Here's a product description for you: an accurate, non-invasive continuous glucose monitor that talks to your iPhone, and will call someone if the CGM alarms and you don't respond. Sounds like something you might have heard about in our annual DiabetesMine Design Contest, isn't it? Well, guess again! It's a product actually under production by the folks at C8 MediSensors, a San Jose-based company. If you're wondering why you've never heard of them, C8 MediSensors has been in "stealth mode" since 2003, working on a device that monitors blood sugar using a sensor that never punctures the skin.
Sounds too good to be true, we know. But after a conversation with Doug Raymond, Vice President of Marketing and Sales, we're truly optimistic.
The device, called the HG1-c (which we admit is NOT a very catchy name), is a small unit weighing 5 ounces that fits in the palm of your hand. It's worn on a belt around the waist. Rather than puncturing the skin, the sensor sits close against the skin, and small drop of gel helps to seal any air gaps.
The technology behind the HG1-c is complicated, but in a nutshell: a special camera, called a raman spectrometer, inside the sensor uses light to identify and analyze glucose molecules under the skin, via interstitial fluid. Each glucose molecule has a special "signature" the sensor identifies, and from there, analyzes and extrapolates a glucose value, which is transmitted via Bluetooth to a handheld device, like an iPhone or Android, or to a computer.
Here's an overview video that C8 MediSensors shared at the recent EASD conference in Portugal:
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Before we get into the nitty-gritty details of why this device is so cool, we have to make clear that it is not approved for use yet, not even in Europe. It's still an "investigational" device, and hopefully will receive the European CE Mark later this fall. Once that happens, C8 MediSensors plans to apply with the FDA. So, needless to say, this is merely a glimpse into the future... but a pretty freakin' cool future.
The HG1-c is similar to other current CGMs in that it reads interstitial fluid, so it has the same lag-time, but it is different in several crucial ways. Here's what we like about it:
- It doesn't need calibration or warm-up. Because the sensor is reading glucose molecules, it's pre-calibrated in the laboratory. All glucose molecules are the same, no matter whose body you're talking about, so it doesn't need warm-up time to adjust to your particular body, "much like you wouldn't calibrate a digital thermometer that you bought from the store," according to Doug.
As for accuracy, clinical data so far shows that the HG1-c is on par with DexCom and Medtronic, and maybe even a little better... "We run in the middle of fingerstick accuracy," Doug says.
- It doesn't need to be changed. With traditional CGMs, the sensors need to be replaced every few days. But this sensor, which resides outside the body, can be reused over and over again. "The body continually coats an internal sensor with enzymes and that changes its performance," Doug says, which is also why internal sensors need constant re-calibration. "The chemical reaction in those sensors gets muted and eventually becomes ineffective."
- It's an all-in-one device. In traditional CGMs, the sensor transmits data to a device for analysis, which then displays the glucose reading. With the HG1-c, all of the monitoring and calculations are inside the sensor. Then readings are transmitted to a display device, like a smartphone or a computer. Patients will need their own display device, because C8 MediSensors doesn't provide one. This sounds strange at first — no way to actually know what the sensor is doing? — but Doug says it's intentional:
"We feel that a lot of people have five or six devices that they have to carry around. By sending the info to an app that runs on an iPhone, it simplifies their life. They have both a phone and their glucose readings."
"One of the things we felt very strongly about is that this has to be painless, continuous, discreet and non-intrusive. For instance, in an environment when the customer is in a business meeting, they can monitor their phone. No one knows what they're doing."
Fewer devices to deal with? Yes, please!
This also means that you can walk away from your phone — or in the unfortunate event that it dies — and you don't lose your glucose readings. The sensor holds up to 120 days readings, and will upload as soon as it reconnects to whatever display device you're using. Your phone will also act as the alarm system, allowing you to customize the type of alarm and the volume, which is perfect for those of us who can snooze through an earthquake.
- It talks to parents (or spouses, doctors, 911...). "If you don't react to a low level alarm, a text message or a pre-recorded call will be sent," Doug explains. "That's the beauty of having the phone as the display device. We think this is pretty exciting." Plus, the GPS in your phone can actually tell the paramedics where to find you.
For parents, we think this will be a life-saver. Bluetooth technology can send data up to 600 feet away, so parents can keep the display device in their room at night. Or they can set the house phone to ring if the child is low and doesn't respond. A friend or family member can also be notified by phone if an alarm receives no response, which can be a life-saver for college students or children on sleep-overs.
But as with any new device, there are potential pitfalls:
- It has a very short battery life. These things eat batteries for breakfast. If you had the sensor monitoring every 3 minutes, the battery would be dead in 10 hours. Monitoring every 10 minutes? 20 hours' battery life. Every 15 minutes? 30 hours. A DexCom or Medtronic CGM monitors blood sugar every 5 minutes, and has an average battery life of several days. C8 MediSensors sends customers two batteries, but what if you left one at home to charge and then were out and about longer than expected? Not good.
- It is awkwardly worn. This more conjecture than actual experience. But a fanny pack belt worn under the shirt? A little weird and uncomfortable in my book. It's four inches wide, and Doug swears it is comfortable, saying that he's worn it with no trouble at all. Still... in terms of "non-intrusive" I'm not sure this fits the bill...
Doug adds that they're still fine-tuning the belt, hoping to make it smaller by the time it launches, and that there may be an option to wear it on the thigh as well.
- No data analysis software. At the time of launch, C8 MediSensors doesn't plan on having any additional tools to analyze trends. "We're going produce and supply an application with the device that will allow users to display 120 days of glucose measurements on their phone," Doug says. But additional tools for analyzing trends will have to be developed by a third-party — maybe even a resourceful patient, Doug suggests!
- It's an expensive up-front investment. It comes with a $4,000 price-tag. But according to Doug, it's still a great value because there are no ongoing supplies to purchase. Remember, the sensor is reusable! And since most insurance carriers now cover CGM systems, it could easily be covered. If you don't have insurance, or if this doesn't get coverage right away, you might want to start saving now... The only consumable used is the bottle of gel for the camera, which costs about $8 and lasts for a year.
We are very excited about this new-and-improved version of the CGM, because we love the vision and believe that this company may finally crack the code on non-invasive monitoring that works.
Doug speculates that because the HG1-c doesn't puncture the skin, it might get through the FDA faster. But with its reliance on wireless technology for usability, there could still be hesitancy from the FDA. Doug says the fact that the sensor doesn't rely on a phone for data calculations could be a boon, but with the FDA, there really is no telling... cross your pocked fingers, our PWD Friends.