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Accession number;01A0391395
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| Title;Report of the Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus. Standardization and Proper Use of Devices for Self-Monitoring of Blood Glucose. |
| Author;
TOMINAGA MAKOTO
(Yamagatadai I Rinshokensaigaku)
KOBAYASHI ISAO
(Gunmadai I Rinshokensaigaku)
KUWA KATSUHIKO
(Univ. of Tsukuba, College of Medical Technology)
TAKEI IZUMI
(Keiodai Naibumpitsuka)
HOSHINO TADAO
(Byotaikaisekiken)
YOSHINO GEN
(Tohodai Omoribyoin Rinshoikensagaku)
KANNO TSUYOSHI
(Hamamatsuidai Rinshokensaigaku)
MAKITA ZENJI
(Kurumedai I Naibumpitsutaishanaika)
SHICHIRI MOTOTAKA
(Kumamotodai I Taishanaika)
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Journal Title;Journal of the Japan Diabetic Society
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Journal Code:Z0279B
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ISSN:0021-437X
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VOL.44;NO.2;PAGE.165-176(2001)
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| Figure&Table&Reference;FIG.10, TBL.8 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To promote standardization and the proper use of 6 devices now available in Japan for self-monitoring blood glucose (SMBG), the Japan Diabetes Society (JDS) Committee on Standardization of Laboratory Testing Related to Diabetes Mellitus conducted surveys in cooperation with committees of the Japan Society of Clinical Chemistry (JSCC) and the Japan Society of Clinical Laboratory Automation (JSCLA). Surveys also targeted confirmation that these devices would meet international requirements for SMBG prepared by the ISO/TC 212 Committee. Surveys consisted of 3 parts: (1) questionnaires submitted to 6 SMBG device-manufacturers, (2) experiments using patient blood samples to evaluate actual device-to-device variation, and (3) questionnaires provided to trustees of the Japan Diabetes Society. Results from questionnaires on SMBG devices manufacturers showed these devices met the ISO/TC 212 requirements, and that all converted measured blood glucose to different data shown on devices displays. Results from experiments showed significant device-to-device variation, with devices falling into 3 types: (1) 2 that indicated values close to adjusted earlobe plasma glucose measured with the reference hexokinase method, (2) 1 that in dicated values close to venous plasma glucose measured by hexokinase method, and (3) 3 that indicated values falling between (1) and (2). Results from questionnaires answered by Japan Diabetes Society trustee showed that they disagreed about data conversion in devices for SMBG. With the committee finding it difficult to propose recommendations on the standardization of devices for SMBG, it will continue discussions on standardizing reference and adjustment methods, to reduce device-to-device variation.... (author abst.) |
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