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Feds Say “no” To Finger-stick A1c: Health Screening Compliance

Feds Say “no” To Finger-stick A1c: Health Screening Compliance

Afew months ago, my company was engaged in a RFP process for one of our most valued municipal clients of over 3 years. As part of that process, our client asked us to provide pricing for “point of care” (a.k.a. finger-stick) Hemoglobin A1c testing. As we began to explain that, practically speaking, there is no compliant solution available for finger-stick A1c, we were surprised to hear that other health screening vendors were proud to offer this test. To provide some background, finger-stick A1c products were developed to help people who have already been diagnosed with diabetes monInterlinitor their blood sugar levels. Over time screening companies began to use these Hemoglobin A1c tests in the field. A few years ago, the FDA issued a letter to manufacturers of finger-stick A1c test kits clarifying that the tests are only approved for monitoring and that no A1c test had been cleared to diagnose diabetes. Now, understand that health screening vendors do not diagnose, we screen. Screened individuals who show a likely condition are referred to a physician for formal diagnosis. Therefore, health screening vendors continued to offer finger-stick A1c under the assumption that as long as the test was used to screen, not diagnose participants, it would comply with the intended restriction. However, in 2013, manufacturers of finger-stick A1c solutions began discontinuing their lines of finger-stick A1c products, including Bayer who then manufactured a product labeled A1cNow+®. The A1cNow+® product is now manufactured by PTS for its intended purpose of monitoring the blood sugar levels of people already diagnosed with diabetes. The manufacturer’s insert clearly states “This test is NOT for the screening or diagnosis of diabetes” under the section labeled “Limitatio Continue reading >>

A1c Home Test Kits For Diabetes

A1c Home Test Kits For Diabetes

Hemoglobin A1C tests are used to screen for and diagnose prediabetes and diabetes. A1C home test kits are a good option if you want to testyour A1C at home in between visits to your doctor, whether you have type 1 or type 2 diabetes. An A1C test gives a picture of how well your diabetes treatment is working by showing your average blood sugar level for the past two or three months. This can be very helpful in your diabetes management plan. All A1C home test kits allow you to provide a small blood sample, about the same as your glucose meter ,in the convenience of your home. Depending on the type of kit you purchase, you either get immediate results at home or you send the sample to a lab for analysis. Home A1C tests are not approved for diagnosing diabetes. You need to see a doctor for a diagnosis. There are factors that will affect the accuracy of A1C tests, so discuss this with your doctor to ensure you know whether they're appropriate for you. A1C results are affected by hemoglobin variants (such as sickle cell), anemia, transfusion, blood loss, pregnancy, and rheumatoid factor. Portable consumer options for immediate results at home are now available at major retailers, with both name brand and house brand versions. A1CNow SELF CHECK was the original FDA-approved brand from Bayer Healthcare. PTS Diagnostics purchased the A1CNow business in 2014 and markets it under the original name, plus they license it for store brand devices. Walmart sells it as ReliOn Fast A1C Test and Walgreens and CVS as At Home A1C Test Kit. This technology received FDA approval and allows you to learn your A1C number in five minutes. It's similar in appearance to your daily glucose meter, but you don't use it on a continual basis. You purchase this A1C meter in a two-test kit. Once you have Continue reading >>

Easy And Accurate Diabetes Monitoring At Home Is Available

Easy And Accurate Diabetes Monitoring At Home Is Available

The A1CNow device is the easiest and most accurate way for those of us who have diabetes to check our key blood glucose level at home. But it still has spotty availability. Chex Diagnostics, formerly known at Polymer Technology Systems, started shipping it six months ago after the company had purchased the A1CNow business from Bayer Diabetes Care last year. But many pharmacies don’t have it yet. The good news, however, is that we can get it for less than ever before. The pharmacist at the local Kroger supermarket told me today that he had never heard of a way to check our A1C at home. A pharmacist at the most upscale pharmacy near me remembered that they had sold the A1C test when Bayer made it but didn’t have any record of the Chex Diagnostics or Polymer Systems Technology device. I couldn’t find it on the Rite Aid, Target, or Costco websites. But Chex Diagnostics provides the A1CNow device to two retailers who sell it as house brands. Chex Diagnostics owns the proprietary names under which Walgreens sells as the “Walgreens At-Home A1C Test Kit” and which Wal-Mart sells as the “ReliOn Fast A1C Test.” You can get the two tests in the Walgreens At Home A1C Kit for $32.99, according to the company website. At least I think that’s the price, because much of the “overview” information is wrong. Besides describing what is obviously a blood glucose meter, it refers to a “lover limit of the A1C target.” Don’t you love it! The situation at Wal-Mart stores is much better, although its website hasn’t caught up. It’s not yet on the Wal-Mart website, which shows the Bayer version at $29.88 but as no longer available. But Wal-Mart stores started getting their ReliOn Fast A1C Test kits from Chex Diagnostics about two weeks ago, Chex’s Director of Marke Continue reading >>

Testing Your Blood Glucose

Testing Your Blood Glucose

Testing your blood glucose, also known as Self-Monitoring of Blood Glucose (SMBG), is a method of checking how much glucose (sugar) is in the blood using a glucose meter -- anywhere, anytime. Here, you'll learn some basics about: Blood sugar targets for adults How your doctor tests your blood The importance of self-testing When to test and what to look for How to share results with your doctor Blood glucose targets for non-pregnant adults* Before meal After meal 80-120 mg/dL Less than 180 mg/dL How your doctor tests your blood -- the A1C test† Your doctor uses what is called an A1C (Glycosylated Hemoglobin) test to see what your average blood glucose level has been over the last two to three months. Used for both Type 1 and Type 2 diabetes, it gives you and your doctor an indication on how well you are responding to your treatment regimen, and if any adjustments are necessary. The goal is to keep your level below seven percent (7%).* The A1C test is sometimes referred to as the hemoglobin A1c, HbA1c or glycohemoglobin test. The connection between A1C and average blood sugar levels.† Your A1C test result will not show the daily effects of food choices and your activity. A blood glucose meter is the best way to observe and track the immediate effects of food choices and activity on your blood glucose levels. This allows you to take immediate action to bring your glucose levels within range if needed. Your doctor will also rely upon your blood glucose meter results to assess and adjust your treatment regimen. When to test and what to look for – a practical guide Use this simple chart to remind you when to test and what to observe to help you manage your blood glucose level on a daily basis. When to test What to look for First thing in the morning, before you eat How Continue reading >>

Home A1c Testing Vs. The Lab

Home A1c Testing Vs. The Lab

So it was time again for my A1C and other blood tests last week. Over-time, in fact. You know how I hate going in to the lab when I have to be fasting for lipid tests and can't even have a latte on the way over in the morning. Ugh! And who ever said diabetics don't mind needles?! Anyway, I'd been saving the review unit A1c Now SelfCheck pack I got from Bayer a few weeks ago for just this occasion. What better way to test the accuracy of home a A1C testing kit? I don't mind admitting I had very little faith in the thing. My endo had some of these in her office last year, and we tried them several times. The results were always differed wildly from the A1C I got at the hospital lab. She thought her packs might be too old, although the date on the box seemed OK. So after dragging my behind to the hospital that day, and then enjoying a lovely post-needle cafe breakfast with my husband, I went home and snipped the seal on my A1C Now pack. Inside were all the trimmings for two tests, along with a lot of documentation and a mini-CD that's supposed to explain how to use it — which I didn't watch of course. I figured I'd be representative of the "average patient" who is too lazy to watch the CD. (Not to mention that I have ZERO patience myself and ripped right into the thing without thinking ;) ) Lucky for me, the little fold-out Reference Guide with photos did the trick. It told me what to open first, how to prick my finger for the blood (not more than a usual BG test!), and what to open only "AFTER blood collection!" And I must have done it right, because wouldn't you know, I got 6.3 on the Bayer test, and a 6.4 reported back from the hospital lab. Pretty impressive! (Yes, for those science guys but also for me -- under 6.5, Baby!) So I got to experience the "5-minute home A Continue reading >>

Easy And Accurate Diabetes Monitoring At Home Is Available

Easy And Accurate Diabetes Monitoring At Home Is Available

The A1CNow device is the easiest and most accurate way for those of us who have diabetes to check our key blood glucose level at home. But it still has spotty availability. Chex Diagnostics, formerly known at Polymer Technology Systems, started shipping it six months ago after the company had purchased the A1CNow business from Bayer Diabetes Care last year. But many pharmacies don’t have it yet. The good news, however, is that we can get it for less than ever before. The pharmacist at the local Kroger supermarket told me today that he had never heard of a way to check our A1C at home. A pharmacist at the most upscale pharmacy near me remembered that they had sold the A1C test when Bayer made it but didn’t have any record of the Chex Diagnostics or Polymer Systems Technology device. I couldn’t find it on the Rite Aid, Target, or Costco websites. But Chex Diagnostics provides the A1CNow device to two retailers who sell it as house brands. Chex Diagnostics owns the proprietary names under which Walgreens sells as the "Walgreens At-Home A1C Test Kit" and which Wal-Mart sells as the "ReliOn Fast A1C Test." You can get the two tests in the Walgreens At Home A1C Kit for $32.99, according to the company website. At least I think that’s the price, because much of the "overview" information is wrong. Besides describing what is obviously a blood glucose meter, it refers to a "lover limit of the A1C target." Don’t you love it! The situation at Wal-Mart stores is much better, although its website hasn’t caught up. It’s not yet on the Wal-Mart website, which shows the Bayer version at $29.88 but as no longer available. But Wal-Mart stores started getting their ReliOn Fast A1C Test kits from Chex Diagnostics about two weeks ago, Chex’s Director of Marketing Laura Wilke Continue reading >>

Hba1c Test Kits: Home A1c Testing Kits

Hba1c Test Kits: Home A1c Testing Kits

Tweet Home HbA1c testing kits allow you the chance to get a good idea of your HbA1c level. This can be useful in between getting scheduled HbA1c tests from your doctor. Note that home HbA1c tests should not be used as a substitute for the tests from your doctor and should be not be used in place of an official diagnosis. How home HbA1c test kits work Home HbA1c tests can often be carried out within a relatively short space of time. Most home HbA1c tests require a sample of blood from the finger which is then applied to a solution. The solution usually requires a small bit of processing, which can vary depending on the kit. The solution may require one or more of the following: shaking, heating or letting to stand. The solution is then applied to a reagent. The result may be given in different ways depending on the kit. Some kits provide a numeric result, others may provide a yes or no answer as to whether the HbA1c value is above or below a certain number. Make sure you read the instructions through carefully before beginning. Tweet Type 2 diabetes mellitus is a metabolic disorder that results in hyperglycemia (high blood glucose levels) due to the body: Being ineffective at using the insulin it has produced; also known as insulin resistance and/or Being unable to produce enough insulin Type 2 diabetes is characterised by the body being unable to metabolise glucose (a simple sugar). This leads to high levels of blood glucose which over time may damage the organs of the body. From this, it can be understood that for someone with diabetes something that is food for ordinary people can become a sort of metabolic poison. This is why people with diabetes are advised to avoid sources of dietary sugar. The good news is for very many people with type 2 diabetes this is all they Continue reading >>

A1c Calculator*

A1c Calculator*

Average blood glucose and the A1C test Your A1C test result (also known as HbA1c or glycated hemoglobin) can be a good general gauge of your diabetes control, because it provides an average blood glucose level over the past few months. Unlike daily blood glucose test results, which are reported as mg/dL, A1C is reported as a percentage. This can make it difficult to understand the relationship between the two. For example, if you check blood glucose 100 times in a month, and your average result is 190 mg/dL this would lead to an A1C of approximately 8.2%, which is above the target of 7% or lower recommended by the American Diabetes Association (ADA) for many adults who are not pregnant. For some people, a tighter goal of 6.5% may be appropriate, and for others, a less stringent goal such as 8% may be better.1 Talk to your doctor about the right goal for you. GET YOURS FREE The calculation below is provided to illustrate the relationship between A1C and average blood glucose levels. This calculation is not meant to replace an actual lab A1C result, but to help you better understand the relationship between your test results and your A1C. Use this information to become more familiar with the relationship between average blood glucose levels and A1C—never as a basis for changing your disease management. See how average daily blood sugar may correlate to A1C levels.2 Enter your average blood sugar reading and click Calculate. *Please discuss this additional information with your healthcare provider to gain a better understanding of your overall diabetes management plan. The calculation should not be used to make therapy decisions or changes. What is A1C? Performed by your doctor during your regular visits, your A1C test measures your average blood sugar levels by taking a Continue reading >>

Home Glucose Monitoring Offers No Benefit To Patients Not Using Insulin

Home Glucose Monitoring Offers No Benefit To Patients Not Using Insulin

Home Glucose Monitoring Offers No Benefit to Patients Not Using Insulin Am Fam Physician.2017Dec15;96(12):online. Does home monitoring of blood glucose levels improve glycemic control or quality of life in patients with type 2 diabetes mellitus who are not using insulin? Home glucose monitoring of patients in primary care does not improve A1C scores or quality of life over one year in patients who are not taking insulin. Patients did not feel more empowered or satisfied as a result of home monitoring, nor did they have fewer hypoglycemic episodes, and their physicians did not seem to respond to the home glucose levels to any beneficial effect. (Level of Evidence = 1b) These researchers identified adults (average age = 61 years) with type 2 diabetes not treated with insulin and who had A1C levels between 6.5% and 9.5%. Most of the patients (75%) monitored their blood glucose levels at home before the study but had not been treated by an endocrinologist. The 450 patients (who had type 2 diabetes for an average of eight years) were randomly assigned, using concealed allocation, to one of three arms: (1) no home glucose monitoring; (2) standard once-daily monitoring; and (3) enhanced once-daily monitoring, consisting of glucose values immediately reported to the patient plus automated, tailored messaging delivered via the meter. The patients' physicians were given the home glucose monitoring results but were not asked to follow a specific protocol to respond to them. After both six months and one year, there were no differences, on average, among the groups in A1C levels, hospitalizations, episodes of severe hypoglycemia, or quality-of-life scores. Similarly, there was no difference among groups in treatment satisfaction or feelings of empowerment. Study design: Randomized Continue reading >>

Study: A1c Now Test Is Crap And So Are Many Doctor Office A1c Tests

Study: A1c Now Test Is Crap And So Are Many Doctor Office A1c Tests

A study published in the January issue of the journal, Clinical Chemistry put eight brands of A1c test kits, including the A1c Now test sold in pharmacies and online, through rigorous testing. The other kits were the ones marketed to doctors for use in their offices. You can read an abstract of this study here: Six of Eight Hemoglobin A1c Point-of-Care Instruments Do Not Meet the General Accepted Analytical Performance Criteria. Erna Lenters-Westra1, and Robbert J. Slingerland. Clinical Chemistry 56: 44-52, 2010. First published November 19, 2009; 10.1373/clinchem.2009.130641 The study concluded only two of the eight kits produced clinically valid results. What is most telling, though, is that the study reports: Because of disappointing EP-10 results, 2 of the 8 manufacturers decided not to continue the evaluation. Their test kits were removed from the study after they completed only one of three CLSI protocols that were planned. CLSI stands for "Clinical and Lab Standards Institute." Since four of the six kits that remained in the study ended up with unacceptable results, but must have had good enough results after the first protocol to encourage their manufacturers to keep them in the study, one can only conclude that the kits removed from the study did abysmally. Which meters were withdrawn from the study after they did very poorly at the first level of testing? A1c Now and Quo-test. Of the six remaining kits that completed all three laboratory test protocols, Only the Afinion and the DCA Vantage met the acceptance criteria of having a total CV <3% in the clinically relevant range. The CV is the "Coeeficient of variation." It is the statistic that represents the ratio of the standard deviation to the mean. It's a measure of how widely scattered data is. The larger it Continue reading >>

How To Lower Your A1c Levels: A Healthful Guide

How To Lower Your A1c Levels: A Healthful Guide

An A1C blood test measures average blood sugar levels over the past 2 to 3 months. The American Diabetes Association (ADA) recommend the use of A1C tests to help diagnose cases of prediabetes, type 1, and type 2 diabetes. A1C tests are also used to monitor diabetes treatment plans. What is an A1C test? An A1C test measures how well the body is maintaining blood glucose levels. To do this, an A1C test averages the percentage of sugar-bound hemoglobin in a blood sample. When glucose enters the blood, it binds to a red blood cell protein called hemoglobin. The higher blood glucose levels are, the more hemoglobin is bound. Red blood cells live for around 4 months, so A1C results reflect long-term blood glucose levels. A1C tests are done using blood obtained by a finger prick or blood draw. Physicians will usually repeat A1C tests before diagnosing diabetes. Initial A1C tests help physicians work out an individual's baseline A1C level for later comparison. How often A1C tests are required after diagnosis varies depending on the type of diabetes and management factors. Lowering A1C levels Many studies have shown that lowering A1C levels can help reduce the risk or intensity of diabetes complications. With type 1 diabetes, more controlled blood glucose levels are associated with reduced rates of disease progression. With type 2 diabetes, more controlled A1C levels have also been shown to reduce symptoms affecting the small arteries and nerves in the body. This influences eyesight and pain while decreasing complications. Long-term studies have also shown that early and intensive blood glucose control can reduce cardiovascular complications in people with type 1 or 2 diabetes. Even small changes in A1C levels can have big effects. The ADA recommend that maintaining fair control Continue reading >>

Symptoms, Diagnosis & Monitoring Of Diabetes

Symptoms, Diagnosis & Monitoring Of Diabetes

According to the latest American Heart Association's Heart Disease and Stroke Statistics, about 8 million people 18 years and older in the United States have type 2 diabetes and do not know it. Often type 1 diabetes remains undiagnosed until symptoms become severe and hospitalization is required. Left untreated, diabetes can cause a number of health complications. That's why it's so important to both know what warning signs to look for and to see a health care provider regularly for routine wellness screenings. Symptoms In incidences of prediabetes, there are no symptoms. People may not be aware that they have type 1 or type 2 diabetes because they have no symptoms or because the symptoms are so mild that they go unnoticed for quite some time. However, some individuals do experience warning signs, so it's important to be familiar with them. Prediabetes Type 1 Diabetes Type 2 Diabetes No symptoms Increased or extreme thirst Increased thirst Increased appetite Increased appetite Increased fatigue Fatigue Increased or frequent urination Increased urination, especially at night Unusual weight loss Weight loss Blurred vision Blurred vision Fruity odor or breath Sores that do not heal In some cases, no symptoms In some cases, no symptoms If you have any of these symptoms, see your health care provider right away. Diabetes can only be diagnosed by your healthcare provider. Who should be tested for prediabetes and diabetes? The U.S. Department of Health and Human Services recommends that you should be tested if you are: If your blood glucose levels are in normal range, testing should be done about every three years. If you have prediabetes, you should be checked for diabetes every one to two years after diagnosis. Tests for Diagnosing Prediabetes and Diabetes There are three ty Continue reading >>

At Home A1c Testing Systems & Kits: Review

At Home A1c Testing Systems & Kits: Review

The A1C, a Glycated hemoglobin, is a form of hemoglobin that is measured primarily to identify the three-month average blood glucose concentration. The A1C test is limited to a three-month average because the lifespan of a red blood cell is only four months. In other words, it’s the indication of your blood sugar level for a three-month period. Typically, your doctor will test your A1C levels every 90 to 180 days depending on how well your blood sugar levels have been managed. In basic terms, the A1C test checks to see how much glucose is attaching to your red blood cells. You can work to keep your A1C within your target range using a recommended diabetes management regimen along with a well-managed diet, exercise routine and other healthy lifestyle . Normal a1C Prediabetes a1C Diabetic a1c Under 5.7 5.7 to 6.4 6.5 and above A1C Test Features and Pricing While most hospital conducted A1C tests cost around $86 per test (depending on your co-pay), you can now buy the A1C self-check home kit for around $40. Each kit includes one test with two strips, but you can buy a double test kit as well. The kits are not reusable so once you use your two lancets, you must buy another kit. Use Most people use this test every 30 days instead of waiting 90 days to be seen by the doctor. This helps patients have a more accurate reading on where their levels fall throughout the month. Insurance Coverage Most insurances will cover 1 or 2 tests per year and some hospitals will have a sample take-home A1C test that you can ask for. However, not all hospitals do so you may still need to buy over the counter kits depending on how many results a year you want to have or how many your doctor requires. Pros and Cons of Home Testing The A1C at home kit needs four large drops of blood which is eas Continue reading >>

The Pros And Cons Of Diagnosing Diabetes With A1c

The Pros And Cons Of Diagnosing Diabetes With A1c

An International Expert Committee was convened in 2008 by the American Diabetes Association (ADA), the European Association for the Study of Diabetes, and the International Diabetes Federation to consider the means for diagnosing diabetes in nonpregnant individuals, with particular focus on the possibility to indicate A1C as an alternative if not a better tool (1). After reviewing the available literature and a thorough discussion on the advantages and the limits of previous diagnostic strategies (essentially based on fasting glucose assessment) and the considered alternative approach (based on A1C measurement), a consensus was reached that the latter (i.e., A1C) should be included among diagnostic tools for diabetes and, with the exception of a number of clinical conditions, should even be preferred in diabetes diagnosis in nonpregnant adults. The main conclusion of the International Expert Committee was implemented in the most recent clinical recommendations issued by the ADA. However, in these guidelines, A1C is indicated as a diagnostic tool alternative but not superior to blood glucose, leaving to the health care professional the decision about what test to use in an individual. The World Health Organization is currently examining the proposal made by the International Expert Committee and is carefully addressing the controversial issues still remaining, most of which have been the subject of letters to the editor and articles recently published in the literature. Nevertheless, the use of A1C for diagnosing diabetes is rapidly becoming a reality in many Western countries. In the text that follows, one of us (E.B.) will present the main points supporting A1C (pros) and the other (J.T.) will illustrate the main counterpoints challenging A1C (cons) as the primary tool Continue reading >>

Bayer Diabetes Care Launches A1cnow(r) Selfcheck, A New A1c Monitor For At-home Use

Bayer Diabetes Care Launches A1cnow(r) Selfcheck, A New A1c Monitor For At-home Use

Through Self A1C Testing, New Monitor Enables Diabetes Management Between Physician Visits TARRYTOWN, N.Y., June 2 /PRNewswire/ -- Bayer Diabetes Care announced today the launch of A1CNow(R) SELFCHECK, a new A1C monitor that enables people with diabetes to check their A1C level at home. Measurement of A1C provides an average assessment of blood sugar levels over the past three months -- and is an indicator of how well diabetes is being managed. The U.S. Food and Drug Administration recently cleared Bayer's A1CNow SELFCHECK which enables patients to more closely watch their A1C level in between healthcare provider visits so they may modify their diet and exercise, or have a more informed discussion with their healthcare provider based on the results. A1CNow SELFCHECK, which is now available without a prescription and through leading online pharmacies, provides at-home results within five minutes, has an easy-to-use design and delivers lab accuracy. Measuring A1C levels is important for consistent diabetes management, as even a one-percent reduction in A1C reduces the risk of serious complications by 40 percent(1). "A1C testing is an important measure of long-term diabetes management, however, some patients will skip having their A1C tested because they're worried about what their healthcare provider will say if their A1C levels are not good," said Steve Edelman, MD, founder and director, Taking Control of Your Diabetes. "A1CNow SELFCHECK is a new tool that allows people with diabetes to test their A1C level in the comfort and privacy of their own home, to get the information they need to manage their disease in-between healthcare provider visits." At the healthcare provider's office patients can be tested with Bayer's A1CNow+ monitor, which provides results within five m Continue reading >>

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