[acb-diabetics] is there a talking...

Sun Feb 19 22:12:57 EST 2012

Where is this in the 510(k) process? Frankly, we've seen people hyping this
and similar technologies for thirty years and it's never panned out because
there are too many variables and "spoilers" that confound those who believe
that such systems will work predictably and reliably. And then, of course,
there's the little matter of making the apps accessible using VoiceOver.

Anyone remember the SugarTrak?

As I say, pardon my skepticism but IMO if this were anywhere near working,
the manufacturer would have been trumpeting this to the skies and thousands
of people would have been begging the FDA to either verify the accuracy of
the process and fast-tracking the device or exposing it as a fraud.

As I say, I know these are harsh words. But IMO there's something smells
funny about all this.

Oh yeah ... anyone also remember the GlucoWatch Biographer? (grin)

Mike Freeman

P.S. Thanks for bringing this to our attention, though.

Mike

-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Claude Everett
Sent: Sunday, February 19, 2012 6:05 PM
To: 'Discussion list for diabetics and/or ACB issues'
Subject: Re: [acb-diabetics] is there a talking...

Just saw this article and thought you might be interested, here is a
adaptation which could be revolutionary. 

***
New Non-Invasive Continuous Glucose Monitor Will Talk to Your SmartPhone

By AllisonB on October 3, 2011 
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.

Posted in CGMs (Continuous Glucose Monitors), Products | Tagged Apple
medical devices, C8 MediSensors, cgm, continuous glucose monitor, continuous
glucose monitoring systems, design innovation, diabetes iPhone, diabetes
medical devices, diabetes medical products, DiabetesMine Design Challenge,
FDA diabetes, FDA regulations, FDA smartphones, iPhone apps for diabetes,
life with diabetes, living with diabetes, medical device design, medical
devices, type 1 diabetes, Type 2 diabetes
 5018 Views Permalink | Comments (13) 
13 Responses

MS October 3, 2011 at 6:41 am | Permalink | Reply
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.

Bernard Farrell October 3, 2011 at 7:01 am | Permalink | Reply
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?

David October 3, 2011 at 9:22 am | Permalink | Reply
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.

Lauren October 3, 2011 at 9:55 am | Permalink | Reply
This. Is. Amazing. Such a great alternative to current devices! I can't wait
for it to be approved!

mcityrk October 3, 2011 at 11:40 am | Permalink | Reply
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-

Julia October 3, 2011 at 7:26 pm | Permalink | Reply
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.

Natalie October 4, 2011 at 2:45 pm | Permalink | Reply
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?

Andrew October 7, 2011 at 3:05 am | Permalink | Reply
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.

The C8 MediSensors HG1-c (nCGM) < CARLA's THESIS BLOG | a way to share my
master thesis progress October 7, 2011 at 7:59 am | Permalink 
[...] http://www.diabetesmine.com/2011/10/ { no comment }  { Tags: } [...]

Dan Fahey October 7, 2011 at 8:26 am | Permalink | Reply
One concern I'd have is the matter of how sweating affects results. i seem
to remember that was a problem with the Glucowatch?

Richa December 10, 2011 at 9:54 pm | Permalink | Reply
Hope it is as useful as expected

Seth December 16, 2011 at 10:22 pm | Permalink | Reply
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-g
lucose-monitors-funding-roundup

Dick January 14, 2012 at 8:12 pm | Permalink | Reply
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.

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Regards,
Claude Everett
"I am opposing a social order in which it is possible for one man who does
absolutely nothing that is useful to amass a fortune of hundreds of millions
of dollars, while millions of men and women who work all the days of their
lives secure barely enough for a wretched existence." 
Eugene Victor Debs  
-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Patricia LaFrance-Wolf
Sent: Saturday, February 18, 2012 1:04 PM
To: 'Discussion list for diabetics and/or ACB issues'
Subject: Re: [acb-diabetics] is there a talking...

Yes, but I hear the device is not always real accurate.  When it beeps, you
are supposed to do your own BG. 

-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Claude Everett
Sent: Saturday, February 18, 2012 12:47 PM
To: 'Discussion list for diabetics and/or ACB issues'
Subject: Re: [acb-diabetics] is there a talking...

So one can set it to beep/ alarm if the bs goes below say 85 and again if it
were to get above 210? 

Regards,
Claude Everett
"I am opposing a social order in which it is possible for one man who does
absolutely nothing that is useful to amass a fortune of hundreds of millions
of dollars, while millions of men and women who work all the days of their
lives secure barely enough for a wretched existence." 
Eugene Victor Debs
-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Patricia LaFrance-Wolf
Sent: Saturday, February 18, 2012 9:43 AM
To: 'Discussion list for diabetics and/or ACB issues'
Subject: Re: [acb-diabetics] is there a talking...

No, there is not, but it can be set to beep at preset BG levels. 

-----Original Message-----
From: acb-diabetics-bounces at acb.org [mailto:acb-diabetics-bounces at acb.org]
On Behalf Of Barbara Mattson
Sent: Friday, February 17, 2012 1:13 PM
To: Discussion list for diabetics and/or ACB issues
Subject: [acb-diabetics] is there a talking...

continuous blood sugar monitor? i'd be surprised if there were.

barb mattson
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