NovioSense Announces Positive Phase 2 Clinical Trial Results and the Commencement of a Second Follow Up Study

NovioSense has demonstrated the measurement of tear glucose in diabetic patients and the correlation to blood glucose with clinically relevant accuracy. The company announced the commencement of a second, 24-patient study, to validate the use of its tear glucose sensor in type 1 diabetic patients.

(BUSINESS WIRE/AETOSWire)-- NovioSense BV, the venture capital-backed clinical stage medical device company, today announced positive data from its NLNSGS2017-02 Phase 2 tear glucose sensor study. The NovioSense Glucose Sensor is a device that, when placed in the lower eyelid, continuously measures glucose levels in the tear fluid of diabetic patients. The results of the six-patient clinical trial are presented in the American Chemical Society Journal Biomacromolecules.

Dr. Wilson, NovioSense’s CEO, said, “Today marks an important step in our tear glucose program. We opted to deploy the tear glucose sensor in diabetic patients to obtain evidence that tear glucose levels may be utilised to predict blood glucose levels with a clinically acceptable accuracy. These positive results from our phase 2 study demonstrate that the NovioSense Glucose Sensor can be used to measure glucose non-invasively in tears and correlates to blood glucose levels with an accuracy comparable to commercial, minimally invasive devices.”

The completed Phase 2 study in six diabetic patients was initiated based on positive results from a Phase 1 pilot safety study in 6 healthy subjects. On October 18, 2018 NovioSense initiated a follow-on study, NLNSGS2018-02, in 24 diabetic patients to gather additional evidence for the use of its sensor platform for diabetic patients.

Linze Dijkstra, Managing Partner of Health Innovations, said, “We invested in NovioSense in 2012 based on positive pre-clinical data and are delighted to see year-on-year progress in the development of this disruptive diagnostic platform.”

NovioSense BV has developed a flexible miniature sensor that, when placed in the lower eyelid, provides glucose measurements directly to a smartphone. NovioSense delivers the first of its kind eye-wearable, wireless, battery-free glucose sensor to provide pain-free, continuous glucose monitoring to all individuals with diabetes at an affordable price. The non-invasive sensor platform, which utilises NFC technology, is placed by the patient to continuously monitor glucose readings, as a useful component of any glucose management system.