Lack of Association of Emotional Distress With Insulin Initiation in the GRADE Randomized Diabetes Comparative Effectiveness Trial

Caroline A. Presley, Department of Medicine (General Internal Medicine and Population Science), University of Alabama at Birmingham, Birmingham, Alabama.
Nicole M. Butera, The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, Maryland.
Heidi Krause-Steinrauf, The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, Maryland.
Cyrus V. Desouza, Division of Diabetes, Endocrinology and Metabolism, University of Nebraska and Omaha VA Medical Center, Omaha, Nebraska.
Priscilla A. Hollander, Baylor Scott & White Research Institute, Dallas, Texas.
Claire J. Hoogendoorn, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, New York.
Violet S. Lagari, Miami VA Healthcare System/University of Miami, Miami, Florida.
Elizabeth A. Legowski, The Biostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, Maryland.
Catherine L. Martin, Division of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.
Neda Rasouli, Division of Endocrinology, Metabolism and Diabetes, Department of Medicine, University of Colorado School of Medicine, and VA Eastern Colorado Health Care System, Aurora, Colorado.
Jeffrey S. Gonzalez, Ferkauf Graduate School of Psychology, Yeshiva University, Bronx, New York.
Andrea L. Cherrington, Department of Medicine (General Internal Medicine and Population Science), University of Alabama at Birmingham, Birmingham, Alabama.

Document Type

Journal Article

Publication Date

8-1-2025

Journal

The science of diabetes self-management and care

Volume

51

Issue

4

DOI

10.1177/26350106251361363

Abstract

PurposeThe purpose of this study is to evaluate whether higher emotional distress (depressive symptoms or diabetes distress) was associated with a lower likelihood of basal or rapid-acting insulin initiation among participants enrolled in the GRADE Emotional Distress Substudy (EDS).MethodsIndividuals with type 2 diabetes <10 years duration on metformin alone were randomized to add 1 of 4 glucose-lowering drugs. Per protocol, participants were expected to start basal or rapid-acting insulin rescue therapy after reaching secondary or tertiary glycemic outcomes (A1C >7.5%). Depressive symptoms and diabetes distress were assessed ≤12 months prior to outcome confirmation. Multinomial and binomial logistic regression models examined associations of depressive symptoms and diabetes distress with basal insulin initiation and rapid-acting insulin initiation, respectively.ResultsOf the 525 participants expected to start basal insulin, 30.9% initiated ≤6 weeks, 35.2% initiated >6 weeks, and 33.9% never initiated. Of the 325 participants expected to start rapid-acting insulin, 67.4% never initiated. Neither depressive symptoms nor diabetes distress were associated with starting basal or rapid-acting insulin.ConclusionsIn the GRADE EDS, approximately one-third of participants did not start basal insulin, and two-thirds of participants did not start rapid-acting insulin. Emotional distress did not appear to play a role in insulin initiation among trial participants.

Department

Biostatistics and Bioinformatics

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