18Aug 2021
Design of clinical trials to assess diabetes treatment: Minimum duration of continuous glucose monitoring data to estimate time‐in‐ranges with the desired precision

Design of clinical trials to assess diabetes treatment: Minimum duration of continuous glucose monitoring data to estimate time‐in‐ranges with the desired precision

To compute the uncertainty of time‐in‐ranges, such as time in range (TIR), time in tight range (TITR), time below range (TBR) and time above range (TAR), to evaluate glucose control and to determine the minimum duration of a trial to achieve the desired precision. Four formulas for the aforementioned time‐in‐ranges were obtained by estimating the equation's parameters on a training set extracted from study A (226 subjects, ~180 days, 5‐minute Dexcom G4 Platinum sensor). The formulas were then validated on the remaining data. We also illustrate how to adjust the parameters for sensors with different sampling rates. Finally, we used study B (45 subjects, ~365 days, 15‐minute Abbott Freestyle Libre sensor) to further validate our results...

  • #endo-diabetology

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