Abbott's FreeStyle® Libre 2 iOS App Cleared in U.S., Providing a Seamless Digital Experience to Simplify Diabetes Management

- Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared the FreeStyle ® Libre 2 iOS application for use with compatible iPhones 1 providing a comprehensive digital offering for its FreeStyle Libre 2 integrated continuous glucose monitoring (iCGM) system . Providing breakthrough technology that is accessible and affordable 4 the FreeStyle Libre portfolio is the number one continuous glucose monitoring (CGM) system worldwide 5 and most prescribed in the U.S. 6 changing the lives of nearly 3.5 million people across more than 50 countries including 1 million users in the U.S.

Now cleared in the U.S., Abbott's FreeStyle Libre 2 app helps people manage diabetes right from their iPhone. The app creates a comprehensive, digital experience for FreeStyle Libre users and healthcare professionals and is the only sensor-based glucose monitoring app that allows users to check their glucose with a compatible iPhone every minute with optional real-time alarms. Photo Source: Abbott

Approved for adults and children (4 and older) with diabetes, the new FreeStyle Libre 2 app creates a seamless experience for users and healthcare professionals. The app enables users to get glucose readings directly on their iPhones without the use of a reader. A key benefit of the app is the ability for caregivers to remotely monitor their loved one's glucose readings and get real-time alarms via the LibreLinkUp app . 7

" The demands of living with diabetes can be overwhelming, and there's a critical need to improve the way people with diabetes manage their condition – easily, affordably, accurately – and in a way that seamlessly fits into their everyday lives," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "The FreeStyle Libre 2 iOS app streamlines how people manage their diabetes on their iPhones – empowering users with the information they need 24/7 while improving their health on the go."

According to a recent Gallup poll, 1 in 5 Americans currently tracks health statistics using a mobile app. 8 Free to download on the iOS App Store soon, the FreeStyle Libre 2 app will offer personalized, up-to-the-minute glucose data for people with diabetes who are using FreeStyle Libre 2 glucose sensors. By scanning the sensor with the  FreeStyle Libre 2 app, users will get their current glucose reading and trend arrow which can help them determine how food, exercise and other lifestyle factors impact diabetes management.

With a 14-day wear time, FreeStyle Libre 2 is the longest-lasting iCGM sensor currently on the market. 9 Available at pharmacies at a fraction of the cost of other CGM systems, 10 the FreeStyle Libre 2 system is widely accessible to people with diabetes. Integrated features include:

  • Optional real-time glucose alarms 2 that automatically alert users when glucose is high or low
  • Unsurpassed 14-day accuracy 11 with readings every minute and an eight-hour glucose history, including comprehensive view of trends
  • Seamless integration with Abbott's connected digital health tools – the LibreLinkUp app and LibreView 12 , a secure cloud-based data management platform – allowing users to easily share their glucose readings with healthcare professionals and caregivers. Accessible remotely, use of LibreView increased about 70% over the past year. 13

"The pandemic taught us the importance of connected devices in managing chronic conditions remotely, and we continue to see the benefit from the latest advances in digital health," said Kurt Midyett , M.D., pediatric endocrinologist and medical director at Midwest Pediatric Specialists. "Continuous glucose monitoring is one of the most significant health tech innovations in the last decade, and I see the life-changing benefits first-hand from my patients every day. As a doctor, it's invaluable to receive my patients' glucose data remotely via systems like LibreView – enabling more meaningful conversations with my patients, and ultimately, improving treatment decisions and their long-term health."

Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 38 countries, including Canada , France , Germany , Japan , the United Kingdom , and the U.S.

The FreeStyle Libre 2 iOS app will be available soon in the U.S. to download on the App Store.

Indications and Important Safety Information

FreeStyle Libre 2 system : Failure to use FreeStyle Libre 2 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, resulting in injury. If glucose alarms and readings do not match symptoms or expectations, use a fingerstick value from a blood glucose meter for treatment decisions. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or https://www.FreeStyle.abbott/us-en/safety-information for safety info.

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at https://www.facebook.com/Abbott and on Twitter @AbbottNews

1 The FreeStyle Libre 2 app is only compatible with certain mobile devices and operating systems. Please check our website for more information about device compatibility before using the app. Use of the FreeStyle Libre 2 app requires registration with LibreView.
2 The High Glucose alarm level can be set between 120-400 mg/dL and the Low Glucose alarm level can be set between 60 – 100 mg/dL Notifications will only be received when alarms are turned on and the sensor is within 20 feet of the reading device. Critical Alerts must be enabled to receive alarms and alerts on the smartphone.
3 The LibreLinkUp app is only compatible with certain mobile device and operating systems. Please check www.librelinkup.com for more information about device compatibility before using the app. Use of FreeStyle Libre-compatible apps and LibreLinkUp may require registration with LibreView. The LibreLinkUp mobile app is not intended to be a primary glucose monitor: users must consult their primary device(s) and consult a healthcare professional before making any medical interpretation and therapy adjustments from the information provided by the app.
4 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
5 Data on file, Abbott Diabetes Care. Data based on the number of users worldwide for the FreeStyle Libre system compared to the number of users for other leading personal-use, sensor-based glucose monitoring systems
6 Data based on the number of patients assigned to each manufacturer based on last filled prescription in US Retail Pharmacy and DME.
7 The LibreLinkUp app is only compatible with certain mobile devices and operating systems. Please check www.LibreLinkUp.com for more information about device compatibility before using the app. Use of the LibreLinkUp app requires registration with LibreView.
8 Gallup News Service; Gallup Poll Social Series Health and Healthcare, Nov. 1 – 4, 2019
9 Data on file, Abbott Diabetes Care.
10 Based on a comparison of list prices of the FreeStyle Libre portfolio versus competitor CGM systems. The actual cost to patients may or may not be lower than other CGM systems, depending on the amount covered by insurance, if any.
11 Based on FDA iCGM special controls.
12 The LibreView data management software is intended for use by both patients and healthcare professionals to assist people with diabetes and their healthcare professionals in the review, analysis and evaluation of historical glucose meter data to support effective diabetes management. The LibreView software is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice.
13 Data on file, Abbott Diabetes Care. (Percent of PAT Accounts – percent of Patient LibreView Accounts that enabled remote monitoring)

Approved for adults and children (4 years and older) with diabetes, Abbott's new FreeStyle Libre 2 iOS app creates a seamless experience for users and healthcare professionals to remotely monitor glucose levels. Free to download from the App Store soon, the FreeStyle Libre 2 app enables users to get glucose readings directly on their iPhones without the use of a reader. Photo Source: Abbott

Abbott Logo (PRNewsFoto/Abbott)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/abbotts-freestyle-libre-2-ios-app-cleared-in-us-providing-a-seamless-digital-experience-to-simplify-diabetes-management-301346035.html

SOURCE Abbott

News Provided by PR Newswire via QuoteMedia

The Conversation (0)

Medtronic: Managing Her Diabetes 'Runner's High'

Medtronic

Technology helps people living with diabetes manage the highs and lows of blood sugar

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Medtronic to announce financial results for its fourth quarter and full fiscal year 2024

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2024 on Thursday, May 23, 2024 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2024, which ended on Friday, April 26, 2024 .

Medtronic will host a video webcast at 7:00 a.m. CDT on Thursday , May 23, 2024, to discuss results for its fourth quarter and full fiscal year 2024. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Salix Pharmaceuticals announces Bellamy Young as Spokesperson for Xifaxan

  • Xifaxan is the first and only FDA approved medication for the reduction in risk of OHE recurrence in adults
  • Overt Hepatic Encephalopathy is caused by cirrhosis of the liver
  • As complications from chronic liver disease increase, recognizing OHE is critical so that patients can work with their healthcare providers to find the right management plan for them

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced award-winning actor, Bellamy Young, as the brand ambassador in a new campaign to raise awareness of Xifaxan, the first and only FDA approved medication to reduce the risk of overt hepatic encephalopathy (OHE) recurrence in adults. Overt hepatic encephalopathy is a complication of cirrhosis that can happen when the liver cannot filter toxins from the blood, and the toxins build up and reach the brain. It is projected that as many as four out of five people with cirrhosis may eventually develop some form of HE

"When I first started talking about OHE, the most common response I received from people was ‘I wish I knew', a sentiment that echoed my experience when my father was diagnosed with OHE. We didn't know the symptoms of OHE could persist or that it could worsen over time. But when my dad had OHE we also didn't know as much as we do today, and we didn't have the same management options," said Bellamy Young, whose father suffered from OHE when she was in high school. "I want to help today's patients and caregivers to know more than my family did with my father, and I encourage them to talk to their health care providers about managing the risk of OHE recurrence. I hope people will go to Xifaxan.com to know more."

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Knight Therapeutics Reports First Quarter 2024 Results

Knight Therapeutics Inc. (TSX: GUD) ("Knight" or "the Company"), a leading pan-American (ex-US) specialty pharmaceutical company, today reported financial results for its first quarter ended March 31, 2024. All currency amounts are in thousands except for share and per share amounts. All currencies are Canadian unless otherwise specified.

2024 Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Enters into Exclusive Supply and Distribution Agreement with Ironshore Pharmaceuticals & Development, Inc. for JORNAY PM® for Canada and Latin America

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, announced today that it has entered into an exclusive supply and distribution agreement with Ironshore Pharmaceuticals & Development, Inc., a wholly owned subsidiary of Ironshore Therapeutics, Inc. ("Ironshore"), granting Knight the rights to seek regulatory approval and commercialize JORNAY PM ® in Canada and Latin America. Currently approved in the US, JORNAY PM ® is an extended-release formulation of methylphenidate, a stimulant medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). Financial terms of the agreement were not disclosed.

JORNAY PM ® is the first and only evening-dosed methylphenidate product commercially available in the United States to treat ADHD in patients 6 years of age and older. JORNAY PM ® consists of microbeads with a delayed-release layer and an extended-release layer. The first layer delays the release of the active ingredient until morning while the extended-release layer controls the release of the active ingredient from the early morning and throughout the day. This unique formulation provides a pharmacokinetic profile that allows ADHD symptom control from the time patients wake up until they go to bed. JORNAY PM ® was studied in two randomized, double-blind, placebo-controlled, phase 3 clinical trials 1,2 . Both studies met their primary and key secondary endpoints demonstrating a statistically significant and clinically meaningful improvement in ADHD symptoms upon awakening, through the afternoon, and into the evening. JORNAY PM ® was submitted for approval in Canada in November 2023.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Knight Therapeutics Inc. announces voting results from the Annual General Meeting

Knight Therapeutics Inc. (TSX:GUD) ("Knight" or the "Corporation") a leading pan-American (ex-US) specialty pharmaceutical company, announced today the voting results from the Annual General Meeting of the Shareholders held virtually in Montreal, Quebec ("Meeting").

Election of Directors

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×