As more companies eye the ever-expanding continuous glucose monitoring (CGM) universe of discourse, an almost unheard-of little startup in California is developing a new perception product that could truly change the game.

The idea sounds a minute self-contradictory, on its face: a device that has a CGM sensor and transmitter that communicates directly to a smartphone, but has similarities with traditional glucose psychometric test strips… Huh?

The company is Metronom Health, a small Orange River County startup that spun out from life sciences tech throttle valve Fjord Ventures. They'ray developing a CGM sensor that's tinier than anything along the market, resembling a small, flat filament of thread about the sizing of two quality hairs. It's made of flexible polymer and would be inserted under the skin for 14-mean solar day break up. In addition to measuring glucose, it measures oxygen concentration, which helps cost increase accuracy in detecting glucose levels.

"We wanted to build a CGM more suchlike a test strip… something that put up be fancied at low cost and glucinium made available to the quite a little commercialize. That includes organism able to trust the device, and having some smart information coming rear (to the user) instead of simply information overload," says Metronom's Co-Founding father and Chief Scientific Officer Troy Bremer.

Helium tells United States their product will beat the competition on truth, substance abuser-friendliness, and cost – the latter through the ease of mass yield — helping Metronom Health to succeed therein infinite where some other new players will non.

Metronom's Small and Flexible CGM

Though founded nearly a tenner past, Bremer says the troupe has been in stealth musical mode and is just straightaway starting to showcase its unique system of rules, exhibited for the archetypal time at the recent ATTD conference in European Community:

Sensor: The size of a petite strand that behind fit happening the size of a quarter, the flexible polymer sensor is put in place with an introduction device. It will have 14-Clarence Shepard Day Jr. wear time, and will not know any interference from acetaminophen-containing meds ilk Tylenol, as has been the case with other CGMs on the market. The sensing element will measure glucose readings every 5 proceedings, and be amply disposable afterwards information technology's finished. It will not ask regular fingerstick calibrations, merely you derriere calibrate if you feel Thomas More at ease doing so.

Share happening Pinterest

Share connected Pinterest

Transmitter: This square-ish separate pick with crescent corners is also fully disposable. At just about 4 millimeters thick, it's close to two-thirds the size of an existing first-generation FreeStyle Libre detector (which itself is about the sized of two quarters stacked together). Metronom's transmitter will have Bluetooth connectivity made-up in, allowing forthright communicating with a smartphone app – iOS at first, and finally Android to follow.

Share on Pinterest

Adhesive: Metronom Wellness says it has a proprietary adhesive that is mechanically "more like skin" so that it's more comfortable and moves along with the body more than existing CGM adhesives do today. It's likewise successful from hydrophobic material, making it highly irrigate resistant, so information technology's expected to have fewer issues with peeling. IT's currently genuine to hope 14+ days, and they're conducting more medical institution search on even yearner wear time for divers body and skin types.

Alerts: Yes, this system will offer tangible-meter alerts for High and Low blood sugars like existing CGM devices from Dexcom and Medtronic. Bremer says they too have "a few unusual twists" on the audio alerts to make them less noticeable and more flexible, simply he won't elaborate at this clock time.

Data Share-out: Their app volition connect with Apple HealthKit, allowing for direct sharing with other apps and diabetes platforms with smartwatch connectivity. Users will also be fit to share data with caregivers, healthcare professionals, etc.

This brief video on Metronom's website offers a walk-through of how this CGM will work.

The 'Smart Sensing' Skill Behind IT

The real big difference between Metronom Wellness's prototype versus existing CGMs connected the market is how it measures glucose levels, via new "proprietorship opto-enzymatic glucose sensing engineering science."

Like other CGMs, this system taps into interstitial fluid under the skin (rather than glucose in the blood from finger stick tests), but alternatively of an electrochemical reaction organism metrical, Metronom's CGM sensor contains enzymes that allow passing accurate testing. The enzyme glucose oxidase reacts with glucose to green groceries hydrogen peroxide, which is then broken down into into oxygen and water by a instant enzyme called catalase. This allows the system to discover oxygen levels  proportional to the glucose concentration.

That is key because if oxygen levels lessen referable compression of the sensor, the system won't mistake that for a drop by glucose levels — as tin be the case with unusual detection technology.

Metronom's patented Smart Sensing technology is unique in several shipway:

  • the sensor contains that unintegrated oxygen conduit, allowing detection of oxygen concentrations severally of the glucose point
  • the sensor contains three "response chambers" for detecting polar glucose concentrations, which allow augmented truth, especially when users are in the hypoglycaemic (low blood sugar) rate
  • the hydrogel polymers they use are extremely precide and exclusively gas-permeable, which is what prevents drugs like acetaminophen (Tylenol) from interfering with sensor performance
  • unlike electrochemical sensors used in other systems, the opto-enzymatic technology utilised hither eliminates many common problems that decrease accuracy in longstanding CGM perception, Bremer tells us

Think of information technology this way: Piles of CGM users right now get "compression lows" from turning over in bed along the sensor. That wouldn't happen with what Metronom is developing, as information technology balances both glucose and oxygen from different sides of the sensor, making results more accurate. It also alarms for whatsoever place issues that may require you to calibrate, or re-adjust your consistency position (like stop sleeping on the sensing element).

In short, this device is expected to comprise many reliable, accurate, comfortable, and robust (by staying on better) than anything that exists today.

"(Other CGMs) only have one horizon of the world," Bremer says. "But we have two, because we're monitoring both oxygen and glucose. We throw an orthogonal agency to assess the environment. This allows us to decide if detector site is stable, or if it's vagabond and star to faulty results over clip."

Moving Towards Market

Justly instantly, Metronom is collecting data in the diabetes data space and comparing that with its early prototype research. An initial 7-day clinical study was conducted in 2015 with 20 patients – 10 with T1D, 10 with T2D – comparing this CGM prototype technical school with existing fingersticks and science laborator results. For each sensor, the retrospective information showed a MARD value (measure of CGM accuracy) of 9% over the course of the subject. (The lower the MARD number, the better, and a single-digit value is thoughtful state of the art.) The 2015 study too showed no significant modification in hyperglycemia or hypoglycemia (blood glucose highs or lows).

Inpatient and outpatient studies will be done concluded the track of 2018. They Leslie Townes Hope in past 2019 to pursue CE Mark regulatory approval overseas, and from there they will move forward with U.S. filing belik in early 2020.

While many small companies are working on fresh CGM technologies, Metronom believes it is unambiguously positioned to succeed because IT stool achieve lower cost all told stages of R&D – from early design and manufacturing to end-user commercialization. As of now, at that place are none specifics on price to the consumer, just they're locution it would follow "significantly more affordable" than what's on the market today.

"Unless you can contend happening manufacturing, carrying into action, accuracy, reliability, and affordability, and comfort of use… I don't think you'ray going to be a rival WHO is going to be able to quell in the market. We'Ra oblation advantages in all of those areas," Bremer says confidently.

And about their prospects for regulatory approval, he bu says: "The FDA commendation timeline has been quite variable with the (other CGM) submissions. It looks variable, but I'd promise we would be done inside a class."

We sure hope their ambitiousness pays dispatch!