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

Abstract

Purpose

The 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).

Methods

Individuals 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.

Results

Of 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.

Conclusions

In 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.