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Freestyle Libre Flash Glucose Monitoring System

Fda Approves Freestyle Libre Flash

Fda Approves Freestyle Libre Flash

It doesnt require regular fingerstick calibration and it has a sensor that can be worn for up to 10 days, but is it a continuous glucose monitor? On September 27th, the FDA announced that the Abbott Freestyle Libre Flash glucose monitoring system would be cleared to enter the U.S. marketplace. The Libre Flash differs from all other wearable glucose monitoring systems for people with diabetes in that it does not require fingerstick calibration and it utilizes a sensor that can be worn for up to 10 days. The FDA announcement of the Freestyle Libre Flash systems approval called it a continuous glucose monitor, but thats a term that even Abbott company officials have been hesitant to use. The Libre Flash differs from continuous glucose monitors on the market in that it does not provide glucose readings without an outside prompt from another device scanned on the sensor. Users of the Libre Flash wear a sensor below the skins surface to monitor their glucose levels; they then wave a specially designed mobile reader to see their readings and trends. The Freestyle Libre Flash is currently only approved for adults 18 years and older with diabetes; the announcement does not specify a type of diabetes, which would indicate that it is cleared for use for treatment of Type 1 diabetes and Type 2 diabetes. Previously, an incarnation of this system, the Libre Pro, was only available for healthcare providers to use with patients. Earlier this month, the UKs National Health System announced it would cover the cost of the system for people with diabetes. The Flashs approval has the potential to change the landscape of the glucose monitoring system market. It remains to be seen whether the innovations offered by the system will allow Abbott to challenge Dexcom for marketshare in intensive Continue reading >>

News: Fda Oks Freestyle Libre For United States!

News: Fda Oks Freestyle Libre For United States!

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. It's an exciting time for people with diabetes in the United States, as we now join the rest of the world in having access to the Abbott FreeStyle Libre Flash Glucose Monitoring technology. Abbott Diabetes Care announced late Wednesday it had received FDA approval of this new device, which has been available overseas for several years already, but stuck in regulatory purgatory for a full year and two months here in the U.S. This is the first device of its kind, different than a traditional continuous glucose monitor (CGM) with a sensor that beams data directly to a separate device or mobile app and has glucose alerts. Instead, the Libre consists of a small round sensor worn on the upper arm that users handheld scanner over to obtain glucose readings, as often or as little as one may want. Unlike any other diabetes device currently available in the USA, the Libre does not require a fingerstick blood sugar check to confirm the data's accuracy. This no-calibration device has been called a game-changer by patients using it around the world. Here's the skinny on the FreeStyle Libre (you can also watch a slick 22-second marketing video from Abbott). Note that there are some key differences between what's approved now for the U.S. versus what's available globally: Scannable Sensor: As opposed to existing rectangular or shell-shaped CGM sensors that constantly beam glucose data onto a receiver or smartphone app, the Libre has a little disc sensor about the size and thickness of two stacked quarters, and users just hold the handheld reader device over the it (from 1-4 cm) to scan it for data. It's approved for use only on the up Continue reading >>

Abbott’s Freestyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside!

Abbott’s Freestyle Libre – Transforming Glucose Monitoring Through Utter Simplicity, Fingersticks Aside!

by Adam Brown and Kelly Close Twitter Summary: Wearing Abbott’s #FreeStyleLibre, a 14-day sensor intended to replace glucose meters, but provide CGM-like info; now available in Europe In October, Abbott launched its highly awaited FreeStyle Libre Flash Glucose Monitoring system in Europe. The unique product is intended as a replacement for blood glucose meters, while giving patients many of the benefits of continuous glucose monitoring (CGM), including real-time glucose values, trend information and comprehensive reports. Though it is not yet approved in the US, we were able to test the product over the past month (the device can only be ordered online from websites in Europe). Given what we had heard from so many European bloggers, we had high expectations going into our test, and FreeStyle Libre absolutely met them at every step – the system was easy to setup and use (a major win for healthcare providers); discreet to wear on the upper arm; accurate enough from which to dose insulin, with performance similar to Dexcom’s G4 Platinum CGM (though no fingersticks were required); and it gave an excellent picture of glucose trends through real-time and on-device reports. In short, it is transformative compared to the limited information provided by traditional blood glucose meters, all in a package anyone can pick up and learn to use. We give FreeStyle Libre an emphatic thumbs up and would recommend it to nearly anyone with diabetes, especially those on insulin who test their blood glucose frequently and want more actionable information than fingersticks alone can provide. One key point of difference from CGM is that FreeStyle Libre does not have high or low alarms, meaning it is not as ideal for those with lots of hypoglycemia or hypoglycemia unawareness. This articl 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 >>

The End Of Finger Pricks? Freestyle Libre Flash Glucose Monitoring System Approved By Fda | Ontrackdiabetes

The End Of Finger Pricks? Freestyle Libre Flash Glucose Monitoring System Approved By Fda | Ontrackdiabetes

The FDA recently approved the FreeStyle Libre Flash Glucose Monitoring System, which eliminates the need for routine finger sticks to check blood glucose levels. Continuous glucose monitoring (CGM) has been linked to better blood sugar control. Now, the FDA has approved a new devicethe Abbott FreeStyle Libre Flash Glucose Monitoring Systemthat may give anyone who hates finger sticks a reason to celebrate. (Does anyone like finger pricks?). The new device is expected to be on the market, by prescription only, by late 2017 or early 2018, says Chris Thomas, a spokesperson for the company. He declined to give exact pricing information but says insurance reimbursement is likely.1,2 Pricing will likely to be similar to costs in Europe, where the device is already in use. In the UK,3 for instance, the price for a starter pack, with the reader and two 14 days of sensors, has been the equivalent of about $200. The new device will reduce hassle and discomfort while providing a more comprehensive view of blood glucose status, Thomas says. "With traditional blood glucose monitoring, some people with diabetes may have to finger stick up to 12 times a day, to test their glucose levels, which only provides readings that represent distinct points in time," he says. "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," he says. The FDA OK'd it for adults 18 years and over. Unlike the professional version or the UK version which is a 14-day wear, it can be worn up to 10 days. There is a 12-hour startup required. It is meant for use by anyone who uses insulin, whether you 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 >>

Accuracy, User Acceptability, And Safety Evaluation For The Freestyle Libre Flash Glucose Monitoring System When Used By Pregnant Women With Diabetes

Accuracy, User Acceptability, And Safety Evaluation For The Freestyle Libre Flash Glucose Monitoring System When Used By Pregnant Women With Diabetes

Diabetes Technology & Therapeutics Vol. 20, No. 3 Original ArticlesOpen AccessOpen Access license Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes Background: Accuracy of the FreeStyle Libre Flash Glucose Monitoring System has not been evaluated in pregnant women with diabetes. The aim of this study was to determine accuracy (compared to self-monitoring of blood glucose [SMBG]), clinical safety, and acceptability of the FreeStyle Libre System when used at home by this population. Materials and Methods: Seventy-four participants, with type 1 (T1D, n = 24), type 2 (T2D, n = 11), or gestational (n = 39) diabetes, were enrolled across 13 sites (9 in United Kingdom, 4 in Austria). Average gestation was 26.6 6.8 weeks (mean standard deviation), age was 30.5 5.1 years, diabetes duration was 13.1 7.3 years for T1D and 3.2 2.5 years for T2D, and 49/74 (66.2%) used insulin to manage their diabetes. Sensors were worn for up to 14 days. Sensor glucose values (masked) were compared with capillary SMBG values (made at least 4 times/day). Results: Clinical accuracy of sensor results versus SMBG results was demonstrated, with 88.1% and 99.8% of results within Zone A and Zones A and B of the Consensus Error Grid, respectively. Overall mean absolute relative difference was 11.8%. Sensor accuracy was unaffected by the type of diabetes, the stage of pregnancy, whether insulin was used, age or body mass index. User questionnaires indicated high levels of satisfaction with sensor wear, system use, and comparison to SMBG. There were no unanticipated device-related adverse events. Conclusions: Good agreement was demonstrated between the FreeStyle Libre System and SMBG. Accuracy of the system w 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 >>

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 >>

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 >>

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 >>

Freestyle Libre Flash Glucose Monitoring System Post Approval Study

Freestyle Libre Flash Glucose Monitoring System Post Approval Study

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. FreeStyle Libre Flash Glucose Monitoring System Post Approval Study The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03448380 Information provided by (Responsible Party): Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information This is a prospective, multi-center, non-randomized, single-arm, post-approval study of the FreeStyle Libre Flash Glucose Monitoring System intended to characterize the safety of the Libre Flash Glucose Monitoring System when used in people with diabetes. Device: FreeStyle Libre Flash Glucose Monitoring System Up to 920 adult subjects, aged 18 years and older with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes, will be enrolled to obtain at least 736 subjects who complete the final visit. Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase). Subjects will maintain a diary/log book of Adverse Events during each phase. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call. FreeStyle Libre Flash Glucose Monitoring System Post Approval Study During the intervention phase, subjects will use FreeStyle Libre Flash Glucose Monitoring S 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 >>

Freestyle Libre Flash Glucose Monitoring System

Freestyle Libre Flash Glucose Monitoring System

FreeStyle Libre Flash Glucose Monitoring System FreeStyle Libre Flash Glucose Monitoring System The FreeStyle Libre Flash Glucose Monitoring System is a form of continuous glucose monitor that requires the user to scan the sensor to obtain current glucose readings. It does not require routine finger sticks for calibration or for insulin dosing. This system, designed by Abbott, received FDA approval in September 2017. It is intended to help adults with diabetes achieve better glucose control without the need for finger sticks. It is expected to be available in the U.S. by the end of 2017. 4 Who Should Not Use the FreeStyle Libre System Similar to other CGMs, the FreeStyle Libre is a small, round plastic device (called a patch) that adheres to the skin and contains a sensor, which is inserted into the skin. The sensor is a tiny filament (0.2 inches in length, about the thickness of a hair, according to a review on Diatribe ) that penetrates the top layers of skin and reads the glucose levels in the interstitial fluid, rather than in the blood directly. Insertion of the sensor is simple and painless. The FreeStyle Libre is only approved to be placed on the back of the upper arm. Other CGMs are often worn on other areas of the body, such as the abdomen, but that is discouraged with this system at this time. Apparently, the sensor may not function properly if placed in other areas. In addition to the sensor, the system includes a reader, which scans the sensor using NFC technology to receive glucose level readings from it. You simply hold it close to the sensor (within 1.5 inches) to initiate the scan. It can read through clothing, as well, which allows for more discreet testing. The scan takes about three seconds. You can scan the sensor an unlimited amount of times during Continue reading >>

Evaluation Of The Freestyle Libre Flash Glucose Monitoring System In Children And Adolescents With Type 1 Diabetes.

Evaluation Of The Freestyle Libre Flash Glucose Monitoring System In Children And Adolescents With Type 1 Diabetes.

Generate a file for use with external citation management software. Horm Res Paediatr. 2018;89(3):189-199. doi: 10.1159/000487361. Epub 2018 Mar 27. Evaluation of the FreeStyle Libre Flash Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Department of Paediatric Endocrinology and Diabetology, Jessa Hospital, Hasselt, Belgium. Clinical Laboratory, Jessa Hospital, Hasselt, Belgium. The FreeStyle Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years in January 2016. Experience in children is still limited. We evaluated the accuracy and usability of the FGM in children with type 1 diabetes mellitus (DM). 67 children with type 1 DM (35 girls), aged 4-18 years, were included. Subjects wore a sensor on the back of their upper arm. For the first 14 days, they regularly measured capillary blood glucose (BG) with their usual BG meter (Accu-Chek Mobile [ACM], Roche [n = 24]; Contour Next Link [CNL], Bayer [n = 26]; OneTouch Verio IQ [OTV], LifeScan [n = 17]) followed by a sensor glucose (SG) scanning. SG readings were compared to BG measurements by consensus error grid (CEG) analysis; the mean difference (MD), the mean relative difference (MRD), the mean absolute difference (MAD), and the mean absolute relative difference (MARD) were calculated. After 14 days, subjects were asked to fill in a questionnaire on the usability of the FGM. 2,626 SG readings were paired with BG results. FGM readings were highly correlated with BG (r = 0.926, p < 0.001). 80.3% of the data pairs were in zone A (= no effect on clinical action) and 18.4% were in zone B (= altered clinical action with little or no effect on the clinical outcome) of the Continue reading >>

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