The U.S. FDA granted Breakthrough Device Designation for Hagar’s GWave, a noninvasive continuous glucose monitoring system that uses radiofrequency waves to measure glucose levels in the blood.

GWave First Generation is a third of the size of a smartphone and involves less radiofrequency exposure than a smartphone. The device measures blood glucose levels without requiring blood from pricking the skin. Measuring blood glucose frequently is essential for people with diabetes on insulin treatment and helpful for most other people with diabetes and prediabetes.

The device can enable early detection of glucose elevations and encouragement of good dietary and exercise practices. Earlier application of these lifestyle changes can help to prevent development of type 2 diabetes.

GWave received the Breakthrough Device Designation from the FDA following a $11.7 million Series B funding round earlier this year led by a returning investor, Columbia Pacific, that saw HAGAR’s total funds raised increase to $17.1 million.

“The GWave technology is impressive. I believe it has the potential to significantly improve the management of diabetes,” says Roy Beck, MD, PhD, a physician and epidemiologist who is the medical director of the JAEB Center for Health Research in Tampa, Fla.

In a completed pilot study, blood glucose levels assessed by GWave were compared to measurements performed by a hexokinase core laboratory assay during an oral glucose tolerance test and found to be accurate in detecting real-time blood glucose. Additional studies are scheduled to be published in coming months.

“Receiving FDA Breakthrough Designation reflects our commitment to deliver innovative technology targeting one of the world’s most significant chronic diseases, one which affects more than 422 million people, 8.5% of the world’s population. Our mission at HAGAR is to materially improve the health and quality of life of people impacted by diabetes,” says Gerry Waintraub, PhD, CTO and co-founder of HAGAR.

Receipt of this designation coincides with HAGAR’s preparation to commence a study before the end of the year at the Schneider Children’s Medical Center in Israel on adults with diabetes.

“The study will involve 250 patients with type 1 and type 2 diabetes and will test the accuracy of GWave on a diverse group of individuals across a range of demographic criteria. We also have a second study due to start this winter, which will test the device’s accuracy during conditions of rapidly changing glucose levels,” says Irl Hirsch, MD, medical advisor to HAGAR and Professor of Medicine and the Diabetes Treatment and Teaching Chair in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington.

HAGAR is also developing a second-generation sensor device that can easily be integrated into common smartwatches currently available on the market.