American Diabetes Association
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Does emotional distress predict worse glycemic control over time? Results from the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

posted on 2024-01-22, 20:14 authored by Andrea L Cherrington, Ionut Bebu, Heidi Krause-Steinrauf, Claire J. Hoogendoorn, Gladys Crespo-Ramos, Caroline Presley, Aanand D. Naik, Ashok Balasubramanyam, Michaela R Gramzinski, Tina Killean, Valerie L Arends, Jeffrey S. Gonzalez

Objectives To evaluate whether baseline levels of depressive symptoms and diabetes specific distress are associated with glycemic control in the GRADE study, a large randomized controlled trial comparing the metabolic effects of four common glucose-lowering medications when combined with metformin in individuals with type 2 diabetes.

Methods The primary and secondary outcomes were defined as an HbA1c value ≥7%, subsequently confirmed, and an HbA1c value ˃7.5%, subsequently confirmed, respectively. Separate Cox proportional hazards models assessed the association between baseline levels of each exposure of interest (depressive symptoms measured by Patient Health Questionnaire (PHQ-8) and diabetes distress measured by Diabetes Distress Scale) and the subsequent risk of metabolic outcome.

Results This substudy included 1,739 participants (56% Non-Hispanic White, 18% Non-Hispanic Black, 17% Hispanic, 68% male, mean [SD] age=58.0 [10.2] years, diabetes duration=4.2 [2.8] years, and HbA1c=7.5% [0.48]). A total of 1,157 participants reached the primary outcome, with time to event of 2.1 years on average, while 738 participants reached the secondary outcome at 3 years on average. Adjusting for sex, race/ethnicity, treatment group, and baseline age, duration of type 2 diabetes, body mass index, and HbA1c, there were no significant associations between the depressive symptoms or diabetes distress and the subsequent risk of the primary or secondary outcomes.

Conclusions The current findings suggest that, at least at for individuals with diabetes of relatively short duration, baseline levels of emotional distress are not associated with glycemic control over time.


The GRADE Study was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under Award Number U01DK098246. The planning of GRADE was supported by a U34 planning grant from the NIDDK (U34-DK-088043). The American Diabetes Association supported the initial planning meeting for the U34 proposal. The National Heart, Lung, and Blood Institute and the Centers for Disease Control and Prevention also provided funding support. The Department of Veterans Affairs provided resources and facilities. Additional support was provided by grant numbers P30 DK017047, P30 DK020541, P30 DK020572, P30 DK072476, P30 DK079626, P30 DK092926, U54 GM104940, UL1 TR000170, UL1 TR000439, UL1 TR000445, UL1 TR001102, UL1 TR001108, UL1 TR001409, 2UL1TR001425, UL1 TR001449, UL1 TR002243, UL1 TR002345, UL1 TR002378, UL1 TR002489, UL1 TR002529, UL1 TR002535, UL1 TR002537, UL1 TR002541 and UL1 TR002548. Educational materials have been provided by the National Diabetes Education Program. Material support in the form of donated medications and supplies has been provided by Becton, Dickinson and Company, Bristol-Myers Squibb, Merck & Co., Inc., Novo Nordisk, Roche Diagnostics, and Sanofi. The content of this manuscript is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The GRADE Study Research Group is deeply grateful to our participants whose loyal dedication made GRADE possible. The GRADE Emotional Distress Substudy was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health under Award Number R01 DK104845. Additional support was provided by grant number P30 DK111022.


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