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Aktivmed GlucoSmart Swing
Device Name:
GlucoSmart Swing
Manufacturer:

OBL: Aktivmed GmbH, Prinzregentenplatz 1, 86150 Augsburg, GERMANY.

OEM: TaiDoc Technology Corporation, 6F - 127 Wugong 2nd Road, 24888 Wugu District, New Taipei City, TAIWAN ROC.

Measuring functions:
Blood glucose
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The Aktivmed GlucoSmart Swing is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the Aktivmed GlucoSmart Swing, to measure blood glucose, has passed in a clinical validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval Legacy approval Older clinical validation; older protocol
Validation Publications:

Freckmann G, Schmid C, Baumstark A, Pleus S, Link M, Haug C. System accuracy evaluation of 43 blood glucose monitoring systems for self-monitoring of blood glucose according to DIN EN ISO 15197. J Diabetes Sci Technol. 2012 Sep 1;6(5):1060-75. PMID: 23063032. Available from: PMC3570840.

15197:2003 - Pass General population

15197:2013 - Fail General population

Hasslacher C, Kulozik F, Platten I. Analytical performance of glucose monitoring systems at different blood glucose ranges and analysis of outliers in a clinical setting. J Diabetes Sci Technol. 2014 May;8(3):466-72. Epub: 2014 Feb 18. doi: 10.1177/1932296814522804. PMID: 24876607. Available from: PMC4455429.

15197:2013 - Fail General population