February 16, 2016

Abbott Receives Approval in Australia for FreeStyle® Libre—the Revolutionary Glucose Monitoring System for People with Diabetes


Today, Abbott (NYSE:ABT) announced that it has received approval from the Therapeutic Goods Administration (TGA) in Australia for its FreeStyle® Libre Flash Glucose Monitoring System, a revolutionary new glucose sensing technology for insulin-using Australians with diabetes2,3. The system eliminates the need for routine finger pricks1, reading glucose levels through a sensor that can be worn on the back of the upper arm for up to 14 days. In addition, no finger prick calibration is needed — a key differentiator from current continuous glucose monitoring systems.

Abbott′s FreeStyle Libre System consists of a small, round sensor — approximately the size of two stacked Australian 20-cent coins — worn on the back of the upper arm; the system measures glucose every minute in interstitial fluid through a small (5mm long, 0.4mm wide) filament that is inserted just under the skin and held in place with a small adhesive pad. A handheld reader is scanned over the sensor to get a glucose result painlessly in less than one second, without the need to draw blood routinely1. Each scan displays a real-time glucose result, a historical trend and the direction the glucose is heading. The reader holds up to 90 days of data, providing a historical snapshot of glucose levels over time. The FreeStyle Libre System software enables the data to be presented in a user-friendly, visual chart driving a more productive discussion with health care professionals around treatment and any necessary modification to it.

"We know through our research that pain, inconvenience and indiscretion of finger pricking were the key reasons people with diabetes aren't managing their diabetes as well as they should," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "Addressing these concerns has guided the development of FreeStyle Libre – a transformational product designed to not only remove the pain of routine finger pricking1 but also seamlessly integrate into daily lives – empowering people with diabetes to make better-informed treatment decisions and live their best lives through better health."

According to the International Diabetes Federation, there are 415 million people around the globe living with diabetes, and that number is projected to increase to 642 million by the year 2040—215 million of which will be in the Western Pacific region4. The FreeStyle Libre System eliminates the challenges of routine finger pricking1 for insulin-using adults with diabetes aged 18 years and older, enabling them to maintain a better understanding of their glucose levels2,3.

"People with diabetes find finger pricking to be painful and inconvenient and in turn, they often test glucose levels less frequently, which can then lead to suboptimal diabetes management,” said Prof. Stephen Twigg, head of the Dept of Endocrinology RPA Hospital and Kellion Professor of Endocrinology at the University of Sydney. “The FreeStyle Libre System will significantly advance the field of glucose monitoring, by offering not only a convenient and painless way to acquire more frequent glucose readings, but also in enabling detailed actionable glucose profiles, to help both healthcare professionals and their patients to better manage diabetes and people to live healthier lives.”

The FreeStyle Libre System is currently available in several countries in Europe, and will be Available in Australia in the coming months. In the meantime, Australians can register their interest in receiving updates on FreeStyle Libre System by visiting www.FreeStyleLibre.com.au.

About Abbott:

At Abbott, we’re committed to helping you live your best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world—in nutrition, diagnostics, medical devices and branded generic pharmaceuticals—that create more possibilities for more people at all stages of life. Today, 74,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

 

Abbott Media:

Vicky Assardo, +1 (510) 864-4690
Jessica Sachariason, +1 (510) 239-2690

Abbott Financial:

Mike Comilla, +1 (224) 668-1872

 


1 A 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.

2 The device FreeStyle Libre Flash Glucose Monitoring System Sensor is only intended to be used by patients (aged 18 years and older) with insulin dependent diabetes mellitus

3 Health professionals and consumers should be aware about the limitations of available scientific evidence for use of FreeStyle Libre Flash Glucose Monitoring System in any other groups of patients who require diabetes management

4 7th Edition of the IDF Diabetes Atlas, http://www.diabetesatlas.org/

February 4, 2016

Children in Europe Now Have Access to First-Of-Its-Kind Diabetes Sensing Technology – Eliminates Routine Finger Pricksi


Today, Abbott (NYSE: ABT) announced that it has obtained CE Mark (Conformité Européenne) for the FreeStyle Libre flash glucose monitoring system indicated for children and teens with diabetes aged 4-17 years old.ii This means that children and young people with diabetes living in Europe are able to experience the liberation from the pain and hassle of routine finger pricks.i

A person with diabetes typically self-monitors their glucose by pricking their fingers routinely to check their glucose level, enabling appropriate adjustments to insulin, diet, and activity based on their health care professionals’ recommendations to help achieve good glycemic control. However, according to research , there is often reluctance from people with diabetes, especially children and adolescents, to perform this task, based in part on the discomfort and pain of finger pricking.

"I still wake up in the night to check my daughter's blood glucose level with a [finger prick]. I'm very much looking forward to the day that I can use a FreeStyle Libre instead, so that I don’t have to wake her up to check her levels," said Joanne Blackham, mother to a Type 1 person with diabetes Madeleine, aged 13.

Abbott’s FreeStyle Libre flash glucose monitoring system, which is available in several European countries, is designed to change how people with diabetes measure their glucose levels and ultimately help them achieve better health outcomes. The system reads glucose levels through a sensor that is worn on the back of the upper arm for up to 14 days, eliminating the need for routine finger pricks.i In addition, no finger prick calibration is needed—a key differentiator from current continuous glucose monitoring systems.

"Children and teens with diabetes and their families have to navigate many challenges in their daily lives as they care for this complex condition," said Jared Watkin, senior vice president, diabetes care, Abbott. "The scientists and engineers at Abbott have made it their life's work to provide the most innovative technology to help people with diabetes improve their diabetes management and ultimately, live happier and healthier lives."

In a recent accuracy study, Abbott’s FreeStyle Libre flash glucose monitoring system was clinically proven to be accurate, stable and consistent for up to 14 days without the need for finger prick calibration, for children and teens aged 4-17 years old. In addition, more than 97 percent of these children and teens said that the FreeStyle Libre system is easier to use than finger prick testing.iv

According to the International Diabetes Federation (IDF), the Europe region has the highest number of children—ages 0-14—with type 1 diabetes compared with the other IDF regions* – approximately 140,000. Within that region, the United Kingdom, the Russia Federation, and Germany have the highest population of children with type 1 diabetes.v

"The availability of FreeStyle Libre for children is a critical milestone for children living with diabetes," said Dr. Emanuele Bosi, associate professor, Department of Endocrinology and Diabetology, Università Vita-Salute, San Raffaele Hospital in Milan, Italy." The technology in Abbott’s FreeStyle Libre is transformative because it changes how self-monitoring has been done for decades—and is proven to be accurate and stable. I look forward to seeing my young patients achieve better diabetes management, while giving their parents and caretakers more peace of mind."

Caregivers of children with diabetes also can be challenged as they worry about such things as night-time hypoglycemia (a low glucose level), which is the number one concern of parents of children with diabetes, and a potentially life-threatening condition. Authors of a 2013 study published in the journal Quality of Life Research noted that people with diabetes — type 1 or type 2 — experience hypoglycemia while sleeping more frequently than many doctors realize.vi A parent or caregiver often has to wake their child up during the night to test glucose—now with FreeStyle Libre flash glucose monitoring system that can be done quickly, painlessly and without disturbing sleep.

Abbott’s FreeStyle Libre system is currently available in Austria, Belgium, France, Germany, Italy, Netherlands, Norway, Spain, Sweden and the United Kingdom.

About Abbott:

At Abbott, we’re committed to helping you live your best possible life through the power of health. For more than 125 years, we’ve brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 74,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Abbott Media:

Vicky Assardo, +1 (510) 864-4690
Jessica Sachariason, +1 (510) 239-2690

Abbott Financial:

Mike Comilla, +1 (224) 668-1872

 

Children in Europe now have access to first-of-its-kind diabetes sensing technology, which eliminates routine finger pricks. Abbott’s FreeStyle Libre flash glucose monitoring system is now indicated for children and teens with diabetes aged 4-17 years old.


i A 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.

ii A caregiver at least 18 years old is responsible for supervising, managing, and assisting the child or young person ages 4-17 years old in using the FreeStyle Libre system and interpreting its readings.

iii http://adc.bmj.com/content/89/6/516.full.pdf

iv Data on file, Abbott Diabetes Care, Inc., Evaluation of the Accuracy of the Abbott Sensor Based Glucose Monitoring System-Paediatric Label Extension Study (CE) (2015)

v 7th Edition of the IDF Diabetes Atlas, chapter 4, http://www.diabetesatlas.org/

* IDF regions include Africa, Europe, Middle East and North Africa, North American and Caribbean, South and Central America, South East Asia, and Western Pacific

vi Quality of Life Research, June 2013, Volume 22, Issue 5, pp 997-1004, http://link.springer.com/article/10.1007/s11136-012-0234-3



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