i-Sens Caresens N-Pop

Device Name:Caresens N-Pop
Manufacturer:i-Sens, 43 Banpo-daero 28-gil, Seocho-gu, Seoul 137-873, 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
Assessment: The technology used in the i-Sens Caresens N-Pop, to measure blood glucose, has passed in a validation study, in a general population, according to a recognised standard protocol, as published in a peer-reviewed publication.
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: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4455421/pdf/10.1177_1932296813518859.pdf.

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.