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i-Sens CareSens N POP
Manufacturer:
i-Sens Inc., 43 Banpo-daero 28-gil, Seocho-gu, Seoul 06646, REPUBLIC of KOREA.
Measuring functions:
Blood glucose
Primary Client Use:
Intended for both professional use and self-measurement
Measurement Site:
Finger and general Alternative Site Testing
Measurement Occurrence:
Single measurements only
Availability:
Available Currently
Availability according to Countries or Regions:
Australia
Device Manual:
Description:
The i-Sens CareSens N POP is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 2-star Medaval rating. Measurements are normally taken from the finger but alternative site testing is allowed and it is intended for both professional use and self-measurement.
Assessment:
The technology used in the i-Sens CareSens N POP, 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
Medaval ★★ Recommendation Recent clinical validation; recent protocol
TÜV Rheinland Nederland General use Unpublished internal data
MDR Criteria Self-measurement and professional use Published evidence
Consumer BodyYear(s)LevelComment
Choice (Australia) Latest: 2019 A
Validation Publications:

Link M, Pleus S, Schmid C, Freckmann G, Baumstark A, Stolberg E, Haug C. Accuracy Evaluation of Three Systems for Self-monitoring of Blood Glucose With Three Different Test Strip Lots Following ISO 15197. J Diabetes Sci Technol. 2014 Mar;8(2):422-4. Epub: 2014 Mar 24. doi: 10.1177/1932296813518859. PMID: 24876597. Available from: PMC4455421.

15197:2003 - Pass General population

15197:2013 - Pass General population

Relevant Publications:

Thompson H, Chan H, Logan FJ, Heenan HF, Taylor L, Murray C, Florkowski CM, Frampton CM, Lunt H. A glucose meter evaluation co-designed with both health professional and consumer input. NZ Med J. 2013 Nov 22;126(1386):90-7. doi: .. PMID: 24316996.

Measurements from the i-Sens CareSens N POP are compared to those from the Roche Accu-Chek Performa, though not in a formal validation.