Sachiko Ohde1, Gautam A Deshpande2, Hiroshi Yokomichi3, Osamu Takahashi4, Tsuguya Fukui5, Zentaro Yamagata6. 1. Graduate School of Public Health, St. Luke's International University, Japan; Department of Health Science, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Japan. Electronic address: saohde@luke.ac.jp. 2. Graduate School of Public Health, St. Luke's International University, Japan; Department of Internal Medicine, University of Hawaii, United States. Electronic address: gdesh@luke.ac.jp. 3. Department of Health Science, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Japan. Electronic address: hyokomichi@yamanashi.ac.jp. 4. Graduate School of Public Health, St. Luke's International University, Japan; Department of General Internal Medicine, St. Luke's International Hospital, Japan. Electronic address: otakahas@luke.ac.jp. 5. St. Luke's International University, Japan. Electronic address: fkts@luke.ac.jp. 6. Department of Health Science, Basic Science for Clinical Medicine, Division of Medicine, Graduate School Department of Interdisciplinary Research, University of Yamanashi, Japan. Electronic address: zenymgt@yamanashi.ac.jp.
Abstract
[Aims] This study aims to suggest an informative interval for HbA1c in DM patients with stable glycemic control, based on test characteristics of the HbA1C assay using the signal-to-noise ratio method. [Methods] This was a retrospective, open cohort study. Data were collected between January 2005 to December 2014 at a tertiary-level community hospital in Japan. All adult patients aged under 75 years, with stable glycemic control on a first pharmaceutical regimen for Type II diabetes, and at least two HbA1c measurements after they achieved glycemic stability, were included in the analysis. We defined stable glycemic control as HbA1c <7.0% (52 mmol/mol) and requiring no change in the medication regimen after three consecutive measurements. We adapted a signal-to-noise method for distinguishing true change from measurement error by constructing a linear random effects model to calculate signal and noise for HbA1c. The screening interval for HbA1c was defined as informative when the signal-to-noise ratio exceeded 1. [Results] Among 1066 adults with diabetes, 639 patients (18.5%) were identified as achieving stable glycemic control (511 male (67.3%)), with a mean HbA1c (SD) of 6.4 (0.4)% (46 mmol/mol). Patients with stable glycemic control increase their HbA1c 0.27% (3 mmol/mol) every year while HbA1c has 0.32% (3.5 mmol/mol) noise, as testing characteristics. Signal exceeds noise after 1.2 years (95%CI: 0.9-1.6). [Conclusion] Once patients achieve stable glycemic control at their HbA1c goal, an informative interval for HbA1c monitoring is once every year. Current guidelines, which suggest testing every six months, may contribute to substantial over-testing.
[Aims] This study aims to suggest an informative interval for HbA1c in DMpatients with stable glycemic control, based on test characteristics of the HbA1C assay using the signal-to-noise ratio method. [Methods] This was a retrospective, open cohort study. Data were collected between January 2005 to December 2014 at a tertiary-level community hospital in Japan. All adult patients aged under 75 years, with stable glycemic control on a first pharmaceutical regimen for Type II diabetes, and at least two HbA1c measurements after they achieved glycemic stability, were included in the analysis. We defined stable glycemic control as HbA1c <7.0% (52 mmol/mol) and requiring no change in the medication regimen after three consecutive measurements. We adapted a signal-to-noise method for distinguishing true change from measurement error by constructing a linear random effects model to calculate signal and noise for HbA1c. The screening interval for HbA1c was defined as informative when the signal-to-noise ratio exceeded 1. [Results] Among 1066 adults with diabetes, 639 patients (18.5%) were identified as achieving stable glycemic control (511 male (67.3%)), with a mean HbA1c (SD) of 6.4 (0.4)% (46 mmol/mol). Patients with stable glycemic control increase their HbA1c 0.27% (3 mmol/mol) every year while HbA1c has 0.32% (3.5 mmol/mol) noise, as testing characteristics. Signal exceeds noise after 1.2 years (95%CI: 0.9-1.6). [Conclusion] Once patients achieve stable glycemic control at their HbA1c goal, an informative interval for HbA1c monitoring is once every year. Current guidelines, which suggest testing every six months, may contribute to substantial over-testing.