Product Roundup: Continuous Monitors (in the Holding Pen), Convenience Enhancers

*ADA Conference News*

With over 150 companies going all out to showcase the latest and greatest here, I was surprised to hear many conference attendees expressing disappointment not to see anything “earth-shattering” on the new technology front this year. Nevertheless, three continuous monitoring products, currently in the holding pen awaiting FDA approval, look promising:

* DexCom was showing off its new Continuous Monitor, featuring a long-term Dexcom_1_1implantable sensor half the size of a triple-A battery, which is placed subcutaneously in the abdominal wall, where it measures glucose levels every 30 seconds and transmits the data wirelessly to a small receiver. This one is very cool because, although “invasive,” the piece that’s implanted on the body is tiny.

* Abbott Diabetes Care (which acquired Therasense) was demoing its new FreeStyle Navigator (which has been in the holding pen quite a while). This one utilizes TheraSense’s patented Wired Enzyme™ technology to measure glucose levels in your interstitial fluid every 60 seconds and transmit the results to a wireless pager-sized receiver. It includes alarms if you’re headed for a low or high, shows graphs of your levels throughout the week or day, and lets you easily download a ton of useful information for your doctor or CDE to use in helping you make improvements. The downside is just that this is not only an “invasive” monitor (requiring blood), but it the device itself is bigger than many pumps, and is attached via an infusion site like that of a pump. So I wonder how many pump wearers would be willing to hook themselves up to a second device?

* Texas-based Calisto Medical premiered its “Gluco Watch Redux” product, the non-invasive, armband-style continuous monitor called Glucoband. First-round clinical trials are apparently successfully complete, and the Glucoband is being touted as safe, convenient (self-calibrating), cost-effective (no disposable accessories required), and multi-functional (with embedded microprocessor, flash memory, computer interface and time-clock). With its new Bioelectric Impedance Spectroscopy (BEIS) technology, based on “bio-electromagnetic resonance,” the company is hoping to avoid the user-unfriendly pitfalls that hampered the GlucoWatch.

New diabetes devices are first aimed at improving BG control, with “patient lifestyle enhancement” coming in at a close second. From that perspective, a couple of other new products, already on the market (!), look extremely interesting:

* Lantus in a PEN! That’s right, in case you missed the announcement earlier this year, long-acting Lantus insulin from Aventis is now available in the Opti-Clik™ injection pen, which is chunkier than most rapid-acting insulin (bolus) pens, but nonetheless extremely convenient. The device uses standard pen needles as well, so no special equipment needed. I’m going to start petitioning my health plans to cover this one as soon as I get home!

* The new Accu-Check “Spirit” pump that sports three levels of menus depending on how many bells and whistles the wearer cares to use. For the very tech-savvy, data can be dowloaded directly to a Treo PDA, so you can truly “converge” your devices: you can view this data in various chart forms, and easily download it to your doctor or care team. The other neat thing this pump does is provide a “flip screen” option, so that you can literally turn the screen display over 180 degrees if you wish to switch the pump to the other side of your body or view it from your waistline just by tipping it upwards.

See my more comprehensive “Patient’s Eye View” report on the conference at the DiabetesMonitor today.

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17 Responses

  1. DensityDuck
    DensityDuck June 13, 2005 at 6:24 am | | Reply

    Re: Continuous BG Monitors.

    I never had any interest in the GlucoWatch, mostly because it looked butt-ugly. It also did seem like a lot of hassle to use. I’m amazed that the company tried to bring it to market (but I guess they were depending on it to be used in hospitals, and for insurance to pay the bills.)

    Any word on Medtronic’s monitor? This isn’t that silly Guardian thing; I’ve been hearing about a monitor which wirelessly transmits information to your pump (as long as it’s a Paradigm with the proper upgrades).

  2. Kathleen Weaver
    Kathleen Weaver June 13, 2005 at 8:46 am | | Reply

    FYI: Actually the Spirit pump will work with any Palm PDA. The Treo is a smart phone, made by Palm.

  3. Alexis
    Alexis June 13, 2005 at 10:03 am | | Reply

    Here’s hoping that the glucoband actually improves on the glucowatch. The website makes it seem as if the watch might actually be something you would wear this time around. Anyone ever see the movie “Panic Room”? The girl in that movie had a watch to monitor her blood sugar. The thing looked like a normal Nike sports watch (I have been bitter ever since I saw that).

    There was another company some time ago which had promised to create a watch like monitor, but it looks like they must have gone out of business or something. http://pendragonmedical.com/ now points to one of those generic squatter sites.

    I used a Humalog Pen for over a year and finally decided to switch back to needles. I found that the pen could be inconsistent. There is a prepping process where you dial in 2 units and then press the button to make sure that insulin is coming out at a steady rate. Some times you have to keep dialing in 2 units at a time until it actually disperses insulin. There have been discussions at other places about how the plunger inside gets stuck on the side walls of the pen. Either way I found that I couldn’t trust the pen 100% of the time. So now I almost always use a needle and keep the pen for emergencies at the office (like when I forget). I am sure others have had much better success with the pen, but since I only use 10 units of Humalog 2 times a day (and 20 for dinner), missing even one unit of insulin can make a big impact on my sugar levels.

  4. Living With Diabetes
    Living With Diabetes June 13, 2005 at 10:12 am | | Reply

    Extremely Disappointing

    I find it very disappointing that there is no progress being made on continous monitors. See snapshots of blood sugar readings is NOT helpful. Also that means we won’t be seeing a closed loop system anytime soon. A close loop…

  5. Nick
    Nick June 13, 2005 at 7:04 pm | | Reply

    I’ve been using Lantus in a Novopen 3 for about a year now. I just put the Lantus into an empty Novolog 3mL cartridge. The pen is a different color, so I don’t get it mixed up with the pens containing fast-acting insulin.

  6. Alexis
    Alexis June 15, 2005 at 8:51 pm | | Reply

    Looks like the trials for glucoband will not be finished till sometime in 2006. Here’s hoping that all goes well and we could have what would probably be the biggest change in diabetes care since the electronic blood meter itself (but I guess we have heard this said to many times before), I think mine was the first ever OneTouch meter.

    “Several prototypes of Glucoband® will undergo clinical studies and we are in the process of development of FDA-compliant clinical trial protocols. First results from standard-based clinical tests should be available by the end of 2005, early 2006” said Dr. Henry A. Punzi, F.C.P., Scientific Advisory Board Member of Calisto Medical, Inc. “Our near-term goals are to proceed with clinical trials on Glucoband® seeking FDA pre-marketing clearance and approval.”

    http://www.medilexicon.com/medicalnews.php?newsid=25926

  7. Martha O'Connor
    Martha O'Connor June 16, 2005 at 9:30 pm | | Reply

    Count me among the disappointed, particularly regarding the Freestyle Navigator. I was given to believe this would be a tiny, implantable device, maybe the size of a pinky nail. Not a device the size of a pump. I had no idea.

    Have heard from multiple people involved in the clinical trials for Glucowatch that it’s more trouble than it’s worth (difficulty calibrating, frequent errors…). Maybe this new version is better.

    *SIGH* I’ve been talking about the Navigator with so many people. I was so hopeful. This doesn’t sound like what I thought it was going to be at all. But, I will stay tuned.

  8. Martha O'Connor
    Martha O'Connor June 16, 2005 at 9:30 pm | | Reply

    Count me among the disappointed, particularly regarding the Freestyle Navigator. I was given to believe this would be a tiny, implantable device, maybe the size of a pinky nail. Not a device the size of a pump. I had no idea.

    Have heard from multiple people involved in the clinical trials for Glucowatch that it’s more trouble than it’s worth (difficulty calibrating, frequent errors…). Maybe this new version is better.

    *SIGH* I’ve been talking about the Navigator with so many people. I was so hopeful. This doesn’t sound like what I thought it was going to be at all. But, I will stay tuned.

  9. Martha O'Connor
    Martha O'Connor June 16, 2005 at 9:30 pm | | Reply

    Count me among the disappointed, particularly regarding the Freestyle Navigator. I was given to believe this would be a tiny, implantable device, maybe the size of a pinky nail. Not a device the size of a pump. I had no idea.

    Have heard from multiple people involved in the clinical trials for Glucowatch that it’s more trouble than it’s worth (difficulty calibrating, frequent errors…). Maybe this new version is better.

    *SIGH* I’ve been talking about the Navigator with so many people. I was so hopeful. This doesn’t sound like what I thought it was going to be at all. But, I will stay tuned.

  10. AmyT
    AmyT June 16, 2005 at 10:07 pm | | Reply

    Hi Martha,
    Sounds like you’d be way more interested in the DexCom product. That one is tiny, and stays put for three days, I believe.

    That’s the one I’m waiting for!

  11. JER
    JER June 27, 2005 at 10:24 am | | Reply

    A quick observation on the Calisto glucoband watch: on their web site, they advertise they’ve had 44 clinical subjects, and their graphs show a total of 56 points – basically a single measurement per subject (for all the research they’ve supposedly done? 56 whopping measurements?). This is NOT enough to show correlation of blood glucose to anything. You can’t cherrypick data and expect it fly with the FDA. I hate to say it, but this company is yet another joke in the monitoring business.

    BTW, great site here; thanks.

  12. Simon
    Simon October 15, 2005 at 1:22 am | | Reply

    Read this in The Guardian the other day…sounds quite interesting:

    Alok Jha
    Thursday October 13, 2005

    Guardian

    Diabetics will soon be able to monitor their blood glucose levels by looking straight ahead, thanks to contact lenses developed at Cambridge University.
    Chris Lowe led a team which developed lenses with a multi-layered hologram imprinted on their surface. The layers react to glucose in tear fluid, changing colour when the levels get dangerously low. Prof Lowe’s work is one of 11 projects funded as part of the Biotechnology and Biological Sciences Research Council’s £20m Link Biotechnology Initiative, started in 1997.

    The project results will be announced at the Royal Society today.

  13. AmyT
    AmyT October 17, 2005 at 4:37 am | | Reply

    Thanks, Simon. I added a bit about the glucose-sensing contact lenses in “Weekly Nuggets” today. Neat!

  14. George
    George July 4, 2006 at 8:40 pm | | Reply

    Well guys i have to tell you. I just have purchased the Dexcom machine and its awesome. Every penny was worth it. When you check your blood sugar 14 times a day, this machine is a life saver.

  15. T Mitch
    T Mitch August 24, 2006 at 5:43 pm | | Reply

    Well I feel like Kathleen Weaver, I have been searching for the blood glucose meter that looks like a regular wrist watch. Yeah like the little girl on Panic Room and I also seen another show on Lifetime where a girl was kidnapped and she also was wearing a watch glucose monitor. i think my son would check his sugars regular if he had something that didn’t point out he was a diabetic. Plus it would be helpful for drivers that are type 1 diabetic. The wrist watch alarm would go off and you could stop for a drink or eat candy in the car. I am so disappointed to know someone has not perfected this idea. I think this would help in so many ways.

  16. Christian Sarwa
    Christian Sarwa November 28, 2006 at 8:32 am | | Reply

    I am a UK based Venture Investor and need you help: Would anyone of you invest continuous non-invasive glucose monitoring using Impedance Spectroscopy? What is your bet? Why yes? Why no? Thanks!

  17. Richard Cutts
    Richard Cutts February 15, 2007 at 10:46 pm | | Reply

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