Know Labs is entering the world of diabetes management and monitoring with its wearable UBAND non-invasive Continuous Glucose Monitor (CGM). The Seattle-based company said strong pre-clinical results were causing it to focus more on the development of the technology.

In fact, results were so overwhelming that Know Labs decided to curtail plans for its previously announced calorie counter product for the consumer market, to work on the device.

In a release, Phil Bosua, Know Labs CEO said, “We initially believed our first product would be a wearable calorie counter for the consumer market. At this point we have seen such dramatic progress in the lab we can now go straight for that ultimate goal and reach the large global market of people with diabetes allowing them to continuously monitor their blood glucose without the need for finger sticks or needles for the insertion of filaments or sensors. The truly non-invasive device and lower costs will also make the UBAND CGM ideal for individuals with pre-diabetes who are trying to modify their lifestyle by diet and exercise. Our dream of creating a wearable FDA-approved non-invasive CGM is just around the corner.”

Know Labs said it will go down FDA’s de novo pathway to get the UBAND CGM approved. Here’s what Dr. James “Andy” Anderson, MD, Know Labs Chief Medical Officer said about the device.

Cruising Down the CGM Scene

If Know Labs manages to gain a nod from FDA for its wearable UBAND CGM, then the company would face some intense (and we do mean intense) competition from other players in the CGM market.

A glance at the CGM landscape shows Dexcom has garnered significant market share. A little more than a year ago, the San Diego-based company was able to reach an important milestone by receiving a green light from FDA to market the Dexcom G6 CGM System. The device is interoperable with other automated insulin dosing systems. The agency said the approval was significant because its decision classifies Dexcom’s CGM as a less stringent medical device and enables a speedier review for similar future systems.

Other major developments in CGM include Abbott Laboratories gaining a nod from FDA for the Freestyle Libre Flash and Medtronic’s continued progress with the Guardian Sensor 3. (For more on Abbott’s record success with the Freestyle Libre, please check out MD+DI News Editor Amanda Pedersen’s article titled “As for Abbott's Libre, 'You Ain't Seen Nothin' Yet'.”

Senseonics is another company charting upwards in the CGM market. In June of 2018, the Germantown, MD-based company won a nod from FDA for the Eversense long-term CGM. The company said the system was the first and only CGM to feature an implantable glucose sensor and provide long-term continuous monitoring for up to three months. The approval wasn’t the final milestone for Eversense.

A few months after FDA gave its blessing for Eversense, the agency went on to approve an indication that would allow qualified healthcare providers to be trained and certified to insert patients with the device.

Before this measure, the sensor insertion and removal procedure could only be performed by trained physicians. And last month, the company received a nod from FDA for a non-adjunctive indication (dosing claim) for the Eversense CGM.