Noninvasive, Low Cost CGM for Type 2 Diabetes Coming in US and EU

A novel lower-cost noninvasive continuous glucose monitor (CGM) combined with a digital education/guidance program is set to launch in the United States and Europe this month for use in type 2 diabetes.

With the goal of improving management, or even reversing the condition, Neumara's SugarBEAT device is thought to be the world's first noninvasive CGM.

Its cost is anticipated to be far lower than traditional CGM, and it's aimed at a different patient population: those with type 2 diabetes or prediabetes who may or may not be performing fingerstick glucose monitoring, but if they are, they still aren't using the information to guide management.

"This isn't about handing out devices and letting patients get on about it on their own accord. This is really about supporting those individuals," Faz Chowdhury, MD, Nemaura's chief executive officer, told Medscape Medical News in an interview.

He pointed to studies showing improvements in glycemic control in patients with type 2 diabetes who were instructed to perform fingerstick blood glucose testing seven times a day for 3-4 days a month and given advice about how to respond to the data.

"This is well-established. We're saying we can make that process a lot more scalable and affordable and convenient for the patient...The behavior change side is digitized," Chowdhury said. "We want to provide a program to help people reverse their diabetes or at least stabilize it as much as possible."

Asked to comment, Nicholas Argento, MD, diabetes technology director at Maryland Endocrine and Diabetes, Columbia, told Medscape Medical News: "It's interesting. They're taking a very different approach. I think there's a lot of validity to what they're looking at because we have great CGMs right now, but because of the price point it's not accessible to a lot of people."

"I think they're onto something that could prove to be useful to a larger group of patients," he added.

Worn a Few Days Per Month and Accurate Despite Being Noninvasive

Instead of inserting a catheter under the skin with a needle, as do current CGMs, the device comprises a small rechargeable transmitter and adhesive patch with a sensor that sits on the top of the skin, typically the upper arm. Glucose molecules are drawn out of the interstitial fluid just below the skin and into a chamber where the transmitter measures the glucose level and transmits the data every 5 minutes via Bluetooth to a smartphone app.

Despite this noninvasive approach, the device appears to be about as accurate as traditional CGMs, with comparable mean absolute relative difference (MARD) from a gold standard glucose measure of about 11%-12% with once-daily calibration versus 10%-11% for the Abbott FreeStyle Libre.

Unlike traditional CGMs, SugarBEAT is meant to be worn for only 14 hours at a time during the day and for 2-4 days per month rather than every day.

It's not aimed at patients with type 1 diabetes or those with type 2 diabetes who are at high risk for hypoglycemia. It requires once-daily fingerstick calibration and is not indicated to replace fingersticks for treatment decisions.

SugarBEAT received a CE Mark in Europe as a Class IIb medical device in May 2019. That version provides real-time glucose values visible to the wearer. In the United States the company submitted a premarketing approval application for the device to the Food and Drug Administration (FDA) in July 2020, which awaits a decision.

However, FDA is allowing it to enter the US market as a "wellness" device that won't deliver real-time values for now but instead will generate retroactive reports available to the physician and the patient.

And last month, UK-based Neumara launched the BEATdiabetes site, which allows users to sign in and link to the device once it becomes available.

The site provides "scientifically validated, personalized coaching" based on a program developed at the Joslin Diabetes Clinic, and will ultimately include monitoring of other cardiovascular risk factors with digital connectivity to a variety of wearables.

Fingerstick Monitoring in Type 2 Diabetes Is Only So Useful

"Fingerstick monitoring for type 2 diabetes is only so useful," Argento told Medscape Medical News.

"It's difficult to get people to monitor in a meaningful way." If patients perform them only in the morning or at other sporadic times of the day, he said, "Then you get a one-dimensional picture...and they don't know what to do with the information anyway, so they stop doing it."

In contrast, with SugarBEAT and BEATDiabetes, "I think it does address a need that fingerstick monitoring doesn't."

Argento did express a few caveats about the device, however. For one, it still requires one fingerstick a day for calibration. "If people don't like needles, that might be a disincentive."

Also, despite the apparently comparable MARD to that of conventional CGMs, that measure can still "hide" values that may be consistently either above or below target range.

"MARD is like A1c in that it's useful but limited...It doesn't tell you about variability or systemic bias."

Argento also said that he'd like to see data on the lag time between the interstitial fluid and blood glucose measures with this noninvasive method as compared to that of a subcutaneous catheter.

However, he acknowledged that these potentials for error would be less important for patients with type 2 diabetes who aren't generally taking medications that increase their risk for hypoglycemia.

In all, he said, "Stay tuned. I think this is part of a movement going away from point-in-time to looking at trends and wearables and data to enrich decision-making…There are still some unanswered questions I have but I think they're onto a concept that's useful for a broader population."

Chowdhury is an employee of Neumara. Argento consults for Senseonics and Dexcom, and is also a speaker for Dexcom.

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