Evidence map›Paper›PMID 38227900›Full record

Trial reportDiabetes care2024

Emotional Distress Predicts Reduced Type 2 Diabetes Treatment Adherence in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE).

Claire J Hoogendoorn, Heidi Krause-Steinrauf, Diane Uschner, Hui Wen, Caroline A Presley, Elizabeth A Legowski, Aanand D Naik, Sherita Hill Golden, Valerie L Arends, Janet Brown-Friday and 6 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes care, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01794143. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
6.8field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01794143 phase3completed

Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study

Ran2013Enrolled7,850Registered outcomes4Posted comparisons0ConditionsComparative Effectiveness of Glycemia-lowering Medications, Type 2 DiabetesArmsDPP-4 inhibitor (sitagliptin), GLP-1 receptor agonist (liraglutide), Insulin (glargine), Sulfonylurea (glimepiride)
Open the trial in the graph
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 19 citations in OpenAlex.

  1. Trial
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  14. Diabetes Educators: Understanding the Role of Finerenone in Chronic Kidney Disease Associated with Type 2 Diabetes Mellitus.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025
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  15. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 8 institutions in 1 country.

Claire J HoogendoornEndocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.ORCID 0000-0003-4526-1952
Heidi Krause-SteinraufBiostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.ORCID 0000-0001-6894-4110
Diane UschnerBiostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Hui WenBiostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Caroline A PresleyGeneral Internal and Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, Birmingham, AL.ORCID 0000-0001-6492-9941
Elizabeth A LegowskiBiostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Aanand D NaikCenter for Innovations in Quality, Effectiveness and Safety, Michael E. DeBakey VA Medical Center, Houston, TX.ORCID 0000-0001-6936-7984
Sherita Hill GoldenDepartment of Medicine, Johns Hopkins University School of Medicine, Baltimore, MD.ORCID 0000-0001-8854-4026
Valerie L ArendsAdvanced Research and Diagnostic Laboratory, Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.
Janet Brown-FridayEndocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.
Jonathan A KrakoffObesity and Diabetes Clinical Research Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, AZ.
Colleen E SurattBiostatistics Center, Department of Biostatistics and Bioinformatics, Milken Institute School of Public Health, The George Washington University, Rockville, MD.
Andrea H WaltjeUniversity of Michigan, Ann Arbor, MI.
Andrea L CherringtonGeneral Internal and Preventive Medicine, Department of Medicine, University of Alabama, Birmingham, Birmingham, AL.ORCID 0000-0002-8321-3567
Jeffrey S GonzalezEndocrinology, Department of Medicine, Albert Einstein College of Medicine, Bronx, NY.
GRADE Research Group
Albert Einstein College of Medicine · USUniversity of Alabama at Birmingham · USMilken Institute · USNational Institute of Diabetes and Digestive and Kidney Diseases · USUniversity of Minnesota · USUniversity of Michigan · USJohns Hopkins University · USMichael E. DeBakey VA Medical Center · US

Funding

Glycemia Reduction Approaches in Diabetes: A comparative effectiveness studyU01DK098246 · NIDDK · GEORGE WASHINGTON UNIVERSITY · PI KRAUSE-STEINRAUF, HEIDI, LACHIN, JOHN M · 2012 to 2022
$238.9M
Vanderbilt Institute for Clinical and Translational Research (VICTR) -Identifying correlates of functional immunity in SARS-CoV-2 convalescent plasmaUL1TR002243 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI Paul A. Harris, Wesley H Self · 2017 to 2026
$130.7M
WU INSTITUTE OF CLINICAL AND TRANSLATIONAL SCIENCESUL1TR002345 · NCATS · WASHINGTON UNIVERSITY · PI William G. Powderly · 2017 to 2026
$97.8M
Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI Peter Todd Katzmarzyk · 2012 to 2026
$69.1M
NIH Prior Approval Process ProfessionalUL1TR002535 · NCATS · UNIVERSITY OF COLORADO DENVER · PI SOKOL, RONALD J. · 2018 to 2022
$51.1M
Clinical and Translational Science Collaborative of ClevelandUL1TR000439 · NCATS · CASE WESTERN RESERVE UNIVERSITY · PI KONSTAN, MICHAEL W. · 2012 to 2016
$50.0M
Re-Entry Supplement: Investigation of Oral Microbial Enzymes for the Detection and Treatment of Periodontal DiseaseUL1TR002489 · NCATS · UNIV OF NORTH CAROLINA CHAPEL HILL · PI BUSE, JOHN BERNARD, SHAHEEN, NICHOLAS J · 2018 to 2022
$48.6M
Vector and Transgenic Mouse CoreP30DK017047 · NIDDK · UNIVERSITY OF WASHINGTON · PI Karin E Bornfeldt · 1986 to 2026
$41.4M
The Vanderbilt Institute for Clinical and Translational Research (VICTR)UL1TR000445 · NCATS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI BERNARD, GORDON RAPHAEL · 2012 to 2016
$41.4M
Maternal Morbidity and Mortality: Risk Factors, Early Detection and Personalized InterventionUL1TR001409 · NCATS · GEORGETOWN UNIVERSITY · PI GONDRE-LEWIS, MARJORIE C, MELLMAN, THOMAS A · 2015 to 2024
$37.8M
UNM HSC Clinical and Translational Science CenterUL1TR001449 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI CAMPEN, MATTHEW J, PANDHI, NANCY · 2015 to 2024
$36.9M
CDC HHSNCATS NIH HHS UL1 TR000439NCATS NIH HHS UL1 TR000445NCATS NIH HHS UL1 TR001108NCATS NIH HHS UL1 TR001409NCATS NIH HHS UL1 TR001449NCATS NIH HHS UL1 TR002243NCATS NIH HHS UL1 TR002345NCATS NIH HHS UL1 TR002378NCATS NIH HHS UL1 TR002489NCATS NIH HHS UL1 TR002529NCATS NIH HHS UL1 TR002535NCATS NIH HHS UL1 TR002537NCATS NIH HHS UL1 TR002548NCATS NIH HHS UM1 TR004528NHLBI NIH HHSNIDDK NIH HHS P30 DK017047NIDDK NIH HHS P30 DK020541NIDDK NIH HHS P30 DK020572NIDDK NIH HHS P30 DK072476NIDDK NIH HHS P30 DK079626NIDDK NIH HHS P30 DK092926NIDDK NIH HHS P30 DK111022NIDDK NIH HHS R01 DK104845NIDDK NIH HHS R01DK104845, U01DK098246, U34DK088043NIDDK NIH HHS U01 DK098246NIDDK NIH HHS U34 DK088043NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveWe examined longitudinal associations between emotional distress (specifically, depressive symptoms and diabetes distress) and medication adherence in Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE), a large randomized controlled trial comparing four glucose-lowering medications added to metformin in adults with relatively recent-onset type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND

methodsThe Emotional Distress Substudy assessed medication adherence, depressive symptoms, and diabetes distress in 1,739 GRADE participants via self-completed questionnaires administered biannually up to 3 years. We examined baseline depressive symptoms and diabetes distress as predictors of medication adherence over 36 months. Bidirectional visit-to-visit relationships were also examined. Treatment satisfaction, beliefs about medication, diabetes care self-efficacy, and perceived control over diabetes were evaluated as mediators of longitudinal associations.

resultsAt baseline, mean ± SD age of participants (56% of whom were White, 17% Hispanic/Latino, 18% Black, and 66% male) was 58.0 ± 10.2 years, diabetes duration 4.2 ± 2.8 years, HbA1c 7.5% ± 0.5%, and medication adherence 89.9% ± 11.1%. Higher baseline depressive symptoms and diabetes distress were independently associated with lower adherence over 36 months (P < 0.001). Higher depressive symptoms and diabetes distress at one visit predicted lower adherence at the subsequent 6-month visit (P < 0.0001) but not vice versa. Treatment assignment did not moderate relationships. Patient-reported concerns about diabetes medications mediated the largest percentage (11.9%-15.5%) of the longitudinal link between emotional distress and adherence.

conclusionsDepressive symptoms and diabetes distress both predict lower adherence to glucose-lowering medications over time among adults with T2DM. Addressing emotional distress and concerns about anticipated negative effects of taking these treatments may be important to support diabetes treatment adherence.

Indexed as

Diabetes Mellitus, Type 2MetforminPsychological DistressAdultAgedComparative Effectiveness ResearchFemaleGlucoseHumansMaleMedication AdherenceMiddle AgedGlucoseMetformin

Identifiers

PMID38227900
PMCPMC10973907
OpenAlexW4390902342

What Socratic holds

Texttitle and abstract
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.