As continuous glucose monitoring (CGM) becomes a more integral part of therapy for many people with diabetes, healthcare tech companies are clamoring to develop new systems to appeal to a broad spectrum of potential users.
We’ve identified at least three dozen efforts to develop new CGMs and novel meters — some of them aiming for the holy grail of noninvasive glucose monitoring: not needing to pierce the skin.
(This, of course, is in addition to the four CGMs currently on the market that are made by Dexcom, Medtronic, Abbott Diabetes Care, and Eversense.)
Here’s a conceptual snapshot of each of these aspiring new systems.
The tech giant has reportedly been working on a noninvasive CGM for much of the last decade, with up to 30 people assigned to the project at one point.
One of their concepts is believed to involve optical sensors, while another report from 2019 discusses Apple’s patent for a CGM sensor built into a smartwatch that would be able to monitor other health data as well.
To date, rollouts of new Apple Watch technology haven’t included this functionality, and Apple hasn’t yet filed anything with the Food and Drug Administration (FDA).
To be clear, this is separate from the Dexcom CGM data display available on Apple smartwatches.
This Florida-based startup is attempting to create a noninvasive CGM system dubbed ANICGM. It would monitor glucose readings using miniaturized MRI-like technology on a wristband.
As of November 2019, the company was recruiting people with type 2 diabetes for a clinical trial at Cleveland Clinic.
This Seattle startup is attempting to create a noninvasive, wearable device dubbed the UBAND. It uses radio waves to measure glucose levels.
The company claims the system can already detect more than blood glucose, “and with the detection of white blood cell levels it’s possible UBAND could become an early warning detection system for cancer and disease.”
On its FAQ page, Know Labs states that it plans to seek FDA approval in 2020.
This Silicon Valley–based startup is developing a noninvasive wearable called LifeLeaf, which it says will be able to detect blood glucose levels, blood pressure, heart rate, sleep apnea, and more utilizing sensors already on the market and an additional light sensor to enhance accuracy.
The company states it’s currently conducting clinical trials around the world.
This relatively new European company is attempting to bring to market a smartwatch that can measure glucose levels and lactic acid levels. The device is said to sample fluid in the body through small microneedles under the watch whenever the wearer pushes a button.
This company from Norway is developing a noninvasive armband CGM called BioMK that’s apparently based on “industrial real-time measurement technology.” Details are scarce, as the project is in the development stages.
The presentation offered few details of the new product, but like others in this list, the company believes it can compete in the CGM market through its ability to keep manufacturing costs low.
What’s difficult to understand, though, is that i-SENS has been working on this for years but sold some or all of an earlier CGM concept to another company called WaveForm in December 2016; see below for more.
Pacific Diabetes Technologies
This Oregon company is working to develop a first-of-its-kind CGM with a different sort of sensor that also has a port for insulin delivery. It’s designed for those on insulin pump therapy or multiple daily injections (MDI).
This company was once part of device-maker AgaMatrix before splitting off on its own. It’s developing a CGM system based (at least in part) on technology acquired from both Bayer and i-SENS back in 2016.
Now named the Cascade CGM system, this device earned CE mark approval from European health regulators in late 2019. The CGM system includes a thin 14-day sensor and rechargeable square transmitter that sends real-time readings via Bluetooth to an iOS or Android mobile app.
The CGM also offers 15-minute predictive high and low glucose alarms, other customizable alerts, and a once-a-day calibration.
As DiabetesMine reported in early 2020, WaveForm expects to file the Cascade CGM with the FDA in 2020 but doesn’t expect to launch this product until 2021.
This company has partnered with fingerstick meter manufacturer Ascensia (formerly Bayer) to commercialize its CT-100 CGM, which gained CE approval in late 2016 for European countries.
It’s a standard-sized sensor and transmitter system built for 7-day wear. Clinical trial data seems to show it may be the most accurate on the market.
As DiabetesMine reported in early 2019, Ascensia was talking about trying to file with the FDA by year-end 2020 on a next-generation product that’s part of this co-development agreement.
Roche Diabetes Care
The company behind the popular Accu-Chek fingerstick meter brand was rumored to be developing a CGM of its own for many years, but it’s a bit unclear whether that’s still happening.
Roche still appears determined to bring the Solo micropump to market after acquiring the tech from an Israeli startup in 2010. It’s teased that a next-generation version will offer CGM data integration.
It’s TBD whether that’s an in-house product in development or a partnership using existing tech, like the implantable Eversense CGM.
This China-based company is developing the A6 TouchCare System, a tubeless semiautomated insulin delivery system that includes an integrated CGM.
DiabetesMine previously reported on the “tiny, flexible, hair-like sensor that would last 7 days and offer a predictive low-glucose suspend feature.” This YouTube video also offers a glimpse of what this sensor and snap-on transmitter look like.
Per an early 2019 report, the A6 TouchCare system has been in European clinical trials since then.
While there are few details of the proposed SanaVita OneTouch Real Time Continuous Glucose Monitoring System, a pilot clinical trial is scheduled to take place in early 2020.
This San Diego startup, founded by former Dexcom alums, has been developing a product called SugarSenz, described as a highly accurate, low-cost wearable CGM.
The company and Dexcom settled lawsuits over intellectual property rights in 2016. Since then, there hasn’t been much public discussion of this new tech.
However, company images of the SugarSenz product show a round sensor transmitter concept. Think FreeStyle Libre with a big X across the top.
This Chinese company has created the Glunovo i3 CGM, which features a sensor similar in size to the Dexcom sensors that can be worn for up to 14 days.
The CGM has been granted a CE mark in 2019 and is expected to enter the European marketplace soon.
This U.K. company appears to be rebranding a CGM system from MicroTech Medical, which uses a traditional sensor to deliver readings to a smartphone.
The system appears to offer needle-free insertion, reusable sensor applicators, and brief warmup time, although confirmed details about the in-development product are scarce.
Integrated Medical Sensors
This startup out of Irvine, California, was born out of research at the California Institute of Technology. It’s developing an implantable CGM the size of a sesame seed.
Seriously, it’s so small it could easily get lost on the tip of a finger or the face of a penny, and it will last under the skin for as long as 6 to 9 months.
The device would be a 10th of an inch long and would be injected under the skin, where it could stay and be used for up to 2 years.
The company has received funding from the U.S. Army, Defense Advanced Research Projects Agency, and National Institutes of Health for its work.
A past Ascensia Diabetes Challenge Winner, this Belgium-based company hopes to bring to market a hair-thick sensor that can be worn under the skin for 14 days and communicate to smartphone apps via a relatively small, disposable transmitter.
The in-development sensor would be able to filter out some environmental inputs that can lead to inaccurate glucose readings in other CGMs.
At last report, the company was hoping to get before FDA regulators by early 2020, but that doesn’t appear to have happened to date.
This Israeli company is attempting to create an implantable CGM that uses an encapsulated fluorescent glucose sensor that can be implanted for up to a year.
In 2017, the company received $2 million in JDRF funding to help with the development of the device, and it’s largely been in stealth mode since then.
When we talked with a company exec at the ADA Scientific Sessions in June 2019, he shared that they’re moving forward on early clinical work, and they may still be a few years out from being ready to submit to regulators.
We may hear more from GluSense in 2020, though, so stay tuned.
This San Diego–based company is developing an implantable CGM called the ICGM that could be worn under the skin for a year or longer.
The system includes a transmitter worn externally that would relay readings to a smartphone. It’s being designed to require infrequent calibration.
The ICGM is currently being evaluated in initial human clinical trials.
The goal of this Southern California–based company is to create an implantable CGM that doesn’t require calibration and utilizes an electromagnetic signal to measure glucose.
The startup has recently partnered with European pump-maker Diabeloop and SFC Fluidics on a JDRF-sponsored project.
This San Diego company is developing a nickel-sized, needle-free CGM that includes a rechargeable battery and built-in transmitter that would monitor glucose trends and other biomarkers.
DiabetesMine profiled Biolinq in fall 2019. While this startup’s been around for many years, it’s had an uptick in interest recently after receiving $4.75 million in funding from the JDRF’s T1D Fund and establishing new leadership from within the diabetes community.
The startup is likely at least a couple years out from bringing this product to the commercialization stage.
This U.K. company recently received CE mark approval for its SugarBEAT CGM product, a patch sensor that utilizes a mild electrical current to draw small amounts of glucose from under the skin.
A transmitter sends wireless readings to a smartphone app every 5 minutes, and the system can predict glucose readings up to 20 minutes in advance.
While not quite as accurate as the latest Dexcom CGM, the company predicts its system will cost just one-fifth of competing product prices.
Nemaura Medical is launching internationally and submitted SugarBEAT to the FDA in July 2019, where it remains pending before regulators.
For the last few years, this San Francisco–based company has been working to develop a continuous patch sensor that can detect biomarkers, including glucose, through sweat.
There are few details, but it appears the company is gearing its continuous sensor toward a broad health market, not just toward the treatment of diabetes.
Sure, this company had the first CGM on the market and is one of the four biggies currently available. That doesn’t mean it isn’t planning for the future with novel new CGM concepts.
The diabetes tech giant filed a patent in September 2018 for a glucose monitoring patch that would change colors based on glucose readings taken by sweat.
Patents, however, often don’t lead to products. There appears to be no further public details about the project since then.
This San Francisco company is endeavoring to create a patch biosensor that can deliver readings for vital stats that include glucose levels.
The circular patch device geared toward the non-diabetes mainstream health market made big news in 2018 after Fitbit invested $6 million into the idea, but it hasn’t sparked much attention after that.
University of California, San Diego
Researchers are testing whether a temporary tattoo with integrated thin and flexible sensors can provide accurate glucose readings from sweat. A pilot study concluded in June 2019.
Details are scarce in English, but this Russian company appears to be attempting to develop a meter that can be worn as an ear clip.
This company recently received the CE mark from European regulators for a self-calibrating version of GlucoTrack, its noninvasive glucose monitoring device.
This device clips to the ear and uses a combination of ultrasonic, electromagnetic, and thermal technologies to measure glucose levels.
This student-led initiative out of UCLA is focused on developing a way to monitor glucose levels through imaging of the retina.
A special lens would be affixed to a smartphone camera to monitor subtle changes in the retina to detect glucose levels in the body. The concept won Microsoft’s Imagine Cup in 2018.
This health tech company from the Netherlands is attempting to bring to market a CGM that can measure glucose through tears.
The device would rest in the lower eyelid. The company conducted a small clinical trial of the device in people with type 2 diabetes in 2018.
This Israeli company has created a CGM dubbed CoG that offers minimal fingerpricks. The hybrid device, which utilizes fingerprick readings for initial calibration and light-emitting diodes for noninvasive readings, has been awarded CE mark approval.
The company is currently working on receiving FDA approval.
This German company is developing a noninvasive CGM system that utilizes an infrared light beam to count glucose molecules under the skin.
The company conducted a successful human clinical trial in 2019 and hopes to launch its product in 2020.
This Belgian company is attempting to develop a noninvasive CGM that would use photonic light to measure glucose levels. The company was featured at the J.P. Morgan 2020 Healthcare Conference.
This U.K. company is developing GlucoWise, a noninvasive glucose monitoring device that would use radio waves to measure glucose levels.
The device has been under development for some time. In 2017, results of a human trial done in collaboration with the University of Roehampton were
The University of Waterloo
Researchers have described a proof-of-concept system that would utilize radar technology from Google to measure glucose levels in a solution.
The goal, of course, would be to use this technology to create a device that can measure glucose levels in the body.
The University of Bath
U.K. researchers are attempting to create a thin, graphene-based glucose sensor. It would use an array of miniature sensors utilizing a small electric current to draw glucose out from the interstitial fluid that’s located between cells within the body’s hair follicles.
The company explains that each sensor covers an individual follicle. Measurements could be taken every 10 to 15 minutes and transmitted to an app.
After successful lab tests, the researchers hope to begin testing the device in a human clinical trial.
Finally, for more than a decade (at least), this company has been talking about building a noninvasive CGM that could track glucose levels through the skin.
That’s never materialized, but the once-named Symphony product reemerges every so often with hope and funding pitches.
Last we heard in 2016, the company had moved to New Jersey and rebranded its CGM concept as the NextGen, but it was still only in early phases of research and development.
It still comes to mind by industry observers when mentioning CGM wannabes.