Primary care detection of chronic kidney disease in adults with type-2 diabetes: the ADD-CKD Study (awareness, detection and drug therapy in type 2 diabetes and chronic kidney disease)

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.

Conflict of interest statement

Competing Interests: The study was financially sponsored by Boehringer Ingelheim Pharmaceuticals Inc. and Eli Lilly and Co., but 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. Compensation at Covance is not dependent on the results of the study presented in the manuscript. Lynda A. Szczech is a nephrologist employed by Durham Nephrology Associates. Her compensation is not dependent on the results of the study presented in the manuscript. These interests do not alter the authors' adherence to all PLOS ONE policies on sharing data and materials.

Figures

Figure 1. Recruitment Flow Diagram.

Figure 2. Percent of Patients with CKD.

Figure 3. Proportion of Patients with CKD Detected by CKD Stage Prior to Study Visit Compared to Proportion of Patient-reported CKD Awareness.