TY - CHAP
T1 - A Mathematical Formula to Determine the Minimum Continuous Glucose Monitoring Duration to Assess Time-in-ranges
T2 - 43rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC 2021
AU - Camerlingo, N.
AU - Vettoretti, M.
AU - Sparacino, G.
AU - Facchinetti, A.
AU - Mader, J. K.
AU - Choudhary, P.
AU - Del Favero, S.
N1 - Funding Information:
This study is part of the Hypo-RESOLVE project. The project has received funding from the Innovative Medicines Initiative 2 (https://www.imi.europa.eu/) Joint Undertaking (JU) under grant agreement No 777460. The JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA and T1D Exchange, JDRF, International Diabetes Federation (IDF), The Leona M. and Harry B. Helmsley Charitable Trust.
Publisher Copyright:
© 2021 IEEE.
PY - 2021
Y1 - 2021
N2 - In diabetes management, the fraction of time spent with glucose concentration within the physiological range of [70-180] mg/dL, namely time in range (TIR) is often computed by clinicians to assess glycemic control using a continuous glucose monitoring sensor. However, a sufficiently long monitoring period is required to reliably estimate this index. A mathematical equation derived by our group provides the minimum trial duration granting a desired uncertainty around the estimated TIR. The equation involves two parameters, p r and α, related to the population under analysis, which should be set based on the clinician's experience. In this work, we evaluated the sensitivity of the formula to the parameters.Considering two independent datasets, we predicted the uncertainty of TIR estimate for a population, using the parameters of the formula estimated for a different population. We also stressed the robustness of the formula by testing wider ranges of parameters, thus assessing the impact of large errors in the parameters' estimates.Plausible errors on the α estimate impact very slightly on the prediction (relative discrepancy < 5%), thus we suggest using a fixed value for α independently on the population being analyzed. Instead, p r should be adjusted to the TIR expected in the population, considering that errors around 20% result in a relative discrepancy of ~10%.In conclusion, the proposed formula is sufficiently robust to parameters setting and can be used by investigators to determine a suitable duration of the study.
AB - In diabetes management, the fraction of time spent with glucose concentration within the physiological range of [70-180] mg/dL, namely time in range (TIR) is often computed by clinicians to assess glycemic control using a continuous glucose monitoring sensor. However, a sufficiently long monitoring period is required to reliably estimate this index. A mathematical equation derived by our group provides the minimum trial duration granting a desired uncertainty around the estimated TIR. The equation involves two parameters, p r and α, related to the population under analysis, which should be set based on the clinician's experience. In this work, we evaluated the sensitivity of the formula to the parameters.Considering two independent datasets, we predicted the uncertainty of TIR estimate for a population, using the parameters of the formula estimated for a different population. We also stressed the robustness of the formula by testing wider ranges of parameters, thus assessing the impact of large errors in the parameters' estimates.Plausible errors on the α estimate impact very slightly on the prediction (relative discrepancy < 5%), thus we suggest using a fixed value for α independently on the population being analyzed. Instead, p r should be adjusted to the TIR expected in the population, considering that errors around 20% result in a relative discrepancy of ~10%.In conclusion, the proposed formula is sufficiently robust to parameters setting and can be used by investigators to determine a suitable duration of the study.
UR - http://www.scopus.com/inward/record.url?scp=85121391990&partnerID=8YFLogxK
U2 - 10.1109/EMBC46164.2021.9630689
DO - 10.1109/EMBC46164.2021.9630689
M3 - Conference paper
C2 - 34891555
AN - SCOPUS:85121391990
T3 - Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS
SP - 1435
EP - 1438
BT - 43rd Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBC 2021
PB - Institute of Electrical and Electronics Engineers Inc.
Y2 - 1 November 2021 through 5 November 2021
ER -
