Aim: The present study is the first to investigate association between Diabetic Kidney Disease (DKD) and Visit-to-Visit Variability (VVV) of HbA1c, blood pressure (BP), and body mass index (BMI) in patients with T2DM whose HbA1c, BP, and BMI were measured ≥12 times during a 2-year period.

Material and Methods: This retrospective clinical trial initially analyzed data on 104,601 persons with T2DM in 38 clinical centers. We included 20- to 75-year-old patients whose HbA1c, systolic BP (SBP), and BMI were measured ≥12 times during a 2-year period. VVV was calculated using the coefficient of variation. VVVs of HbA1c, SBP, and BMI respectively, were divided into two groups by median value (high or low VVV). Risk of DKD were analyzed by multivariate logistic regression analysis. DKD was defined as urine albumin-to-creatinine ratio ≥30mg/g Cr or eGFR <60 mL/min/1.73 m2.

Results: A total of 12,575 patients who met the inclusion criteria were finally analyzed. Adjusted odds ratios (ORs) for high risk of DKD were 1.33 (95% CI 1.22-1.46, p < 0.001) for high VVV of HbA1c, 1.18 (1.08-1.28, p < 0.001) for high VVV of SBP, and 1.19 (1.10-1.30, p < 0.001) for high VVV of BMI. Male sex 1.29 (1.12-1.34, p < 0.001), advanced age, longer diabetes duration, presence of hypertension 1.19 (1.03-1.38, p = 0.02), anti-hypertensive agent use 1.40 (1.22-1.61, p < 0.001), presence of dyslipidemia 1.24 (1.11-1.39, p < 0.001), higher 2-year mean HbA1c, higher 2-year mean SBP, and higher 2-year mean BMI were also related to high risk of DKD. Additionally, the analysis of antidiabetic drug use revealed that particularly use of insulin 1.50 (1.34-1.68, p < 0.001) and sulfonylurea use 1.24 (1.13-1.37, p < 0.001) were associated with high risk of DKD.

Conclusion: High VVV of HbA1c, SBP, and BMI were associated with DKD independently of mean HbA1c, SBP, and BMI values.


D. Matsutani: None. S. Minato: None. Y. Tsujimoto: None. H. Maegawa: Speaker’s Bureau; Self; Astellas Pharma Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Merck Sharp & Dohme Corp., Mitsubishi Tanabe Pharma Corporation, Sanofi K.K., Takeda Pharmaceutical Company Limited. M. Sakamoto: None.

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