Three to five times a day, patients with diabetes have to prick their fingers to draw a drop of blood to determine if their blood glucose levels need to be adjusted.
The demands of the regimen can wear patients down, threatening their compliance with monitoring and, therefore, their health.
“In the diabetes community, it’s called ‘diabetic burnout.’ Patients just want to be free from the disease, and they can’t,” said Harry Gandhi, CEO and co-founder of Waterloo, Canada-based Medella Health.
Medella aims to prevent diabetic burnout with a non-invasive method to continuously monitor blood glucose levels with “smart lenses.”
Half-Dozen Companies At Work
Worldwide, about a half-dozen companies are developing smart lenses that contain a sensor. Those sensors measure the minute levels of blood glucose secreted in the eye and transmit the readings to a smartphone interface so patients can manage their levels with insulin, diet and exercise.
Probably the best-known smart lens developer is Alcon, a contact lens maker, which is a division of Novartis.
Gregory Herman, a chemical engineering professor at Oregon State University in Corvallis, Oregon, and his colleagues also have been developing sensors to measure glucose levels in the eyes using a transparent contact.
He said: “The idea behind these lenses is they are less intrusive than finger pricks. If people are already wearing contact lenses, for example, it just isn’t going to be that much of a hindrance to their lifestyle and they will not need to be pricking their finger after meals or before meals and make decisions.”
For Patient With Type 1 Diabetes
Herman, whose research is funded by JDRF (formerly the Juvenile Diabetes Research Foundation in New York City), said the lenses are ideal for patients with Type 1 diabetes. “For Type 1 diabetes, it’s best to do continuous glucose monitoring, which tracks the glucose levels throughout the day and night. This way the patient and doctor can get a lot more data as opposed to just pricking your finger several times a day,” Herman said. “This data will help make predictions based on someone’s history—for example, typical times for meals or physical activity.”
This data will help make predictions based on someone’s history—for example, typical times for meals or physical activity.
Google announced the lens in 2014 to great fanfare. Developers said they were testing a smart contact lens that’s built to measure glucose levels in tears using a tiny wireless chip and miniaturized glucose sensor that are embedded between two layers of soft contact lens material.
“We’re testing prototypes that can generate a reading once per second. We’re also investigating the potential for this to serve as an early warning for the wearer, so we’re exploring integrating tiny LED lights that could light up to indicate that glucose levels have crossed above or below certain thresholds,” they said.
The prototypes had a geeky Google look with visible monitors. Competitors are planning transparent lenses.
Verily Under Fire
The lenses came under fire in 2016 when a STAT investigation found that “the lens was regarded by many researchers—and even experts inside Verily—as technically infeasible because tears are not a reliable fluid for measuring blood sugar.”
Neither Verily nor its partner Novartis responded to MedicalExpo e-Magazine’s requests for interviews. An Alcon spokeswoman told STAT that the Verily lenses are in early clinical development and “for complex, cutting-edge technology, the projects are progressing steadily.”
Our big breakthrough was figuring out how to monitor glucose continually
Gandhi left the University of Waterloo, where the Medella project started, to focus on this technology and said his group’s sensors have been a success. “Our big breakthrough was figuring out how to monitor glucose continually, and in a way that it lasts for a very long time and simultaneously detects the minute levels of glucose with the basal tears,” he said.
Herman said there is a fraction of glucose in the eyes compared with fluids under the skin. Still, he said the proper array of transparent sensors can accurately measure blood glucose levels accurately and reliably.
The science debate is crucial, but so are economic issues. Gandhi said the potential market in North America alone is $25 billion per year.
He said the smart lenses, which would be changed once a month, had to be priced about the same as current monitoring methods. That can be anywhere from $1,500 to $5,000 per year (in the U.S., with prices being significantly lower in Europe), depending on the brand and whether patients with Type 1 or Type 2 diabetes are being monitored (Type 1 patients require more testing).
Gandhi said he expects to know within a year when the lenses can be brought to market.
Herman’s group is focused on developing sensors rather than the entire device. “We should be able to make the contact lens just nominally more expensive. So I think at the end it would be a more cost-effective solution,” he said.