{"id":46718,"date":"2017-04-10T08:21:24","date_gmt":"2017-04-10T12:21:24","guid":{"rendered":"https:\/\/asweetlife.org\/?p=46718"},"modified":"2017-04-06T08:22:39","modified_gmt":"2017-04-06T12:22:39","slug":"needle-free-patch-cgm-to-launch-in-europe","status":"publish","type":"post","link":"https:\/\/asweetlife.org\/?p=46718","title":{"rendered":"Needle-free Patch CGM to Launch in Europe"},"content":{"rendered":"

A new CGM that just was approved for use in Europe, called sugarBEAT<\/a>, from Nemaura Medical<\/a>, in the United Kingdom, was designed only after \u201cmultiple focus group studies and feedback from clinical studies\u201d 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.<\/p>\n

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<\/a>, which started in 2005 to \u201cdevelop state-of-the-art transdermal drug-delivery systems for a wide range of drugs and vaccines.\u201d The company says it has filed for FDA approval for an Alzheimer\u2019s drug delivery patch, and is also developing \u201cmore than 16 drugs in house.\u201d<\/p>\n

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. \u201cToday, 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,\u201d he says. \u201cOur decision to move from a \u2018watch\u2019 to a \u2018wireless patch\u2019 based format was driven by our desire to try easily integrate into the App-centric smart device \u2014 phone, watch, tablet \u2014lifestyle many users are adopting.\u201d<\/p>\n

\"Needle-freeThe sugarBEAT CGM uses a patch without needles, Timol says. More specifically, according to a news release from the company, \u201cthe 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.\u201d<\/p>\n

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.<\/p>\n

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, \u201con an ad hoc basis,\u201d according to Nemaura. Many CGMs require inserting a sensor and replacing that sensor every three to seven days.<\/p>\n

That flexibility was one of three primary considerations in how sugarBEAT was envisioned, Timol says. The other two were, \u201cIt is low-cost, with a price point anticipated to be comparable to cost of multiple daily finger stick use and it is non-invasive \u2014 so you do not have to stick a needle\/sensor inside the skin.\u201d<\/p>\n

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.<\/p>\n

According to Nemaura, the sugarBEAT CGM achieved a Mean Absolute Relative Difference, or MARD \u2014 which is the difference between finger stick readings and CGM readings \u2014 of 11.8% in a \u201c540 patient day clinical program of Type I and Type II diabetic\u201d subjects in 2015. That 11.8% appears to stack up well compared to other monitors on the market.<\/p>\n

\u201cThis 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%,\u201d according to an article in diabettech.com<\/a>. \u201cIn a system where lower is better, and MARD on test strips has an ISO standard of 15%, this is a very usable number.\u201d<\/p>\n

The possibility of a needle free CGM has piqued the interest of diabetics online.<\/p>\n

\u201cI know not everyone will want one of these or like it. But from my family’s perspective, this thing looks awesome,\u201d one woman who is the mother of a diabetic said on the tudiabetes.org forum<\/a>. \u201cMy 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.\u201d 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.<\/p>\n

\u201cThis seems too good to be true,\u201d one woman wrote<\/a>. \u201cIf it works and if it’s accurate and if it becomes available in the US, it would be wonderful.\u201d<\/p>\n","protected":false},"excerpt":{"rendered":"

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