i-Sens CareSens N

Device Name:

CareSens N

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:

Click here to download the Device Manual

Description:

The i-Sens CareSens N is an automatic blood glucose meter. Its blood glucose measurement technology has been proven to be accurate, with a 1-star Medaval rating. Blood glucose measurements are normally taken from the finger but alternative site testing is allowed. It is intended for both professional use and self-measurement.

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.

Recommendations:

	Accuracy Assessment	Recommendation	Basis
BG	Medaval	★ Recommendation	Older clinical validation; recent protocol
BG	TÜV Rheinland Nederland	General use	Unpublished internal data
BG	Institute of Health Economics (CA)	General use	No evidence provided
BG	MDR Criteria	Self-measurement and professional use	Published evidence

	Consumer Body	Year(s)	Level	Comment
BG	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 (aka 15197:2015) - 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 (aka 15197:2015) - Fail General population

15197:2003 - Fail General population