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

Authors

• 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.

APA Citation

Presley, Caroline A.; Butera, Nicole M.; Krause-Steinrauf, Heidi; Desouza, Cyrus V.; Hollander, Priscilla A.; Hoogendoorn, Claire J.; Lagari, Violet S.; Legowski, Elizabeth A.; Martin, Catherine L.; Rasouli, Neda; Gonzalez, Jeffrey S.; and Cherrington, Andrea L., "Lack of Association of Emotional Distress With Insulin Initiation in the GRADE Randomized Diabetes Comparative Effectiveness Trial" (2025). GW Authored Works. Paper 7840.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/7840

Department

Biostatistics and Bioinformatics