Accuracy of the 18 most commonly used glucose meters in the US

Klonoff DC, Parkes JL, Kovatchev BP et al (2018) Investigation of the accuracy of 18 marketed blood glucose monitors. Diabetes Care 41: 1681–8

• This study was an independent assessment of the accuracy of marketed fingerstick blood glucose monitors. The 18 best-selling meters in the US, comprising approximately 90% of the market, were each in three separate studies in a round-robin.
• The devices were tested on a total of 1032 subjects. Recruitment was designed to obtain a wide range of glucose readings; therefore, participants included people with type 1 and type 2 diabetes, non-diabetic hyperglycaemia and no diabetes, and some were asked to come to the clinic fasting or 1–2 ours after a meal.
• In each study, glucose meter readings were compared with reference laboratory values. To pass the test, meters had to have ≥91% of readings within 15% of the reference value (or within 15 mg/dL [0.83 mmol/L] for values under 5.55 mmol/L), a standard similar to, but slightly more lenient than, current international and US standards.
• Only six of the 18 glucose meters met the accuracy standard in all three studies; five failed in one study, three failed in two studies and four failed in every study.
  – The six most accurate meters, ranked by the proportion of data points that were within the protocol limits, were the Contour Next (Bayer), Accu-Chek Aviva Plus (Roche), Walmart ReliOn Confirm Micro (ARKRAY), CVS Advanced (AgaMatrix), Freestyle Lite (Abbott) and Accu-Chek SmartView (Roche).
• The six top-performing meters also performed the best according to four other accuracy metrics.
• The authors conclude that a large number of blood glucose monitors that have previously received marketing authorisation are now insufficiently accurate to meet regulatory standards. Whether this is due to performance deterioration due to scaled-up production or other unknown issues, healthcare professionals should exercise caution when recommending meters for self-monitoring of blood glucose.

Click here to access the article in full.