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TearDown: Contour Next One Glucose Meter

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  A recent study by the Diabetes Technology on a cohort of 1000 people found that of 18 popular glucometers in the US, only 6 met the FDA standard for accuracy: Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors.  David C. Klonoff, Joan Lee Parkes, Boris P. Kovatchev, David Kerr, Wendy C. Bevier, Ronald L. Brazg, Mark Christiansen, Timothy S. Bailey, James H. Nichols and Michael A. Kohn. Diabetes Care 2018 Aug; 41(8): 1681-1688. and another good study on accuracy here:  Performance Evaluation of Three Blood Glucose Monitoring Systems Using ISO 15197 I was surprised by 2 things: Of course that only 6 BGMs met the standard…. The FDA standard itself which specifies accuracy of only +- 15mg/dL at or below 100mg/dl and +-15% above that number. If your fasting blood glucose was measured at say 95mg/dl, that could mean to a 95% confidence level you are anywhere from 80mg/dl (relatively close to hypoglycemia) to 110mg/dl (pre-diabetic). I decided to take a look inside the best

Why glucometer

Glucometer is no newthing but till now there is no glucometer made in india, although the technology is very simple. Glucose strip development does not need a PhD in chemistry or physics unless you are not deleceloping a novel method, but yes may need a phD in production engineering. As there are hundreds of glucose meters in market so for developers it became very easy.

Glucose Strip Design

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The first research on ampreometric determination of blood glucose using a redox couple-mediated, glucose oxidase (GOx)-catalyzed reaction was demonstrated by Williams et al. (1970). But this study did not lead to the rapid application of amperometry in self-monitoring blood glucose in the home. The first electrochemical blood glucose monitor for selfmonitoring diabetic patients was pen-sized and was launched in 1987 as ExacTech by Medisense Inc. Many studies on the development of blood glucose sensors have been carried out since the 1980s Most glucose sensors use enzyme based detection where the first one is Glucose oxidase(GOD) and the second one is Glucose dehydrogenase(GDH). (ref 12) (ref 12) Contents of Glucose Strip GOD or GDH Enzyme Cofactor/Coenzyme enzyme  glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ) Mediator (less than 300mg)  potassium hexacyanoferrate (III), phenazine methosulfate, phenothiazine, and hexaammineruthenium (III) chloride)  (ref 3) Buffer  Other Non