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 >>
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- High rates of scanning with Abbott′s FreeStyle Libre system linked to improved glucose control in diabetes patients
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
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 >>
- No More Routine Finger Sticks(1) for Americans with Diabetes: Abbotts FreeStyle Libre Approved in the U.S.
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
Hi, Freestyle Libre System. Bye, Routine Fingersticks (1).
Have diabetes? This glucose monitoring tool could revolutionize your life with fast, reliable results without the need for routine fingersticks1. Daily diabetes monitoring hurts. If you or a loved one has diabetes, you’re probably familiar with the tedious routine of glucose monitoring. The painful finger pokes to draw a drop of blood. The daily fingerstick calibrations. Or the expensive, bulky CGM equipment. For many, that's been the reality. But what if you could take the pain and inconvenience out of glucose monitoring? What if you could transform the way people with diabetes manage their condition? Well, today, you can. For the 30 million Americans who have diabetes2, the approval of the FreeStyle Libre Flash Glucose Monitoring System by the U.S. Food and Drug Administration is a significant stride in offering new options for people with diabetes in the United States. We've introduced a revolutionary system that eliminates the hurdles of traditional glucose monitoring. No routine fingersticks1. No fingerstick calibrations. How does the FreeStyle Libre System work? Abbott's FreeStyle Libre system measures glucose levels through a small sensor applied to the back of your upper arm. The sensor, which is the size of two stacked quarters, provides real-time glucose readings for up to 10 days, both day and night3. The sensor can also read glucose levels through clothes4, making testing discreet and convenient. The FreeStyle Libre system provides people with diabetes three key pieces of data with each scan: a real-time glucose result, an 8-hour historical trend, and a trend arrow showing the direction their glucose is going. The touch-screen reader holds up to 90 days of data, which allows people to track their glucose levels over time. Across the globe, more than 400,00 Continue reading >>
Freestyle Libre Flash Glucose Monitoring Technology Gains Reimbursement Approval From The United Kingdom's National Health Service - Sep 13, 2017
FreeStyle Libre Flash Glucose Monitoring Technology Gains Reimbursement Approval from the United Kingdom's National Health Service - Revolutionary FreeStyle Libre System allows people with diabetes to check their glucose without calibration or routine finger sticks[i] - First-of-its-kind product has driven significant reimbursement in key markets, due to exceptional clinical outcome data and proven accuracy[ii] ABBOTT PARK, Ill., Sept. 13, 2017 / PRNewswire / --Abbott (NYSE: ABT)today announced that the FreeStyle Libre system is now available for reimbursement in the United Kingdom (UK). The National Health Service (NHS) Business Services Authority has approved the listing on the Drug Tariff for the FreeStyle Libre system for people with diabetes using insulin. This means that from Nov. 1, 2017 it will be available for reimbursementiii via the NHS across England and Wales, NHS Scotland, and the Health and Social Care in Northern Ireland. "The FreeStyle Libre system has been shown to offer life-changing improvements for people with diabetes to help them live healthier and fuller lives," said Neil Harris, general manager of Abbott's UK diabetes care business. "We are delighted with the NHS decision, and we look forward to partnering with them to provide people with diabetes our innovative technology to help manage their condition." Abbott's FreeStyle Libre system is designed to change how people with diabetes measure their glucose levels and ultimately help them achieve better health outcomes. The system automatically reads glucose levels through a sensor, approximately the size of a U.S. quarter, that is worn on the back of the upper arm for up to 14 days, eliminating the need for calibration and routine finger sticksi. "FreeStyle Libre has allowed me to properly track Continue reading >>
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- The FreeStyle Libre, a device for monitoring blood sugar, is a pleasure to use.
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes - Jun 29, 2017
Abbott's Flash Glucose Monitor To Be Made Available On Nhs
Abbott's FreeStyle Libre – a flash glucose monitor that allows diabetes patients to track their blood sugar without pricking – will be reimbursed by the NHS from 1 November, subject to local health economy approval. The device's starter pack previously cost around £170, with readers for the sensors costing as much as £60, but will now be available for reimbursement via the NHS across England and Wales, NHS Scotland and Health and Social Care in Northern Ireland for people with type 1 and 2 diabetes who are intensively-using insulin. The system uses a sensor the size of a £2 coin, worn on the back of the upper arm, to automatically read glucose levels. Clinical studies and real-world evidence have suggested that FreeStyle Libre users scan their glucose levels an average of at least 15 times per day, and that these higher rates of self-monitoring are strongly associated with improved glucose measures. Chris Askew, Chief Executive of Diabetes UK, said: “Today’s announcement is fantastic news: Not since the transition from urine testing to finger-prick testing has there been such potential to transform the lives of people living with Type 1 and Type 2 diabetes through technology. “Flash glucose monitoring can free people living with diabetes from the pain and rigour of frequent finger-prick testing, and puts them in greater control of their condition. In doing so, it has the potential to help prevent a host of devastating long-term complications. Today’s decision is testament to the commitment of campaigners, clinicians and policy makers to making this technology available." He added: “The challenge now will be that everyone who could benefit from this technology is able to access it where they live; Diabetes UK will be looking to local decision makers to e Continue reading >>
- BREAKING: Flash glucose sensing available on NHS for type 1 diabetes from November
- No More Routine Finger Sticks(1) for Americans with Diabetes: Abbotts FreeStyle Libre Approved in the U.S.
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Freestyle 14 Day | The Freestyle Libre System
* Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose. The reader can capture data from the sensor when it is within 1 cm to 4 cm of the sensor. Based on the sensor being replaced once every 14 days, and scanned at least once every 8 hours. Sensor is water-resistant in up to 1 meter (3 feet) of water. Do not immerse longer than 30 minutes. || Choose a site that is at least 2.5 cm (1 inch) away from an insulin injection site. CAUTION: The Sensor Pack and Sensor Applicator have the same sensor code. The sensor codes should be checked to ensure they match before using Sensor Pack and Sensor Applicator. Do not use Sensor Packs and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings. # Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened. Do NOT use if past expiration date. ** The Sensor Applicator now contains a needle. Do not touch inside the Sensor Applicator or put it back into the Sensor Pack. Do not push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury. Applying the Sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor, and apply a new one at a different site. The FreeStyle LibreLink app is compatible with NFC-enabled smartphones running Android OS 5.0 or higher and iPhone 7 or later running iOS 11 or later. Use of the FreeStyle LibreLink app requires registration with LibreView, a service provided by Abbott and Newyu, Inc. |||| Abbott intends to ease FreeStyle Libre system users Continue reading >>
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes - Jun 29, 2017
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 >>
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's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- High rates of scanning with Abbott′s FreeStyle Libre system linked to improved glucose control in diabetes patients
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
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 >>
- No More Routine Finger Sticks(1) for Americans with Diabetes: Abbotts FreeStyle Libre Approved in the U.S.
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
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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 >>
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- High rates of scanning with Abbott′s FreeStyle Libre system linked to improved glucose control in diabetes patients
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
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 >>
- Abbott's Revolutionary Continuous Glucose Monitoring System, FreeStyle Libre, Now Available To Medicare Patients - Jan 4, 2018
- High rates of scanning with Abbott′s FreeStyle Libre system linked to improved glucose control in diabetes patients
- The FreeStyle Libre, a device for monitoring blood sugar, is a pleasure to use.
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 >>
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes
- Abbott Secures Health Canada License for FreeStyle Libre System for People with Diabetes - Jun 29, 2017
- High rates of scanning with Abbott′s FreeStyle Libre system linked to improved glucose control in diabetes patients
Abbotts New Freestyle Flash: Instant, Painless Glucose Monitoring Without Finger Sticks
Abbotts New Freestyle Flash: Instant, Painless Glucose Monitoring Without Finger Sticks A new glucose monitoring system has recently received U.S. FDA approval, which removes the need for routine finger sticks and is still reliably accurate enough to use for insulin dosing. The FreeStyle Libre Flash Glucose Monitoring (FGM) System by Abbott Diabetes Care is designed to help adults over 18 years old with diabetes to achieve tighter control over their blood sugar levels. Jeffrey Brewer, CEO of Bigfoot Biomedical, who has partnered with Abbott to bring this technology to the U.S., said, FreeStyle Libre is a dramatic advance the first product that truly makes life with diabetes easier and addresses the most important problem plaguing people with diabetes: real-world, day-to-day, moment-to-moment usability. The FreeStyle Libre launched in Europe in October of 2014 and just received U.S. FDA approval on September 28, 2017. Abbott expects that it will be available for purchase in the States by the end of the year. Similar to continuous glucose monitors (CGMs), the FreeStyle Libre consists of a sensor embedded just under the skin that tests your glucose levels every minute. Other CGMs take readings about every five minutes and send those automatically to a readout device. The FreeStyle Libre stores up to eight hours of readings. You get your current glucose level and a graph showing the last eight hours when you scan the sensor using a mobile, handheld reader device. The reader has a touchscreen for ease of use. It can take a reading through clothing as thick as four centimeters, so checking your glucose levels is now much more convenient and discreet. The reader allows you to also add tags to each scan, such as carbs, insulin, exercise, and customizable options, explained Dia Continue reading >>
Fda Approves Abbott's Blood Glucose Monitoring Device
(Reuters) - The U.S. Food and Drug Administration said it approved Abbott Laboratories’ glucose monitoring device for adults with diabetes, allowing millions of people to track their blood sugar levels without having to prick their fingers. Abbott's FreeStyle Libre Flash reduces the need for fingerstick testing, which is painful and inconvenient, by inserting a small sensor wire below the skin to continuously measure and monitor glucose levels. The device can be worn for up to 10 days. (bit.ly/2xxbrbt) Chicago-based Abbott’s shares were trading up 3.6 percent at $54 after the bell on Wednesday. Traditionally, diabetes patients measured their glucose levels nearly a dozen times a day by pricking their finger tips for blood samples. Nowadays, advanced continuous glucose monitoring devices, such as DexCom Inc’s G5 Mobile and Medtronic Plc’s iPRO2 Professional, which have sensors to measure glucose readings are used. However, these devices require fingertip testing two to four times a day for optimal accuracy. DexCom’s shares were down 14.3 percent at $57.85, while Medtronic’s stock rose marginally in after-market trading. Most diabetes patients do not measure glucose as often as they should because of the discomfort caused by these kinds of tests, Jared Watkin, senior vice president of Abbott’s Diabetes Care unit, told Reuters. According to studies, the majority of people with diabetes test glucose levels less than three times a day, Abbott said. Abbott’s device, however, is a long-lasting glucose sensor, which does not require fingerstick testing to ensure its accuracy. The company plans to launch the device before the end of this year, Watkin said on Wednesday. Abbott already has a continuous glucose monitoring device called FreeStyle Libre Pro in the Uni Continue reading >>
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 >>
