Page 106 - Glucose Monitoring Devices

References 105

Conclusion
In conclusion, models of SMBG measurement error are needed to generate synthetic
SMBG data in ISCT, which can complement in vivo experiments, with a large saving
of resources. Recently, our research group proposed a methodology to develop and
validate SMBG measurement error models, which take into account the variability
of error characteristics over the glucose range and the possible asymmetric distribu-
tion of the error. This methodology is general and, in principle, can be applied to any
dataset containing SMBG measurements and BG references, like the OTU2 and
BCN datasets presented in this chapter. In silico experiments based on SMBG
measurement error models can play an important role in the regulatory approval
of medical devices for diabetes therapy. Notably, the BCN model presented in
this chapter was used, as part of the T1D patient decision simulator, to demonstrate
the safety and effectiveness of CGM nonadjunctive use, in the regulatory process
that brought to the FDA approval of the first nonadjunctive CGM system in the
United States.

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