ABBOTT PARK, Ill., Aug. 31, 2017 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the Ministry of Health Labour and Welfare (MHLW) in Japan has granted national reimbursement for the FreeStyle® Libre glucose monitoring system effective September 1, 2017. The revolutionary system will be widely available to the more than 1 million Japanese people ages six and above with diabetes, both Type 1 and Type 2, on insulin therapy.
Japan has one of the highest rates of diabetes with an overall population of 9.5 million people living with the condition.1
"This is a significant development for the Japanese diabetes community – both for the people living with the condition and for their healthcare professionals," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "FreeStyle Libre has had a demonstrable impact around the world in helping people with diabetes, and we are pleased with the MHLW decision to make the product available through government reimbursement to those who need it."
Abbott's FreeStyle Libre system helps address the challenges of routine finger sticking2 for people with diabetes with a quick one second scan over a small sensor that is worn on the back of the upper arm. In addition, no finger stick calibration is needed— a key differentiator from current continuous glucose monitoring systems. With the data from the device, users can have a better understanding of their glucose levels through the Ambulatory Glucose Profile (AGP), a chart that provides a visual snapshot of glucose levels, trends and patterns over time. The AGP also provides doctors with deeper insights to make more informed treatment decisions.
"For people living with diabetes frequent glucose measurement is key to effective diabetes management. It is often challenging for my patients to comply with glucose testing because of the pain, inconvenience and stigma of using finger sticks," said Yoshihito Atsumi, M.D., director of the Diabetes Center at Eiju General Hospital. "FreeStyle Libre not only enables my patients to check their glucose more frequently due to the convenience of the technology, but it also provides valuable glucose trends and patterns to help me make more informed treatment decisions."
Two published clinical trials3 and real-world evidence from more than 50,0004 users show that people who use FreeStyle Libre system test their glucose levels an average of at least 15 times per day. The studies also show that people who scan more frequently spend less time in hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar) while having improved average glucose levels, demonstrating improved glucose control overall.
Abbott's FreeStyle Libre system was introduced across Europe in 2014, and is now available in 39 countries. Japan now joins a group of 16 countries that have partially or fully covered Libre, including large markets such as France and Germany. In the U.S., the FreeStyle Libre system is currently under review by the U.S. Food and Drug Administration.5
About the FreeStyle Libre System
Abbott's FreeStyle Libre system 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 can be worn on the back of the upper arm for up to 14 days, and does not require finger stick calibration.
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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
1 National Health and Nutrition Survey, MHLW
2 A fingerprick test using a glucometer is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels; or if hypoglycemia or impending hypoglycemia is reported by the system; or when symptoms do not match the system readings
3 Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial [published online September 12, 2016]. Lancet. 2016; Haak, T., Hanaire, H., Ajjan, R., Hermanns, N., Riveline, J., & Rayman, G. (2016, February). Use of novel Flash Glucose-Sensing technology by individuals with Type 2 diabetes on intensive insulin therapy to support self-management. Presented ATTD: Advanced Technologies & Treatments for Diabetes - 9th International Conference, Milan, Italy.
4 Data on file. 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
5 Pending FDA approval. Not available for sale in the United States