Medical device firm NovioSense has reported positive data from its NLNSGS2017-02 phase 2 study of tear glucose sensor device and started a second follow up trial.
The glucose sensor is a device that continuously measures glucose levels in the tear fluid when placed in the lower eyelid of diabetic patients.
NovioSense has presented the results of the six-patient clinical trial at the American Chemical Society Journal Biomacromolecules.
The completed phase 2 study in six diabetic patients was begun from a phase 1 pilot safety study in six healthy subjects.
This month, NovioSense has started a follow-on study, NLNSGS2018-02, in 24 diabetic patients to collect additional information for the use of its sensor platform for diabetic patients.
Health Innovations managing partner Linze Dijkstra 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, which is the venture capital-backed clinical stage medical device firm, has developed a flexible miniature sensor that offers glucose measurements directly to a smartphone when placed in the lower eyelid.
The firm’s eye-wearable, wireless, and battery-free glucose sensor will offer pain-free and continuous glucose monitoring to all individuals with diabetes.
The non-invasive sensor platform uses NFC technology, and can be placed by the patient to continuously monitor glucose readings.
Its non-invasive sensor can detect race levels of glucose in tears and accurately provides values of blood glucose levels.
NovioSense CEO Wilson 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.”
According to the company, diabetes is a global problem and around 600 million patients are expected to be suffered from this disease by 2032.