PMID- 38227900 OWN - NLM STAT- MEDLINE DCOM- 20240327 LR - 20240420 IS - 1935-5548 (Electronic) IS - 0149-5992 (Print) IS - 0149-5992 (Linking) VI - 47 IP - 4 DP - 2024 Apr 1 TI - Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE). PG - 629-637 LID - 10.2337/dc23-1401 [doi] AB - OBJECTIVE: We examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: The Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations. RESULTS: At baseline, mean +/- SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 +/- 10.2 years, diabetes duration 4.2 +/- 2.8 years, HbA1c 7.5% +/- 0.5%, and medication adherence 89.9% +/- 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%-15.5%) of the longitudinal link between emotional distress and adherence. CONCLUSIONS: Depressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence. CI - (c) 2024 by the American Diabetes Association. FAU - Hoogendoorn, Claire J AU - Hoogendoorn CJ AUID- ORCID: 0000-0003-4526-1952 AD - Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY. AD - Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY. FAU - Krause-Steinrauf, Heidi AU - Krause-Steinrauf H AUID- ORCID: 0000-0001-6894-4110 AD - Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. FAU - Uschner, Diane AU - Uschner D AD - Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. FAU - Wen, Hui AU - Wen H AD - Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. FAU - Presley, Caroline A AU - Presley CA AUID- ORCID: 0000-0001-6492-9941 AD - General Internal and Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, Birmingham, AL. FAU - Legowski, Elizabeth A AU - Legowski EA AD - Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. FAU - Naik, Aanand D AU - Naik AD AUID- ORCID: 0000-0001-6936-7984 AD - Center for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX. AD - University of Texas Health Science Center (UTHealth) School of Public Health, Houston, TX. AD - Consortium on Aging, University of Texas Health Science Center (UTHealth), Houston, TX. FAU - Golden, Sherita Hill AU - Golden SH AUID- ORCID: 0000-0001-8854-4026 AD - Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD. FAU - Arends, Valerie L AU - Arends VL AD - Advanced Research and Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN. FAU - Brown-Friday, Janet AU - Brown-Friday J AD - Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY. FAU - Krakoff, Jonathan A AU - Krakoff JA AD - Obesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ. FAU - Suratt, Colleen E AU - Suratt CE AD - Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD. FAU - Waltje, Andrea H AU - Waltje AH AD - University of Michigan, Ann Arbor, MI. FAU - Cherrington, Andrea L AU - Cherrington AL AUID- ORCID: 0000-0002-8321-3567 AD - General Internal and Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, Birmingham, AL. FAU - Gonzalez, Jeffrey S AU - Gonzalez JS AD - Endocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY. AD - Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY. AD - Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, NY. AD - New York-Regional Center for Diabetes Translation Research, Albert Einstein College of Medicine, Bronx, NY. CN - GRADE Research Group LA - eng GR - UL1 TR000445/TR/NCATS NIH HHS/United States GR - HL/NHLBI NIH HHS/United States GR - UL1 TR002529/TR/NCATS NIH HHS/United States GR - P30 DK111022/DK/NIDDK NIH HHS/United States GR - UL1 TR000439/TR/NCATS NIH HHS/United States GR - P30 DK020541/DK/NIDDK NIH HHS/United States GR - UL1 TR002378/TR/NCATS NIH HHS/United States GR - UM1 TR004528/TR/NCATS NIH HHS/United States GR - P30 DK020572/DK/NIDDK NIH HHS/United States GR - UL1 TR002345/TR/NCATS NIH HHS/United States GR - UL1 TR002548/TR/NCATS NIH HHS/United States GR - U34 DK088043/DK/NIDDK NIH HHS/United States GR - R01 DK104845/DK/NIDDK NIH HHS/United States GR - UL1 TR002537/TR/NCATS NIH HHS/United States GR - P30 DK092926/DK/NIDDK NIH HHS/United States GR - UL1 TR002535/TR/NCATS NIH HHS/United States GR - P30 DK072476/DK/NIDDK NIH HHS/United States GR - P30 DK079626/DK/NIDDK NIH HHS/United States GR - UL1 TR001409/TR/NCATS NIH HHS/United States GR - U01 DK098246/DK/NIDDK NIH HHS/United States GR - UL1 TR001449/TR/NCATS NIH HHS/United States GR - UL1 TR002489/TR/NCATS NIH HHS/United States GR - U54 GM104940/GM/NIGMS NIH HHS/United States GR - UL1 TR001108/TR/NCATS NIH HHS/United States GR - UL1 TR002243/TR/NCATS NIH HHS/United States GR - R01DK104845, U01DK098246, U34DK088043/DK/NIDDK NIH HHS/United States GR - P30 DK017047/DK/NIDDK NIH HHS/United States GR - CC/CDC HHS/United States PT - Journal Article PT - Randomized Controlled Trial PL - United States TA - Diabetes Care JT - Diabetes care JID - 7805975 RN - IY9XDZ35W2 (Glucose) RN - 9100L32L2N (Metformin) SB - IM MH - Adult MH - Aged MH - Female MH - Humans MH - Male MH - Middle Aged MH - *Diabetes Mellitus, Type 2/complications MH - Glucose/therapeutic use MH - Medication Adherence/psychology MH - *Metformin/therapeutic use MH - *Psychological Distress MH - Comparative Effectiveness Research PMC - PMC10973907 COIS- Duality of Interest. C.J.H. reports grants from the National Institutes of Health and JDRF outside the submitted work. C.A.P. reports a grant from the National Center for Complementary and Integrative Health and a contract with American Diabetes Association outside the submitted work. A.D.N. reports funding from the Department of Veterans Affairs Center for Innovations in Quality, Effectiveness and Safety outside the submitted work. S.H.G. served on the National Board of Directors at the American Diabetes Association. J.B.-F. reports travel for board-related meetings paid for by the American Diabetes Association and was a board member for the American Diabetes Association outside the submitted work. S.H.G. reports consulting fees from Abbott Diabetes outside the submitted work. J.B.-F. reports payment from Harvard Medical School for a presentation outside the submitted work. J.S.G. reports payment from Worldwide Initiative for Diabetes Education for a virtual presentation, support from the American Diabetes Association Professional Conference Planning Committee in 2022 and 2023 for attending meetings, and consulting fees from Virta Health outside the submitted work. J.S.G. also participated on a data safety monitoring board for Lindsay Mayberry served as a principal investigator at Vanderbilt University (no payment was received for this), and served as planning committee chair for behavioral medicine at the American Diabetes Association outside the submitted work. No other potential conflicts of interest relevant to this article were reported. 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Triplitt, C IR - Triplitt C FIR - Juarez, D IR - Juarez D FIR - Mullen, M IR - Mullen M FIR - Garza, R I IR - Garza RI FIR - Verastiqui, H IR - Verastiqui H FIR - Wright, K IR - Wright K FIR - Puckett, C IR - Puckett C FIR - Raskin, P IR - Raskin P FIR - Rhee, C IR - Rhee C FIR - Abraham, S IR - Abraham S FIR - Jordan, L F IR - Jordan LF FIR - Sao, S IR - Sao S FIR - Morton, L IR - Morton L FIR - Smith, O IR - Smith O FIR - Osornio Walker, L IR - Osornio Walker L FIR - Schnurr-Breen, L IR - Schnurr-Breen L FIR - Ayala, R IR - Ayala R FIR - Kreymer, R B IR - Kreymer RB FIR - Sturgess, D IR - Sturgess D FIR - Utzschneider, K M IR - Utzschneider KM FIR - Kahn, S E IR - Kahn SE FIR - Alarcon-Casas Wright, L IR - Alarcon-Casas Wright L FIR - Boyko, E J IR - Boyko EJ FIR - Tsai, E C IR - Tsai EC FIR - Trence, D L IR - Trence DL FIR - Trikudanathan, S IR - Trikudanathan S FIR - Fattaleh, B N IR - Fattaleh BN FIR - Montgomery, B K IR - Montgomery BK FIR - Atkinson, K M IR - Atkinson KM FIR - Kozedub, A IR - Kozedub A FIR - Concepcion, T IR - Concepcion T FIR - Moak, C IR - Moak C FIR - Prikhodko, N IR - Prikhodko N FIR - Rhothisen, S IR - Rhothisen S FIR - Elasy, T A IR - Elasy TA FIR - Martin, S IR - Martin S FIR - Shackelford, L IR - Shackelford L FIR - Goidel, R IR - Goidel R FIR - Hinkle, N IR - Hinkle N FIR - Lovell, C IR - Lovell C FIR - Myers, J IR - Myers J FIR - Lipps Hogan, J IR - Lipps Hogan J FIR - McGill, J B IR - McGill JB FIR - Salam, M IR - Salam M FIR - Schweiger, T IR - Schweiger T FIR - Kissel, S IR - Kissel S FIR - Recklein, C IR - Recklein C FIR - Clifton, M J IR - Clifton MJ FIR - Tamborlane, W IR - Tamborlane W FIR - Camp, A IR - Camp A FIR - Gulanski, B IR - Gulanski B FIR - Inzucchi, S E IR - Inzucchi SE FIR - Pham, K IR - Pham K FIR - Alguard, M IR - Alguard M FIR - Gatcomb, P IR - Gatcomb P FIR - Lessard, K IR - Lessard K FIR - Perez, M IR - Perez M FIR - Iannone, L IR - Iannone L FIR - Magenheimer, E IR - Magenheimer E FIR - Montosa, A IR - Montosa A FIR - Fradkin, J IR - Fradkin J FIR - Burch, H B IR - Burch HB FIR - Bremer, A A IR - Bremer AA FIR - Nathan, D M IR - Nathan DM FIR - Lachin, J M IR - Lachin JM FIR - Krause-Steinrauf, H IR - Krause-Steinrauf H FIR - Younes, N IR - Younes N FIR - Bebu, I IR - Bebu I FIR - Butera, N IR - Butera N FIR - Buys, C J IR - Buys CJ FIR - Fagan, A IR - Fagan A FIR - Gao, Y IR - Gao Y FIR - Ghosh, A IR - Ghosh A FIR - Gramzinski, M R IR - Gramzinski MR FIR - Hall, S D IR - Hall SD FIR - Kazemi, E IR - Kazemi E FIR - Legowski, E IR - Legowski E FIR - Liu, H IR - Liu H FIR - Suratt, C IR - Suratt C FIR - Tripputi, M IR - Tripputi M FIR - Arey, A IR - Arey A FIR - Backman, M IR - Backman M FIR - Bethepu, J IR - Bethepu J FIR - Lund, C IR - Lund C FIR - Mangat Dhaliwal, P IR - Mangat Dhaliwal P FIR - McGee, P IR - McGee P FIR - Mesimer, E IR - Mesimer E FIR - Ngo, L IR - Ngo L FIR - Steffes, M IR - Steffes M FIR - Seegmiller, J IR - Seegmiller J FIR - Saenger, A IR - Saenger A FIR - Arends, V IR - Arends V FIR - Gabrielson, D IR - Gabrielson D FIR - Conner, T IR - Conner T FIR - Warren, S IR - Warren S FIR - Day, J IR - Day J FIR - Huminik, J IR - Huminik J FIR - Scrymgeour, A IR - Scrymgeour A FIR - Soliman, E Z IR - Soliman EZ FIR - Pokharel, Y IR - Pokharel Y FIR - Zhang, Z M IR - Zhang ZM FIR - Campbell, C IR - Campbell C FIR - Hu, J IR - Hu J FIR - Keasler, L IR - Keasler L FIR - Hensley, S IR - Hensley S FIR - Li, Y IR - Li Y FIR - Mihalcea, R IR - Mihalcea R FIR - Min, D J IR - Min DJ FIR - Perez-Rosas, V IR - Perez-Rosas V FIR - Prosser, L IR - Prosser L FIR - Resnicow, L IR - Resnicow L FIR - Ye, W IR - Ye W FIR - Shao, H IR - Shao H FIR - Zhang, P IR - Zhang P FIR - Luchsinger, J IR - Luchsinger J FIR - Sanchez, D IR - Sanchez D FIR - Assuras, S IR - Assuras S FIR - Groessl, E IR - Groessl E FIR - Sakha, F IR - Sakha F FIR - Chong, H IR - Chong H FIR - Hillery, N IR - Hillery N FIR - Abdouch, I IR - Abdouch I FIR - Bahtiyar, G IR - Bahtiyar G FIR - Brantley, P IR - Brantley P FIR - Broyles, F E IR - Broyles FE FIR - Canaris, G IR - Canaris G FIR - Copeland, P IR - Copeland P FIR - Craine, J J IR - Craine JJ FIR - Fein, W L IR - Fein WL FIR - Gliwa, A IR - Gliwa A FIR - Hope, L IR - Hope L FIR - Lee, M S IR - Lee MS FIR - Meiners, R IR - Meiners R FIR - Meiners, V IR - Meiners V FIR - O'Neal, H IR - O'Neal H FIR - Park, J E IR - Park JE FIR - Sacerdote, A IR - Sacerdote A FIR - Sledge, E IR - Sledge E FIR - Soni, L IR - Soni L FIR - Steppel-Reznik, J IR - Steppel-Reznik J FIR - Turchin, A IR - Turchin A FIR - Golden, S IR - Golden S FIR - Gonzalez, J IR - Gonzalez J FIR - Naik, A IR - Naik A FIR - Walker, E IR - Walker E EDAT- 2024/01/16 18:41 MHDA- 2024/03/27 06:43 PMCR- 2025/04/01 CRDT- 2024/01/16 16:03 PHST- 2023/07/28 00:00 [received] PHST- 2023/10/18 00:00 [accepted] PHST- 2025/04/01 00:00 [pmc-release] PHST- 2024/03/27 06:43 [medline] PHST- 2024/01/16 18:41 [pubmed] PHST- 2024/01/16 16:03 [entrez] AID - 154121 [pii] AID - 231401 [pii] AID - 10.2337/dc23-1401 [doi] PST - ppublish SO - Diabetes Care. 2024 Apr 1;47(4):629-637. doi: 10.2337/dc23-1401.