So my “mole” who attended the Diabetes Technology Society meeting in Maryland last week got back to me, and the news was kind of disappointing.  On the whole, it doesn’t sound like there’s anything particularly new under the sun for us PWDs at the moment; it’s all about more baby steps in research and development.

But Aaron Kowalski, Research Director of the JDRF, might disagree with me there. He delivered a keynote address entitled “Accelerating the Availability of an Artificial Pancreas.” (He even offered me a peek at this slideset, although he asked me not to publish them here because he’s working on a paper about this topic right now.)

The upshot of his talk is summarized in a JDRF press release HERE.

He’s essentially explaining that the Artificial Pancreas Project is proceeding on three different tracks:

1) The extensive JDRF Continuous Glucose Monitoring clinical trials, which are providing the necessary scientific evidence that CGM does in fact significantly improve diabetes control.  (Trial participants who used the devices regularly — six days per week or more — saw a reduction in A1c levels, without an increase in hypoglycemia.)

2) JDRF’s Artificial Pancreas Consortium, which is working to bring together scientists from multiple disciplines “to safely and effectively link blood sugar sensors with insulin delivery systems, using a sophisticated algorithm to ensure the device accurately mimics how a human pancreas does.”  That means the device should be able to sense glucose and deliver just the right amount of insulin, taking into account all the relevant variables including insulin sensitivity, exercise, stress levels, meal types and others.

3) JDRF’s campaign to create partnerships with industry companies “to build artificial pancreas technologies and create a robust, competitive marketplace for them.”

OK, No. 1 is great news.  No. 2 sounds like a gargantuan challenge. And No. 3 — well, that’ll be a slow incremental process that will depend a lot on further development in Numbers 1 and 2.

I know that we have come a long way in the last 10 years or so with diabetes technology, but people have been forecasting the closed-loop system for too long and there are too many obstacles to get too excited about “acceleration” just now, if you ask me.

Meanwhile, my mole tells me that there was a great deal of detailed discussion at the conference about the possibility of including glucagon in the closed-loop / artificial pancreas system: i.e. how to overcome the complexity of delivery?  (Ooh, this is going to take a while.)

But what was new this year, my mole says, was the apparent consensus that “CGM technology is here to stay” — which was apparently not a foregone conclusion last year’s event. Hmmm…

I also learned that Dr. David Klonoff, who heads the Diabetes Technology Society, gave another talk calling into question the value of self-monitoring of blood glucose (SMBG) for Type 2 diabetics.  His take was apparently a little different, however. He states that the “human factors” of self-testing haven’t been studied enough to give us a good overview of what’s happening out there. There should be more focus on the behavior of both patients and caregivers, he claims.  That I would have to agree with! The “behavior” side of things (otherwise known as “real life with diabetes”) has been summarily ignored by conventional medicine for far too long.

So are we on the fast track to major changes in the way most people’s diabetes is treated in this country?  Probably not.  But again, all progress is good, so stay tuned.

While we’re on the topic of diabetes technologies and advancements this week, I’d like to share what I’ve learned about two more companies working on some alluring diabetes innovations.

DiaSome Pharmaceuticals, located in Conshohoken, PA, is developing a “proprietary nanotechnology cell-receptor targeting system” designed to deliver insulin to the hepatocyte cells in the liver via both oral and injectable drug routes. According to their documentation, “the site-specific targetting of insulin essentially restores ‘normal physiology’ to the liver, allowing for improved glucose regulation in diabetic patients.”

DiaSome’s calls its system HDV-Insulin: “a nano-sized carrier for all commercially available insulins.”

Their main product at the moment is an oral version (Oral HDV-Insulin), which is a low-dose, short-acting insulin delivered in a pill or capsule form for use in Type 2 diabetics.  At only 20-50 nanometers, the particles are small enough to “cross membrane barriers” in the body, and “avoid enzymatic degradation.”

Whoa, that’s small!  Keep in mind that a nanometer is one-billionth of a meter — or about one-billionth of a yard, or 25 millionths of an inch. This is approaching the size of an atom, and 3-10 atoms end-to-end are about one nanometer long!

So how fast is this tiny technology coming to market?  According to their most recent press release, DiaSome already completed Phase 2 talks with the FDA last year, and is working on more long-term human trials this year.  I guess something this new takes a lot of painstaking research.  All I keep thinking is: Monsanto at Disney. Who remembers riding under that gigantic eye?



Meanwhile, GluMetrics out of Irvine, CA, is utilizing futuristic technology to tackle an altogether different diabetes problem. Tom Peyser, the company’s VP of Clinical Affairs, who has a daughter with Type 1 diabetes, explains that the company’s founders had become “very concerned about uncontrolled blood sugars in patients undergoing surgery in the hospital setting.”  Heart surgery patients were often running in the 400s.  “Between one-third and one-half of the patients had diabetes, and they did very poorly post-surgery compared to other patients.”  The mortality rate was unacceptably high and they were often in for serious complications, like major infections, following surgery.

Clearly this was — and is — a problem in search of a solution.  I’ve personally heard many horror stories of diabetics’ losing glucose control while hospitalized. The idea of going under anesthesia and allowing some hospital staff to take over my BG control scares the BG-outta-me, if you know what I mean.

Peyser tells me that the current focus on tight glucose control in the intensive care unit (ICU) came about when a group of Belgian researchers discovered that heart patients in a surgical ICU receiving insulin intravenously (through their IV hookup) fared better, whether they actually had diabetes or not.

“There needed to be a concerted effort to control blood glucose in the hospital, but there were no good tools to do that,” he says.  “CGMs based on interstitial fluid were not good enough, not immediate enough, and since patients in the ICU already have intravenous lines running, we can measure blood that way.”

GluMetrics’ solution is called GluCath™, a “single-use, disposable system, inserted into the venous periphery, which will communicate with a dedicated monitor allowing the real-time, direct monitoring of blood glucose for up to 48 continuous hours.”

Interestingly, its core glucose sensing technology is based on a unique fluorescent chemistry developed at UC Santa Cruz and extended by GluMetrics: “boronic acid-based polymeric material that is capable of detecting and measuring the blood glucose level of diabetics and other hospitalized patients in a way that will enable clinicians to monitor blood sugar control more closely and accurately than has ever been possible previously.”

Sounds good. GluMetrics is “just on verge of human trials” which will probably begin with feasibility studies in patients who are not critically ill, for obvious reasons.  But the technology will eventually be applicable to any inpatient surgery — even that knee surgery you might have been putting off.  Nice to know the physicians will soon have the tools they need to keep your BG in check while they’re cutting and pasting.



Speaking of diabetes innovations, I just have to ask: Who saw Oramed’s newest: insulin suppositories? Because the company wants diabetics to “be able to receive insulin in the form which is most suitable to their lifestyle and/or age.”  Anyone else wondering what their target group is here?!

On Wednesday of this week, the eighth annual Diabetes Technology Meeting convenes in Bethesda, MD, for a three-day event (spanning this year’s World Diabetes Day on Thursday) that will survey the latest technological advances for people with diabetes.  How I’d love to be a fly on the wall at that conference!

Nevermind that I’ve been trying to gain press access to this meeting for at least the last 3 years; I have a mole this year, who’s promised to report back directly, especially if someone as influential as the ADA’s Richard Kahn gets up again and raises eyebrows by making an anti-diabetes-technology speech right there among the country’s leading D-tech experts.

That probably won’t happen again.  But reviewing the agenda (also published here on DiabetesMine, below this post) reveals that there will still be a lot of discussion about the relative value of glucose monitoring in Type 2 diabetics (sheesh!)  Since this stuff is so crucial to our lives with diabetes, allow me to walk you through some agenda highlights:

You can see that early in on Day 1, there’s a two-part, 3.5-hour panel on non-invasive glucose monitoring (the dream is not dead!) including new technology for measuring glucose in tears ( Sandy Asher, University of Pittsburgh).

Mid-afternoon will feature a workshop on new ways to measure the effects of diet and exercise on glucose control, using — you guessed it!—  continuous glucose monitoring (aka CGM systems). Proof points for our fight for insurance coverage of this technology, I wonder?

This is followed by another lengthy two-part workshop (divided into academic and industry perspectives) on Self-Monitoring of Blood Glucose (SMBG) in Type 2 patients. A representative from the FDA will be speaking on “Challenges for Decision-Making Software” (?) and another from Roche Germany will be presenting “The Value Chain of SMBG” (?)  Coming from Roche it must be pro-meter use, I figure.  At 5pm, a guy from Microsoft Health Solutions Group will be discussing “Bringing Diabetes Care into the Internet Age.”  Those are the slides I’m after!

On Day 2, Aaron Kowalski, strategic research director of the JDRF will be giving a keynote address on Accelerating the Availability of the Artificial Pancreas. Wow. I’ve pinged him to try to get some details on the “A” word there (acceleration).

Later they’ll be an in-depth session on applying nanotechnology to diabetes care — manipulating matter at the atomic and molecular scale.  The companies iSense and Diasome will be presenting their unique approaches. (More on the latter here soon.)

And on Day 3, Saturday, the experts will discuss the latest in insulin delivery technology and tissue engineering for insulin production, including a Novocell presentation on the “Bioartificial Pancreas.” For details, see this reference from 2002: “Slow Progress, But Much Promise.”  Yeah, we know.

After lunch, there’ll be a session on “Techonologies for Improving Adherance,” including video games and an “Online Accelerometer” for weight loss and fitness from the Diabetes Prevention Source in Los Angeles. (Note: I’d like to have an “Online BG-management-Ometer” to take over for me, thank you very much!)

Finally, there are some sessions covering “tele-medicine” including using cell phones for better disease managmenet, and a “Tele-Foot program” for assessing diabetic foot health from a group in Warsaw, Polland.

All-in-all, the topics aren’t much different from the DTS Meeting in past years.  One can only hope that the content is significantly updated, and that it all translates to improvements in PWD’s lives asap!

{Stay tuned for relevant updates.}

Diabetes Technology Society - Nov 2008 Agenda

iPod, iPhone, iPump, iPort, iV-drip (?)… so no reason to look surprised when you hear about another futuristic diabetes technology company by the name of iSense.

This one, a privately held company based in Oregon, has been working on developing a “minimally invasive” continuous glucose monitoring system (CGMS) for about ten years.  (I’m guessing the company name sounded a lot more futuristic back then.)

From what I gather, what’s new and different with the iSense system versus the current CGM models that have recently hit the market (DexCom, Medtronic Guardian, Abbott Navigator) are two things: the special flexible micro-wire technology of their sensor, and the sophisticated data reporting system they’re developing, which they call The Glycemic Signature™.  Some basics:

The microsensor: “a multi-layered electrochemical sensor that is about 4 times the size of a human hair. Like the MiniMed CGMS system, the small sensor portion would be placed through the skin, but the reduced size would greatly reduce the effort and minimize pain.”

The Glycemic Signature™: “a real-time representation of a patient’s blood glucose condition in both graphical and numerical form… it consists of four metrics: SnapShot, Movie, Box Graph and Continuous Glucose Moving Average.”

Sounds to me like the latter could be a really useful and powerful system for extracting meaning out of your CGM data. How nice would it be for you and your doctor to review a few large, clear graphs that illustrate your personal “glycemic signature” for the last few weeks or months?

Presumably the third big benefit of the iSense technology is increased accuracy. At last year’s Diabetes Technology Meeting, iSense’s Chief Scientific Officer gave a presentation about “Simultaneous Use of Multiple Glucose Sensing Units,” in which he showed the potential benefit of using several sensors and a voting algorithm to improve the overall accuracy of a glucose sensing system.  He stated that the voting method yielded significantly better accuracy than a simple averaging method, and could therefore “be used to address accuracy concerns in a closed loop system.”

So why is it taking so long for iSense to come to market?  Apparently the company is currently conducting human trials with quite positive results.  “But bootstrapping finance is certainly an issue.  You can only do what you can afford,” said a company insider, who asked not to be named. They hope to come to market within the next year or two, pending FDA approval.

A few other interesting side notes:

* Not long ago, reader tipped me off that iSense was experimenting with all sorts of allergenic medical adhesives (”super-glue was tried, believe it or not, as a way to attach a 30-day sensor, but it didn’t go very far as a practical choice”).  No official data was available on this, but I’m thinking that if they can overcome issues with skin reactions to medical adhesives, they might be sitting on a gold mine!

* According to Diabetic Investor David Kliff, Bayer Healthcare has already made a strategic investment in iSense and its Glycemic Signature system. He also says Bayer has its eye on acquiring Abbott’s Diabetes unit, in particular the Navigator CGM system. While this may seem a bit odd, Kliff explains: “One of the major issues with the Navigator isn’t whether the unit works, the real issue is that Abbott cannot manufacturer sensors consistently or with any scale. Bayer properly understands that when it comes to the insulin pump market, it’s critical that pumps have the ability to communicate with a CGM system.”

Yup, that sure looks like the future.  And whether they’re swallowed up immediately or not, iSense technology is looking pretty engaging.

If you don’t know about Kelly Close and her work in the diabetes industry, you’re definitely missing out.  She’s a Type 1 herself, a former Wall St. analyst, smart as a whip, and just about the sweetest person you could ever hope to admire.

A Guest Post by Kelly Close, diabetes industry consultant

We recall our grandparents talking about their first experience watching “moving pictures” — for that generation, a revolutionary development from still photographs. But that technology is quite primitive compared to the visually stunning pyrotechnics that are featured in theaters today.

In the diabetes world, we will someday recall self-monitoring of blood glucose (SMBG) with the same quaint fondness that our elders remember those early moving pictures. SMBG was indeed a revolutionary technology (in this case, from the poor proxy of urine tests), but home glucose monitoring was the equivalent of still shots, and we are now inching our way toward the moving pictures of continuous glucose monitoring (CGM).

We try to be cautious in forecasting how quickly any new technology will be adopted, but in the past week or so, the results of an important study has been released that make us have a more optimistic take about the acceptance of, and reimbursement for, CGM.

We were thrilled to see exciting news from the European Association for the Study of Diabetes (EASD) conference last week, which was simultaneously reported in the New England Journal of Medicine.  Researchers reported the results from the JDRF CGM trials, showing that CGM use in adults resulted in a -.5% drop in A1c over six months for adults with about an 8% A1c baseline. That improvement is critical because many payers have been reluctant to cover CGM partly because there is not enough “medical literature” showing the merits of CGM — this literature is the best you could do — the New England Journal of Medicine!

The trial funded by JDRF and supported by all the manufacturers showed that in addition to a better A1c, there was also a corresponding rate of decreased hypoglycemia at the same time as A1c decreased, which we are all cheering about.  Many will remember the landmark DCCT trial that showed intensive control caused lower A1c but with lots more hypoglycemia, especially severe hypoglycemia. While this trial included highly motivated patients with extraordinary health care teams and incredible psychosocial support, we hope it will serve as a model around the world to help patients seek better control — and that it will do a lot for insurance reimbursement!

We know that CGM use isn’t for everyone, particularly for people who aren’t yet ready to deal with its body image issues, and it’s certainly far from being hassle-free. CGM also takes a lot of support from the health care team, so it’s pretty hard to go on one if you are isolated or don’t have a doctor or educator who sees its value. This trial didn’t find, by the way, that CGM yet caused significant A1c reductions in teens or children – then again, teens used the devices only 30% of the time and children only 50% of the time — like that lotto tagline: “You can’t win if you don’t play.”  Here’s to improving devices so that more people play.

On that note, we believe that CGM can be the same type of transformative technology that home glucose monitoring was, if the device companies work to make the technology more patient-friendly.  We know that improvement with the devices — more accurate, smaller sensors, less painful insertion methods, etc. — will accelerate their use. And while we often hear from patients who’ve been denied reimbursement (sign Gina’s amazing petition if you haven’t already), coverage is actually moving faster than we had expected. For example, Medtronic estimates that the majority of its sensors sold last quarter were reimbursed — that’s progress! Now let’s get that to nearly all…

We know that we are fortunate to live in a country where these devices are even available. Many places around the world struggle to maintain basic insulin supplies.  Our expectations are high as we eagerly await the advent of more combined devices (pump + CGM + who knows?) and more patient-friendly tools.

The show has just begun.

*    *     *

Kelly Close is editor of diaTribe, a free online diabetes newsletter focused on research and new products, and President of Close Concerns, a healthcare information firm focused on the business of diabetes.

Talk about adding insult to injury! It was bad enough when my Type 1 diabetes ushered in a new era of being allergic to wheat.  But now I’ve received some equally upsetting news: it seems I am also allergic to medical adhesives.  Would you believe…?

“You’re the only one in the family who needs medical adhesives, and now you’re allergic to them.  Isn’t that ironic or something?” my 11-year-old blurted out on the way home from the dermatologist late last week.

We were actually there for her, for goodness’ sake (she had a minor irritation around her mouth that wouldn’t heal).  But in my infinite wisdom, I thought I’d ask the good doc what was going on with the swollen, red-speckled spot on my belly where my Navigator had recently been.

We had to exit the exam room first, to register me as a separate appointment, and call my primary care physician for a referral before the dermatologist could legally tell me a thing.  Then they escorted us back in to the same exam room and we waited another requisite 20 minutes, only to have the same doctor open the door and tell me I was allergic.  There’s a co-pay well spent.

According to this doctor, it’s not just the latex, but some sort of gel used in the type of adhesive that comes with the Navigator (the same type as those DexCom shower patches, which used to irritate me so).  She took a look at my OmniPod site as well, which wasn’t acting up at the moment but certainly does irritate me sometimes, especially on the belly.  The adhesive used with that one contains more cotton, she said, so less like to irritate as quickly or as severely.

(Got a better image idea?)

Me: “So what can I do about it?

Dr. Derm: “I can prescribe a Triamcinolone cream for that pretty severe allergic reaction you’re having right now.”

Me: “OK, but I mean preemptively — what can I smear on there in advance to make it less sensitive? Or can’t I pop a pill or something?”

That got chuckles.

Dr. Derm: “′Fraid not.  And it’s probably going to keep getting worse.  You may not have been so allergic the first few times you wore it, but you build up a reaction to something like that.”

Me (in my head) : “WtF?  Isn’t it resistance that’s supposed to build up?!”

I am, in a word, simply incensed.  I consider this the further wrath of my already rebellious immune system.  I shall persevere!

Me: “Well, this thing here is a new technology called a Continuous Glucose Monitor.  It has the potential to change my life and the lives of many other diabetics.  Wearing it requires medical adhesive.  So I’m going ahead and trying it on my arm next, no matter what.”

Dr. Derm: “Well, that’s your choice.”

Me (in my head): “Don’t talk to me about choices! I never asked for any of this.”

So… how many of you out there have been blindsided by allergies on top of your diabetes?  Speak up, won’t you?  Misery loves company.

I don’t want this post to sound negative, as I’m quite liking the modus operandi of the FreeStyle Navigator.  But as you can see, reader June S. hit the nail on the head when she said, “Yikes! How can you fit a large ‘Pod’ on your body PLUS the large Navigator transmitter/receiver?” Two lumps are a lot of gear on your skin, especially in the sizzling summer heat.

After wearing this double-duty almost all week, I have some additional observations to share.

First, did I mention that the Navigator has a 10-hour warm up period?  That means once you insert the Transmitter, you have to wait 10 full hours until you can fire up the Receiver and get monitoring.  This kind of shocked me at first — until I remembered that the DexCom folks had actually suggested doing the same. It’s not officially in their product literature, but the rep did suggest that the sensor needs time to “settle in,” so one ought to insert it the night before and “sleep on it” before activating the session. A number of articles remind me that “all the sensors presently on the market need a number of hours to settle in to the body before they can start giving accurate glucose information.”

Hmmm.  This interstitial fluid method has its drawbacks, no?

There’s also that lag time issue, which can create a lot of frustration.  I noticed most of my hypos before the alarm ever went off, for one thing.

In fact, had some internal strife about setting my BG alarm targets here.  My inner perfectionist insisted that “targets” should always be very tight, like the 90-120 set on my pump.  But the Abbott rep reminded me that CGM “targets” are really only for alarms, and record-keeping, i.e. to illustrate when you are in the “zone,” that shaded stripe on the graphs in which your BG is happily within range.  The key is deciding when you want your alarms to go off: at 70? or 60?  At 200? or 180?  Too much alarm action can drive you nuts.  I also had to remind myself that tight BG targets on the pump are necessary because you want that device to calculate insulin corrections based on getting you back under 120 asap.

Low Troubles

I must report that I had the same overnight issue with Navigator that I’ve had with other CGMs: I usually run in the high 70’s or low 80’s while sleeping, and the darn thing just won’t stop beeping me awake all night trying to alert me to a hypo I’m not having.  I set my low alarm to 65, and for some reason the CGM keeps reading me there, even when I’m not.  But I don’t want to raise my hypo alarm either, as I sure as heck need to be alerted of impending lows during the day.  So like its predecessors, the Navigator ended up in the hall laundry basket a few nights this week. Aaargh.

High Troubles

Please don’t balk, but I set my high alarm for 200.  Because if I set it any lower, it beeps like crazy after every meal — which is unbelievably aggravating when you’re trying to conduct conference calls, watch a movie, or shop without creating a scene (all the little things collectively known as having a life).  But if don’t set the “hyper” alarm to a lower level, I miss some 170s and 180s throughout the day.  This is an ongoing dilemma for me with CGM, I find.

Skin Troubles

Finally, I must admit I had to abort my first Navigator mission a day early.  That adhesive started bothering me on Day 2, and in this incredible heat wave we’re having, the spot turned into a full-blown hive by Thursday morning.  Actually, the adhesive peeled up on Wednesday, so I smacked an extra Smith & Nephew adhesive patch over it (provided in the Navigator start-up kit). But this got bunchy and created a pool of trapped water after my first shower, that served only to turn the hive into a welt.  Yipes!  My poor belly has been through a lot in this heat.

I’m aiming for my arm next, so can I dig down into the features of this nice, clear new system — which I’m convinced I would love best if only the lump were smaller.

As of Sunday evening at 9pm, I’m on the Navigator!  That would be the newest continuous glucose monitoring system from Abbott Diabetes, approved by the FDA this past March.  Approval took much longer than expected, while the company had been promising me a close look at the product for over a year, in part because I’d just missed out on participating in the local study. Anyway I’m hooked up now, and quite excited to share my thoughts!

I spent about an hour and a half going through the basics with the company’s clinical science manager, who happens to live in the next town and was kind enough to make a house call.  It was an easy setup because: 1) I’ve used two other CGM systems before, and 2) I’m a long-time FreeStyle user, so totally familiar with their test strips, lancets, etc.  The latter probably makes me a little biased toward this CGM system; I loved the look and feel and perceived ease-of-use right away.

Here are some of my first impressions:

WHAT’S DIFFERENT

Well, the first thing that hit me was the packaging; nobody eating carrot cake on the front of the box.  And they were pretty sparing with the excess cardboard and foam. Both pluses right there for my “feel good” factor, although utterly irrelevant to system performance

The default view of the main screen features big, clear numbers, not graphs.  If you want to see the graphs, you have to push a series of buttons to enter the “Reports” menu, then select “Line Graphs” and choose from 2, 4, 6, 12, or 24 hour views.  I’m not sure yet whether I like the fact that I’m only seeing a single number most of the time.

A heck of a lot fewer calibrations required!  You only need to conduct four calibrations in the five-day wear period — and they are super-easy because the Navigator has a FreeStyle fingerstick meter built right in. You just stick a test strip into the little port on the lower left corner and feed it some blood.

There’s nothing to recharge.  The “Transmitter” (Abbott’s term for the piece you wear on your body that houses the sensor) takes a Silver Oxide 357 HC watch battery, and the “Receiver” (controller unit) takes two triple-A Energizer batteries.  But here’s the catch: estimated battery life for the Transmitter is 30 days, and the Receiver is 60 days.  If the batteries die on you mid-session, you lose the current sensor.  So you have to be diligent about watching battery life. Ugh.

The Navigator Transmitter is quite comfortable, if slightly large.  The insertion process differs from both the DexCom and Guardian, too.  DexCom’s got that nice mini-size sensor (or “Transmitter”), and a pretty easy and painless snap insertion with a smallish disposal plastic piece.  Guardian’s insertion is nastier, with that gi-normous needle I hated, but the insertion device is reusable, which is good (less trash).  The Navigator, on the other hand, has a largish insertion device that is fully disposable (shown here). You have to push really hard, and it makes a rather unpleasant noise during insertion.

SO FAR…

So my very first morning with the Navigator was a workout day.  I calibrated when the thing woke me up at 7am, as required.  But I was a little late getting to my breakfast, so the second required calibration, at 9am, was actually rejected: “Cal Failed.”  Huh? Turns out the Navigator automatically rejects any attempted calibration when you are “trending,” i.e. when your blood sugar is moving rapidly upwards or downwards.

(hey, that was right after breakfast!)

I think this is a very clever and important feature, as I’m sure my many ill-timed calibrations contributed to my frustration with the DexCom.  Calibrations should always be done when your BG level is steady, I have learned, since feeding any CGM system numbers that are moving targets only confuses it.

Right now I’m scrolling through the graphs and checking my post-meal peaks: 231 after breakfast; 208 after lunch (cookies, yeah).  I’m loving the way this thing looks and feels and seems to be in pretty tight synchronization with my fingerstick meter (accuracy, hooray!)  But I find a can barely see a darn thing without activating the back light each time I pick it up.  You can’t change the settings to keep the backlight on, presumably because that would run the battery down way too fast. Dern. That might bother me.

More updates on Flying with Navigator coming here soon.

The online diabetes community, led by Gina Capone, has dubbed today a special day to lobby for insurance coverage of new continuous glucose monitoring systems. The idea is that we all raise our voices, by talking openly about how important CGMS is to our health, whether it’s simply for preventing lows at the gym or for dodging fatal heart attacks and strokes.

As most of you know, CGM systems are new to the market and still in early stages. I’ve been lucky enough myself to try out the first two commercially available, one from DexCom and one from Medtronic (the Guardian).  I’m looking forward to testing the third system recently approved by the FDA, the Navigator from Abbott Diabetes.

Because these systems are still considerably difficult to use, need a lot of calibration and/or warm-up time, and are not nearly as accurate as fingerstick testing, there’s been a lot of hot debate about how hard we as the patient community should push for insurance reimbursement. The JDRF has a big campaign going, and the CEO of Diabetech has even set up an informational site called CGMS Central.  Some significant progress has already been made, with Aetna and Wellpoint stepping up to the plate.

Manny from TuDiabetes recently created this video exploring the frustration of those who want and need CGM systems the most.

From my vantage point, I’m a little torn: My personal experience says CGM systems are not (yet) the panacea of diabetes care you might imagine.  I’ve actually tried three systems if you count the early DexCom Three version, and learned the hard way that it was a good thing I hadn’t lobbied too hard for insurance coverage of a system I later chose not to use, for all the reasons mentioned above. I know there’s a limit to how many devices I can lobby my insurance for, so I want to pick my battles carefully.

Thus, I can see how insurance companies aren’t quite ready to plunge into ubiquitous coverage for CGM devices just yet.

On the other hand, two big points:

1) There are plenty of patients with hypoglycemic unawareness or severely fluctuating glucose levels who could really use this technology for a quality of life improvement NOW.

and

2) CGM is improving and on its way to becoming mainstream, so if we EVER want the insurance companies to cover it, we probably do need to start lobbying immediately.  We don’t want to give them any reason to back off supporting the best tools available for diabetes care.

Assuming today’s goal is to catch the attention of people not already knee-deep in the CGMS campaign, I’m going to direct you all to find out more about CGM systems and how the JDRF views this as the critical bridge to an eventual Artificial Pancreas HERE.

And keep your eyes peeled for more information here at DiabetesMine; my review unit of the new Navigator is due to be delivered next week. I’m hoping this is going to be the one to solidify CGM’s place in the permanent D-care toolkit.

Who’s ever heard of the GlucoDay® S semi-invasive continuous glucose monitor?

I didn’t think so. I picked up a hint from a medblogger’s footnote. Then I found it described over at DiabetesMall, although the link to the product on the manufacturer’s site doesn’t seem to be working.

That manufacturer would be A.Menarini Diagnostics, Italy’s largest pharmaceutical R&D company, which released the GlucoDay across Europe a year ago (or two? — I’ve had no luck getting hold of them despite attempted introductions). The GlucoDay is apparently the first system in the world based on a “microdialysis” technique to obtain the CE marking for the Medical Device Directive, required to market any product in the European Union. But don’t get too excited; I read the fine print, and it’s only designated for clinical use, “worn by the subject for a 48-hour period.”

So why am I bringing this up? Well, I happen to love innovation, and like Kerri, I’m finding the Guardian MiniLink sensor to be rather uncomfortable. Meanwhile, I didn’t like using the DexCom much at all. I’m feeling ready for something less invasive. So these guys had me at semi-invasive. But what the heck does that mean?

Apparently the only thing going in your body with the GlucoDay is a “microfiber” inserted under the skin, as part of a small “biosensor.”

The description is a bit cryptic, but it appears to be a two-part wireless system where the controller unit is sort of Walkman-sized. Granted, in this day of micro-devices that’s not too exciting, but maybe that’s the current trade-off for less invasive. I love the data I was get from the Guardian. But I don’t love that long cannula and the mobility of the sensor that often makes your skin sore.

So I’m thinking, maybe we’ve all been too ambitious expecting a jump straight from needles & cannulas to the non-invasive dream. Maybe there’s a step in between — something semi-invasive that will help us with the comfort imperative. Then again, the data on that last link is at least two years old. And then I found this neat overview which is, oh… just about 10 YEARS OLD.

*Sigh…*