Posts

TearDown: Contour Next One Glucose Meter

Image
  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.