); Killean, T (SC); Khalid, M (SC); Joshevama, E (RC, past); Diaz, E (RS); Martin, D (RS); Tsingine, K (RS); Karshner, T (RS, past)SUNY Downstate Medical Center/New York Hospital‐Queens, Brooklyn, NY, USA:Banerji, MA (PI); August, P (Co-I); Lee, M (Co-I); Lorber, D (Co-I); Brown, NM (SC, RC); Josephson, DH (SC); Thomas, LL (SC, RC); Tsovian, M (SC, RC); Cherian, A (SC, RC, past); Jacobson, MH (RS); Mishko, MM (RS)University of Alabama Birmingham, Birmingham, AL, USA: Garvey, WT (PI); Dyer, D (SC); Lawson, MCR (SC); Griffith, O (SC, past); Agne, A (RC); McCullars, S (RC) University of Cincinnati/Cincinnati VA Medical Center, Cincinnati OH, USA: Cohen, RM (PI); Craig, J (SC); Rogge, MC (SC; past); Burton, K (SC, past); Kersey, K (SC, RC, past); Wilson, C (SC, past); Lipp, S (RC, past); Vonder Meulen, MB (RC, past); Adkins, C (RS); Onadeko, T (RS)University of Colorado‐Denver/VA, Aurora, CO, USA: Rasouli, N (PI); Baker, C (Co-I);Schroeder, E (Co-I, past); Razzaghi, M (Co-I); Lyon, C (Co-I, past); Penaloza, R (Co-I, past); Underkofler, C (SC); Lorch, R (SC); Douglass, S (SC, past); Steiner, S (SC, past)University of Iowa, Iowa City, IA, USA: Sivitz, WI (PI); Cline, E (SC); Knosp, LK (SC); McConnell, J (SC, past); Lowe, T (RC)University of Michigan, Ann Arbor, MI, USA: Herman, WH (PI); Pop-Busui, R (Co-PI); Tan, MH (Co-I); Martin, C (SC); Waltje, A (SC, RC); Katona, A (SC); Goodhall, L (SC, past); Eggleston, R (RC, past); Kuo, S (RS); Bojescu, S (RS, past); Bule, S (RS, past); Kessler, N (RS, past); LaSalle, E (RS, past); Whitley, K (RS, past)University of Minnesota, Minneapolis, MN, USA: Seaquist, ER (PI); Bantle, A (Co-I); Harindhanavudhi, T (Co-I); Kumar, A (Co-I); Redmon, B (Co-I); Bantle, J (Co-I, past); Coe, M (SC); Mech, M (SC); Taddese, A (RC); Lesne, L (RS); Smith, S (RS)University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA: Desouza, C (PI); Kuechenmeister, L (Co-I); Shivaswamy, V (Co-I); Burbach, S (SC); Rodriguez, MG (SC); Seipel, K (SC); Alfred, A (SC, past); Morales, AL (SC; past); Eggert, J (RS); Lord, G (RS); Taylor, W (RS, past); Tillson, R (RS, past)University of New Mexico, Albuquerque, NM, USA: Schade, DS (PI); Adolphe, A (Co-PI); Burge, M (Co-PI, past); Duran-Valdez, E (SC); Martinez, J (RC, past); Bancroft, A (RS); Kunkel, S (RS); Ali Jamaleddin Ahmad, F (RS, past); Hernandez McGinnis, D (RS, past); Pucchetti, B (RS, past); Scripsick, E (RS, past); Zamorano, A (RS, past)University of Texas‐Southwestern Medical Center, Dallas, TX, USA: Raskin, P (PI);Rhee, C (Co-I, past); Abraham, S (SC); Jordan, LF (SC); Sao, S (SC); Morton, L (SC, past); Smith, O (SC, past); Osornio Walker, L (RC, past); Schnurr-Breen, L (RC, past); Ayala, R (RS); Kreymer, RB (RS); Sturgess, D (RS, past)VA Puget Sound Health Care System/University of Washington, Seattle, WA, USA: Utzschneider, KM (PI); Kahn, SE (Co-I); Alarcon-Casas Wright, L (Co-I); Boyko, EJ (Co-I); Tsai, EC (Co-I); Trence, DL (Co-I, past); Trikudanathan, S (Co-I, past); Fattaleh, BN (SC); Montgomery, BK (SC, past); Atkinson, KM (RS); Kozedub, A (RS); Concepcion, T (RS, past); Moak, C (RS, past); Prikhodko, N (RS, past); Rhothisen, S (RS, past)Yale University/Fair Haven Community Health Center/West Haven VA Medical Center, New Haven, CT, USA: Tamborlane, W (PI); Camp, A (Co-I); Gulanski, B (Co-I); Inzucchi, SE (Co-I); Pham, K (Co-I); Alguard, M (SC, RC); Gatcomb, P (SC); Lessard, K (SC); Perez, M (SC); Iannone, L (RC);Magenheimer, E (RC); Montosa, A (RC)Study UnitsNIH/NIDDK (Sponsor), Rockville, MD, USA: Cefalu, WT (Director, Division of Diabetes, Endocrinology and Metabolic Diseases);Fradkin, J (Director, Division of Diabetes, Endocrinology and Metabolic Diseases, past); Burch, HB (Project Scientist); Bremer, AA (Project Scientist, past)Chairman’s Office, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA: Nathan, DM (Study Chair, Study Co-PI)Executive Committee: Nathan, DM (Study Chair, Study Co-PI, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Lachin, JM (U01 Contact PI, Study Co-PI, The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA); Buse, JB (Co-I, The University of North Carolina School of Medicine, Chapel Hill, NC, USA); Kahn, SE (Co-I, Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, VA Puget Sound Health Care System and University of Washington, Seattle, WA, USA); Krause-Steinrauf, H (Co-I, Project Director, The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA); Larkin, ME (Co-I, SC, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Tiktin, M (Co-I, SC, Case Western Reserve University, Cleveland, OH); Wexler, D (PI, Diabetes Research Center, Massachusetts General Hospital and Harvard School of Medicine, Boston, MA, USA); Burch, HB (Program Scientist, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Rockville, MD, USA); Bremer, AA (Project Scientist, past, National Institutes of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Rockville, MD, USA)Coordinating Center, The George Washington University Biostatistics Center, Rockville, MD, USA: Lachin, JM (U01 Contact PI, Study Co-PI); Younes, N (Co-I); Bebu, I (RS); Butera, N (RS); Buys, CJ (RS); Fagan, A (RS); Gao, Y (RS); Ghosh, A (RS); Gramzinski, MR (RS); Hall, SD (RS); Kazemi, E (RS); Legowski, E (RS); Liu, H (RS); Suratt, C (RS); Tripputi, M (RS); Arey, A (RS, past); Backman, M (RS, past); Bethepu, J (RS, past); Lund, C (RS, past); Mangat Dhaliwal, P (RS, past); McGee, P (RS, past); Mesimer, E (RS, past); Ngo, L (RS, past)Central Biochemical Laboratory, University of Minnesota Advanced Research and Diagnostic Laboratory, Minneapolis, MN, USA: Steffes, M (PI); Seegmiller, J (Co-I); Saenger, A (Co-I, past); Arends, V (SC); Gabrielson, D (SC, past)Drug Distribution Center, VA Cooperative Studies Program Clinical Research Pharmacy Coordinating Center, Albuquerque, NM, USA: Conner, T (PI); Warren, S (PI, past); Day, J (RS); Huminik, J (RS); Scrymgeour, A (RS)Collaborating Investigators (Recruitment Sites): Abdouch, Ivan (University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA); Bahtiyar, Gul (SUNY Downstate Medical Center, Brooklyn, NY, USA); Brantley, Paula (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Broyles, Frances E. (Swedish Medical Center, Seattle, WA, USA); Canaris, Gay (University of Nebraska Medical Center/Omaha VA, Omaha, NE, USA); Copeland, Paul (Massachusetts General Hospital, Boston, MA, USA); Craine, Jeri J. (UW Valley Medical Center, Seattle, WA, USA); Fein, Warren L. (Swedish Medical Center, Seattle, WA, USA); Gliwa, Agnieska (SUNY Downstate Medical Center, Brooklyn, NY, USA); Hope, Lisel M. (SUNY Downstate Medical Center, Brooklyn, NY, USA); Lee, Melissa S. (SUNY Downstate Medical Center, Brooklyn, NY, USA); Meiners, Rebecca (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Meiners, Vaughan (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); O’Neal, Hollis (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Park, James E. (UW Valley Medical Center, Seattle, WA, USA); Sacerdote, Alan (SUNY Downstate Medical Center, Brooklyn, NY, USA); Sledge, Jr., Edward (Pennington Biomedical Research Center (LSU) , Baton Rouge, LA, USA); Soni, Lisa (SUNY Downstate Medical Center, Brooklyn, NY, USA); Steppel-Reznik, Jeanne (Massachusetts General Hospital, Boston, MA, USA); Turchin, Alexander (Massachusetts General Hospital, Boston, MA, USA).Emotional Distress Sub-study: Golden, Sherita H. (Johns Hopkins University, Baltimore, MD, USA); Naik, Aanand D. (Baylor College of Medicine, Houston, Texas, USA); Walker, Elizabeth A. (Albert Einstein College of Medicine, Bronx, NY, USA).
: This manuscript is based on follow-up data and outcome assessments from the 1739 participants enrolled into the Emotional Distress Sub-Study (EDS) of the Glycemia Reduction Approaches in Type 2 Diabetes: A Comparative Effectiveness (GRADE) study. The GRADE and EDS database will be available in 2025 at the NIDDK Data Repository ().
: Open Access funding enabled and organized by Projekt DEAL. The GRADE study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number U01DK098246. The planning of GRADE was supported by a U34 planning grant from the NIDDK (U34-DK-088043). The American Diabetes Association supported the initial planning meeting for the U34 proposal. The National Heart, Lung, and Blood Institute and the Centers for Disease Control and Prevention also provided funding support. The Department of Veterans Affairs provided resources and facilities. Additional support was provided by NIH through grant numbers P30 DK017047, P30 DK020541, P30 DK020572, P30 DK072476, P30 DK079626, P30 DK092926, U54 GM104940, UL1 TR000170, UL1 TR000439, UL1 TR000445, UL1 TR001102, UL1 TR001108, UL1 TR001409, 2UL1TR001425, UL1 TR001449, UL1 TR002243, UL1 TR002345, UL1 TR002378, UL1 TR002489, UL1 TR002529, UL1 TR002535, UL1 TR002537, UL1 TR002541 and UL1 TR002548. Educational materials (the 4 Steps to Manage Your Diabetes for Life booklet) were provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies was provided by Becton, Dickinson and Company, Bristol-Myers Squibb, Merck & Co. Inc., Novo Nordisk, Roche Diagnostics and Sanofi. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The GRADE Study Research Group is deeply grateful to our participants whose loyal dedication made the GRADE study possible.The GRADE Emotional Distress Sub-Study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under award number R01 DK104845. Additional support was provided by grant number P30 DK111022.
: DE reports consulting fees from Roche and Dexcom Germany, payment or honoraria from Roche, Dexcom Germany, Sanofi Aventis, Berlin Chemie AG, Boehringer Ingelheim/Lilly and Eli Lilly. CJH reports grants or contracts from the National Institute on Aging (NIA), the NIDDK and JDRF. CP reports grants or contracts from the National Center for Complementary and Integrative Health (NICCH) and ADA. RMC reports grants or contracts from NIH and Dexcom and the chairmanship of the Cincinnati Veterans Affairs Research and Development Committee. WTG reports grants or contracts from NIDDK, Novo Nordisk, Eli Lilly, Epitomee, Neurovalen and Pfizer to his university, consulting fees from Boehringer Ingelheim, Eli Lilly, Novo Nordisk, Pfizer, Fractyl Health, Alnylam Pharmaceuticals, Inogen, Zealand, Aluurion and Merck, payment or honoraria from Brown University, Auburn University, Wayne State University, the University of Illinois, Mount Sinai Hospital, the Cleveland Clinic, the University of Miami, the Georgia Endocrine Society and Auburn University for invited lectureships, participation in a data and safety monitoring board/advisory board for Boehringer Ingelheim and Eli Lilly, and membership of the Lancet Commission on Obesity. TM reports grants or contracts from Abbott, Dexcom, Insulet, Eli Lilly, Medtronic, Novo Nordisk, Sanofi and Tandem, payment or honoraria from Abbott and Dexcom, support for attending meetings or travel from Abbott, the ADA and the American College of Physicians (ACP) and participation in a data and safety monitoring board/advisory board for Eli Lilly. HJW reports grants or contracts from Abbott, Dexcom, the ADA and the Academy of Nutrition and Dietetics, consulting fees from Dexcom, payment or honoraria from Abbott, and support for attending meetings or travel from the ADA. JSG reports participation in a data and safety monitoring board/advisory board for Vanderbilt University. HK-S, DU, HW, GC-R, VLA and AC declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
: All authors affirm that authorship is merited based on the ICMJE authorship criteria. DE, HK-S, DU, HW, CJH, GC-R, VLA, WTG, AC and JSG contributed to the conception and/or design of the study. VLA, RMC, WTG and TM contributed to the acquisition of data. DU and HW conducted the statistical analysis. All authors contributed to the interpretation of data and results. HK-S and JSG acquired funding. HK-S, DU, VLA, WTG, HW and JSG contributed to the supervision and management of the research. DE, HK-S, DU, HW, WTG and JSG drafted the manuscript. All authors contributed to the critical review of the manuscript and approved the final version to be published. DE, DU and HW are the guarantors of this work, and as such had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
