C8 MediSensors Answers My Questions about the HG1-c Noninvasive CGM
C8 MediSensors HG1-c noninvasive CGM (left) next to its external battery (right).
Can you offer more information regarding a potential time frame for FDA approval and subsequent availability in the US?
“As you mentioned in your posting, we expect CE Mark regulatory approval early next year [2012] and we anticipate making our non-invasive glucose monitor available in Europe by April. After that, we will pursue FDA approval for the US. We can’t say when we expect FDA approval, because that is up to the FDA, not us, but we hope to be able to make the product available in the US by early 2013.”
Although I’m aware that the HG1-c works with smartphones, another blogger posted that the device would be able to call an emergency contact number if the wearer wasn’t responding to the device’s alarms. Is this true? It would be a great feature to have.
“Yes, our glucose monitor will be able to ‘call for help’. Our display device is the user’s smartphone, initially Android and then we will add iPhone (but we do not sell the phone). Using the phone opens up new functionality, like being able to set the phone to alert anyone the user specifies, and that functionality is being built into our new non-invasive glucose monitor. If that functionality is not available when we ship the first product, it will be available a few months later, via a software update. I can give you an update on that as we get closer to final EU regulatory approval and shipping dates early next year.”
I like the idea of the device interacting with my iPhone (particularly because my Minimed alarm is often difficult to hear), but will there be a solution for users who don’t own smartphones?
“Our current plans are for smartphones only as the display device. Using a smartphone means new functionality and one less device to carry around, which is something diabetics told us would be nice. If we see a demand for alternatives, we can develop a non-smartphone display option.”
I understand that the HG1-c comes pre-calibrated from the factory. Does this mean that the wearer will NEVER have to calibrate the device?
“Yes, the monitor comes pre-calibrated. When the user gets the device, she/he should do a finger stick to validate that the device is working properly and giving accurate readings (in case of damage in shipping etc). As our device is considered an adjunct device, a user should do a finger stick before making any medical decision. But the user need not do finger sticks to calibrate or recalibrate the device. It arrives pre-calibrated and stays that way. It is important to note that our device measures glucose optically, not chemically, and this is one of the innovations that makes a universal calibration possible. It also means the device works just as well in cold weather and hot weather, at altitude, and is not affected by any other chemicals in the bloodstream, like medications.”
Diagram of an individual wearing the belt that holds the nCGM device (external battery not shown).
“Yes, the device is worn on a belt, usually around the abdomen. The belt material is flexible and breathable, suitable for a variety of activities, including working out. When worn under a shirt, the belt is difficult to notice. The belt can be quickly removed to take a shower or go for a swim and put back on as the user needs. Once the device is again in contact with skin, it will start taking readings in about five minutes. We looked at adhesives as an option but the belt seemed more convenient and practical, plus it avoids the added expense of a consumable like tape.”
With regard to the HG1-c device itself, it is stated that there are no ongoing consumables, but is there a lifespan on the laser? Will it and/or the whole device eventually need replaced? If so, how long will the device last and will users need to incur the cost of a whole new device when it dies?
“Yes, the device has no consumables except for some inexpensive gel, a year’s supply of which comes with the product. Users can buy more gel online for less than $5 for a year’s supply. No lancets. No disposable sensors. No test strips. No tape. The device has no moving parts and is expected to last at least four years. We do not expect a user will need to replace it sooner than that unless they want to upgrade to a newer version.”
How does the HG1-c receive its power? Is it rechargeable itself, or does it use batteries? How long will the charge/batteries last?
“The device is powered by two re-chargeable lithium-ion batteries, which come with the product. The charge will vary depending on how frequently the user sets the device to take a reading. If the user sets the device to take a reading every four minutes (it can read as frequently as every three minutes), the battery will last about 10 hours. If the user sets the device to take a reading every ten minutes, the battery will last about 20 hours. In general, we expect users will wear one battery when at work, then come home and swap to the fresh battery.”
After Doug Raymond returned to the office, he responded to me and included a link to the video embedded below that shows C8 MediSensors HG1-c nCGM device and its battery, which he confirmed is worn separately on the belt, external to the device itself.
“The ‘white rectangular thing’ you asked about in the Dr. Marcio Krakauer video [above] is the rechargeable battery. The external battery uses current cell phone battery technology. The benefit of using an external battery allows one to swap out batteries without having to remove the HG1-c from the body. The battery is carried in a soft cloth pouch in the HG1-c belt and is very easy to remove and replace. We plan to supply two batteries with every HG1-c, providing the user the ability to have one on charge while the other is being used. The run time per battery is dependent on the measurement frequency. The user will be able to set the measurement frequency from every 3 minutes, 10 minutes, or 15 minutes. Run time per battery is 10 hrs, 20 hrs, 28 hrs, respectively. Also, we felt that having the battery external gives us the opportunity to take advantage of new battery development moving forward.”
After I apologized for asking so many questions, which in turn can take legitimate amount time to answer, in closing, Paul Connolly shared the following remarks.
“Kevin, no need to apologize about asking questions. I welcome them. Ask more. It helps us understand how to introduce this new innovation to you and your peers.
Thanks for sharing your experience with the invasive CGM sensors [I had described to him a recent uncomfortable and bloody experience that I had inserting a conventional invasive CGM sensor]. We are well aware of how archaic and barbaric some of those sensors can be, and we are happy that we can now provide a better way of getting continuous glucose measurements to improve the lives of diabetics.”
At this point, I am optimistic about C8 MediSensors Noninvasive Continuous Glucose Monitor. The company plans to present its latest clinical data at the Diabetes Technology Meeting in San Francisco at the end of October.
“As for accuracy,” says Connolly, “we are finishing another set of clinical trials and the data is promising, indicating accuracy that is better than invasive CGM and about equal to finger sticks.”
If that data holds true, it could mean a significant leap forward for diabetes self-management. The next challenge for the company will be obtaining FDA approval for the HG1-c. For me to expect that process to be swift may be foolhardy. Then again, unnecessarily continuing to send a spring-loaded piece of metal into my abdomen on a regular basis seems a bit ridiculous as well.
My name is Kevin Lang and I am a Type 1 Diabetic who was diagnosed in May of 2004 at the age of 27. My last A1C was 6.0 in May 2015. I used to use daily shots of Lantus and Novolog to control my blood sugar until I switched to the MiniMed Paradigm Revel Insulin Pump in February 2011. To learn more about me, follow the about link in the menu bar.
I’d like to know what version of android the HG1-c will pair up with when it is launched next April?
I just saw this on their website.
http://www.c8medisensors.com/faq/#faq-smartphone-application
Sounds like a great product, I am a 60 year old who has had diabetes since I was 12 years old so have been through a fair amount of change. It is unfortunate that the marketing of the product involves another hi priced item with a monthly fee, (which makes your statement of no continuous maintenance costs kind of faulty) but be that as it may my costs for the cheapest blood strips available per year is between $1200 and $1800 I test between 10 and 17 times each day. I hope that the large companies that sell blood strips don’t buy you out before marketing, which has happened to a few companies since 2001 some with very good products, one IR reader for sale in 2001 went for as little as $1000 dollars before they where consumed by larger competition with 4 years set as your planned life expectancy your profits should be in line with blood strips. Hope you make it the more competition for the blood strip industry the better. Chris Ashley
Chris, you make a good point about the cell phone plans being an ongoing cost. I should’t have assumed in my article that most users will have smartphones. Yes, I agree that the strip companies are a major concern in getting in the way of this device being released. They could, as you stated, attempt to buy out the company or lobby the FDA into never approving the device. All are significant concerns.
There is no requirement for a monthly phone plan for the device to work. The device needs a phone but not a phone plan.
Abegoodness, thanks for pointing that out. It’s easy to assume that having a smartphone means that you would have a phone plan, but that doesn’t have to be the case. Plus, if you didn’t have a plan, you could just jump on a Wi-Fi network to download the app, or even possibly upload it from a computer. Great point.
Thanks for this posting. I do hope that they receive FDA approval, that the device is accurate, and that the company is not bought out by the strip companies.
It sound like a wonderful CGM system however because of my sensitive skin it might make me uncomfortable wearing the wrap around belt.
I use the current CGM qand do very well taping the sensor to my skin.
It makes me wonder if this unit could be attached without the belt?
But then, if I ever tried it as it is now, it might bother me at all.
Richard, I believe the belt also holds a separate battery for the device, which is another reason that the belt is needed. However, I can definitely relate to your concerns. I perspire easily and am a little worried that it could lead to a rash under the belt, especially during the summer months.
Wow, this would be a blessing. I have so much anxiety about testing–fear of needles, fear of blood that predates my Dx. I hope this happens soon!
Gostaria de saber como faço para comprar o equipamento e qual seu custo posto no Brasil.
Aguardo
Please, suggest where is it possible to purchase the C8 MediSensors HG1
Unfortunately, the company is now defunct. This appears to be due to an issue of funding and overall accuracy of the device.