Fda Approves First-ever Blood Sugar Monitor That Doesn't Require A Fingerstick
In a milestone for Americans with diabetes, the Food and Drug Administration (FDA) has cleared the first-ever continuous blood sugar monitoring device that doesn’t require patients to take potentially painful and invasive blood tests that require pricking their fingertips to collect samples. The approval was granted to Abbott Diabetes Care, Inc. The device, Abbott’s FreeStyle Libre Flash Glucose Monitoring System, is approved for adult diabetes patients 18 years of age and older, and the approval sent Abbott stock up 3.5% in Thursday trading. It slashes the need for the so-called fingerstick tests that people with diabetes regularly endure to figure out whether their blood sugar levels are too high or too low, and to monitor general fluctuation in blood glucose so they can adjust their diets or medication. The device itself uses an under-the-skin sensor wire which keeps tabs on sugar levels. In order to get a gauge on where those glucose levels are at, users simply have to wave an accompanying, specialized mobile reader device over the sensor like a wand. “The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said the FDA’s Donald St. Pierre in a statement. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.” Medical device and tech companies alike have shown growing interest in diabetes management and monitoring devices. Last year, the FDA approved an artificial pancreas from device giant Medtronic to treat people with type 1 diabetes with a largely automated glucos Continue reading >>
Imagine Living A Healthier Life With Glucowise™
We are developing a new non-invasive glucose monitor that will help you take control of your life. (Caution: GlucoWise is still under development and not available for public testing. If you are interested please use the "Get involved" signup form on this page. Due to the overwhelming demand we are unable to respond to individual emails - we are focused on getting the device to the market quickly). Glucowise™ is a non-invasive, 100% pain-free device that makes traditional blood sampling a thing of the past. Our unique sensor technology will allow you to monitor blood glucose levels without the need to pierce your skin. Simple yet highly reliable, Glucowise™ will exceed industry standards for self-monitoring blood glucose accuracy. You will be able to sample as often as you like and wherever you like, ensuring you avoid sudden hypoglycemic events. Our App and Smart Cloud technology delivers personalised advice and alerts, helping you to fully manage your condition. Intelligent analytics will use your current and historical data to calculate and forecast immediate trends in your blood glucose levels, allowing you to adjust your food or medication intake according to your activities or how you are feeling. Glucowise™ will offer unlimited testing without the need for costly consumables, so you can test as often as you like without having to worry about the cost or pain. The compact design will offer you high levels of privacy. It will take no more than 10 seconds to provide a simple, fast and highly discrete testing experience – anytime, anywhere. The data can then sent wirelessly and securely to your smartphone or tablet. Take control There are many situations whereby conventional testing is challenging. Often people with diabetes will unnecessarily expose themselv Continue reading >>
When To Get A New Blood Glucose Meter?
I have had my current glucose meter for over 10 years. When should one consider getting a new meter? As long as the manufacturer still makes the strips, does it matter? Can meters become unreliable? Karen Adsit, Chattanooga, Tennessee Belinda Childs, ARNP, MN, BC-ADM, CDE, responds: When I am asked this question in the office, I usually answer that the glucose meter you are using is acceptable as long as it is giving you accurate readings. The best way to know if your meter is accurate is to use the "glucose control" solution for your brand of glucose meter and strips. The meter companies recommend that you do this with each new bottle of test strips and any time you suspect that you may not be getting accurate readings. However, the glucose control solution is generally only good for 30 days after you open the bottle. Some health care providers correlate meters with lab readings, but you must remember that there can be as much as a 10 to 15 percent variation between the readings you get with your meter from one test to the next, as well as between a home test and a lab result. The key to your question, though, is that you have not had a new meter in more than 10 years. Technology has improved significantly over the past decade. Meters now require much less blood, and thus a smaller needle stick. This means less pain on the fingers. With many meters, you can also use alternate site testing and give your fingertips a break. Test strip technology is better, too. Some strips allow reapplying blood on the same strip if there's not enough there to get a reading, so you do not use as many strips (and save on cost). Most manufacturers have removed the need to enter a code or change a code strip with each new bottle of strips. Many meters now have data management programs to h Continue reading >>
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Glucose Meter
Four generations of blood glucose meter, c. 1993–2005. Sample sizes vary from 30 to 0.3 μl. Test times vary from 5 seconds to 2 minutes (modern meters typically provide results in 5 seconds). A glucose meter is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained by pricking the skin with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dl or mmol/l. Since approximately 1980, a primary goal of the management of type 1 diabetes and type 2 diabetes mellitus has been achieving closer-to-normal levels of glucose in the blood for as much of the time as possible, guided by HBGM several times a day. The benefits include a reduction in the occurrence rate and severity of long-term complications from hyperglycemia as well as a reduction in the short-term, potentially life-threatening complications of hypoglycemia. History[edit] Leland Clark presented his first paper about the oxygen electrode, later named the Clark electrode, on 15 April 1956, at a meeting of the American Society for Artificial Organs during the annual meetings of the Federated Societies for Experimental Biology.[1][2] In 1962, Clark and Ann Lyons from the Cincinnati Children’s Hospital developed the first glucose enzyme electrode. This biosensor was based on a thin layer of glucose oxidase (GOx) on an oxygen electrode. Thus, the readout was the amount of oxygen consumed by GOx during the enzymatic reaction with the substra Continue reading >>
The Best Glucometers Of 2018
Our Process We spent over 80 hours researching the best 30 glucometers on the market. We considered the specifications, features, user reviews, medical studies, availability and cost. After eliminating models that used old technology, like coding, or were too difficult to find in stores, we purchased the best 12 blood glucose meters so we could perform hands-on evaluations of each device. Before diving into our recommendations for the best glucometers, it’s important to note that Top Ten Reviews is not a substitute for your primary care physician. Our recommendations are made based on common scenarios, hands-on experience, market cost evaluations and a comparison of important features, but they’re not a replacement for advice from your doctor. We are not medical experts. $19.99 The Accu-Chek Aviva Connect gets its name from its main feature – Bluetooth that connects it to a mobile app on your smartphone. This provides excellent data management of your readings so you can spot patterns and better treat your diabetes. In addition, the device's interface is one of the easiest to navigate. It has multiple buttons so you can get to the features you need quickly, and the display is high-contrast with big numbers. Another reason why the Aviva Connect is the best glucometer is the availability of its test strips – they are everywhere. We couldn't find a pharmacy or online store that didn't stock them. Of course, the one significant downside to the test strips is their cost. At $1.39 per strip in a pack of 100 and $1.52 per strip in a pack of 50, they’re more expensive than most test strips on the market. Best Glucometer for Value & Availability $13.95 The CONTOUR NEXT is our pick for the best glucometer if your primary concerns are overall value and the availability o Continue reading >>
Top 10 Popular Blood Glucose Meters Put To The Test
With countless blood glucose meters on the market, how do you know which one to choose? Do you choose the most expensive one; it must work the best if it costs the most, right? Or are you a techie looking for a Bluetooth meter that syncs to your smartphone? Perhaps, you’re concerned with the cost and you’re looking for the most affordable meter. Top 10 Glucose Meters We’ve taken the time to test the ten most popular blood glucose meters. Take a look to find the meter that’s the best fit for you. Winner and our favorite meter is One Touch Ultra 2. OneTouch Ultra 2 Accu-Chek Aviva Connect Walmart ReliON Confirm OneTouch Verio Abbott FreeStyle Lite Walgreens True2Go Contour Next EZ Livongo Health In Touch Meter Nova Max Plus Sanofi iBGStar Our Pick After a careful review of the top glucose meters on the market, our #1 recommendation is the One Touch Ultra 2. It’s simply one of the best in terms of functionality and price. Click here to learn more. (Helpful Tip: Although you can get one from your local pharmacy, you’ll find it cheaper on Amazon. Click here to get yours.) Accu-Chek Aviva Connect The Accu-Chek Aviva Connect gets its name from the Bluetooth connection that syncs to the user’s smartphone. The Connect utilizes an app to keep track of both short-term and long-term readings on a person’s smartphone. The user can also view their trends via bar graphs and maps on the app. The Accu-Chek Aviva Connect will cost you $29.99 and $1.75 for a single test strip. One con to this meter is that the test strips are one of the highest priced strips on the market. However, they are readily available in almost all drug stores and pharmacies. Accu-Chek also offers a supplemental program called Preferred Savings which can reduce most test-strip co-pays to $15-$45. Ot Continue reading >>
Glucose Meters: What's On The Horizon?
If you've got diabetes, regular blood glucose (sugar) testing is a fact of life. And getting your all-important glucose level has become easier. Today's glucose meters are more sensitive, and require less blood -- which likely equates with less pain. That advance has been a big one for people with diabetes. But will the "ouch" ever go away? Researchers are hard at work -- developing special contact lenses, fluorescent "tattoos," infrared devices, and smart sensors to decipher your glucose levels -- with them being "ouchless" as their goal. In some cases, no blood testing is required -- maybe one prick at the most. Guenther Boden, MD, chief of endocrinology at Temple University School of Medicine, has monitored developments in this field over the last few decades. "The GlucoWatch Biographer seemed like the answer," Boden tells WebMD. "The underside of the watch has a membrane that can suck interstitial fluid through the skin; get 'juice' out of skin, so to speak. And that's what you need to measure glucose; you need to get some body fluid. The technology seems to work. But skin irritation has been a problem for some people." That problem is being corrected, says Audrey Finkelstein, a spokeswoman for Animas Corporation, the product's maker. "We are presently working on Biographer III, which will combine the Biographer with tiny microneedles that will extract fluid to provide a better blood sample than is possible with other technologies. It will also greatly reduce or even eradicate skin irritation." Products like GlucoWatch are good at alerting patients to impending danger -- especially necessary during sleep hours. "It's a dangerous thing for people to buy a product like this, thinking they won't need to do finger sticks anymore ... You simply can't replace finger stick Continue reading >>
Accuracy Evaluation Of A New Glucometer With Automated Hematocrit Measurement And Correction
Volume 356, Issues 12 , June 2005, Pages 178-183 Accuracy evaluation of a new glucometer with automated hematocrit measurement and correction Author links open overlay panel Lokinendi V.Raoa Blood glucose meters are widely used in point of care testing, however, many studies have shown inaccuracies in the glucose measurement due to a number of factors. The present study evaluated the accuracy of a new glucometer capable of simultaneous measurement of patient's hematocrit with algorithmic adjustment of glucose result. This meter was compared with a reference method and 2 other existing meters widely used in the market. Venous whole blood samples from healthy volunteers were pooled and reconstituted to produce 5 different hematocrit (3060%) concentrations. Each hematocrit specimen was spiked to produce 4 different glucose (50500 mg/dl) concentrations. Hematocrit measured by the new meter correlated well with the reference method. Mean percentage error differences, compared to the reference method, showed obvious differences between existing meters across the wide hematocrit range at various glucose concentrations. The new meter showed a steady and consistent glucose concentrations compared to the reference method. The new glucometer, which simultaneously measures hematocrit and performs automated correction for the hematocrit effect, provides a glucose result with improved accuracy. Its measurement of hematocrit from the same blood sample will eliminate the need for additional collection of blood or measurement using another method. Continue reading >>
- Diagnostic accuracy of resting systolic toe pressure for diagnosis of peripheral arterial disease in people with and without diabetes: a cross-sectional retrospective case-control study
- Screening for neonatal diabetes at day 5 of life using dried blood spot glucose measurement
- A Craftsman Blames His Tools: Blood Glucose Meter Accuracy & Long-Term Diabetes Control
Are Blood Glucose Meters Accurate? New Data On 18 Meters
Results from the Diabetes Technology Society’s Blood Glucose Meter Surveillance Program identifies only six out of 18 meters that passed. Did yours make the cut? The Diabetes Technology Society (DTS) recently revealed long-awaited results from its Blood Glucose Monitor System (BGMS) Surveillance Program. The rigorous study tested the accuracy of 18 popular blood glucose meters (BGM) used in the US. These FDA-cleared meters were purchased through retail outlets and tested rigorously at three study sites in over 1,000 people (including 840 people with diabetes). The results were troubling: only six out of the 18 devices met the DTS passing standard for meter accuracy – within 15% or 15 mg/dl of the laboratory value in over 95% of trials. The devices that passed were: Contour Next from Ascensia (formerly Bayer) – 100% Accu-Chek Aviva Plus from Roche – 98% Walmart ReliOn Confirm (Micro) from Arkray – 97% CVS Advanced from Agamatrix – 97% FreeStyle Lite from Abbott – 96% Accu-Chek SmartView from Roche – 95% The devices that failed were: Walmart ReliOn Prime from Arkray – 92% OneTouch Verio from LifeScan – 92% OneTouch Ultra 2 from LifeScan – 90% Walmart ReliOn Ultima from Abbott – 89% Embrace from Omnis Health – 88% True Result from HDI/Nipro (Trividia) – 88% True Track from HDI/Nipro (Trividia) – 81% Solus V2 from BioSense Medical – 76% Advocate Redi-Code+ from Diabetic Supply of Suncoast – 76% Gmate Smart from Philosys – 71% Get the full data and all the accuracy information here. While all of these meters received FDA clearance at some point, this study shows that not all are equivalent in terms of accuracy. The FDA looks at company-reported trials when it reviews new meters; this study took an independent look, purchasing the meters di Continue reading >>
All-in-one Smart Glucose Meter
The Dario All-In-One Smart Glucose Meter is specially designed to fit your lifestyle in the digital age. This sleek, complete glucose monitoring solution includes a simple-to-use glucose meter, a disposable test strip cartridge holding 25 test strips, and lancing device – and easily fits in your pocket. Using the technology and mobility of your smartphone, the Dario connects to your mobile device and automatically logs your blood glucose measurements, sharing your results with caregivers and doctors – no matter where you are on the globe. Why You’ll Love the Dario Smart Glucose Meter Connects directly to your Smartphone – no need for extra cables or adapters Rapid results – receive your blood glucose reading within 6 seconds Accurate – Dario accuracy meets ISO standards with only a small blood sample Pocket-Size Meter – easily fits into your purse or pocket, no need for a bulky pouch or case Battery free – the power comes from the SmartPhone. No need to carry extra batteries for your glucose meter Strip Cartridge Each strips cartridge holds 25 disposable strips. Reloading your strips is simple, just pull out the old cartridge and insert a new one. Glucose Meter The simple-to-use Dario Smart Glucose Meter automatically tracks your blood sugars with a tiny meter that plugs into your phone’s audio jack. Blood glucose readings are directly tracked, charted, and analyzed for you. Lancing Device The Dario All-In-One Smart Glucose Meter contains a lancing device for convenient blood glucose testing. Simply place your finger on the lancet end of the Dario, pull down on the lancet slider, and push the release button to use. Smart Mobile Device Integration The Dario Smart Glucose Meter is cleared for use with a variety of mobile devices. The glucose meter pops o Continue reading >>
Goodbye Glucometer: New Device Could Make Pinpricks History For Diabetics
Goodbye Glucometer: New device could make pinpricks history for diabetics This week , two scientists, formerly students at MITs George R. Harrison Spectroscopy Laboratory, announced they had further refined a device that could let we diabetics monitor blood sugar levels without piercing our fingers several times daily. The Raman spectrograph works by shining a low-powered laser though the thin fold of skin between the thumb and forefinger, eliminating the need to draw blood. They have reduced the size of the previous prototype (a tabletops worth of equipment) to the current prototype (which is the size of a shopping cart). The corresponding tests would take about one minute. As most of us can imagine, it wouldnt be too convenient to push along our glucometer shopping carts all day (unless of course, someone was pushing you to work down a hill . . . =whee!). The scientists are working to reduce the size of the device to a portable level. This story was like a walk down memory lane to the time I received my first glucometer at the age of six. The thing was the size of a car battery (I may be exaggerating here, but I was six years old and my hands were a lot tinier). I remember this thing vividlyit took about half the size of a dimes amount of blood, and had a sixty second countdown. During those sixty seconds, if you so much as TOUCHED the machine or looked at it funny, you would get a giant beeping ERROR message and have to start the process all over again. Three or four of such errors in a row could leave you feeling dizzy and in need of a transfusion. Every few days, you would need to disassemble the interface of the glucometer, to clean off the dried blood that had seeped into its machinery. A tummy-churning routine to be sure. Ive met people in the recent past thoug Continue reading >>
New Plasma Separation Glucose Oxidase-based Glucometer In Monitoring Of Blood With Different Po2 Levels - Sciencedirect
New Plasma Separation Glucose Oxidase-based Glucometer in Monitoring of Blood With Different PO2 Levels The PalmLab glucometer is a newly designed plasma separation glucose oxidase (GO)-based glucometer. Past studies have shown that the accuracy of GO-based glucometers is compromised when measurements are taken in patients with high PO2 levels. We performed a two-arm study comparing the fitness of the PalmLab blood glucometer with that of a standard glucose analyzer in monitoring blood glucose levels in pediatric patients, especially when arterial partial pressure of oxygen (PO2) was high. In the first arm of the study, arterial blood samples from pediatric patients were measured by the PalmLab blood glucometer and the YSI 2302 Plus Glucose/Lactate analyzer. In the second arm of the study, venous blood samples from adult volunteers were spiked with glucose water to prepare three different levels of glucose (65, 150, and 300mg/dL) and then oxygenated to six levels of PO2 (range, 40400mmHg). The biases of the PalmLab glucometer were calculated. A total of 162 samples were collected in the first arm of the study. Results of linear regression showed that the coefficient of determination (R2) between PalmLab glucometer and standard glucose analyzer was 0.9864. Error grid analysis revealed that all the results were within Zone A (clinically accurate estimate zone). The biases between the two systems were low at different PO2 levels. In the second arm of the study, the results were also unaffected by changes in PO2. The PalmLab glucometer provides accurate results in samples with high PO2 and is suitable for measuring arterial glucose levels in pediatric patients. Continue reading >>
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A Diabetes Monitor That Spares The Fingers
For the past year and a half I’ve been buying a medical device from Italy that has improved my life immeasurably. It wasn’t easy: I roped in a good friend who had moved to Milan to buy the device and ship it to me because it wasn’t yet available in the States. And it was expensive: over $1,600 a year. But my black-market purchase helps me manage my Type 1 diabetes without the need to draw blood from my callused fingers 10-plus times a day to track my glucose level, a ritual that had been an unpleasant part of my life for decades. The FreeStyle Libre, made by Abbott, is a flash glucose sensor that allows people with diabetes to view our blood sugar every minute of the day without a single finger prick. While there are similar devices on the market — called continuous glucose monitors, or CGMs — the Libre is the least invasive one I’ve seen. It takes readings from a sensor under the skin but doesn’t require finger sticks for calibration, and is about the size of a quarter and as thick as two. And it’s helping me keep my diabetes under better control. There have been some challenges: The Milanese UPS store wanted a letter detailing exactly what was in the box. My credit card’s fraud department called (“Yes, the charge for $365 from Milan is mine”). So I was thrilled to learn that the Food and Drug Administration recently approved the sale of the Libre in the United States, a decision that may help some of the 29 million Americans with diabetes. The Libre I buy from Italy has a self-adhesive, waterproof white sensor that sticks to my arm for 14 days. It took some trial and error to get used to it. One sensor flipped off from over-aggressive toweling at the gym; another came loose after a backpack strap nicked it. Finally, rather than the spot on my out Continue reading >>
Fda Approves First Blood Sugar Monitor Without Finger Prick
U.S. regulators have approved the first continuous blood sugar monitor for diabetics that doesn't need backup finger prick tests. Current models require users to test a drop of blood twice daily to calibrate, or adjust, the monitor. The pain of finger sticks and the cost of testing supplies discourage many people from keeping close tabs on their blood sugar, which is needed to manage insulin use and adjust what they eat. Abbott's new FreeStyle Libre Flash Glucose Monitoring System, approved Wednesday by the Food and Drug Administration, uses a small sensor attached to the upper arm. Patients wave a reader device over it to see the current blood sugar level and changes over the past eight hours. Most of the 30 million Americans with diabetes use standard glucose meters, which require multiple finger pricks each day and only show current sugar level. More-accurate continuous glucose monitoring devices are used by about 345,000 Americans. But most don't do the finger pricks to calibrate them and may get inaccurate readings, said Dr. Timothy Bailey, who helped test FreeStyle Libre. "We're able to lower blood sugar safely" with this technology, said Bailey, director of the Advanced Metabolic Care and Research Institute in California. He receives consulting fees from various diabetes device makers. Too-high blood sugar levels can damage organs and lead to heart attacks, strokes, blindness and amputations. Very low blood sugar can cause seizures, confusion and loss of consciousness. Abbott's device was approved for adults with Type 1 or Type 2 diabetes and should be available in pharmacies within months. The company, based near Chicago, did not disclose the price of the reader or the sensors. Abbott's system can't be used with an insulin pump, a device worn against the skin th Continue reading >>
- Tiny sensor placed under the skin to replace finger prick tests for diabetes: Smartphone app will alert patients if their blood sugar level drops or is too high
- No More Finger Prick. New Technology May Help with Diabetes Management.
- FDA Approves MiniMed 670G System – World’s First Hybrid Closed Loop System
New Diabetes Products For 2017: Glucometers And Cgms
For the last year, Diabetes Self-Management has been following all the new innovations and products aimed at helping to improve the lives of those living with diabetes. From the latest glucometers and monitoring systems to insulin pumps, pens, and treatments, several major advancements made their impact on the diabetes community in 2016. When selecting some of the new products, we first talked to Gary Scheiner, MS, CDE, clinical director of Integrated Diabetes Services of Wynnewood, Pennsylvania. Scheiner, known as the MacGyver of diabetes products, has lived with Type 1 diabetes for more than 30 years. He tries out new products before recommending them to patients. “It’s important to see new products from the user’s point of view, not just from the [health-care practitioner’s] side of things,” said Scheiner. In 2016, the pace of innovation continued to race ahead with unbelievable technology right out of a Star Trek episode. The growing use of smartphone technology and mobile applications has led to better access to blood glucose readings, general health information, and much more. Read on to learn about the newest products. We guarantee you there’s something here for everyone, whether you live with Type 1 or Type 2 diabetes. In this installment, we look at glucometers and CGMs that have recently hit the market. Glucometers and CGMs With the FDA’s approval of Medtronic’s MiniMed 670G, people with Type 1 diabetes will have the option of the first hybrid closed-loop insulin pump and continuous glucose monitoring system. According to study results, the MiniMed 670G will reduce time at dangerous high and low blood glucose levels, improve time in range, reduce glucose variability, bring much greater nighttime safety, and target morning blood glucose. “The Continue reading >>
