News Release

 

• FREESTYLE® LIBRE GAINS EXPANDED INDICATION FOR PEOPLE (AGE 4 TO 17 YEARS) WITH INSULIN DEPENDENT DIABETES MELLITUS IN NEW ZEALAND (*5)

•  SYSTEM MEASURES GLUCOSE LEVELS THROUGH SMALL SENSOR ON THE BACK OF THE UPPER ARM FOR UP TO 14 DAYS, REQUIRING NO ROUTINE FINGER PRICK CALIBRATION (*2)

Abbott today announced the availability of FreeStyle ® Libre for over 2,500 children and teens living with diabetes in New Zealand.(* 6)

Young individuals with diabetes, who may have experienced painful, routine finger pricks (*4) for testing glucose levels, sometimes at night, now have access to a new, easy-to-use option for measuring interstitial fluid glucose levels.

The announcement follows the acceptance for the expanded indication of the FreeStyle Libre Flash Glucose Monitoring system to children (age 4 to 17 years) (*5) with insulin-dependent diabetes mellitus and limited to those who are supervised by a caregiver who is at least 18
years of age.

The system reads glucose levels through a sensor worn on the back of the upper arm for up to 14 days and eliminates the need for routine finger pricks.(*1-4) It also requires no finger prick calibration – a key differentiator from current continuous glucose monitoring systems.(*7-9) Now children and teens in New Zealand, as well as their parents and caregivers, have access to a monitoring system that does not get in the way of a busy, active life, and is easier and less painful than traditional finger prick testing. (*4,10)

Liam Easton, a 14-year-old from Dunedin, says the FreeStyle Libre has allowed him to spend more time playing with his school friends.
“The FreeStyle Libre is easy to use and discreet. Before using the FreeStyle Libre, I felt embarrassed to check my glucose levels and I wouldn’t test at school. The system has allowed me to spend more time playing basketball with my friends, while also helping me manage my
diabetes better.”

While the FreeStyle Libre system has been available to adults in New Zealand for just over six months, the expanded indication to children and teens (age 4 to 17 years) (*5) will help redefine how younger New Zealanders living with diabetes and their parents and caregivers measure their glucose levels.(*4)

Dr Ben Wheeler, Paediatric Endocrinologist for the University of Otago and Southern District Health Board comments; “Diabetes is one of the most common chronic diseases in childhood and carries a very significant burden for children and their families. I think it is great news that the FreeStyle Libre system is now available as an option for some children and their families. Having another tool available to help manage this illness is so important, and we look forward to more treatments and monitoring choices into the future. The great thing about this device is the potential reduction in diabetes burden it offers, by reducing the need for frequent finger prick blood glucose measures. It is my great hope that this system and systems like it will be funded by the New Zealand government in the future.”

The expanded indication of a revolutionary diabetes sensing technology such as the FreeStyle Libre system in New Zealand also comes as welcome news for the wider diabetes community.

Ruby McGill, Director of Youth at Diabetes New Zealand comments: “We’re really excited about this announcement and the difference using a FreeStyle Libre can make to young people living with diabetes and their families. Glucose tests can be done quickly and discreetly, which allows people living with, or supporting someone with diabetes to feel confident to carry on with what they are doing. And being able to identify blood glucose trends and patterns means they can see where their levels are heading and make tweaks to their diabetes management as needed.”

As the factory-calibrated sensors require replacement every 14 days, families with children living with diabetes would benefit from PHARMAC (The Pharmaceutical Management Agency) funding of the FreeStyle Libre sensors. This would allow more users to experience the system that can provide discreet, data-rich feedback and improved glycaemic control. (*4,9-13)

“Our aim at Abbott is to enable people with diabetes to live a healthier life, using innovative products. FreeStyle Libre’s revolutionary technology now offers children in New Zealand freedom from routine, painful finger-pricks. It is also discreet, and makes it easy for caregivers to monitor glucose, as many times as is needed, over many days” explains Peter Chalikias, regional director, Diabetes Care, Abbott ANZ.
Abbott has submitted an application to New Zealand’s PHARMAC, to seek appropriate funding for FreeStyle Libre, to ensure timely, equitable and affordable access to this revolutionary sensing technology for people living with diabetes.

Abbott′s FreeStyle Libre Flash Glucose Monitoring System is distributed in New Zealand by Mediray NZ Ltd and is available for purchase online at www.FreeStyleLibre.co.nz.

Caregivers and parents of young New Zealanders with diabetes are encouraged to speak to their healthcare professional to determine if the FreeStyle Libre system would be the right product for their children.

About the FreeStyle Libre System

Abbott′s FreeStyle Libre system consists of a small, round sensor— approximately the size of two stacked two dollar coins—worn on the back of the upper arm for up to 14 days, which 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 reader is scanned over the sensor to get a glucose result painlessly (*3) in less than one second. Each scan displays a real-time glucose result, an eight-hour historical trend and the direction the glucose is heading.

Unlike current continuous glucose monitoring devices (those that measure glucose levels in real-time throughout the day and night), the FreeStyle Libre system is factory calibrated—meaning that it does not require a finger prick test for calibration, where some current continuous glucose monitoring systems might require two or more finger prick calibrations per day.(*7-9)

The FreeStyle Libre Flash Glucose Monitoring System received inclusion on the Web Assisted Notification of Devices (WAND) from the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) in New Zealand in April 2017 for people aged 18 and older with insulin-dependent diabetes. This indication was extended to measuring interstitial fluid glucose levels in people aged 4 and older with insulin-dependent diabetes mellitus in February 2018. The indication for children (age 4 to 17 years) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the FreeStyle Libre Flash Glucose Monitoring System and also for interpreting or assisting the child to interpret FreeStyle Libre readings.

About Abbott

At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Abbott’s diabetes care unit in Australia provides a range of glucose monitoring solutions for people with diabetes, including blood glucose monitors and flash glucose monitoring, via Mediray NZ Ltd.

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

Abbott Media:
Anand Kadkol, +91 97690 04051
Vicky Assardo, +1 (510) 864-4690
Abbott Financial:
Mike Comilla, +1 (224) 668-1872

References
1. Scanning the sensor to obtain glucose values does not require lancets
2. 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 3. Most people did not feel any discomfort while applying or wearing the FreeStyle Libre sensor. In a 2013 US study conducted by Abbott Diabetes Care, 100% of patients surveyed (n=30) rated that applying the sensor was painless or almost painless and 93.4% of patients strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin. Data on file. 4. Campbell, F., Kordonouri, O., Murphy N. & Stewart, C. FreeStyle Libre use for Self-Management of Diabetes in Children and Adolescents. Diabetes. 2017 June: 66(Suppl 1):A229-A398; 110-LB; LB28). The self-assess questionnaire was offered to participants 13 and over.
5. The indication for children (age 4 to 17 years) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the FreeStyle Libre Flash Glucose Monitoring System and also for interpreting or assisting the child to interpret FreeStyle Libre readings.
6. Diabetes Youth New Zealand 2018, http://www.diabetesyouth.org.nz/about-diabetes/ accessed 30 January 2018 7. Hoss U. & Budiman E. Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology. Diabetes Technology & Therapeutics. 2017 May 1; 19(Suppl 2): S-44–S-50. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444502/ 8. User’s Manual for Dexcom and Medtronic Continuous glucose monitoring system, data on file, reviewed Aug 2017
9. Dunn T, Xu Y, Hayter G; Evidence of a Strong Association Between Frequency of Flash Glucose Monitoring and Glucose Control Measures During Real-World Usage. ATTD 2017.
10. Edge, J., Acerini, C. et al. An alternative sensor-based method for glucose monitoring in children and young people with diabetes. Arch dis child. 2017 January 30; http://adc.bmj.com/content/archdischild/early/2017/01/30/archdischild-2016-311530.full.pdf
11. The reader can capture data from the sensor with a one second scan
12. The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor
13. Reader dimensions 95 mm x 60mm x 16 mm and weight 65 grams