Ottai M8 - Page 42

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12. Information on Clinical Trials
ěąģąÙ¼ěňą¼ědűãƒąãŲ
āąŌŅňīßřÙŔā¼ŌØããģãű¼ěř¼ŔãßŔāňīřùāÙěąģąÙ¼ěŔňą¼ěŌ˚
āãÙěąģąÙ¼ěŔňą¼ěŲ¼ŌßãŌąùģãßŲąŔā¼ŅňīŌŅãÙŔąűã˛
ġřěŔąÙãģŔãň˛ŌąģùěãùňīřŅŔ¼ňùãŔű¼ěřãġãŔāīß˚āã
ãŷŅãňąġãģŔ¼ěň¼ģùãŲ¼Ō¼ßřěŔßą¼ØãŔąÙŅ¼ŔąãģŔŌ˛¼ģßŔāã
product was worn on the lateral margin of the biceps
ġřŌÙěãīģŔāãؼÙėīøŔāãřŅŅãň¼ňġ˛ġ¼ėąģùŔāãřŌã
Ņãňąīßɣɦß¼ŸŌ˚øŔãňŔāãŇř¼ěąƍãßŌřØēãÙŔŌŲãňããģňīěěã߲
ŔāãÙīģŔąģřīřŌùěřÙīŌãġīģąŔīňąģùŌŸŌŔãġŲ¼ŌŲīňģ˛¼ģß
the EKF glucose detector was used as the gold standard
Ŕīġã¼ŌřňãąģŔň¼űãģīřŌùěřÙīŌã˚āããƆãÙŔąűãģãŌŌīøŔāã
ÙīģŔąģřīřŌùěřÙīŌãġīģąŔīňąģùŌŸŌŔãġŲ¼Ōãű¼ěř¼Ŕã߲
and the safety of the product was evaluated during
wearing.
āãŌŸŌŔãġŅãƐīňġ¼ģÙã¼ÙÙřň¼ÙŸąģßąÙ¼ŔīňŌ¼ģßňãŌřěŔŌ
īøŔāããģŔąňãġã¼ŌřňãġãģŔň¼ģùã¼ňã¼ŌøīěěīŲŌ˜
Types of Indicators
~ňąġ¼Ɣãű¼ěř¼Ŕąīģ
indicators
20/20% concurrence with
control reference value
~ňīŅīƑąīģīøġã¼ŌřňãġãģŔ
points falling in the A+B
ňãùąīģīøŔāãě¼ňėããňňīň
grid analysis
~ňīŅīƑąīģīøġã¼ŌřňãġãģŔ
points falling in the A+B
region of the Consensus
error grid analysis
\ã¼ģØŌīěřŔããě¼Ŕąűã
)ňňīň©¼ěřã˺\%͹˻
93.3%
99.6%
99
.
8%
8.106%±3.869%
Evaluation Indicators Clinical Trial Results
ãÙīģß¼Ɣ
evaluation indicators
īňňãÙŔěãƑ¼Ŕã āãŌřÙÙãŌŌň¼ŔãīøāąùāùěřÙīŌã
¼ěãƑŲ¼Ōɫɧ˚ɪ͹˝ŔāãŌřÙÙãŌŌň¼Ŕã
īøěīŲùěřÙīŌã¼ěãƑŲ¼Ōɪɦ˚ɣ͹˚
āãŌřÙÙãŌŌň¼ŔãīøāąùāùěřÙīŌã
ßãŔãÙŔąīģŲ¼Ōɫɧ˚ɩ͹˝ŔāãŌřÙÙãŌŌ
rate of low glucose detection was
88.0%.