Best Glucose Meter Review – Healthcare Product Reviews

Best Glucose Meter Review

Best glucose meter

Accuracy Summary and Main Features of Major Glucose Meters

 

Meter
Accuracy (Editorial Rating)*
Main Features
Interference (Incomplete list, Ask your physician for details)
Strips
Overall Editorial Rating
Abbott FreeStyle Flash
8.5 No coding
7 sec / 0.3 µl
Hematocrit: 15-65%
xylose > 6 mg/dl. This device should not be used during xylose absorption testing
3.5 out of 5 stars.

Pros: Decent Accuracy. Smallest blood volume in the market.
Cons: Slightly longer test time. Requires coding.

Abbott Freestyle Freedom Lite
8.5 No coding
5 sec / 0.3 µl
Hematocrit: 15-65%
xylose > 6 mg/dl. This device should not be used during xylose absorption testing
4.2 out of 5 stars.

Pros: High accuracy. Smallest blood volume in the market.

Abbott FreeStyle Lite
9 No coding
5 sec / 0.3 µl
Hematocrit: 15-65%
xylose > 6 mg/dl. This device should not be used during xylose absorption testing
4.5 out of 5 stars.

Pros: High accuracy. Smallest blood volume in the market.

Abbott Precision Xtra 7 No coding
5 sec / 0.6 µl
Hematocrit: 20-70%
Xylose may produce falsely high glucose readings. This device should not be used during xylose absorption testing
3.5 out of 5 stars.

Pros: Ketone testing available.
Cons: No new accuracy data on new ISO.

AgaMatrix Jazz
8 No coding
5 sec / 0.5 µl
Hematocrit: 20-60%
Results may be overestimated with abnormally high concentrations of ascorbic acid (vitamin C) > 2 mg/dl
4.0 out of 5 stars.

Pros: Decent accuracy. Very reasonable price.

AgaMatrix Presto
8 No coding
5 sec / 0.5 µl
Hematocrit: 20-60%
Results may be overestimated with abnormally high concentrations of ascorbic acid (vitamin C) > 2 mg/dl
4.0 out of 5 stars.

Pros: Decent accuracy. Very reasonable price.

Bayer Contour Next USB 9 No coding
5 sec / 0.6 µl
Hematocrit: 15-65%
Bilirubin > 54 mg/dL, Uric Acid > 59 mg/dL, Ascorbic Acid > 10 mg/dL, Acetaminophen > 35 mg/dL.
Maltose and galactose have no interference.Do not use CONTOUR® NEXT test strips during or shortly after a xylose absorption test.
4.8 out of 5 stars.

Pros: High accuracy. Compatible with galactose and maltose. Easy-to-use built in software.

Bayer Contour USB 6 No coding
5 sec / 0.6 µl
Hematocrit: 0-70%
Bilirubin > 20 mg/dl, Uric Acid > 32 mg/dl, Ascorbid acid > 36 mg/dl, Acetaminophen > 22 mg/dl. Xylose is an interference.
2.5 out of 5 stars.

Cons: Poor accuracy.
This meter does not not meet new ISO 2013 standard.

Bayer Contour 6 No coding
5 sec / 0.6 µl
Hematocrit: Unknown
Bilirubin > 20 mg/dl, Uric Acid > 32 mg/dl, Ascorbid acid > 36 mg/dl, Acetaminophen > 22 mg/dl. Xylose is an interference.
2.5 out of 5 stars.

Cons: Cons: Poor accuracy.
This meter does not not meet new ISO 2013 standard.

LifeScan OneTouch Ultra 2
6 Requires coding
5 sec / 1 µl
Hematocrit: 30-55%
Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), and other reducing substances at high concentrations may cause high glucose readings.
2.2 out of 5 stars.

Cons: Poor accuracy.
This meter does not meet 2013 ISO standard.
Small hematocrit range. High sample volume required.

LifeScan OneTouch UltraMini 6 Requires coding
5 sec / 1 µl
Hematocrit: 30-55%
Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), and other reducing substances at high concentrations may cause high glucose readings.
2.5 out of 5 stars.

Pros: Small, and nice looking.
Cons: Poor accuracy. The device does not meet ISO 2013 standard. Small hematocrit range. High sample volume required.

LifeScan OneTouch UltraSmart 6 Requires coding
5 sec / 1 µl
Hematocrit: 30-55%
Acetaminophen, salicylates, uric acid, ascorbic acid (vitamin C), and other reducing substances at high concentrations may cause high glucose readings.
2.2 out of 5 stars.

Pros: Small, and nice looking.
Cons: Poor accuracy. The device does not meet ISO 2013 standard. Small hematocrit range. High sample volume required.

LifeScan OneTouch Verio IQ 7 No coding
5 sec / 0.4 µl
Hematocrit: 30-55%
Elevated concentrations of acetaminophen, ascorbic acid (>6 mg/dl), uric acid (> 24 mg/dl), tolazamide, and xylose (>100 mg/dl) may affect the blood glucose results.
3.8 out of 5 stars.

Pros: Small blood volume required.
Cons: Relatively small temperature range. Average accuracy.

Roche Accu-Chek Aviva
8 One-time coding
5 sec / 0.6 µl
Hematocrit: 10-70%
Maltose incompatible. Triglycerides >4800 mg/dl, Galactose > 10 mg/dl, Maltose > 13 mg/dl.
3.0 out of 5 stars.

Pros: Wide hematocrit range. Decent accuracy.

Roche Accu-Chek Aviva Plus 8.5 One-time coding
5 sec / 0.6 µl
Hematocrit: 10-65%
Maltose compatible. Triglycerides >1800 mg/dl, Galactose > 15 mg/dl, Ascorbic Acid > 3 mg/dl
4.2 out of 5 stars.

Pros: Dialysis compatible. Maltose compatible. Decent accuracy. Wide hematocrit range.
Cons: require onetime coding per vial.

Roche Accu-Chek Compact Plus 9 No coding
5 sec / 1.5 µl
Hematocrit: 30-55%
Maltose incompatible. Galactose > 15 mg/dl, Ascorbic Acid > 3 mg/dl
3.8 out of 5 stars.

Pros: High accuracy.
Cons: Hematocrit range too small, too much blood is required.

Roche Accu-Chek Nano SmartView 9 No coding
5 sec / 0.6 µl
Hematocrit: 10-65%
Maltose compatible. Triglycerides >1800 mg/dl, Galactose > 15 mg/dl, Ascorbic Acid > 3 mg/dl
4.5 out of 5 stars.

Pros: High accuracy. Dialysis compatible. Maltose compatible. Wide hematocrit range.

Sanofi iBGStar
6.5 No coding
5 sec / 0.5 µl
Hematocrit: 20-60%
Results may be overestimated with abnormally high concentrations of ascorbic acid (vitamin C) > 2 mg/dL (0.11 mmol/L)
2.8 out of 5 stars.

Cons: Fairly poor accuracy. Expensive strips. Only compatible up to iphone 4.

1 | How to Choose the Best Blood Glucose Meter

The FDA has guidelines regarding how to choose the best glucose meter and strips by considering the following aspects:

  • Accuracy
  • Amount of blood needed for each test
  • Ease of use
  • Pain associated with product use
  • Testing speed
  • Overall size
  • Ability to store test results in memory
  • Likelihood of interference
  • Ability to transmit data to a computer
  • Meter cost
  • Test strip cost
  • Doctors’ recommendation
  • Technical support provided by the manufacturer
  • Special features, such as automatic timing, error codes, large display screen, or spoken instructions and/or results

 

2 | Blood Glucose Meter Accuracy

Among all the criteria, the FDA considers meter accuracy to be the most important feature. While this is the most important criterion, it is also the most neglected among consumer reports.  So how is accuracy specified?

  • Consistency or Precision, which describe how reproducible a reading is if you measure your blood glucose multiple times. Consistency and precision say nothing about accuracy, however.  A meter/strip can consistently provide readings that are lower than true glucose values, thus being inaccurate but still consistent.  Both accuracy and consistency are important for assessing a meter and the corresponding strips. The user can easily test the consistency of the meter/strips by applying the same blood drop to multiple strips and seeing if the readings are different. However, it is difficult for a user to test the device accuracy, since there is no reference reading that one can easily access at home. This may explain why, in most consumer reports, the accuracies of glucose meters are not fully assessed. Why? It is difficult unless we do a lot of research!
  • The accuracy of a meter can be verified by comparing the glucose reading with a laboratory instrument. In hospitals, there is a large instrument, called a YSI, that performs very accurate glucose readings (<2.5% deviation from true value), and all existing meters must reference their readings to this instrument. However, since a normla user would not have access to such an instrument at home, it is difficult for them to determine if the glucose reading is correct at all times.  The FDA actually recommends that you bring your meter with you when you visit your doctor, and ask your doctor to check your blood glucose so that your meter results can be compared to the lab instrument. If the values you obtain on your glucose meter match the laboratory values, then your meter is working well and you are using good techniques to take the measurements.
  • It is important to understand that pretty much all meter manufacturers claim that their own meters are more accurate than others, and sometimes even support this claim with their own data.  However, as a user, we have to be very careful about believing these claims, and data collected by a third party, who has no affiliation with the meter company, are the most reliable source of data regarding meter accuracy.

 

3 | FDA and ISO Standard for Blood Glucose Meter Accuracy

If we are discussing meter accuracy, we also have to talk about FDA and ISO standards. Users should never simply assume that, because it is approved by the FDA, the meter they have is very accurate.  In fact, when people own more than two meters (even from the same manufacturer), they can often obtain different readings from the same sample.

Here are some some posts from various users (from other websites)

Three completely different readings from the same sample – 66, 80, 89 mg/dl

Different meter readings from Walgreens meter and Prodigy meter, which one is correct?

In fact, if you just Google “two glucose meters give different results”, you can see hundred of posts about this.  This can be generally be very confusing to a user.

No glucose meter will be perfectly accurate 100% of the time, and with this understanding, the FDA allows a certain amount of reading variability in certified meters.  For meter approval, the FDA largely follows ISO 15197:2003 criteria, which we strongly suggest users to read if you want to understand what guidelines these meter manufacturers are following.  Generally:

95% of the glucose readings have to be either one of the following:

  • Within 20% error from true glucose values when the glucose concentration is above 75 mg/dl
  • Within +- 15 mg/dl error from true glucose values when the glucose concentration is below 75 mg/dl.

If you do the math, you will see that a variation between 66 – 89 mg/dl, as shown in the first post above, is likely to be fully allowed by the FDA, even during the testing done by the manufacturer. If the true value were 75 mg/dl, one reading could report as low as 60 mg/dl, while another reading could report as high as 90 mg/dl, and both readings would meet the 2003 ISO standard!  Isn’t this terrible?

In addition, remember that the above “15 mg/dl / 20%” criterion only needs to apply to 95% of the readings.  The other 5% can be completely off the chart, and the meter/strips can still be approved.  Imagine that you get one of the “bad” strips, obtain a completely inaccurate reading, and then treat yourself with what you believe to be the correct dose of insulin … what a disaster! It can be very dangerous.

Many diabetes experts, and in fact the entire industry, gradually came to a realization that this old 2003 standard is too lenient, and may not be able to provide diabetic patients with the best care. Finally, a new standard came out, this year, as a result of collaborative efforts between medical experts and various manufacturers, which is often referred to as the new ISO or ISO 15197:2013.  This new standard specifies that 95% of the data have to be within 15% error from the true value when the glucose concentration is above 100 mg/dl, and +- 15 mg/dl error for glucose concentrations below 100 mg/dl.  As you can tell, this is still not very tight, and will still allow for large measurement variability.  As before, even with this new standard, a glucose level of 75 mg/dl can read anywhere between 60 – 90 mg/dl. Still a very wide range, isn’t it? The new regulation also specifies that the rest of the readings (5%) have to be within Zones A or B of the Consensus Plot, which we will not go into the details of here. But this represents a very wide range, as well.  Currently, most existing meters are filed under the old 2003 ISO standard, even though some might still comply with the new, 2013 ISO.  Only through the careful review of detailed data from both manufacturers and independent reviewers can we draw conclusions about the accuracies of these meters.

 

4 | Technical Challenges for Ensuring Blood Glucose Meter Accuracy

So if this industry has been around for 20+ years, why can’t manufactures make better meters and strips?  Here is the reality:  It is not that challenging to get an accurate reading if we can allow for complicated technologies to be used in these strips.  A YSI, for example, can give very accurate readings, down to 2.5% error consistently.  So why not these glucose strips?  To make accurate readings at such a low cost with such a small meter (therefore relatively cheap electronics) is very challenging. Cost reduction from market competition has forced all glucose diagnostic companies to utilize relatively simple chemistries and manufacturing processes, and therefore compensate to improve the accuracy through very complicated algorithms.

Common Factors that Influence Glucose Meter Accuracy

Hematocrit range:

Hematocrit is the red blood cell level in human blood, and is strongly person-dependent; typically, males have higher hematocrit levels than females.  Generally, a higher hematocrit level will result in a lower (inaccurate) glucose reading, so it is important to correct for that either in the strip chemistry or the algorithm development. A very good example is Agamatrix’s WaveSense Jazz meter, which utilizes a specialized WaveSense technology algorithm to correct for many variations in blood samples, resulting in more accurate readings.  It was one of the first meters to have a wide hematocrit range. Nowadays, many glucose meters have hematocrit correction built into the system, and therefore, it is important to look for these built-in functions when purchasing the meter.

Temperature / Humidity range:

There are two types of temperature/humidity ranges that are typically indicated by the manufacturer.  Storage temperature/humidity and testing temperature/humidity. Obtain meters and strips that can operate at your normal storage and testing conditions. Otherwise, the strips can easily go off calibration, and give inaccurate results.

Chemical Interference:

This is one of the main features on which a user should consult his or her physician. Interference refers to chemicals in your blood that can potentially influence meter readings. This is an area that should never be neglected. There have been many incidents in the history where interfering agents in the body has caused false glucose readings, and resulted in severe medical consequences (including death) (see reference).  This website tries to summarize the major interfering agents for each of the glucose meters in the Glucose Meter Reviews chart.  However, we are not medical doctors.  It is your responsibility to consult your physician about choosing a meter and strip combination that will not be influenced by your current treatment, medicine, or diet.

5 | Editorial Choices

Please go to Glucose Meter Reviews chart, and sort by “Overall Editorial Rating” and find the best rated meter(s).

At this moment, Bayer Contour Next USB, Abbott FreeStyle Lite, Roche Accu-Chek Nano SmartView, and Roche Accu-Chek Aviva Plus are our top four choices.

How To Read the “Glucose Meter Accuracy” Chart

1. If you just want the editorial rating, your job is easy! Just read the second column! This information is also summarized in the Glucose Meter Reviews table in the main page.

2. If you want to know a bit more about accuracy criteria, please read the column of “Within Accuracy limits (+- 15 mg/dl and +- 20%)” criterion, which is the 2013 standard. The new standard requires that >95% data fall within this range, the higher the percentage, the better the accuracy. Correspondingly, the “Within Accuracy limits (+- 15 mg/dl and +- 20%)” criterion, which is the 2003 standard that can be used as a reference.

3. If you want to know even more about the actual data. Read critically and follow the tips below

  • There are 4 types of documents. “Third-party” means the experiments are performed by an independent research group; “Sponsored by A” means the data are physically collected by a research group, but the funding can come from the sponsor. It is difficult to say whether or not the data are influenced by the sponsor; but what can most likely to be true is that if the data turn out to be really bad, or not in favor of the sponsor, the research group probably would not be allowed to publish the data. “Performed by A” means that the specific manufacturer, A, performed the data. Those data set should be reviewed in a most skeptical way. “FDA documents” are performed by the specific manufacturer.
  • However, even data collected by sponsored research or even the manufacturer themselves can be useful. For instance, if manufacturer A reviewed meters from B and C, it is likely you can still trust the comparison between B and C, but be particularly skeptical about data presented by A itself.
  • If the manufacturer collected data or sponsored data show poor accuracy, readers can pretty much believe that their meter/strips are not accurate. There is no incentive for the company to show poor data if their meter/strips have good performance. You would be surprised that sometimes it is the case – the data collected by the manufacturers themselves are not good enough. See Bayer’s Contour USB as an example.
  • We want to make things simple for you – Different color indicates the manufacturer. If there are multiple studies involved, we tried to include all of them. See references in the last column for the source.

4. Left hand site follows 15197: 2003 (old ISO) and right hand side follows 15197:2013 (new ISO). New ISO data are what you should follow, but because most meters are filed under old ISO requirement, we can still use that as a reference especially when new ISO data are not available.

Glucose Meter Accuracy Table (DIN EN ISO 15197: 2003)

This table summarizes accuracy information of major blood glucose meters following the 2003 ISO standard.

Blood Glucose Monitoring Systems
Editorial Rating
Within Accuracy limits (+- 15 mg/dl and +- 20%)
BG concentration < 75 mg/dl
BG concentration >= 75 mg/dl
References
+- 15 mg/dl +- 10 mg/dl +-20% +-15% +-10%
n % % % % % %
Abbott FreeStyle Lite 9 (178/179) 99.4-100 100 100 99.4-100 98.8-99.5 92.5-95.2 FDA doc(k092602)
(200/200) 100 100 100 100 100 100 [2] Sponsored by Roche
(799/800) 99.5-100 100 84-100 99-100 86-100 66-100 [3] Sponsored by Roche
(474/480) 99 100 94 99 97 93 [4] Sponsored by Abbott
Abbott FreeStyle Freedom Lite 8.5 (178/179) 99.4-100 100 100 99.4-100 98.8-99.5 92.5-95.2 FDA doc(k092602)
(204/208) 98.1 97.6 97.6 97.7 94 86.8 [5] Sponsored by Sanofi
(200/200) 100 100 100 100 100 98 [2] Sponsored by Roche
(187/200) 93.5 83 95 [6] Sponsored by Nipro

Glucose Meter Accuracy Table (DIN EN ISO 15197: 2013)

This table summarizes accuracy information of major blood glucose meters following the 2013 ISO standard.

Within Accuracy limits (+- 15 mg/dl and +- 15%)
BG concentration < 100 mg/dl
BG concentration >= 100 mg/dl
+- 15 mg/dl +- 10 mg/dl +-15% +-10% +-5%
n % % % % % %
Abbott FreeStyle Lite 9 (294/301) 97.7 100 83.3 97.3 88.4 61.4 [1] Third Party
(200/200) 100 100 100 100 100 86 [2] Sponsored by Roche
(779/800) 89.5-100 100 86-100 85-100 63-100 31-86 [3] Sponsored by Roche
(471/480) 98 98 92 98 93 69 [4] Sponsored by Abbott
Abbott FreeStyle Freedom Lite 8.5 (200/200) 100 100 100 100 98 90 [2] Sponsored by Roche
(466/488) 95 94 91 96 89 63 [4] Sponsored by Abbott
WaveSense Jazz 8 (173/180) 96.1 100 75 95 80 47 [2] Sponsored by Roche
Bayer Contour 6 (439/510) 94 96 72 94 82 49 [4] Sponsored by Abbott

References

Resources

The information presented on this website is compiled from three categories of resources:

1. Glucose Meter Review Articles or Scientific Literature that are published by independent, third parties.  This type of resources gives the most unbiased, and thus most useful information of all three.  However, sometimes, a given study can only investigate a limited number of meters and strips, and oftentimes, can only study one aspect of performance.  For instance, most studies are focused on system accuracy.  Therefore, we still used the other two types of resources to compile the information presented in this website.

2. Data provided by each manufacturer during 510(k) submission to FDA.  It is worth mention that although the data are from official documents on the FDA website, it is each manufacturer’s responsibility to ensure the validity and accuracy of information.  Most of the 510(k) submissions were filed following the old ISO 19157 (2003) standard, and therefore, it is difficult to assess whether or not these meters also comply with the new ISO 19157 (2013) standard.  However, if detailed data are available, we would manually calculate the accuracy based on the data to evaluate if the device would meet the new ISO 19157 (2013) standard.

3. User’s manual from the manufacturer.  When FDA submission documents are not available (especially with certain old filings), we refer to these documents to obtain information such as hematocrit range, interference level, and others.  Here, it is also the manufacturer’s responsibility to provide as accurate and valid information as possible.

Important:Our website does not take responsibility for the accuracy or validity of the information from any of the (three) resources, above.  It is important for the reader to check with his or her physician before any medical decisions are made.

 

Refereces

 

Review Articles

1.   Hasslacher, C., F. Kulozik, and I. Platten, Accuracy of self monitoring blood glucose systems in a clinical setting: application of new planned ISO- standards. Clinical Laboratory, 2012. 59(7-8): p. 727-33.
2.   Freckmann, G., et al., System Accuracy Evaluation of 43 Blood Glucose Monitoring Systems for Self-Monitoring of Blood Glucose according to DIN EN ISO 15197. Journal of Diabetes Science and Technology, 2012. 6(5): p. 1060-1075.
3.   Baumstark, A., et al., Lot-to-Lot Variability of Test Strips and Accuracy Assessment of Systems for Self-Monitoring of Blood Glucose according to ISO 15197. Journal of Diabetes Science and Technology, 2012. 6(5).
4.   Tack, C., et al., Accuracy Evaluation of Five Blood Glucose Monitoring Systems Obtained from the Pharmacy: A European Multicenter Study with 453 Subjects. Diabetes Technology & Therapeutics, 2012. 14(4): p. 330–337.
5.   Pfützner, A., et al., Clinical assessment of the accuracy of blood glucose measurement devices. Current Medical Research and Opinion, 2012. 28(4): p. 525-531.
6.   Bell, D.E. and T.A. Sasse, Accuracy study of blood glucose monitoring systems: Evaluation of the TRUEresult, OneTouch Ultra2, Ascensia Contour, FreeStyle Freedom Lite.

 

Glucose Meter Accuracy Studies Sponsored or Performed by Manufacturers

Abbott

7.    FreeStyle Lite and FreeStyle Freedom 510(k) decision summary, k092602
8.    FreeStyle Lite Blood Glucose Test Strips 510(k) summary, k092602
9.    FreeStyle Blood Glucose Test Strips 510(k) summary, k092638
10.  FreeStyle Blood Glucose Freedom Style/Freedom Flash 510(k) decision summary, k092638
11.  FreeStyle Lite and FreeStyle Freedom Lite User Manual
12.  Precision Xtra Owner’s Guide

Agamatrix

13.  Presto User Guide
14.  Jazz User Guide
15.  AgaMatrix® White Paper: Performance of the AgaMatrix Presto® Advanced Blood Glucose Monitoring System. 2007.

Bayer

16.  Ascensia Contour blood glucose monitoring system 510(k) decision summary, k060470
17.  Ascensia Breeze 2 blood glucose monitoring system 510(k) decision summary, k062347
18.  Classical Contour USB user’s guide
19.  List, S., et al., Performance Evaluation and Labeling Comprehension of a New Blood Glucose Monitoring System with Integrated Information Management. Journal of Diabetes Science and Technology, 2011. 5(5).
20.  Classical Contour user’s guide
21. Bayer Contour Next USB 510(k) summary,
22. Bayer Contour Next Test Strips 510(k) decision summary, k110894 (click here)

LifeScan

23.  OneTouch Ultra and OneTouch Ultrasmart blood glucose monitoring system 510(k) decision summary, k043197 (click here)
24.  OneTouch Verio IQ blood glucose monitoring system 510(k) decision summary, k110637 (click here)
25.  One Touch user’s guide with accuracy information, (click here)

Roche

26. Roche Accu-Check Aviva 510(k) decision summary, k060620
27. Roche Accu-Check Aviva 510(k) decision summary, k043474
28. Roche Accu-Check Aviva Plus 510(k) decision summary, k101299
29. Roche Accu-Chek Compact Plus 510(k) decision summary, k113614

Sanofi

30. iBGStar 510(k) decision summary, k103544
31. iBGStar User’s Guide

Leave a Reply

Your email address will not be published. Required fields are marked *