i-Sens Caresens N

Device Name:Caresens N
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, 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.

Accuracy AssessmentRecommendationBasis
Medaval★★ RecommendationRecent clinical validation; recent protocol
TÜV Rheinland NederlandGeneral useUnpublished internal data.
 
Consumer BodyVersionQuartileComment
Choice Australia2019A 

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

Wolde M, Tarekegn G, Kebede T. Comparative Evaluations of Randomly Selected Four Point-of-Care Glucometer Devices in Addis Ababa, Ethiopia. J Diabetes Sci Technol. 2018 May;12(3):673-9. Epub: 2018 Jan 17. doi: 10.1177/1932296817751747. PMID: 29338325.

15197:2013 - Fail General population

15197:2003 - Fail General population