Clinical studies

During 2017 our technology successfully passed through two clinical studies at an Israeli hospital. For both of these studies we integrated our technology into commercially available smartwatch devices. The studies were made for two applications of our technology, the first one was for Dehydration Monitor and the second for our non-invasive Blood Glucose Monitor. In both studies our technology achieved the required results.

Non-invasive Blood Glucose Monitor study

This study's main objective was to check the accuracy of our non-invasive blood glucose monitor integrated into one model of commercially available smartwatch. Secondary objective was to evaluate the safety of our technology usage. The main part of the study was performed on 200 subjects in age range 18-75. Each subject had his blood glucose measured with our non-invasive glucometer and simulteneously blood sample was taken from vein to be analyzed in laboratory. This was performed twice, before food and after. Later was decided to make 34 additional measures from diabetic subjects with blood glucose level higher than 200 mg/dL. Our performance goal for this study was to meet the standard of ISO 15197 for blood glucometers. The standard requires that at least 95 of our glucometer results should be within ±15 mg/dL from laboratory results at concentrations under 100 mg/dL, and at least 95 of our glucometer results should be within ±15% from laboratory results at concentrations of 100 mg/dL and more. Both performance and safety requirements in this study were satisfied by our technology.

To view the full clinical study report please click here.

To view this study on the NIH site please click here.

Dehydration Monitor study

This study's main objective was to check the accuracy of our Dehydration Monitor integrated into two models of commercially available smartwatches. Secondary objective was to evaluate the safety of our technology usage. The study was performed on a total of 200 healthy subjects in age range 18-50. Participants followed a protocol which included physical activity in form of walking on a treadmill. The performance of Dehydration Monitor was compared with reference weight loss results obtained using high precission balances. In lack of existing standard in that field, the performance goal for this study was the following: At least 95 percent of results should have no more than 20 percent difference from the reference. Both performance and safety requirements in this study were satisfied by our technology.

To view the full clinical study report please click here.

To view this study on the NIH site please click here.