Differential Effects of Type 2 Diabetes Treatment Regimens on Diabetes Distress and Depressive Symptoms in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): A Randomized Clinical Trial

Jeffrey S. Gonzalez, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY.
Ionut Bebu, The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Heidi Krause-Steinrauf, The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Claire J. Hoogendoorn, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY.
Gladys Crespo-Ramos, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, NY.
Caroline Presley, Division of Preventive Medicine, University of Alabama at Birmingham, Birmingham, AL.
Aanand D. Naik, School of Public Health, University of Texas Health Science Center, Houston, TX.
Shihchen Kuo, Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI.
Mary L. Johnson, International Diabetes Center, Minneapolis, MN.
Deborah Wexler, Diabetes Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, MA.
Jill P. Crandall, Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.
Anne E. Bantle, Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, University of Minnesota, Minneapolis, MN.
Valerie Arends, Advanced Research and Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.
Andrea L. Cherrington, Department of Medicine (General Internal and Preventive Medicine), University of Alabama at Birmingham, Birmingham, AL.

Document Type

Journal Article

Publication Date

2-28-2024

Journal

Diabetes care

DOI

10.2337/dc23-2459

Abstract

OBJECTIVE: We evaluated whether adding basal insulin to metformin in adults with early type 2 diabetes mellitus (T2DM) would increase emotional distress relative to other treatments. RESEARCH DESIGN AND METHODS: The Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE) of adults with T2DM of <10 years' duration, HbA1c 6.8-8.5%, and taking metformin monotherapy randomly assigned participants to add insulin glargine U-100, sulfonylurea glimepiride, the glucagon-like peptide-1 receptor agonist liraglutide, or the dipeptidyl peptidase 4 inhibitor sitagliptin. The Emotional Distress Substudy enrolled 1,739 GRADE participants (mean [SD] age 58.0 [10.2] years, 32% female, 56% non-Hispanic White, 18% non-Hispanic Black, 17% Hispanic) and assessed diabetes distress and depressive symptoms every 6 months. Analyses examined differences at 1 year and over the 3-year follow-up. RESULTS: Across treatments, diabetes distress (-0.24, P < 0.0001) and depressive symptoms (-0.67, P < 0.0001) decreased over 1 year. Diabetes distress was lower at 1 year for the glargine group than for the other groups combined (-0.10, P = 0.002). Diabetes distress was also lower for liraglutide than for glimepiride or sitagliptin (-0.10, P = 0.008). Over the 3-year follow-up, there were no significant group differences in total diabetes distress; interpersonal diabetes distress remained lower for those assigned to liraglutide. No significant differences were observed for depressive symptoms. CONCLUSIONS: Contrary to expectations, this randomized trial found no evidence for a deleterious effect of basal insulin on emotional distress. Glargine lowered diabetes distress modestly at 1 year rather than increasing it. Liraglutide also reduced diabetes distress at 1 year. Results can inform treatment decisions for adults with early T2DM.

Department

Biostatistics and Bioinformatics

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