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ACCU-CHEK Eversense XL Manual

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Gebruikershandleiding van EversenseXL CGM
19
Algehele prestaties van het systeem in vergelijking met YSI
Het onderzoek liet zien dat 84,4% van de algehele metingen van het CGM-systeem zich bevond binnen ±20% van de
YSI-waarden, 94,3% binnen ±30% van de YSI-waarden en 97,6% binnen ±40% van de YSI-waarden. De onderstaande
tabel geeft een overzicht van de percentages per glucosebereik.
Verschil tussen metingen met het CGM-systeem en YSI-metingen per glucosespiegel
YSI-
glucosebereik
(mmol/l)
Aantal metingen
van paren van
CGM en YSI
Percentage
binnen
20% van YSI
Percentage
binnen
30% van YSI
Percentage
binnen
40% van YSI
≤ 3,9* 632 78,3% 90,2% 94,5%
3,9 - 0,0 14699 81,8% 93,0% 97,0%
> 10,0 6196 91,3% 97,7% 99,3%
Algeheel 21527 84,4% 94,3% 97,6%
*Het absolute verschil ten opzichte van de YSI-meting is gemeten in mmol/l als de YSI-meting ≤ 3,9 mmol/l was.
Hoewel er meetfouten kunnen zijn geweest in de YSI-metingen en/of sensormetingen, en hoewel van interstitiële
waarden (gemeten met de sensor) bekend is dat deze in vergelijking met bloedwaarden (gemeten met YSI) een
vertraging vertonen in de reactie op een verandering in de glucosespiegel, is aangetoond dat 80% of meer van de
verschillen zich bevond binnen 20%/1,1mmol/l (20% voor YSI-waarden boven de 3,9mmol/l, binnen 1,1mmol/l voor
YSI-waarden ≤ 3,9mmol/l). De mate van overeenkomst was meer dan 90% voor verschillen binnen 30%/1,7mmol/l
en meer dan 95% voor verschillen binnen 40%/2,2mmol/l.
… 142 …


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