How accurate is your blood glucose meter?
A major study found that almost half of meters do not meet the minimum required standards:
- For blood sugars over 75 mg (4.2 mmol): Accurate within 20%. For example, if your blood sugar is 200 mg (11 mmol), the meter must read between 160 (8.8 mmol) and 240 (13.3 mmol) at least 95% of the time.
- For blood sugars under 75 mg (4.2 mmol): Accurate within 15 mg. For example, if your blood sugar is 60 mg (3.3 mmol),the meter must read between 45 (2.5 mmol) and 75 (4.2 mmol) at least 95% of the time.
There is a new proposal that would require all results to be within 15%.
But how do you know if your meter is meeting this standard? Today, there is no systematic verification of meter accuracy after it gets approved for sale. And as you will see below, many meters are sub-standard.
This puts people relying on these tools in unnecessary danger. If you’re going to take a shot of insulin, a number that’s 15% off is a really big deal. Taking too much insulin can result in severe low blood sugars, hospitalization and even death.
Comparison of Meter Accuracy
The chart below is fromSystem Accuracy Evaluation of 43 Blood Glucose Monitoring Systemsfor Self-Monitoring of Blood Glucose according to DIN EN ISO 15197 by Dr. Guido Freckmann and others published in Journal of Diabetes Science and Technology, Volume 6, Issue 5, September 2012.
Between 2009 and 2011, over a hundred people were recruited to test each of the meters listed below. The test strips were taken from at least seven different vials of one manufacturing lot. Over at least ten days, the patients tested their blood sugar with the meter and then a second sample was taken for analysis in a lab.
Before using this data, it is important to know the limitations:
- The study only looked at one manufacturing lot. Every time a manufacturer makes a set of test strips, quality can go up or down. This chart only gives us a peek at a single manufacturing run a few years ago.
- The methods used to test the meters have a margin of error of up to 8%.Therefore,notall of the inaccuracies can be automatically attributed to the meters themselves. This is especially true if you look at the “within 5%” column.
- The meters below were tested in Europe.Not all meters are available in the USA. Some meters may have differences between their European counterparts with the same name.
- There is no way to compare current meter accuracy.This is the sad truth. Independent testing of accuracy is very expensive, and no one is doing it. It is up to us to fight for independent testing.
How to Read This Table
The table compares meters based on the proposed, tighter standards that will likely be approved this year.
- The left three columns show the accuracy of results for blood sugars under 100 mg (5.5 mmol).
- The right three columns show the accuracy for blood sugars over 100 mg (5.5 mmol).
- There are columns showing how many of the tests were with 15%, 10% and 5%.
| Meter | Within 15% Under 100 mg | Within 10% Under 100 mg | Within 5% Under 100 mg | Within 15% Over 100 mg | Within 10% Over 100 mg | Within 5% Over 100 mg |
|---|---|---|---|---|---|---|
| Accu-Chek Active | 100% | 100% | 72% | 100% | 100% | 79% |
| Accu-Chek Aviva | 100% | 97% | 80% | 99% | 91% | 64% |
| Accu-Chek Nano | 100% | 96% | 80% | 99% | 95% | 65% |
| Accu-Chek Compact Plus | 100% | 86% | 27% | 100% | 94% | 69% |
| Accu-Chek Go | 100% | 100% | 94% | 100% | 96% | 79% |
| Accu-Chek Mobile (maltose dependent) | 98% | 98% | 73% | 100% | 96% | 66% |
| Accu-Chek Mobile (maltose independent) | 100% | 98% | 71% | 100% | 94% | 66% |
| Accu-Chek Performa (maltose dependent) | 100% | 95% | 72% | 99% | 94% | 68% |
| Accu-Chek Performa (maltose independent) | 98% | 97% | 78% | 98% | 92% | 66% |
| Accu-Chek Performa Nano | 100% | 98% | 87% | 100% | 96% | 64% |
| Bayer Contour usb | 90% | 69% | 45% | 91% | 68% | 34% |
| BGStar | 98% | 92% | 80% | 97% | 87% | 62% |
| Beurer GL32 | 85% | 62% | 40% | 99% | 91% | 56% |
| Beurer GL40 | 98% | 90% | 52% | 95% | 78% | 42% |
| Biocheck TD-4225 | 76% | 52% | 22% | 97% | 80% | 49% |
| Element | 90% | 79% | 48% | 83% | 64% | 30% |
| FreeStyle Freedom Lite | 100% | 100% | 98% | 100% | 98% | 90% |
| FreeStyle Lite | 100% | 100% | 93% | 100% | 100% | 86% |
| Futura Monometer | 90% | 68% | 27% | 79% | 59% | 26% |
| GlucoCheck Classic | 97% | 84% | 55% | 85% | 66% | 38% |
| GlucoCheck Comfort | 96% | 86% | 56% | 95% | 74% | 41% |
| GlucoCheck XL | 97% | 92% | 58% | 88% | 65% | 40% |
| Glucohexal II | 50% | 21% | 7% | 80% | 64% | 32% |
| GlucoRx (TD-4230) | 83% | 41% | 14% | 65% | 40% | 14% |
| GlucoSmart Swing | 84% | 53% | 15% | 94% | 67% | 33% |
| GlucoTel | 89% | 70% | 33% | 92% | 72% | 41% |
| Gluco-test Plus+ TD-4230 | 96% | 94% | 76% | 95% | 79% | 42% |
| iBGStar | 96% | 90% | 52% | 90% | 72% | 35% |
| iDia | 96% | 80% | 47% | 90% | 71% | 40% |
| IME-DC Fidelity | 72% | 43% | 18% | 94% | 85% | 48% |
| iXell | 100% | 98% | 68% | 89% | 75% | 38% |
| iXell OLED | 97% | 85% | 52% | 97% | 79% | 39% |
| microdot+ | 98% | 95% | 62% | 94% | 83% | 43% |
| Omnitest 3 | 94% | 86% | 64% | 91% | 79% | 48% |
| OneTouch Verio | 97% | 78% | 40% | 100% | 95% | 64% |
| OneTouch Verio Pro | 88% | 53% | 21% | 93% | 75% | 40% |
| OneTouch VITA | 98% | 93% | 72% | 99% | 87% | 50% |
| Pura | 100% | 95% | 48% | 100% | 74% | 30% |
| SeniorLine GM210 | 15% | 0% | 0% | 79% | 55% | 29% |
| smartLAB genie | 84% | 52% | 23% | 98% | 87% | 57% |
| smartLAB global | 91% | 85% | 57% | 93% | 79% | 48% |
| WaveSense Jazz | 100% | 75% | 38% | 95% | 80% | 47% |
| Wellion CALLA Light | 68% | 33% | 13% | 89% | 73% | 52% |
We Must Fight for Meter Accuracy
These study results are disturbing. They suggest that barely half of the meters tested are meeting today’s minimum standards. Because there’s no systematic testing of meter accuracy, we don’t really know how bad the situation is.This data is already two to four years old. Many meters have never been publicly tested.
Due to cost-cutting measures, there are millions of Americans who are going to beingforced into cheaper, lower-performing meters.If you think that this is unacceptable, we urge you to join the Strip Safely campaign and contact your political representatives. Tell them that you are concerned about meter accuracy and want to see accuracy verified on a regular basis.
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Read more about blood glucose/sugar meter accuracy, insulin, low blood sugar (hypoglycemia), test strip accuracy, type 1 diabetes, type 2 diabetes.
