CE Mark for FreeStyle Libre

CE Mark for FreeStyle Libre

Abbott’s FreeStyle Libre system eliminates routine finger pricks for glucose measurements and requires no finger pricks for calibration

September 16, 2014

Abbott Park, Illinois – Abbott officials announced that it has received CE Mark for its FreeStyle Libre Flash glucose monitoring system. 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. The system will be available in seven countries across Europe in the coming weeks.

Abbott′s FreeStyle Libre system consists of a small, round sensor – approximately the size of a two Euro coin – worn on the back of the upper arm, 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 in less than one second. Scanning can take place while the sensor is under clothing2, making testing more discreet and convenient. 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 for both healthcare professionals and patients, driving a more productive discussion around treatment and any necessary modification.

"The FreeStyle Libre system fulfills a major need for people living with diabetes," said Robert Ford, senior vice president, Diabetes Care, Abbott. "Our customers told us that the pain, inconvenience and indiscretion of finger pricking were the key reasons they weren't managing their diabetes as well as they should. Addressing these concerns has guided the development of FreeStyle Libre – a transformational product designed to not only remove the pain of finger pricking but also seamlessly integrate into their daily lives."

According to the International Diabetes Federation, there are 382 million people around the globe living with diabetes, more than 56 million of whom live in Europe, and that number is projected to increase by more than 20% by the year 20353. FreeStyle Libre system eliminates the challenges of routine glucose monitoring for people with diabetes, enabling them to maintain a better understanding of their glucose levels.

Key features of Abbott′s FreeStyle Libre system include:

  • The system requires no finger prick calibration
  • Disposable, water-resistant sensor can be worn on the back of the upper arm for up to 14 days
  • Glucose readings can be taken as many times per day as needed or desired, with a painless one second scan
  • Each scan provides a current glucose reading, 8-hour history and the direction glucose is heading

The data generated by the system is designed to provide actionable trends and patterns that may help people determine how to modify food and other behaviors to better manage their diabetes in consultation with their healthcare professionals

"For decades, people with diabetes have had to prick their fingers routinely to check their glucose levels," said Cliff Bailey, professor of Clinical Science and Director of Biomedical Sciences Research at Aston University in Birmingham, England. "The pain and inconvenience of finger pricks has contributed to less frequent testing and suboptimal diabetes management. By eliminating the need for routine finger pricks, the FreeStyle Libre system will significantly advance the field of glucose monitoring. It offers a convenient and painless way to get more frequent glucose readings, which should help to improve diabetes management." 

Ambulatory Glucose Profile – visual depiction of glucose trends
The majority of people with diabetes are not at their target glucose levels4 5 6 often because the data generated by their glucose meters don't provide a clear picture of where their glucose has been in the past or how their actions impact their glucose levels. The FreeStyle Libre system provides users and their physicians with the Ambulatory Glucose Profile (AGP), a report providing a visual snapshot of a person′s typical day by utilizing dense glucose data revealing hypoglycemic and hyperglycemic trends to facilitate better patient therapy and education. The data are presented in a single, user-friendly, visual chart providing health care professionals the vantage point to link glucose trends to clinical decision-making, enabling a more productive discussion between health care provider and patient. For more information, go to www.AbbottNextFrontier.com.

The FreeStyle Libre System will be available in France, Germany, Italy, Netherlands, Spain, Sweden, and United Kingdom in the coming weeks and will be available for purchase online through a website in each market. 

Source: Abbott

1A 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 

2The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor 

3IDF Diabetes Atlas; sixth edition www.idf.org/diabetesatlas   

4Davies M. The reality of glycaemic control in insulin treated diabetes: defining the clinical challenges. Int J Obes Relat Metab Disord 2004;28 Suppl 2:S14–22. http://www.ncbi.nlm.nih.gov/pubmed/15306833 

5Del Prato S, Felton AM, Munro N et al. Improving glucose management: 10 steps to get more patients with type 2 diabetes to glycaemic goal. Int J Clin Pract 2005;59:1345–55 http://www.ncbi.nlm.nih.gov/pubmed/16236091       

6Alvarez Guisasola F, Mavros P, Nocea G et al. Glycaemic control among patients with type 2 diabetes mellitus in seven European countries: findings from the Real-Life Effectiveness and Care Patterns of Diabetes Management (RECAP-DM) study. Diabetes Obes Metab 2008;10 Suppl 1:8