OBJECTIVE: Self-monitoring of blood glucose (BG) is an essential part of diabetes therapy. Accurate and reliable results from BG monitoring systems (BGMS) are important especially when they are used to calculate insulin doses. This study aimed at assessing system accuracy of BGMS and possibly related insulin dosing errors. RESEARCH DESIGN AND METHODS: System accuracy of six different BGMS (Accu-Chek® Aviva Nano, Accu-Chek Mobile, Accu-Chek Performa Nano, CONTOUR® NEXT LINK 2.4, FreeStyle Lite, OneTouch® Verio® IQ) was assessed in comparison to a glucose oxidase and a hexokinase method. Study procedures and analysis were based on ISO 15197:2013/EN ISO 15197:2015, clause 6.3. In addition, insulin dosing error was modeled. RESULTS: In the comparison against the glucose oxidase method, five out of six BGMS fulfilled ISO 15197:2013 accuracy criteria. Up to 14.3%/4.3%/0.3% of modeled doses resulted in errors exceeding ±0.5/±1.0/±1.5 U and missing the modeled target by 20 mg/dL/40 mg/dL/60 mg/dL, respectively. Compared against the hexokinase method, five out of six BGMS fulfilled ISO 15197:2013 accuracy criteria. Up to 25.0%/10.5%/3.2% of modeled doses resulted in errors exceeding ±0.5/±1.0/±1.5 U, respectively. CONCLUSIONS: Differences in system accuracy were found, even among BGMS that fulfilled the minimum system accuracy criteria of ISO 15197:2013. In the error model, considerable insulin dosing errors resulted for some of the investigated systems. Diabetes patients on insulin therapy should be able to rely on their BGMS' readings; therefore, they require highly accurate BGMS, in particular, when making therapeutic decisions.
OBJECTIVE: Self-monitoring of blood glucose (BG) is an essential part of diabetes therapy. Accurate and reliable results from BG monitoring systems (BGMS) are important especially when they are used to calculate insulin doses. This study aimed at assessing system accuracy of BGMS and possibly related insulin dosing errors. RESEARCH DESIGN AND METHODS: System accuracy of six different BGMS (Accu-Chek® Aviva Nano, Accu-Chek Mobile, Accu-Chek Performa Nano, CONTOUR® NEXT LINK 2.4, FreeStyle Lite, OneTouch® Verio® IQ) was assessed in comparison to a glucose oxidase and a hexokinase method. Study procedures and analysis were based on ISO 15197:2013/EN ISO 15197:2015, clause 6.3. In addition, insulin dosing error was modeled. RESULTS: In the comparison against the glucose oxidase method, five out of six BGMS fulfilled ISO 15197:2013 accuracy criteria. Up to 14.3%/4.3%/0.3% of modeled doses resulted in errors exceeding ±0.5/±1.0/±1.5 U and missing the modeled target by 20 mg/dL/40 mg/dL/60 mg/dL, respectively. Compared against the hexokinase method, five out of six BGMS fulfilled ISO 15197:2013 accuracy criteria. Up to 25.0%/10.5%/3.2% of modeled doses resulted in errors exceeding ±0.5/±1.0/±1.5 U, respectively. CONCLUSIONS: Differences in system accuracy were found, even among BGMS that fulfilled the minimum system accuracy criteria of ISO 15197:2013. In the error model, considerable insulin dosing errors resulted for some of the investigated systems. Diabetespatients on insulin therapy should be able to rely on their BGMS' readings; therefore, they require highly accurate BGMS, in particular, when making therapeutic decisions.
Entities:
Keywords:
Blood glucose monitoring; ISO 15197; Insulin dosing error; Self-monitoring of blood glucose; System accuracy