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:
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.
FDA clears plenty of wireless devices. Of all things, I’m not sure why this gentleman feels that the wireless component would hold up the process.
If it ends up cost $4K and it’s considered a piece of durable medical equipment then it’s going to cause us to consume all of our DME allowance. Which might be OK if it truly works as planned. Any idea why the battery life is so bad? Does it require a lot of current to run the raman spectrometer?
The solid state laser for the spectrometer may be what eats up the power.
The biggest plus I’m seeing is you get the accuracy of current CGM systems without the inconsistency of the initial 24 hours after sensor insertion and the fall-off in accuracy as the sensor gradually croaks. The belt covers where I inject or would put pump, so it would be great if wearing on the thigh works.
This. Is. Amazing. Such a great alternative to current devices! I can’t wait for it to be approved!
No offense, but this sounds like the same type of claims made for near IR spectroscopic devices 15 years ago there turned out to be all sizzle and no steak. Why would a Raman signal be so much more glucose specific than the spectral regions used in these previous devices? It seems like they would run into the same questions about baseline fluctuations, temperature effects, surface contact artifacts, etc. And to claim that a factory calibration would hold forever?? Color me skeptical—
I wish this company had remained in “stealth mode.” I fear it will go the way of the OrSense noninvasive monitor that reputedly worked and was immediately bought up by big pharm, never to be marketed. But fingers crossed. Our teen does not want to wear two sites, though she agrees Dexcom doesn’t hurt. She may not want to wear a fanny pack either, but she would wear this at home. I would be thrilled to have one of these devices. Not holding my breath, though. Every advance I have had my eye on the past five years has fallen by the wayside. Mass demonstrations against the FDA policies are in order. I’m tired of their ridiculous guidelines … they are holding the lives of our children hostage while they keep devices like this and the Veo pump off the market.
Once upon a time there was a glucose meter that relied on a film that you could wash off and use again. No repeated cost for strips or anything. What happened to it? The market was quickly saturated, and they could no longer make a profit, so they went belly-up. Does that seem a likely scenario for this product?
Like you say, Amy, great vision. This is a good place to start. I’m looking forward to such a device in a small, convenient package. One day…
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One concern I’d have is the matter of how sweating affects results. i seem to remember that was a problem with the Glucowatch?
Hope it is as useful as expected
This device looks like it may be the real deal.
I just found story that GE invested in them this month.
http://www.massdevice.com/news/diabetes-ge-invests-non-invasive-continuous-glucose-monitors-funding-roundup
It’s now January 14, 2012. Have you heard anything lately? I have good insurance and probably will have unless our states’ Atty Generals lose their case against Nanny-care, so I can afford the 20% deductible, which is still steep.
What I don’t understand is why no-one has developed a wrist band which reads the chemicals exuded from the epidermis – the one’s the female mosquitoes smell and know that YOU are the one with more sugar in your blood. Surely, these chemicals vary as the glucose increases and decreases.
Wouldn’t some University researcher or pharma company scientist who wants to make a billion or so dollars per year could come up with the proper criteria – or is there another “friend” of the FDA standing in the way of the research?
I hate to sound so negative, but we seem to have reached a point where business has to lie to government and us in order to protect themselves from a government which lies to them.. and us.
This does look promising. Certainly the Raman Spectroscopy should afford one the ability to detect glucose in a mixed medium. I agree that the real world influence of sweat, temp, etc will most likely pose a substantial technical hurdle. Power consumption most likely high due to light source and detection optics. As a T1D and father of a 14month old T1D I am looking forward to hearing more about this.
I can’t wait for this to come out. I have a cgm and it always makes me bruise and hurts more then all my shots I do. If this really does what it says it’s well worth the $$ and I love the emergency end of things. I’d they need anyone to test it out I would love to help
I wouldn’t hold your breadth. The pitfalls, especially how its worn, will kill it in market. Why did the insulin inhaler fail? People found it, most of all, too cumbersome.
The FDA has to protect people from themselves and make sure there is a market to support the government, that’s why a cure won’t happen unless its a pill that is about as toxic as Tylenol. Why do you think the Edmonton Protocol and all this other stuff won’t ever be approved. Supply is the scapegoat.
This device sounds great but its so far off from any marketability and at $4k and where healthcare is going in this country, good luck!
Amen, Brother! Let me only add the question, whatever happened to the glucose sampler that was supposed to use visual through the earlobe – no prick????
My son 12 yrs old just got diagnosed with Type-1, looking for non-invasive (no blood sample ) device to monitor the blood sugar level. Any suggestion
This looks good. My father is a test system engineer and I think I’m going to run this by him. Keep in mind that old IR Sensors are that…old. electronics have come a long way and newer sensors are much more accurate. The fact that it focuses on the molecule itself is the key….oh, btw why not wear it on your arm like an ipod. I hope this gets through fda and doesn’t get bought up by a test strip making pharmacy company. After all, we are a source of revenue first …then concern for our well being follows.
Size and accuracy are two huge issues for me. I’m very lean, with an athletic body… That device is waaaaay too large to remain hidden under clothes.
i am a type 1 diabetic for about 24 years in india,, i would really like to use this device as this would be probably the best thing to happen to type 1 diabetics if this really works.. whenever your company wants to launch this product , in my opinion india would be a great market for it as a lot of users would use it,,. by the way when is this product supposed to be launched ,, any idea???
[...] CE Mark approval on Oct. 25 to market this non-invasive CGM device in Europe — a good year after we wrote about this company back in 2011 and they forecasted the [...]
My wife, a 52 year type one survivor, is really interested in this sensor. Is there any recent news? We live in Ecuador, but can travel to Europe or the US for it.
It is the natural tendency of science to find out new things….we have to wait with patience and see if the cost, advantage and weaknesses are balancing to be an usable product…..I thing the company should make all efforts to make it accurate and cheaper so that people can afford the cost. Global diabetic researchers…one question …why DM is proliferating in India than any other country?