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Abbott’s Freestyle Libre Flash Glucose Monitoring System

Abbotts Freestyle Libre Approved In Us To Replace Routine Fingersticks

Abbotts Freestyle Libre Approved In Us To Replace Routine Fingersticks

Abbotts FreeStyle Libre Approved in US to Replace Routine Fingersticks Launch by end of 2017 in major pharmacies at lower price than other CGMs; No fingerstick calibration needed, 10-day wear, 12-hour warmup The FDA and Abbott finally announced long-awaited US approval of the FreeStyle Libre real-time flash glucose monitoring system. In the US, it is approved for adults with diabetes only. Like the international version, the FreeStyle Libre sensor is considered a replacement for fingersticks it does not require any daily fingerstick calibrations and real-time readings and trends can be used for insulin dosing. FreeStyle Libre will be available in major retail pharmacies across the US by the end of the year ( sign up for updates here ). The cash price without insurance will be far less expensive than other sensors we expect it will be sold for around $120 per month for three sensors, and each reader will be around $60 (one-time purchase). Were not sure how FreeStyle Libre will be reimbursed by insurance, and if it is, what the out-of-pocket spending will be. In the US, FreeStyle Libre has three notable changes: A much longer 12-hour warmup after insertion. Outside the US, FreeStyle Libre is 14-day wear, 1-hour warmup, and does not need a prescription see our 2015 test drive here . The longer warm-up period is definitely the biggest change it means when a new sensor is inserted, FreeStyle Libre will not show any real-time glucose data for the first 12 hours. During this time, users will go back to fingersticks. One option is to put a sensor on just before bed, which will get through much of the 12-hour warm-up for those who sleep close to eight hours or more per night. Another workaround is for users to buy two reader devices, alternate using them, and overlap sensor wea Continue reading >>

Isrctn - Isrctn87654534: Performance Check Of The Abbott Freestyle Libre Flash Glucose Monitoring System

Isrctn - Isrctn87654534: Performance Check Of The Abbott Freestyle Libre Flash Glucose Monitoring System

Performance Check of the Abbott FreeStyle Libre Flash Glucose Monitoring System The FreeStyle Libre Flash Glucose Monitoring System is a new system for measuring glucose levels and is CE marked and marketed within the UK. The aim of this study is to evaluate the accuracy of the system for people with diabetes, especially those who take insulin. Adults aged 18 and over who have type 1 or 2 diabetes. Participants wear the two Sensors according to labelling instructions. The data is transferred and stored in the Reader memory by regular scanning of the Sensor by the participants. Each study event aims to recruit between 18 and 36 participants across approximately six sites. Once a study event is complete another one commences, on a continuing basis. Each participant is in the study for up to 15 days. Participants wear a FreeStyle Libre Flash Glucose Monitoring System for 14 days while going about their daily activities. Participants perform four BG fingerstick readings per day for each day of Sensor wear using the built-in test strip port in the Reader to allow evaluation of Sensor accuracy. During Visit 1 participants provide demographic data, their height and weight is recorded. Participants are trained on how to use the FreeStyle Libre Flash Glucose Monitoring System. They are also instructed to scan the Sensor with the Reader immediately after they do a fingerstick test. Participants return to the clinic on day 15 where their Sensors are scanned before removal and the data is uploaded. This is the end of their study participation. The data is subsequently be analysed at Abbott Diabetes Care. What are the possible benefits and risks of participating? This study gives participants the opportunity to use flash glucose monitoring as a way of managing their diabetes, which Continue reading >>

Say Goodbye To Finger Sticks: Fda Approves Abbott’s Freestyle Libre Flash Glucose Monitoring System

Say Goodbye To Finger Sticks: Fda Approves Abbott’s Freestyle Libre Flash Glucose Monitoring System

The U.S. FDA has approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System as a replacement for blood glucose monitoring (BGM) for adults with diabetes. This revolutionary new glucose sensing technology eliminates the need for routine finger sticks and is the only personal continuous glucose monitor (CGM) that does not require finger stick calibration. Designed to be approachable, accessible and affordable for the 30 million people with diabetes in America, the FreeStyle Libre system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 10 days, making it the longest lasting personal glucose sensor available in the U.S. The BGM replacement indication means that people with diabetes and their physicians can now make treatment decisions based on information from the FreeStyle Libre system, without the need for finger sticks. The cost of the Libre Flash Glucose Monitoring System is just a fraction of the cost of other CGM systems currently available. “Today, we are celebrating a breakthrough moment for people with diabetes in the U.S.–an end to the worry and hassles associated with routine finger sticks which have been the standard of glucose testing for more than 40 years,” said Jared Watkin, senior vice president, Diabetes Care, Abbott. “At Abbott, we believe that FreeStyle Libre will transform diabetes management and we’re proud to be at the forefront of innovation that empowers people to take control of their health to live their best lives.” How The Freestyle Libre System Works With the FreeStyle Libre system, people with diabetes can: Self-apply the sensor, which is approximately the size of two stacked quarters, to the back of the upper arm. Capture real-time glucose readings with one-second painless scans of Continue reading >>

Abbott's Revolutionary Continuous Glucose Monitoring System, Freestyle Libre, Now Available To Medicare Patients - Jan 4, 2018

Abbott's Revolutionary Continuous Glucose Monitoring System, Freestyle Libre, Now Available To Medicare Patients - Jan 4, 2018

Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - CMS reimbursement provides opportunity for Medicare patients who meet eligibility criteria to access FreeStyle Libre System - FreeStyle Libre System can replace traditional blood glucose monitoring, eliminating the need for routine fingersticks(1) or any user calibration ABBOTT PARK, Ill., Jan. 4, 2018 / PRNewswire / --Abbott (NYSE: ABT) today announced that the FreeStyle Libre System, the company's revolutionary new continuous glucose monitoring (CGM) system, is now available to Medicare patients, having met the codes for therapeutic CGM systems used for coverage by the U.S. Centers for Medicare & Medicaid Services (CMS). Coverage includes all Medicare patients with diabetes who use insulin and who meet the eligibility criteria2. The factory-calibrated FreeStyle Libre system is the only CGM system recognized by Medicare that requires no user calibration whatsoever (either by fingerstick or manual data entry). The system also does not require the need for routine fingersticks1. The high accuracy of the FreeStyle Libre system allows for patients to dose insulin based on the results1. "At Abbott, we are continuously challenging ourselves to ensure our innovative technology is accessible to the majority of people who need it," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "CMS's recognition of this revolutionary health technology, which removes the need for any user calibration, is ultimately going to empower Medicare beneficiaries with diabetes to live better, healthier lives." Designed to be approachable, accessible and affordable for the 30 million people with diabetes in the United States3, the FreeStyle Libre system reads glucose level Continue reading >>

The Freestyle Libre Review

The Freestyle Libre Review

While continuous glucose monitoring (CGM) is not a new technology in terms of managing your diabetes. What the FreeStyle Libre is doing is actually quite different. Its bringing to the world of diabetes management a new concept in CGM technology and blood glucose testing , while still being much more affordable in comparison to other systems on the market. Before we continue with this article, I wanted to let you know we have researched and compiled science-backed ways to stick to your diet and reverse your diabetes. Want to check out our insights? Download our free PDF Guide Power Foods to Eat here. The FreeStyle Libre system includes what is known as Flash glucose monitoring. Instead of pricking your finger, you simply scan a sensor. Sounds pretty good right? Lets take a look more in detail on what this new system really does. Because the FreeStyle Libre is unlike any other CGM systems on the market today it does offer a few benefits: Reducing the number of blood glucose checks during the day Provides a graph to show you the trends in your blood sugar readings The sensor is waterproof, which makes it easier to shower or bathe with it on. Scanning the sensor will provide you with how much your levels are trending up or down. A small, round sensor is placed on your arm. The sensor is around 5mm in height and 35 mm in diameter. It is applied using a handheld applicator and is able to remain on for up to 14 days. Many of those in the trial of the Libre have reported that it is almost virtually painless. For up to 14 days the sensor can be scanned with a handset to send data of your blood sugar levels over the past 8 hours to the systems handset device. When you scan the sensor, you dont just get your blood sugar readings , you can also see if your levels are going up, do Continue reading >>

Fda Approves Abbott Freestyle Libre Flash Glucose Monitoring System

Fda Approves Abbott Freestyle Libre Flash Glucose Monitoring System

FDA Approves Abbott Freestyle Libre Flash Glucose Monitoring System The FDA has approved the FreeStyle Libre Flash Glucose Monitoring System, which eliminates the need for routine finger sticks to check blood glucose levels.1 "Studies have shown that a majority of people test less than three times per day because of the pain and hassles associated with finger sticks. Without comprehensive glucose data, significant glucose fluctuations may be missed, which can lead to major health consequences," says Chris Thomas, PhD, director of biosensor technology for Abbott Diabetes Care, which makes the device. The company says the Abbott Freestyle Flash Glucose Monitoring System will be available by prescription in U.S. pharmacies by the end of 2017 or early 2018. Thomas declined to provide exact pricing information but says it will be similar to the cost of the cash pay of FreeStyle Libre in Europe. In the UK, the price for that has been about $362 U.S. for 14 days of sensors, the reader, and the sensor, according to the Diabetes UK website. The Freestyle Libre system is already in use by more than 400,000 in about 40 other countries, according to Abbott. It can be used by anyone who uses insulin, whether by injection or by a pump. The FreeStyle Libre Flash includes a small sensor wire, about the size of two quarters stacked together, applied to the back of the upper arm and inserted below the skin's surface. This continuously measures and monitors glucose levels in the fluid under the skin. A small, hand-held reader is held over the sensor to provide real-time blood glucose readings. The reader can identify high, low or stable trends and review 8 hours of blood glucose history. Unlike the professional version or the UK version which is a 14-day wear, this version is approved fo Continue reading >>

Diabetes Product Review: Abbott Freestyle Libre

Diabetes Product Review: Abbott Freestyle Libre

We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. I confess:When I first heard about the new FreeStyle Libre from Abbott, before ever using it,I thought it sounded like a stupid product. It was billed as sort of a magicwand that used a sensor stuck onto your body like a regular CGM (continuous glucose monitor) but less powerful. You'd have to wave the monitor over the sensor to get that poof! And like magic it would tell you your blood sugar. Thisso-called Flash Glucose Monitoring seemedlike a waste of modern D-tech to me. But withinminutes of booting up one of two sample sensors provided for review, I knew Abbott had a potential game-changer on their hands. Pricedright, and covered by insurance, I knew in a flash that Abbott was poised tomake a fortune and to re-write the rules of glucose monitoring. And for once,this economic juggernaut would also benefit the vast majority of people withdiabetes, especially those living with type 2. The FDA approved this new system in September and launched it the week of Thanksgiving, and Abbott offered us at the 'Mine a test-drive along with some others in the Diabetes Online Community. Here aremy initial impressions of the Libre system, after using it for a couple weeks. Letsbackup to offer a bit of background, for starters. The Libre systemconsists of a combined sensor/transmitter, and a handheld receiver that Abbottcalls a reader. Sensor/Transmitter: By comparison to the existing CGMsensors on the market, this one is ultra-flat and about the size of aquarter. Literature from Abbott tells us it must be worn on the back of theupper arm. A disposable inserter that comes with each sensor makes placing thesensor quick and painless; a Continue reading >>

Fda Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration

Fda Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration

Release The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days. “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 Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “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.” People with diabetes must regularly test and monitor their blood sugar to make sure it is at an appropriate level, which is often done multiple times per day by taking a fingerstick sample and testing it with a blood glucose meter. Typically patients use results of a traditional fingerstick test to make diabetes Continue reading >>

Patient Information - Abbott Freestyle Libre Pro

Patient Information - Abbott Freestyle Libre Pro

Notify security at the airport checkpoint. Pull up the edge of the adhesive that keeps your sensor attached to your skin. Slowly peel away from your skin in one motion. Note:Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol. You have irritation or discomfort at the sensor site Indications and Important Safety Information The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns and glucose level excursions above or below the desired range, facilitating therapy adjustments in persons (age 18 and older) with diabetes. The system is intended for use by health care professionals and requires a prescription. IMPORTANT: The device may inaccurately indicate hypoglycemia. The results of the clinical study conducted for this device showed that 40% of the time when the device indicated that user sensor glucose values were at or below 60 mg/dL, user glucose values were actually in the range of 81-160 mg/dL. Therefore, interpretation of the FreeStyle Libre Pro Flash Glucose Monitoring System readings should only be based on the trends and patterns analyzed through time using the reports available per the intended use. CONTRAINDICATIONS: Remove the Sensor before MRI, CT scan, X-ray, or diathermy treatment. WARNINGS/LIMITATIONS: The FreeStyle Libre Pro system does not provide real-time results and patients should adhere to their blood glucose monitoring routine while using the system. If a sensor breaks, contact physician and call Customer Service. Patients with high levels of ascorbic acid (Vitamin C) or salicylic acid (used in Aspirin) or severe dehydration or excessive water loss or medications containing acetaminophen Continue reading >>

Freestyle Libre

Freestyle Libre

Tweet The Abbott FreeStyle Libre has come as an entirely new concept in glucose monitoring by providing much greater data than blood glucose testing whilst being more affordable than continuous glucose monitors (CGM). The FreeStyle Libre provides ‘flash glucose monitoring’ with glucose readings provided by scanning a sensor rather than pricking your finger. What are the benefits of FreeStyle Libre? Due to way the Libre works, there are a number of benefits: Reduced need to take so many blood glucose tests Provides graphs of how your sugar levels have been varying - in a similar way to how a CGM does Scanning the sensor shows how much your results are trending upwards or downwards More affordable than a CGM Sensor is waterproof in up to 1m of metre for 30 minutes How the FreeStyle Libre works The FreeStyle Libre works by having a small round sensor applied to your arm. The sensor is a round disc, 5mm high and 35mm diameter, making it roughly the size of a £2 coin. The sensor is applied to the skin with a handheld applicator and then lasts for 14 days. Most people that were used in patient trials of the Libre rated the application of the sensor as being painless. Within the 14 days of usage, the sensor allows you to scan the sensor with the handset which sends data of your sugar levels over the previous 8 hours to the Libre system’s handset. When you scan, you therefore get not just a glucose reading, as you would with a blood glucose meter, but can also see whether your sugar levels are starting to go up, down or are stable. How much does the FreeStyle Libre cost? At the time of writing, the FreeStyle Libre is available at the following prices direct from Abbott’s FreeStyle Libre website: Starter Pack - reader plus two 14 day sensors: £159.95 FreeStyle Libre Re Continue reading >>

How I Got My Freestyle Libre Flash Glucose Monitor

How I Got My Freestyle Libre Flash Glucose Monitor

Is there any more iconic symbol for diabetes than a drop of blood on a finger? Throughout my diabetes career––yes, it’s work––piercing my finger with a lancet and placing a drop of blood on a test strip has been the constant reminder that I am tethered to a disease that is much bigger than I am. In the past, when I’ve read about continuous glucose monitors (CGM), it always sounded bulky and uncomfortable. I wasn’t eager to get one. And today people are touting the bionic pancreas as the answer to all of our dreams, but being bionic doesn’t appeal to me either. I’ve also read about contacts that Google is working on with Novartis. The contacts will use tear fluid to obtain blood sugar readings that will be wirelessly transmitted to a smart phone. When I found out how long it would be before the contacts were released, 5-10 years, I shrugged it off as another sign that my work would continue. When I first spotted the FreeStyle Libre from Abbott, my initial thought was that it looked tiny––the size of a quarter, and friendly––approachable and simple. I wanted it, but the problem then was that it was only available in Europe. (The Pro version is available in the U.S. and the company is actively working towards FDA approval for the personal version.) I decided I needed to try and get my hands on one. As I wondered who to ask for help, I read more. The meter and matching sensor aren’t labeled a CGM because you have to scan the sensor to see your numbers, rather than numbers automatically being logged and recorded. Abbott calls its device a Flash Glucose Monitoring system. They do essentially the same thing, so, whatever, I call it a CGM. The Abbott device doesn’t have an alarm. I know that not everyone knows when they’re high or low. Since I do Continue reading >>

Abbott Wins Fda Approval For Diabetes Device That Doesn't Require Routine Finger Pricks

Abbott Wins Fda Approval For Diabetes Device That Doesn't Require Routine Finger Pricks

The U.S. Food and Drug Administration approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries. Abbott Laboratories has gained clearance to start selling in the U.S. the first continuous glucose monitor that does not require people with diabetes to routinely prick their fingers. The U.S. Food and Drug Administration on Wednesday approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries. The device consists of a small sensor, about the size of a quarter, that’s worn on the back of the upper arm to continuously track glucose levels. The sensor, unlike other wearable sensors, does not require patients to prick their fingers for calibration. Patients can place a hand-held reader near the device to see their current glucose levels, trends, patterns and where those levels might be headed. They can then use those readings to figure out how much insulin to take to manage their diabetes. The device has not yet been approved for use by children in the U.S. but Abbott hopes to gain approval from the FDA. The company is not disclosing pricing information until it gets closer to launching the product in the U.S., which will likely be before the end of the year, said Abbott spokeswoman Vicky Assardo. But she said in an email the price will be “very similar” to the price in Europe, where the reader costs about $69, and each sensor, which lasts about 14 days, also costs about $69, before insurance. In the U.S., the sensor will last about 10 days. “We intentionally designed the product to make it as affordable as possible,” said Jared Watkin, Abbott senior vice president of diabetes care. In the U.S., continuous glucose monitors are often covered Continue reading >>

Flash Glucose Monitoring System | Overview

Flash Glucose Monitoring System | Overview

The FreeStyle Libre Sensor represents technology that is much less intrusive than traditional blood glucose monitoring and makes glucose testing hassle-free9. Discreet - convenient to wear under clothing10 Designed to stay on the body for up to 14 days Only needs to be applied once every 2 weeks Eliminates painful finger pricks needed for calibration 9 The FreeStyle Libre system liberates you from the hassles of glucose monitoring. In a 2013 US study conducted by Abbott Diabetes Care, 95.7 % of patients surveyed (n=30) agreed that the FreeStyle Libre system reduces the hassles of glucose monitoring. Data on file. 10 The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor. 11 Sensor is water-resistant in up to 1 metre (3 feet) of water for a maximum of 30 minutes. The FreeStyle Libre reader harnesses advanced sensor-based technology to read glucose data, then instantly displays the data in a meaningful, user-friendly way. FreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott Laboratories, except to identify the product or services of the company. This website and the information contained herein is intended for outside of the US only. For any product related information and further details on Abbott Products in Australia please visit www.myfreestyle.com.au .The FreeStyle Libre Flash Glucose Monitoring System Sensor is only intended to be used by patients (aged 4 years and older) with insulin dependent diabetes mellitus.Always read the label and use as directed. Abbott Diabetes Care, 666 Doncaster R Continue reading >>

Abbott's Freestyle Libre System Becomes First Cgm To Be Fda Cleared For Use Without Fingersticks

Abbott's Freestyle Libre System Becomes First Cgm To Be Fda Cleared For Use Without Fingersticks

Abbott's Freestyle Libre system becomes first CGM to be FDA cleared for use without fingersticks Abbott Diabetes Care's Freestyle Libre Flash Glucose Monitoring System has been approved by the FDA. As well as finally bringing the system, which is already available in 39 other countries, home to the US where Abbott is based, the approval also represents a first for continuous glucose monitoring, as it doesn't require the user to use a fingerstick, even for calibration. "From an emotional perspective, its especially important to us because Abbotts an American company, this is a product that was designed in California, and diabetes is personal to many of us," Abbott Research Fellow and Director of Biosensor Technology Christopher Thomas told MobiHealthNews. "Every part of the design we come to with an incredible amount of passion ... so to be able to make that available in America is one of the most satisfying things that we could work for ever." Abbot's Freestyle Libre fully disposable system consists of atiny insertable sensor and a patch about the size of a quarter worn on the arm for up to 10 days (though it's cleared for 14 in other countries). The patch records glucose data every 15 minutes. Using a special reader, the wearer can scan the patch with NFC technology, checking their glucose painlessly as often as they want. In addition to the current reading, a scan gives eight hours of historical data and trend information. "You get where you are, where youve been, and where youre going, all in that painless, one second scan," Thomas said. "You can scan it as many times as you want per day. What weve done at Abbott, is we want to help this revolutionary technology to blend seamlessly into your life." The device is factory calibrated, which means it allows the user to Continue reading >>

Freestyle Libre Glucose Monitoring System | Singapore

Freestyle Libre Glucose Monitoring System | Singapore

Now you can check your glucose with a painless5 The FreeStyle Libre system liberates you from the hassles of routine finger pricking. Just scan the reader over the small sensor worn on the back of your upper arm to check your glucose. *Images and readings are for illustration purpose only 1 Scanning the sensor to obtain glucose values does not require lancets. 2A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels or if hypoglycaemia or impending hypoglycaemia is reported by the system or when symptoms do not match the system readings. 3A caregiver at least 18 years old is responsible for supervising, managing, and assisting the child in using the FreeStyle Libre system and interpreting its readings. 4Edge, Julie., et al. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Archives of Disease in Childhood 102.6 (2017): 543-549. 5Most people did not feel any discomfort under the skin while wearing the FreeStyle Libre sensor. In a study conducted by Abbott Diabetes Care, 93.4% of patients surveyed (n=30) strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin. [29 persons have finished the study; 1 person terminated the study after 3 days due to skin irritations in the area where the sensor touched the skin]. Each FreeStyle Libre sensor is painless to apply, easy to use (for up to 14 days) and water resistant6. 6Sensor is water resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes. You can do it anytime. Get glucose readings with a painless one-second scan, even through clothing7. 7The FreeStyle Libre read Continue reading >>

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