NovioSense has demonstrated the measurement of tear glucose in diabetic patients and a close correlation to blood glucose with clinically relevant accuracy. A second, 24-patient study, to validate the use of the new glucose sensor in type 1 diabetic patients is already commencing.
NovioSense BV, a company based in The Netherlands, announced positive data from its 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 and is able to send readings to a paired smartphone. The results of the six-patient clinical trial are presented in the latest issue of the American Chemical Society’s journal Biomacromolecules.
The NovioSense device is the first of its kind eye-wearable that is wireless, battery free, and non-invasive. It uses NFC (near-field communication) technology to transfer its readings to a smartphone or another device that can display the measurements and keep a record of them.
“Today marks an important step in our tear glucose sensor program,” said Dr. Christopher Wilson, NovioSense’s Chief Executive Officer. “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 level of 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 that of 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 six 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 in the measurement of glucose levels for diabetic patients.
“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,” said Linze Dijkstra, Managing Partner of Health Innovations.