Determination of Time in Range Associated With HbA1c ≤7% in a Prospective Cohort of Patients With Type 1 Diabetes Using CGM for Three Months.

ABSTRACT

INTRODUCTION: Finding a goal of time in range (%TIR) that defines good glycemic control is necessary. Previous retrospective studies suggest good concordance between HbA1c ≤7% with a TIR >70%; however, the studies that included the largest number of patients used blood glucose measurement data with a follow-up time of less than 90 days. This study defined the TIR value that best discriminates HbA1c ≤7%. METHODS: We performed a prospective study of diagnostic tests based on a cohort of patients with type 1 diabetes (T1D) treated with a hybrid closed loop (HCL) followed for three months. The ability of %TIR to distinguish patients with HbA1c ≤7% was evaluated through receiver operating characteristic curve analysis. We determined the %TIR cutoff point with the best operating characteristics. RESULTS: A total of 118 patients were included (58.1% women, 47% overweight or obese, and 33% with high glycemic variability). A moderate negative correlation (R = -.54, P < .001) was found between %TIR and HBA1c. The discrimination ability was moderate, with an area under the curve of 0.7485 (95% confidence interval = 0.6608-0.8363). The cutoff point that best predicted HbA1c ≤7% was %TIR ≥75.5 (sensitivity 70%, specificity 67%). The findings were similar among those with a coefficient of variation (CV%) ≥36%. CONCLUSIONS: Our data suggest that the %TIR adequately identifies patients with HbA1c ≤7%. A target of TIR ≥75%, rather than the currently recommended TIR ≥70%, may be a more suitable value for optimal glycemic control.