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

Sci Diabetes Self Manag Care. 2025 Aug 1:26350106251361363. doi: 10.1177/26350106251361363. Online ahead of print.

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.

PMID:40751289 | DOI:10.1177/26350106251361363