Abstract
This US, multicenter, observational study assessed the CKD prevalence in adult patients with type-2 diabetes mellitus (T2DM) and characterized the proportion of detected and undiagnosed CKD in the primary care setting using the following: a clinician survey; a patient physical exam and medical history; a single blood draw for estimated glomerular filtration rate (eGFR) and glycosolated hemoglobin (HbA1c); urine dipstick for protein; urine albumin-creatinine ratio (ACR); two patient quality of life questionnaires; and a 15-month medical record review. The study consisted of 9339 adults with T2DM and 466 investigator sites. Of the 9339 enrolled, 9307 had complete data collection for analysis. The 15-month retrospective review showed urine protein, urine ACR, and eGFR testing were not performed in 51.4%, 52.9% and 15.2% of individuals, respectively. Of the 9307 patients, 5036 (54.1%) had Stage 1-5 CKD based on eGFR and albuminuria; however, only 607 (12.1%) of those patients were identified as having CKD by their clinicians. Clinicians were more successful in diagnosing patients with Stage 3-5 CKD than Stages 1 and 2. There were no differences in clinicians' likelihood of identification of CKD based on practice setting, number of years in practice, or self-reported patients seen per week. Awareness or patient self-reported CKD was 81.1% with practitioner detection versus 2.6% in the absence of diagnosis. Primary care of T2DM demonstrates recommended urine CKD testing is underutilized, and CKD is significantly under-diagnosed. This is the first study to show CKD detection is associated with awareness.
Publication types
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Multicenter Study
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Observational Study
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Research Support, Non-U.S. Gov't
MeSH terms
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Adolescent
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Adult
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Aged
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Albuminuria / urine*
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Awareness
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Creatinine / urine*
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Diabetes Mellitus, Type 2 / complications
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Diabetes Mellitus, Type 2 / diagnosis
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Diabetes Mellitus, Type 2 / physiopathology
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Diabetes Mellitus, Type 2 / urine*
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Female
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Glomerular Filtration Rate
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Glycated Hemoglobin / metabolism
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Health Knowledge, Attitudes, Practice
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Humans
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Male
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Middle Aged
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Primary Health Care / statistics & numerical data*
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Quality of Life
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Renal Insufficiency, Chronic / complications
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Renal Insufficiency, Chronic / diagnosis
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Renal Insufficiency, Chronic / physiopathology
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Renal Insufficiency, Chronic / urine*
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Retrospective Studies
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Severity of Illness Index
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Surveys and Questionnaires
Substances
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Glycated Hemoglobin A
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hemoglobin A1c protein, human
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Creatinine
Grants and funding
The ADD-CKD Study was financially sponsored by Boehringer Ingelheim Pharmaceuticals Inc. (
www.boehringer-ingelheim.com) and Eli Lilly & Co. (
www.lilly.com) The funders, Boehringer Ingelheim Pharmaceuticals Inc. (
www.boehringer-ingelheim.com) and Eli Lilly & Co. (
www.lilly.com), had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. The National Kidney Foundation was responsible for the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript. Richard J. Deloskey and Hsu-Lin Su are employed by Covance Inc. Covance Inc. provided support in the form of salaries for authors Richard J. Deloskey and Hsu-Lin Su, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section. Lynda A. Szczech is a nephrologist employed by Durham Nephrology Associates. Durham Nephrology Associates provided support in the form of salary for author Lynda A. Szczech, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript. The specific role of this author is articulated in the ‘author contributions’ section.