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How Accurate Are Glucose Meters

Glucose Meters - How Accurate Are They?

Glucose Meters - How Accurate Are They?

I test my blood a lot. If I had to put money on it, I believe I average 8-10 finger pricks a day. Even with a continuous glucose monitor (CGM), I double check my levels every time (okay most times) I eat, feel off and/or need to calibrate. However, I find it interesting when I test my glucose seconds apart, my meter doesn't always tell me the exact same readings. Admittingly, I do not wash and dry my hands everytime before testing (yes it matters), but even when I am well-groomed in the process, two readings can be 5-15 mg/dl different. Sometimes the difference is even more, and if that is the case, I will test a third time. But which glucose reading do I believe? Often I go with what the second reading is (if I am using the same poked finger) or I do a quick average of the two. Overall, if I test and get a number that doesn't relate to how I am feeling, I test again. Besides washing my hands, I try to ensure the test strips are stored in a cool dry place, the lancet is new (I struggle here) and I try to measure my meter's accuracy, comparing it to a lab at my endo appointment, once a year. Thankfully, the technology of blood sugar control is getting better and as of 2016 the standards for all new meters were heightened: 95% of all measured blood glucose meter values must be within 15% of the true value, 99% of meter values must be within 20% of the true value, research on new meters must include at least 350 people with diabetes, larger than previously required, and they require greater hypoglycemia (low blood sugar) accuracy than the 2013 ISO standard. Putting this into practical terms, if the true glucose value is 100 mg/dl, the over the counter meter has to be within 15 mg/dl (85-115 mg/dl) in 95% of cases, and within 20 mg/dl (80-120 mg/dl) in 99% of cases. For hea Continue reading >>

How Accurate Are Home Blood-glucose Meters With Special Respect To The Low Glycemic Range?

How Accurate Are Home Blood-glucose Meters With Special Respect To The Low Glycemic Range?

Abstract Comparisons were made between four blood-glucose meters (Diascan®, Glucometer II®, Reflolux II® and ExacTech®) and a reference method (YSI) for the full, clinical, blood-glucose range and for the subranges < 4.4 mmol/l, 4.4–10.0 mmol/l and > 10.0 mmol/l, respectively. In the low-glucose range, the error-grid analysis was also applied. All the meters showed acceptable agreement with the reference method when the whole glucose range was considered, yielding r-values between 0.96 and 0.99. However, when the results were separated in the different subranges, the outcome was different, in that the Diascan® meter displayed systematically high glucose levels and the ExacTech® meter showed a great spread of the values within the low-glucose range, whereas the Glucometer II® and the Reflolux II® meter were less accurate within the high-glucose range. By applying the error-grid analysis, several errors of clinical importance within the low glycemic range were revealed, while other significant errors, which might lead to inadequate therapeutic decisions, were classified as ‘clinically accurate’. Continue reading >>

Blood Glucose Meter Accuracy

Blood Glucose Meter Accuracy

Tweet Blood glucose meters in the UK should meet the standards set by the International Organization for Standardization (ISO). However, there are a number of factors which could affect the accuracy of a blood glucose result. ISO guidelines state that blood glucose meters should provide results which fall between the upper and lower error bounds, given in the table below, 95% of the time: Within ± 0.83 mmol/L of laboratory results at concentrations of under 4.2 mmol/L Within ± 20% of laboratory results at concentrations of 4.2 mmol/L or more ISO 2003 guidelines on blood glucose meter accuracy bounds Test result given Lower bound Upper bound 1.0 0.17 1.83 1.5 0.67 2.33 2.0 1.17 2.83 2.5 1.67 3.33 3.0 2.17 3.83 3.5 2.67 4.33 4.0 3.17 4.83 5.0 4.00 6.25 6.0 4.80 7.50 7.0 5.60 8.75 8.0 6.40 10.00 9.0 7.20 11.25 10.0 8.00 12.50 12.0 9.60 15.00 14.0 11.20 17.50 16.0 12.80 20.00 18.0 14.40 22.50 20.0 16.00 25.00 Accuracy standards set to improve By the end of May 2016, new standards are being implemented to ensure that blood glucose meters meet stricter accuracy standards. Under the new standard, meters will need to meet the accuracy guidelines 95% of the time: Within ± 0.83 mmol/L of laboratory results at concentrations of under 5.6 mmol/L Within ± 15% of laboratory results at concentrations of 5.6 mmol/L or more ISO 2013 guidelines on blood glucose meter accuracy bounds Test result given Lower bound Upper bound 1.0 0.17 1.83 1.5 0.67 2.33 2.0 1.17 2.83 2.5 1.67 3.33 3.0 2.17 3.83 3.5 2.67 4.33 4.0 3.17 4.83 5.0 4.17 5.83 6.0 5.10 7.06 7.0 5.95 8.24 8.0 6.80 9.41 9.0 7.65 10.59 10.0 8.50 11.76 12.0 10.20 14.12 14.0 11.90 16.47 16.0 13.60 18.82 18.0 15.30 21.18 20.0 17.00 23.53 Expired test strips Always check the expiry date of test strips before performing a test as expi Continue reading >>

The Most Accurate Blood Glucose Meter

The Most Accurate Blood Glucose Meter

Credit: Accu-chek.com The Accu-Chek Aviva was first in an evaluation of a dozen meters conducted by a team of testing experts at Germany’s University of Ulm led by Guido Freckmann, M.D. It led the field in accuracy and precision. Few studies of meter accuracy have appeared in the more than 20 years that I have been writing about diabetes. Dr. Freckmann and his team of researchers have been the most relevant, reliable, and prolific in testing our meters. But some of the meters that they evaluated aren’t available in the United States. The leading diabetes journal that evaluates our meters just released the full text of this meter accuracy study. The editors tell me that the study will be free online only until March 31. Most Relevant Info So don’t wait too long if you want to review the whole thing. Meanwhile, I summarize below what I think is the most relevant information. The journal is Diabetes Technology & Therapeutics, and the study is “Evaluation of 12 Blood Glucose Monitoring Systems for Self-Testing: System Accuracy and Measurement Reproducibility.” The journal published it two years ago, but until now only the abstract has been freely available to us. Dr. Freckmann and his colleagues rated the meters against both the current and proposed standards. The current standard can be met more easily. It requires that at least 95 percent of the results fall within plus or minus 15 mg/dl at blood glucose levels below 75 mg/dl and within plus or minus 20 mg/dl at levels greater than or equal to 75 mg/dl. The International Organization for Standardization (ISO) set this level back in 2003, and it is the standard not only in Europe but also in the United States because the U.S. Food and Drug Administration uses it. The Tighter Standard ISO’s 2013 standard is tigh Continue reading >>

Blood Glucose Monitoring Devices

Blood Glucose Monitoring Devices

What does this test do? This is a test system for use at home to measure the amount of sugar (glucose) in your blood. What is glucose? Glucose is a sugar that your body uses as a source of energy. Unless you have diabetes, your body regulates the amount of glucose in your blood. People with diabetes may need special diets and medications to control blood glucose. What type of test is this? This is a quantitative test, which means that you will find out the amount of glucose present in your blood sample. Why should you take this test? You should take this test if you have diabetes and you need to monitor your blood sugar (glucose) levels. You and your doctor can use the results to: determine your daily adjustments in treatment know if you have dangerously high or low levels of glucose understand how your diet and exercise change your glucose levels The Diabetes Control and Complications Trial (1993) showed that good glucose control using home monitors led to fewer disease complications. How often should you test your glucose? Follow your doctor's recommendations about how often you test your glucose. You may need to test yourself several times each day to determine adjustments in your diet or treatment. What should your glucose levels be? According to the American Diabetes Association (Standards of Medical Care in Diabetes 2011, Diabetes Care, January 2011, vol.34, Supplement 1, S11-S61) the blood glucose levels for an adult without diabetes are below 100 mg/dL before meals and fasting and are less than 140 mg/dL two hours after meals. People with diabetes should consult their doctor or health care provider to set appropriate blood glucose goals. You should treat your low or high blood glucose as recommended by your health care provider. How accurate is this test? The ac Continue reading >>

Assessing Glucose Meter Accuracy

Assessing Glucose Meter Accuracy

Background: Self-monitoring of blood glucose plays an important role in the management of diabetes, particularly in patients treated with insulin. Blood glucose meters must have sufficient accuracy to allow patients and clinicians to monitor glycemic control and then modify treatment accordingly. Although several standards have been proposed, a consensus about how to measure glucose meter accuracy is not available. Scope: An informal review of recently published articles dealing with glucose meter accuracy was conducted to provide recommendations for evaluating accuracy relevant to the practicing clinician. Findings: Whether in clinical practice or in accuracy studies, the accuracy of blood glucose meters is typically determined by comparing meter results to those obtained by a clinical laboratory method on samples collected from the same patient at the same time. However, multiple sample-related, analysis-related, and data display-related factors can have an impact on accuracy determination. Clinicians need to recognize these factors and take steps to minimize their impact when assessing the accuracy of glucose meters used by their patients. Conclusions: Although modern glucose meters show variable results with respect to analytical measures of accuracy, error grid analysis demonstrates that measurements deemed clinically acceptable approach 100%. Continue reading >>

How Accurate Is My Blood Glucose Meter?

How Accurate Is My Blood Glucose Meter?

As diabetics, we do it twice a day, sometimes more. We prick our finger, gather a drop of blood, and it is sucked up by a little plastic strip inserted in our blood glucose meter. Then we wait for a few seconds to see how we are doing. Am I on track? I think I have been pretty good. …then the result comes and it’s not what you expected. Where did I go Wrong? On the day this happened to me, my first instinct was to look at my behaviors. It was a Sunday and I spent the whole day cleaning the house, cooking, and helping the kids with homework. Not too active but moving all day. I double checked myfitnesspal. Did I log all my food? Yes Were my carbohydrates high? No (only 35 grams for the whole day!) If you don’t believe me, you can check my daily log for that day here. What else could it be? What changed My Blood Glucose Meter is brand new. In fact this is the first time I have used it. That couldn’t be it though, could it? I am testing on my finger instead of my forearm, but that couldn’t be it either could it? Well it turns out both of those things could be it. I had just gotten a new glucose meter and it required testing from my finger, instead of my forearm like my old one. Up to this point I assumed all of the blood glucose meters available at my local pharmacy, or online were the same. And for the most part, they are. But I did a little bit of research and found some interesting information. How Accurate is My Blood Glucose Meter? Finally Avi…Get to the point already!!! I know, the suspense is killing you. You have been waiting on the edge of your seat for first 250 words for me to finally reveal the big news. Well here it is. The FDA says that home blood glucose meters don’t have to be 100% accurate. Wait…What? You read that correctly. The reading on Continue reading >>

What Are Satisfactory Blood Glucose Meter Readings?

What Are Satisfactory Blood Glucose Meter Readings?

As of 2007, 7.8 percent of the U.S. population has diabetes, according to the American Diabetes Association. Although this condition can lead to life-threatening complications if not controlled, monitoring your blood sugar with a blood glucose meter can help you maintain healthy glucose levels and avoid complications. If you have diabetes, consult a health care provider about the glucose meter readings that are ideal for you. Video of the Day If you don't have diabetes, your blood glucose meter readings should be between 70 to 100 mg/dL at all times. Your fasting blood glucose, measured after 8 hours without food, should be less than 100 mg/dL. A glucose level below 70 indicates hypoglycemia, or low blood sugar. If your fasting blood glucose level is between 100 to 125 mg/dL, you may have impaired fasting glucose, also called prediabetes. Levels above 126 mg/dL indicate diabetes. Those with diabetes should aim for a fasting blood glucose level of between 70 to 130 mg/dL and less than 180 mg/dL after a meal, advise experts from the American Diabetes Association. The above ranges refer to readings on plasma calibrated meters. Infants and Children Normal, non-diabetic fasting blood glucose ranges are the same as for adults. In children with diabetes, fasting blood glucose levels may be somewhat higher. For children younger than 5 years old, 80 to 200 mg/dL is an acceptable range, note child health experts from Boys Town Pediatrics. From ages 5 to 11, these levels should be 70 to 180 mg/dL and for children ages 12 and older, levels should be 70 to 150 mg/dL. Glucose is the source of energy for all systems in the body; without sufficient glucose, the body and brain can't function normally. Hypoglycemia can cause rapid heartbeat, trembling and dizziness, and severe cases may Continue reading >>

Experts Question The Accuracy Of Blood Glucose Meters

Experts Question The Accuracy Of Blood Glucose Meters

A letter published in Diabetes Care raises concerns about the accuracy of blood glucose meters at low glucose levels. The authors point to recent studies that reached this conclusion by testing the blood glucose meters made by Roche ($RHHBY), Abbott ($ABT), Bayer, Johnson & Johnson ($JNJ), Nipro Diagnostics and others. The deviations from reference values established by an advanced glucose analyzer, "might be one reason why the FDA does not accept BG measurement data from point-of-care or self-monitoring BGMs as evidence for the efficacy of any insulins or antidiabetes drugs with regard to reduction in hypoglycemic events. Consequently, this raises the question of which BGMs can be used in clinical trials that aim at showing a benefit in terms of hypoglycemia risk that must document a sufficient accuracy in the low range," the letter states. Blood glucose monitors must meet guidelines set by the International Organization for Standardization and the FDA. The letter's authors point out that the requirements apply to the entire glycemic range, meaning that if the devices are very accurate at measuring glucose levels at high concentrations, they can consequently make more errors at low glucose concentrations and still meet the requirements. They suggested use of a certain technique for measuring blood glucose levels. One of the studies referenced in the letter found that the Bayer's Contour Next System blood glucose meter was the most accurate. But Bayer is slated to sell its diabetes care business to Panasonic Healthcare, which is 80% owned by private equity giant KKR. Restrictive reimbursement measures in the U.S. have sent revenues from basic diabetes supplies tumbling, making the business less attractive. Critics have said that the federal Centers for Medicare & Medica Continue reading >>

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

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 Arkr Continue reading >>

When Should I Replace My Blood Glucose Meter?

When Should I Replace My Blood Glucose Meter?

Replace your blood glucose meter for diabetes every one to two years. That's how long a typical glucose monitor will last if you're diligent about proper maintenance—like cleaning the lens, keeping batteries fresh and using the "check strip" with each new container of diabetic test strips. If an unusually high or low blood sugar result occurs, retest to verify the result; when the blood glucose meter stops being 100 percent reliable, check with your health insurance company about replacing it. When you do get a new glucose machine, keep the old one as a backup unless the doctor treating your diabetes feels it has become too unreliable. By Joyce A. Generali, M.S. FASHP, R.Ph., director of the University of Kansas Drug Information Center and the author of The Pharmacy Technician’s Pocket Drug Reference From our sister publication, Diabetes Focus, Summer 2011 Continue reading >>

Accuracy Standards In Glucose Meters: Why Do Different Meters Read Different Results?

Accuracy Standards In Glucose Meters: Why Do Different Meters Read Different Results?

Our diabetes educator helps you understand your blood glucose meter. My patients frequently come to me with questions concerning their blood glucose testing equipment. A commonly asked question is “Why do my testing results vary meter to meter?” The answer simplified is that meters are tested for accuracy and must adhere to standards that prior to 2014 in the US, could vary by 20 percent and can now only vary by 15 percent. The variation allowance confused a lot of patients. This can be especially alarming when using a new product that doesn’t seem to “match up” to a blood glucose meter you have been using. The ISO, International Standards Organization, has guidelines that meter companies must meet. The FDA in the US follows these guidelines. Currently, all measured blood glucose meter values must be within 15 percent of the true lab value of blood glucose 95 percent of the time and within 20 percent of the lab value 99 percent of the time. The standards also go on to state that 95 percent of all test results be within 20 percent of test results greater than 75mg/dl and within 15mg/dl for values The standards also go on to state that 95 percent of all test results be within 20 percent of test results greater than 75mg/dl and within 15mg/dl for values below 75mg/dl (this additional criterion was set up for meters used in physician offices.) Although this can be confusing, a blood glucose value that is a lab value of 100mg/dl could conceivably show up on a meter as 80-120mg/dl and still be considered accurate. Fortunately, Dario has undergone considerable testing and meets and/or exceeds ISO standards by being within blank percent 99% of the time. What does this mean for you, the end user? This means that meters manufactured before the stricter ISO standards wer Continue reading >>

Accuracy Evaluation Of Five Blood Glucose Monitoring Systems Obtained From The Pharmacy: A European Multicenter Study With 453 Subjects

Accuracy Evaluation Of Five Blood Glucose Monitoring Systems Obtained From The Pharmacy: A European Multicenter Study With 453 Subjects

Go to: Abstract This multicenter study was conducted to evaluate the performance of five recently introduced blood glucose (BG) monitoring (BGM) devices under daily routine conditions in comparison with the YSI (Yellow Springs, OH) 2300 Stat Plus glucose analyzer. Five hundred one diabetes patients with experience in self-monitoring of BG were randomized to use three of five different BGM devices (FreeStyle Lite® [Abbott Diabetes Care Inc., Alameda, CA], FreeStyle Freedom Lite [Abbott Diabetes Care], OneTouch® UltraEasy® [LifeScan Inc., Milpitas, CA], Accu-Chek® Aviva [Roche Diagnostics, Mannheim, Germany], and Contour® [Bayer Vital GmbH, Leverkusen, Germany]) in a daily routine setting. All devices and strips were purchased from local regular distribution sources (pharmacies, four strip lots per device). The patients performed the finger prick and the glucose measurement on their own. In parallel, a healthcare professional performed the glucose assessment with the reference method (YSI 2300 Stat Plus). The primary objective was the comparison of the mean absolute relative differences (MARD). Secondary objectives were compliance with the International Organization for Standardization (ISO) accuracy criteria under these routine conditions and Clarke and Parkes Error Grid analyses. MARD ranged from 4.9% (FreeStyle Lite) to 9.7% (OneTouch UltraEasy). The ISO 15197:2003 requirements were fulfilled by the FreeStyle Lite (98.8%), FreeStyle Freedom Lite (97.5%), and Accu-Chek Aviva (97.0%), but not by the Contour (92.4%) and OneTouch UltraEasy (91.1%). The number of values in Zone A of the Clarke Error Grid analysis was highest for the FreeStyle Lite (98.8%) and lowest for the OneTouch Ultra Easy (90.4%). FreeStyle Lite, FreeStyle Freedom Lite, and Accu-Chek Aviva perform Continue reading >>

Meter Accuracy

Meter Accuracy

Two things landed on my desk recently. One was a newspaper article saying that the Food and Drug Administration has asked the international body that sets standards for home blood glucose meters to tighten its accuracy requirements. (A public meeting on the topic is scheduled for March 16 and 17.) The other was a letter from a Diabetes Self-Management subscriber who described how she had attempted to compare two home meters with a plasma glucose measurement done in a laboratory — and how she was unnerved when she got three different readings. Stricter standards for meter accuracy would be a welcome development: Currently, most available blood glucose meters are accurate only to within 10% to 15% of the actual blood glucose level. But it will likely be a while before standards are changed and more accurate meters become the norm. In the meantime, there are steps you can take to get the best possible results from your meter. One of the most important is to use only strips made for your meter and to use them correctly. This includes making sure the strips have not passed their expiration date, coding your meter for each new batch of strips (if you use a meter that requires coding), and being careful to store your strips in their original container, away from sources of heat, cold, or humidity. Improperly used or stored strips are one of the biggest sources of error in home blood glucose monitoring. To check whether a batch of strips is OK, use a drop of the control solution (unexpired!) that’s compatible with your meter on one of the strips in the batch. If you still want to check the accuracy of your meter by comparing it to a laboratory measurement, there is a way to do that. But getting meaningful results requires doing it right — both on your end and on the labor Continue reading >>

Blood Glucose Monitors

Blood Glucose Monitors

Uncompromising Accuracy All of our meters feature WaveSense™ technology, a proprietary suite of measurement techniques using dynamic electrochemistry® to correct factors that can impact the accuracy of blood glucose measurements. Device % of readings within ± 15% of reference* BGStar® (AgaMatrix/Sanofi) 98.8% iBGStar® (AgaMatrix/Sanofi) 96.5% Leading Competitor 1 91.8% Leading Competitor 2 93.5% Leading Competitor 3 94.0% Leading Competitor 4 91.2% *For readings with reference glucose value ≥ 75 mg/dL, n=170 Source: Institute for Clinical Research and Development, Mainz, Germany; Pfützner A et al. Clinical assessment of the accuracy of blood glucose measurement devices. Curr Med Res Opin. 2012;28:525-531. Intelligent Meters Current and upcoming blood glucose monitors push the boundaries of blood glucose monitoring technology. MyStar Extra® is the first self-monitoring device to provide estimated hemoglobin A1c values.* Blood glucose readings and other user input are used as a tool for insulin dose calculations, complementing widely prescribed and newly developed insulin therapies. Connected Meters Developing meters that can connect to external devices and systems means that a simple blood glucose test can lead to actionable insights: an estimated A1c, a dose calculation, a detected pattern, etc. Wireless Connection The emergence of faster, more reliable wireless technology means that the days of searching for the right cable are over. Perform a blood glucose test and the results are seamlessly transferred to any compatible system for storage and analysis. Just test – it's that easy. Where to Buy Products available at major retailers including: and online: Buy Now Continue reading >>

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