Lähteet: www.diabetes.org
~ ISO 15197:2023-standardin hyväksymiskriteerien mukaan 95 % mitatuista glukoosiarvoista on oltava joko ±0,83 mmol/L sisällä referenssimenetelmällä mitatuista keskiarvoista glukoosipitoisuuksilla <5,55 mmol/L tai ±15 % sisällä glukoosipitoisuuksilla ≥5,5 mmol/L.
† Ad hoc -analyysi osoitti, että 95 % tuloksista oli ±0,3 mmol/L tai ±5,3 % laboratorion viitearvoista glukoosipitoisuuksille <5,5 mmol/L ja ≥5,5 mmol/L.
1. Pleus S et al (2022) User Performance Evaluation and System Accuracy Assessment of Four Blood Glucose Monitoring Systems With Color Coding of Measurement Results. J Diab Sci and Technol;1-9.2. International Organization for Standardization. In vitro diagnostic test systems – requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus (ISO 15197). International Organization for Standardization, Geneva, Switzerland, 2013.
3. Eichenlaub M et al (2023) Impact of Blood Glucose Monitoring System Accuracy on Clinical Decision Making for Diabetes Management. J Diab Sci Technol ;1-7 17 (3) 683-689.
4. Richardson J et al (2021) Impact of CONTOUR
®PLUS ELITE Blood glucose monitoring system on bolus insulin dosing and blood glucose results variance. ePoster presented at the 14th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) 2–5 June.
5. Boettcher C et al (2015) Accuracy of Blood Glucose Meters for Self-Monitoring Affects Glucose Control and Hypoglycemia Rate in Children and Adolescents with Type 1 Diabetes. Diab Technol & Therap;17(4) http://doi.org/10.1089/dia.2014.0262
6. Boye K.S et al (2022) Adv Ther 39:2208-2221. doi: 10.1007/s12325-022-02106-4
7. Breton MD et al. (2010), Impact of blood glucose self-monitoring errors on glucose variability, risk for hypoglycemia, and average glucose control in type 1 diabetes: an in silico study. J Diab Sci Technol;4(3):562-570.
8. CONTOUR
®NEXT, käyttöohje versio 07/21.