Journal article Open Access
Camerlingo, Nunzio; Vettoretti, Martina; Sparacino, Giovanni; Facchinetti, Andrea; Mader, Julia K.; Choudhary, Pratik; Del Favero, Simone
Reliable estimation of the time spent in different glycaemic ranges (time-in-ranges) requires sufficiently long continuous glucose monitoring. In a 2019 paper (Battelino et al., Clinical targets for continuous glucose monitoring data interpretation: recommendations from the international consensus on time in range. Diabetes Care. 2019;42:1593-1603), an international panel of experts suggested using a correlation-based approach to obtain the minimum number of days for reliable time-in-ranges estimates. More recently (in Camerlingo et al., Design of clinical trials to assess diabetes treatment: minimum duration of continuous glucose monitoring data to estimate time-in-ranges with the desired precision. Diabetes Obes Metab. 2021;23:2446-2454) we presented a mathematical equation linking the number of monitoring days to the uncertainty around time-in-ranges estimates. In this work, we compare these two approaches, mainly focusing on time spent in (70-180) mg/dL range (TIR).
The first 100 and 150 days of data were extracted from study A (148 subjects, ~180 days), and the first 100, 150, 200, 250 and 300 days of data from study B (45 subjects, ~365 days). For each of these data windows, the minimum monitoring duration was computed using correlation-based and equation-based approaches. The suggestions were compared for the windows of different durations extracted from the same study, and for the windows of equal duration extracted from different studies.
When changing the dataset duration, the correlation-based approach produces inconsistent results, ranging from 23 to 64 days, for TIR. The equation-based approach was found to be robust versus this issue, as it is affected only by the characteristics of the population being monitored. Indeed, to grant a confidence interval of 5% around TIR, it suggests 18 days for windows from study A, and 17 days for windows from study B. Similar considerations hold for other time-in-ranges.
The equation-based approach offers advantages for the design of clinical trials having time-in-ranges as final end points, with focus on trial duration.
Diabetic Medicine - 2021 - Camerlingo - Choosing the duration of continuous glucose monitoring for reliable assessment of.pdf
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