A new CGM that just was approved for use in Europe, called sugarBEAT, from Nemaura Medical, in the United Kingdom, was designed only after “multiple focus group studies and feedback from clinical studies” were taken into account, according to Bashir Timol, Director of Strategy and Corporate Development at Nemaura. The company put user-experience high on their list of considerations in designing a new piece of tech that might ease the burden of monitoring blood sugar.
The system is expected to hit the market in Europe by the end of the year, according to a news release from Nemaura. The company was spun off its parent company, Nemaura Pharma, which started in 2005 to “develop state-of-the-art transdermal drug-delivery systems for a wide range of drugs and vaccines.” The company says it has filed for FDA approval for an Alzheimer’s drug delivery patch, and is also developing “more than 16 drugs in house.”
The reason the end user experience was so paramount in developing the CGM product, Timol says, is because the user has become a key arbiter in deciding how technology is designed. “Today, CGMs are expected to be more user friendly and discreet, and technology has moved on to enable that to happen, hence our R&D efforts have been guided by trying to enhance the user experience within the technical limits of our product,” he says. “Our decision to move from a ‘watch’ to a ‘wireless patch’ based format was driven by our desire to try easily integrate into the App-centric smart device — phone, watch, tablet —lifestyle many users are adopting.”
The sugarBEAT CGM uses a patch without needles, Timol says. More specifically, according to a news release from the company, “the core platform diagnostic technology is based on micro-electro-mechanical-systems (MEMS) designed to non-invasively draw out glucose through the skin to a reservoir within a skin-patch, where it is measured by a sensor. The data is then sent by bluetooth to a mobile phone application where it is displayed in numerical or graphical form.”
The patch is applied after a finger stick blood test to calibrate the path. It then takes up to 30 minutes to warm up before it starts delivering glucose readings once every five minutes to an app.
The patch can be worn for up to 24 hours at a time but users have the flexibility to wear it for only a few hours or, “on an ad hoc basis,” according to Nemaura. Many CGMs require inserting a sensor and replacing that sensor every three to seven days.
That flexibility was one of three primary considerations in how sugarBEAT was envisioned, Timol says. The other two were, “It is low-cost, with a price point anticipated to be comparable to cost of multiple daily finger stick use and it is non-invasive — so you do not have to stick a needle/sensor inside the skin.”
But, while the comfort from a needle-free sensor might be crucial in attracting customers, accuracy is also an important factor that diabetics consider when deliberating which CGM to use to track their glucose levels.
According to Nemaura, the sugarBEAT CGM achieved a Mean Absolute Relative Difference, or MARD — which is the difference between finger stick readings and CGM readings — of 11.8% in a “540 patient day clinical program of Type I and Type II diabetic” subjects in 2015. That 11.8% appears to stack up well compared to other monitors on the market.
“This is in line with what we see from the Libre (at 11.4%), better than the Dexcom G4 and slightly behind the Dexcom G5, which quotes single figure MARD of 9%,” according to an article in diabettech.com. “In a system where lower is better, and MARD on test strips has an ISO standard of 15%, this is a very usable number.”
The possibility of a needle free CGM has piqued the interest of diabetics online.
“I know not everyone will want one of these or like it. But from my family’s perspective, this thing looks awesome,” one woman who is the mother of a diabetic said on the tudiabetes.org forum. “My son with Type 1 is 7 years old. We have a Medtronic CGM in the closet that we do not use. My son wears a pump and does not want something else inserted into him.” And, while other users on that site at least were somewhat skeptical about whether the sugarBEAT will work as well as advertised, and whether there might be some unknown limitations, there was a general consensus that it was intriguing.
“This seems too good to be true,” one woman wrote. “If it works and if it’s accurate and if it becomes available in the US, it would be wonderful.”