The Accu-Chek Mobile blood glucose monitoring system used under controlled conditions meets ISO 15197 standards in the hands of diabetes patients.
BACKGROUND
Self-monitoring of blood glucose is a cornerstone of diabetes management. The aim of this study was to evaluate the analytical quality and the ease of use of the Accu-Chek Mobile, a new glucose monitoring system designed for capillary blood testing by diabetic patients.


METHODS
The performance of the Accu-Chek Mobile was evaluated both in the hands of a scientist and of diabetes patients. The designated comparative method was a hexokinase-based laboratory method (Architect ci8200). Diabetics (N = 88) with previous experience of self-testing were recruited for the study. Patient samples, containing glucose in concentrations mainly between ˜4 and ˜20 mmol/L, were analyzed in duplicates both on the Accu-Chek Mobile and with the comparative method. The patients answered a questionnaire about the ease of use of the meter.


RESULTS
The meter yields reproducible readings, with an imprecision CV <5% as required by the American Diabetes Association (ADA). Of the glucose concentrations obtained by both the scientist and the patients, more than 95% of the individual results were within ± 20% of the comparative method, meeting the ISO 15197 accuracy goal, but not the stricter ± 10% ADA goal.


CONCLUSIONS
Accu-Chek Mobile is a user-friendly glucometer that in a normo- and hyperglycemic range fulfils the ISO 15197 accuracy requirement, also in the hands of diabetes patients.
Department of Medical Biochemistry, University of Oslo/Oslo University Hospital, Oslo, Norway. daniel@sachse-zhang.com
Daniel
D
Sachse
Nils
N
Bolstad
Magnus
M
Jonsson
Ingjerd
I
Sæves
Carolina Backman
CB
Johansson
Weronika
W
Delezuch
Martin
M
Hagve
Ingrid Marie M
IM
Hardang
Helena S
HS
Isaksson
Anna
A
Ivarsson
Liisa
L
Lehto
Elina
E
Keikkala
Niklas
N
Mattsson
Jenni K
JK
Ranta
Anne
A
Stavelin
Ashild Amelie
AA
Sudmann
Kristin
K
Varsi
D000328:Adult; D000368:Aged; D001786:Blood Glucose; D015190:Blood Glucose Self-Monitoring / Q000295:instrumentation / Q000592:standards; D003922:Diabetes Mellitus, Type 1 / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012015:Reference Standards; D012016:Reference Values; D015203:Reproducibility of Results; D011795:Surveys and Questionnaires
D001786:Blood Glucose