How Accurate Is Your Glucose Meter? Investigators Tested 18 of Them

If your blood glucose meter were put through a rigorous, scientific trial for accuracy, do you think it would pass? A study run by the Diabetes Technology Society put 18 FDA approved, commercially available Blood Glucose Monitor Systems (BGMSs) to the test, and the results were surprising.

DTS Surveillance Study

A nonprofit organization, the Diabetes Technology Society (DTS) exists to promote the “development and use of technology in the fight against diabetes.” Their BGMS Surveillance Program was initiated because glucose meters do not always live up to the accuracy claims that resulted in their FDA approval, or to international standards of accuracy.

For this study:

  • 18 popular blood glucose meters (BGMs) were obtained through retail outlets and tested in three separate trials, each done at different U.S. locations.
  • More than 1,000 people participated in the study: 370 with type 1 diabetes, 470 with type 2 diabetes, and 4 with pre-diabetes. The remaining participants were not diabetic. Ages ranged from 18 to 87.
  • To get a passing grade, each meter had to function within 15 percent, or 15 mg/dl of laboratory values over 95 percent of the time.

The BGMs were coded, so no one involved with the study - investigators, statisticians, lab staff, or sponsor - knew which meter brands were passing or failing until all the results were calculated and published.

More detailed study information can be obtained at the DTS website (link below).

Meter Results

The 18 BGMs tested represent about 90 percent of the commercially available products used from 2013 to 2015 by diabetes patients, and only six of them received passing marks:

  • Contour Next by Ascensia (was Bayer) - accurate 100 percent of the time
  • Accu-Chek Aviva Plus by Roche - 98 percent
  • Walmart ReliOn Confirm (Micro) by Arkray - 97 percent
  • CVS Advanced by Agamatrix - 97 percent
  • FreeStyle Lite by Abbott - 96 percent
  • Accu-chek SmartView by Roche - 95 percent

Though 12 of the BGMs failed to meet the study’s standards, some did not fail by much, but others fared less well:

  • Walmart ReliOn Prime by Arkray - 92 percent
  • OneTouch Verio by LifeScan - 92 percent
  • Prodigy Auto Code by Prodigy - 90 percent
  • OneTouch Ultra2 by LifeScan - 90 percent
  • Walmart ReliOn Ultima by Abbott - 89 percent
  • Contour Classic by Bayer - 89 percent
  • Embrace by Omnis Health - 88 percent
  • True Result by HDI/Nipro - 88 percent
  • True Track from HDI/Nipro - 81 percent
  • SolusV2 by BioSense Medical - 76 percent
  • Advocate Redi-Code+ by Diabetic Supply of Suncoast - 76 percent
  • Gmate Smart by Philosys - 71 percent

A reason why 12 FDA approved meters failed the study may be manufacturer-submitted trials that the FDA reviews when assessing a meter. The DTS study was run independently, and the BGMs were purchased directly from retailers.

For those interested, there are charts on the DTS website detailing how each meter did at each of the three trial locations.

Time For A Change?

Though studies like the BGMS Surveillance Program can be disconcerting, they help ensure the devices we buy are dependable and accurate. It will benefit consumers with diabetes if DTS can fund and perform this research every few years.

Anyone whose meter type failed this study might want to discuss it with their physician or diabetes educator. If A1C and other lab results are on the mark, getting a new meter may not be necessary. However, individuals who need or want more accurate glucose readings might opt for a BGM change.

Sources: Diabetes Technology Society, Diatribe
Photo: Pixabay

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