i-Sens CareSens Dual
Device Name:
CareSens Dual
Manufacturer:
i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, REPUBLIC of KOREA.
Measuring functions:
Blood glucose, β-Ketones
Primary Client Use:
Intended for self-measurement and home use
Measurement Site:
Finger
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Description:
The i-Sens CareSens Dual is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 3-star Medaval rating. Blood glucose measurements are taken from the finger. It is intended for self-measurement and home use.
Assessment:
The technology used in the i-Sens CareSens Dual, to measure blood glucose, is among the best rated for accuracy by Medaval Ltd. It has passed in five clinical validation studies, between general and specific populations, according to recognised standard protocols, as published in peer-reviewed publications.
Recommendations:
Accuracy AssessmentRecommendationBasis
BG Medaval ★★★ Recommendation Recent clinical validation; recent protocol; multiple clinical validations
BG TÜV Rheinland Nederland General use Unpublished internal data
BG MDR Criteria Self-measurement Published evidence
Validation Publications:

Pleus S, Jendrike N, Baumstark A, Mende J, Haug C, Freckmann G. Evaluation of Analytical Performance of Three Blood Glucose Monitoring Systems: System Accuracy, Measurement Repeatability, and Intermediate Measurement Precision. J Diabetes Sci Technol. 2019 Jan;13(1):111-117. Epub: 2018 Oct 5. doi: 10.1177/1932296818804837. PMID: 30286620. Available from: PMC6313280.

15197:2013 - Pass General population

Dunseath GJ, Bright D, Luzio SD. Comparative Accuracy Evaluation of a Blood Glucose Meter With Novel Hematocrit Correction Technology, With Three Currently Used Commercially Available Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2019 May;13(3):568-574. Epub: 2019 Jan 9. doi: 10.1177/1932296818821389. PMID: 30623673. Available from: PMC6501526.

15197:2013 - Pass General population (Note: Modified protocol: Single batch of test strips only. Some hematocrit associated bias noted.)

Pleus S, Baumstark A, Jendrike N, Mende J, Link M, Zschornack E, Haug C, Freckmann G. System accuracy evaluation of 18 CE-marked current-generation blood glucose monitoring systems based on EN ISO 15197:2015. BMJ Open Diabetes Res Care. 2020 Jan;8(1):e001067. doi: 10.1136/bmjdrc-2019-001067. PMID: 31958308. Available from: drc.bmj.com.

15197:2013 - Pass General population (Note: Modified protocol: One reagent system lot.)

Freckmann G, Baumstark A, Jendrike N, Mende J, Schauer S, Link M, Pleus S, Haug C. Impact of Two Different Reference Measurement Procedures on Apparent System Accuracy of 18 CE-Marked Current-Generation Blood Glucose Monitoring Systems. J Diabetes Sci Technol. 2022 Sep;16(5):1076-1088. Epub: 2020 Aug 19. doi: 10.1177/1932296820948873. PMID: 32814455. Available from: PMC9445332.

15197:2013 - Pass General population

15197:2013 - Pass General population

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