Today Abbott reported that the FDA has (finally) approved the FreeStyle Navigator continuous glucose monitor(CGM) for sale in the US.
This is one of the most anticipated CGM devices. Many people I've spoken with have expected that this CGM will solve all the shortcomings of the Dexcom and Minimed devices. I've also talked with several people who have been using the Navigator. My take is that this is no more perfect that the existing CGM alternatives.
Abbott, who even has a special site for the Navigator, says that it will be available in the second quarter of 2008. Like all CGMs you will need a prescription to get hold of one.
A few interesting aspects of the Navigator:
Five-day sensor.
Five direction arrows to indicate rising or falling blood sugar
The receiver has a built-in FreeStyle meter.
Designed to 'accomodate' swimming. Does that mean the receiver is waterproof?
The receiver can be up to 10 feet from the transmitter
You can see a short movie illustrating how the system works. It's available on the Abbott site.
One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.
I'll post more news about the FreeStyle Navigator as I learn about it.
Update: My understanding is that the built-in FreeStyle meter is used to calibrate the Navigator. I do not think they support manual input of the values. I'll try to confirm this and update the page when I learn more.
The FDA has a new approach for reporting problems with blood glucose meters and continuous glucose monitoring systems (CGMS).
Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because FDA's approval process cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) after the device is on the market.
If you use any of these systems they'd like to hear from you when you encounter any of the following type of problems.
Device problems including
reagent or instrument failure
defects in product design
product instability
any other device problems that compromise patient health or safety
failure to perform according to performance characterized in package insert
incorrect test results that cause or contributed to an incorrect patient diagnosis and/or treatment
Use-related problems including
inadequate and/or misleading labeling or confusing user instructions Use-related problems
inadequate packaging or poor package design
any other user problems that compromise patient health or safety
The FDA will hold your identity in strict confidence. This means they won't release it to the public. But they may share it with the maker of the device, unless you request them not to do so.
Finally a way to get attention to system issues that annoy you! Full details on the FDA website.
Today the two companies announced that they will work together to integrate Dexcom continuous glucose monitoring into Animas insulin pumps.
"The new technology will enable the Animas® pump to receive glucose readings and display this information on the pump’s color screen. Users will have access to real-time glucose readings and trending in addition to receiving alerts for low and high glucose readings. Having real-time readings displayed on the pump screen will not only allow users to make more timely adjustments to their insulin delivery – it will eliminate a separate receiver, reducing the amount of equipment required to use CGM and the pump system."
According to the news report this should be available in 2009 or early 2010. And again it's a non-exclusive agreement, leaving Dexcom free to work with other pump makers.
I know that I've been very quite on the blogosphere for the last several weeks. I appreciate more than I can express all the comments and e-mails asking me how I'm doing and wishing me the best.
I won't bore you with the details here except to say that I'm in the middle of some type of depression. It's not earth-shattering and for those of you who have diabetes, it's probably not entirely unexpected. Taking care of a chronic disease is a big burden and it takes its toll. The good news is that I'm working pro actively to get this under control and get through it. And in the meantime I'm focusing on essential activities because I've not got a whole lot of energy for other things.
It's been a busy year on the blogosphere and busy one for me. I've been blessed with a lot of accomplishments over the last year, in no particular order:
I met Allison and Mel in Boston. It's always fun to get together with fellow diabetics! If you're going to be near Boston in 2008, please let me know.
I got to some meetings of the insulin pumpers group that meets in Woburn, MA each month. A fun, supportive and informative group. Every state should have a group like this.
I marked my 35th year with diabetes by raising over $11,500 for research in a diabetes bike ride. Hint: it's not too late to support this.
I received an award from Lilly and Joslin for 25 years with diabetes. Thanks Dr. Spatola for organizing this one.
I setup the diabetes search engine. It now indexes over 800 sites and I like to think that it's helpful for folks.
I joined the great TuDiabetes.com social networking site for diabetes. Big kudos to Manny for starting this.
I worked together with Beth to start the diabetes365 project (originally her idea). As of today there are about 1,750 photos that give some insight into what it's like to live with diabetes.
I almost completed NaBloPoMo for this year. I didn't post for every day of November. Next year will be better.
I started using the Dexcom STS continuous glucose monitoring system and moved to the Dexcom SEVEN system later in the year. Life with a CGM is a lot easier, though it still has its frustrations.
And of course I posted many blog entries. Along the way I hope that I informed some readers. I know that I learned a lot from your comments and I also managed to get lots of practice with my writing skills.
So what's in the cards for 2008?
I'm getting some blood drawn in January as part of the research for Dr. Faustman's work on a possible cure for Type 1 diabetes. No, I'm not getting an early version of the cure, I'm just donating blood samples for the work. I hope to meet her and ask a few questions, I'll let you all know what I learn.
I'll keep blogging, though maybe a little less.
I hope to get involved in another fund-raising bike ride in September.
Dexcom SEVEN is cleared to calibrate with any meter
Dexcom announced today that it had received clearance from the FDA to calibrate its Dexcom SEVEN continuous glucose monitoring system using any approved blood glucose meter.
Once this feature is made available, Dexcom users will no longer need the dreaded six foot plus calibration cable. It'll need a software update to allow input of the glucose meter values. I hope they use a good algorithm to let us input those numbers!
Dexcom expects to make this feature available on new systems by the end of the first quarter of 2008, and to upgrade existing users during the second quarter of 2008.
I know that they've already started trials on their 3rd generation system, but so far there's no news about the upcoming features in the 3rd generation or the likely date for the system.
to be the resource on the web for anything about CGMS reimbursement.
And on Monday the Centers for Medicare & Medicaid Services (CMS) finally approved billing codes for continuous glucose monitor systems.
In theory this means it will become a little easier to claim for these systems from your insurance company. In reality, it's not such a slam dunk. Until there is more proof that use of a continuous glucose monitor improves blood sugar control, insurance companies are not going to cover these devices as a matter of course.
While we're waiting for better coverage, if you've got any information about insurance coverage for CGMS based on your experience, do visit CGMS Central and share the information with others.
I just read on the Yahoo! diabetescgms group that Dexcom has a special price on their system through September 28th. Instead of $800 for the system, the price until September 28th (tomorrow) is $350. Update is that it's $450. Remember this cost does not include any sensors. A four pack of sensors will cost you an additional $240.
This seems like a great deal for a system that works well for the most part. But before purchasing it, I'd suggest asking if there is any guarantee that allows you to return it within a certain time if it doesn't work for you. CGM systems are not for everyone. And the only way you can figure this out is by trying one.
Apparently the deal is being kept quiet. Contact Dexcom at 1-877-DEXCOM4 (1-877-339-2664) for details. And let me know if this rumor is not true.
Note: I still own shares in Dexcom. I try not to let this influence what I say about about the company or its products.
I know where the week went. After a lovely Labor Day, I've been taking the children to school. Which means I've been adjusting my sleep schedule. And that's just...tiring.
Anyway, here are some random things.
Terry Keelan has a poll on TuDiabetes asking how people tape up their Dexcom sensors. For those not in the know, the Dexcom 7 continuous glucose monitor has sensors that can be used for more than seven days. I previously blogged about how to reset the receiver to do this.
But one of the problems is that about day 7 the adhesive on the sensor starts to fade. So how do you tape it up to keep it on. Inquiring minds would like to know. Have a look at the picture Terry provided
Then go to TuDiabetes and let him know your technique for keeping Dexcom sensors in place.
Some time ago I created the Diabetes Search Engine using Google's Custom Search Engine facilities. I think the DSE provides very useful results when you want to search about anything related to diabetes. Building the engine was a little tricky, so I wrote an article about the process. The article was published today on O'Reillys ONLamp.com web site. Warning, the contents are strictly for Geeks with Diabetes. You have been warned.
Finally, this weekend in Connecticut is the big ride. I've already raised over $10,000 to support the important research by Denise Faustman into a cure for Type 1 diabetes. But you might like to stop by and cheer the riders on. The race is in New Canaan and most riders will be coming back between noon and 12:30. Maybe I'll see you there. I'll be the 50-year old diabetic with the big grin on his face! And hey, it's not too late to support me.
I've posted a video to YouTube that shows how to reset the Dexcom 7 receiver to tell it that the sensor has been removed. You can do this if you want to end a sensor early.
The second part shows how to tell the Dexcom 7 receiver that a new sensor has been inserted. You can do this whether or not you have actually replaced the sensor.
I hope you find the video is helpful. Sorry it's a little shaky.
I got two similar questions recently about the Dexcom 7 continuous glucose monitor (CGM) and I realized it's probably worth summarizing what I know about it for those who might be interested in using one. So here's a fairly long post with most of what I know about this interesting device. Note that the Dexcom 7 is officially approved for use in adults, but there are some folks on that list who are using it successfully with their children.
For the record. I start using the Dexcom 3 in March 2007, after a one week free trial. I switched to the Dexcom 7 on July 24th 2007 and have been using it ever since. After 35 days I'm on my 3rd 7-day sensor, so I'm getting an average of at least 12 days out of each one. Remember the sensors are approved for 7 days of use, but most people continue to use them after the seven days are up. I'll post in the future about how to do this, because it's not immediately obvious for everyone.
There are several bloggers who have posted a lot about their Dexcom experiences. You can find a list using the Diabetes Search Engine. Anthony has his Dexcom Seven blog, and Clemma has her Comrade Dex blog, both of which are very informative.
Trying out the Dexcom
You should not purchase a Dexcom without first trying it out. The cost of a Dexcom 7 system with four sensors is $640. And each box of four sensors is $240. And, no you cannot buy these individually.
I do not (yet) have insurance coverage for the Dexcom or the sensors. I'm hoping to start filing for this sometime during this week. From the Yahoo! diabetescgms group it sounds as if more companies are starting to cover the costs of this system. Unless you know that your insurer actually covers it, you need to consider the ongoing Dexcom sensor costs ($60 each for at least 7 days) before deciding to use one.
On the Yahoo! diabetescgms group, someone pointed out that CGMS users seem to be broken into 4 groups.
Those for whom the Minimed REAL time works well.
Those for whom the Dexcom 7 works well.
Those for whom either system works well, and
Those for whom neither works well.
Unless you try it out, you can't tell whether it will work for you. Contact your endo's office and see if they'll arrange a trial for you. You will need a prescription from your endo before you can get a trial. Originally I tried out the Dexcom 3 for a week, which allowed me to make a sensor change. I think this is crucial, so make sure you get to try out the Dexcom 7 for at least 9 days, ideally aim for 2 weeks. And make sure you get a copy of the software when you're doing the trial, the system is much better when you can actually use the (PC-only) software.
Sensor Insertion
Inserting a Dexcom sensor takes some work. With the Dexcom 7, the insertion is a lot less painful than with the Dexcom 3, but it's still tougher than for a pump. There's no spring-loaded inserter, you just have to jab it in. I continue to use it in my abdomen, but I know several people on the Yahoo! diabetescgms group have used arms and buttocks.
Once the sensor is inserted you connect the transmitter to the back of it. This combined unit is waterproof, and you can shower or swim with it and don't need to cover it in any way. The waterproofing is done by having the transmitter lock very firmly in place on the back of the sensor. You can only remove it using the plastic 'safety lock' that stops you from first accidentally inserting the sensor.
The Dexcom requires care and feeding. You need to calibrate it at least twice each day with a test taken using a OneTouch Ultra meter. Calibrating means you take a test with the OneTouch and then connect the OneTouch to the Dexcom via a supplied 5-foot cable, the synchronization takes about 10-15 seconds.
Alarming
You can change the alarm settings on the Dexcom with one setting for the low alarm (changeable in 10 mg/dL increments) and one for the high alarms (20 mg/dL increments). There's a hard-wired alarm that triggers at 55 mg/dL.
Except for the hard-wired one, the alarms only trigger each time the readings cross the boundary from normal to high or to low. So if your high alarm is set to 160 and the reading goes from 155 to 164, the alarm will trigger. If the Dexcom is reading 210 an hour later and the numbers never went below 160 you will not get another alarm. In the case of the hard-wired alarm, you'll get another one 15 minutes after the first.
The alarms can be loud. The first one is a loud buzz. If you miss it, or don't acknowledge it the next alarm is a loud buzz and noise. This happened to me yesterday and three co-workers in surrounding cubes wondered what it was and whether I was OK. So if you're easily embarrassed, watch out for this. In a recent webcast, the Dexcom CEO mentioned that the next generation Dexcom (no idea on dates) will have must more customizable alarms.
The Receiver
The receiver unit is fairly large, a little bigger than most of the insulin pumps available today. I usually carry it in my jeans pocket. It comes with a carrying case, but this is basically unusable. It sticks out very far from your belt and you can't connect the sync cable to it while it's in the case. And remember that it needs to be within 5 feet of the transmitter, so carrying it in a purse may not work.
The Dexcom receiver must be synchronized with a OneTouch Ultra meter at least twice a day. The recommendation is that you check your blood glucose using the meter before making decisions based on the Dexcom readings. In practice I probably test an average of 5 times a day, so don't expect a huge decrease in finger sticks because of the Dexcom. Note that Dexcom provided me with the OneTouch Ultra when I purchased my Dexcom 3 system, I assume they're still doing the same with the Dexcom 7. I also know that many insurance companies won't cover you for two makes of test strips. So if you're going to use the Dexcom, you're forced to switch from your current meter to the new one. The good news is that the Dexcom software will show you both the Dexcom system readings and the meter readings.
The picture below shows the 9-hour graph from the new and the old Dexcom receivers.
You need to charge the receiver about every 3 days, with the supplied charger. It's about the same size as my cellphone charger. I generally do this at night by plugging it in and then sleeping on top of the charging cable so the Dexcom can be beside me in bed. When sleeping I usually leave the Dexcom beside me because the receiver needs to be within 5 feet of the transmitter/sensor. And leaving it on my night stand means I may not hear it when it alarms.
With the Dexcom you'll get their new data management software. I complained loudly on this blog about the original DM software. The new version is much better with lots of useful and useablestatistics. You can also export the data as an XML file, or a comma-separated values (CSV) file which Excel can read.
What do I think about the Dexcom?
In April 2007, I described this as like having a superpower. And I still feel like this about it. My April A1C, just after starting the Dexcom, was 8.2% and my July A1C was 7.0%, a 15% reduction. I don't think I could have accomplished this without the Dexcom. It's also partially due to using Symlin more, and I really found the Dexcom invaluable to help me manage using Symlin.
For me, this has been a life-changing device. Diabetes management has become a lot easier all round. But there are also times when I want to throw it out the window. If I'm woken in the middle of the night (tonight) by a sensor alarm, it can be very annoying. If the usually smooth graph starts to have a lot of gaps in it for no reason that's also a pain.
But I'll stick with it, and I'm aiming for a further improvement in my A1C.
I hope this writeup helps you some in deciding about this device. Note: I still own shares in Dexcom. I try not to let that influence what I say in any of my posts.
A while ago, some of us on the Yahoo! diabetescgms group were asked to participate in a survey about our continuous glucose monitoring systems (CGMS) and what we thought about them.
This short and readable document includes the following sections:
Key Findings about CGM Users
How Patients Use CGM Systems
Comparison between Minimed and Dexcom
Why Patients Stop Using CGM systems
Some thoughts on Reimbursement
I think you'll find this a useful document and well worth the read.
On a personal note, I'm about to start the reimbursement process for my Dexcom 7 STS with my insurer this week. Can I tell you how much I'm not looking forward to this? Why is this so hard?
Given that my A1C went from 8.2% to 7.% while I was using my Dexcom STS without hardly any significant lows it should be clear this system is beneficial and reduces costs in the long term. I just hate having to argue this all with many levels of insurance bureaucracy. I'll let you know how that goes also.
I've been wearing both Dexcom CGM systems for about 24 hours now. It amazes me how closely they track one another, though yesterday the old one was always about 10 points below the new one. Today I'm seeing about the same difference. You can also see there are some gaps in readings for the Dexcom 7. I think the receiver is a bit fussier about rejecting possibly bogus readings. I wonder how that will look when I'm more than seven days into the Dexcom 7 sensor.
I came across a 19-page HSBC Global Research report(PDF) comparing Minimed and Dexcom based on the ADA conference and a survey that HSBC took. The report estimates there will be about 140,000 CGMS users by the end of 2009 versus about 15,000 today (and 6,000 at the end of 2006). That's a huge growth rate, and you know it will impact insurance coverage. I think it will also drive the demand for software to help healthcare teams interpret the huge amount of numbers they'll see in place of log books.
I hope this quote will come about
We would view any such collaboration between DexCom and any of the leading insulin pump manufacturers – Johnson & Johnson (Animas), Roche (Disetronic), Smiths Group (Deltec), or Insulet – as a positive for both parties, as both companies would better com
Personally, I think that CGM will become the standard for testing for anyone with Type 1 diabetes. Read the report, I think you'll find it interesting.
I'll post some pictures from the Dexcom 7 software later in the week. I did try the new software with my old data values and it worked just fine. So I've much more interesting statistical views of my readings available back to March.
Note: I currently own some shares in Dexcom, I work not to let this influence what I say about the company or its products.
Finally here's a picture from last weekend of some of the lovely flowers in my sister-in-law's place in Rhode Island. What a lovely weekend we had there.
When I got home last night a surprise was waiting for me. No, not the Harry Potter book -- that was earlier in the weekend.
A box from Dexcom was sitting on my porch, the new Dexcom 7 CGMS had arrived. The box contained an updated Receiver, a transmitter, and the new software box including download cable. I didn't get a new recharger, and unfortunately they didn't provide a shorter cable to connect the Dexcom 7 receiver with my OneTouch Ultra meter for synchronizing.
So I read the instruction manual while eating my dinner. Then I plugged the receiver in for a few hours to charge it up. I decided to insert the new sensor around bedtime. And wow that was a lot easier for me. That small change they've made in the sensor needle gauge made the insertion pain feel a lot less for me.
The Dexcom SEVEN transmitter design changed slightly. It now has two small extensions on the back to lock it into the sensor. This much be part of making the system waterproof. This did make it a lot harder to actually lock the transmitter into the sensor. The little piece of plastic left after sensor insertion really just didn't work.
Luckily I have such wonderful stomach muscles (hah!) that I was able to just push the transmitter into place. It was really tough! It'll be interesting to try and remove it in when the sensor is all used up.
I waited until this morning to tell the Dexcom 7 receiver about the new sensor. A lot of people have reported better results if you wait more than 2 hours after insertion of the sensor.
Dexcom has made several small changes to the screen between the Dexcom 3 and the Dexcom 7. All of these improve it greatly. They've replaced the time range on the Dexcom 3 (9:30 AM to 10:30 AM) with just the current time (10:30 AM) in a larger font and 1 Hr in an even larger font. Net result, it's much easier to figure out which screen you're looking at.
They've also changed the screens you use when telling the receiver that a new sensor is available. I think this will mean less confusion between the sensor insertion and sensor removal screens.
I've posted a short (and slightly fuzzy, sorry) video on YouTube that shows some of the differences between the screens. I'll try and most more about differences between the Dexcom 3 and the Dexcom SEVEN tomorrow.
Note: I currently own some shares in Dexcom, I work not to let this influence what I say about the company or its products.
During this week I've read more about the new Dexcom SEVEN continuous glucose monitor that was approved back in May.
I see some traffic on various mailing groups and I've spoken with Dexcom service/sales about the new device. So I now have a little additional information that I wanted to share (because there's so little out there in webland).
The new system appears to be available now. The person at Dexcom that I spoke with was ready to take my order on Friday.
The upgrade price for the system is $350. This includes new receiver, transmitter and software. You'll need to mail in the old transmitter and receiver. You'll receive a reconditioned receiver.
Warranty on the upgraded system is one year.
The price for a box (four) of new sensors is $175 when ordered with the upgrade. Future boxes are the full price. I think this is still $240 for a box of four.
The software is much improved. It can read data from the current Dexcom system as well as the Dexcom SEVEN. It includes statistics that can give you an hourly breakdown. I don't know whether it supports data export yet.
The receiver has not changed much. It still shows a graph of readings from 50 to 400 mg/dL. Major change is that it now shows you how long until the sensor expires.
I don't know how long the new sensors last beyond the official 7-day life span.
That's all the details that I have right now.
I hope to get the new system to try out for two weeks before purchasing. The software is the current Dexcom system was such a disappointment that I won't upgrade without trying the entire system out first (including software).
In the meantime, if you're already using the Dexcom SEVEN why not let us know what you think about it? Maybe you could post about it on the CGM Users group on TuDiabetes?
Do you use the Dexcom continuous glucose monitor, or the Minimed system? Or maybe you even used the FreeStyle Navigator while it was in trials? Then here's a survey for you.
Directly from Caroline Corner's posting on TuDiabetes:
Hello,
I am doing some CGMS market research and I thought that perhaps some of you would like to participate. I am a health care financial analyst and I think that patient input on the devices is a key metric for smart investing. So, I would really like to get your input. There is a $5 Starbucks card for the first 50 responses. Thank you in advance for your time and feedback. I will be glad to share the results of the survey with the group.
This Monday at 1:30 PM (PDT) Dexcom management will be having a conference call to discuss the approval and launch of the Dexcom SEVEN CGMS. Hopefully this will answer some of the questions raised during the earlier announcement about the FDA approval for this system.
The number and codes have changed for this call. The new numbers are given below.
The number for the call is (866) 290-0920 (US/Canada) or (913) 312-6670 (International). And the participant code is "7146581". You should dial in about 1:25 PM (PDT). This seems to be a listen-only line. Does anyone know what number to call so you can ask questions?
The conference call will also be webcast. You can find the link to the webcast on the Dexcom webcast page. You can go there today and pre-register for this call.
I'd like to know the answers to the following questions:
When will the Dexcom SEVEN system be available to consumers?
Will the new software be available on the same date? If not, when will the software ship?
What's the pricing for the system and sensors?
What's the upgrade pricing for the new system?
I hear the transmitter and sensors are waterproof. Is the receiver also waterproof?
I'd like more details about the software. Does it provide statistics, including the the average, and standard deviation for blood glucose values? Does is allow access to the data?
If this is such great news, how come the stock price is still depressed?
I'll be camping at the time. So I'll wait and listen to the archive later in the week.
The updated Dexcom press release doesn't give much more details than I reproduced here.
What questions would you ask Dexcom, if you could? Perhaps you'd like to e-mail them to Jessica Ching, Marketing VP for Dexcom. Her e-mail address is jching@dexcom.com.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
Finally (because I've been waiting for it), Dexcom received FDA approval for both it's 7-Day continuous glucose monitoring system and it's next generation software to go with it. Though it will be a while longer before most of us see it.
The company press release doesn't provide much additional details besides the fact that the new sensors are approved for seven days of use.
But there's also a product announcement webcast from Las Vegas. It's over 39 minutes long, and does not come with any additional slides, though there were slides shown during the presentation.
In the remainder of this long blog post, I've summarized what I picked up from listening to the webcast.
Webcast Summary
In the webcast Andy Rasdal, CEO of Dexcom says that there were no conditions from the FDA on the approval. Dexcom plans to have a limited launch of the new product offerings (presumably both hardware and software) at the end of this quarter with a full launch in the 3rd quarter.
He says that Dexcom has eliminated the use of a shower patch. The needle size has also been reduced, so it should be more comfortable to insert (yay!). Mr. Rasdal claims that Dexcom has listened to their users so features we have asked for will be included. He mentioned that the price is likely to be increased, though the price per day is effectively reduced. (For those of us already getting more than 7 days out of a sensor, it just may end up being more expensive.)
Andy Rasdal also talked about studies that show improved outcomes (over 7 day periods) when using the Dexcom system. This shows a 40% reduction in time spent hypoglycemia, a 33% reduction in hyperglycemia, and a 24% increase in the time spent euglycemic (normal blood sugar levels, also called normoglycemia).
The study looked at folks with less control and found that within a few days they could effectively double the time they spent in euglycemia. These were people for whom it was believed that CGM would not provide any benefits.
The new Dexcom data manager supports downloads of data to the PC for more analysis and for communicating to doctors. I guess we'll see what this means when I can get my hands on it. I still haven't succeeded in cracking the Dexcom data format, and this alone would be a big improvement
Dexcom has 3 peer-reviewed studies published in various journals. During the webcast he referenced a new study on long term outcomes to be published in the June issue of Diabetes Technology and Therapeutics
Dexcom emphasized that this is the second generation of the Dexcom technology with more coming in the future.
Towards the end of the presentation (31 minutes in) he mentioned the new CMS codes for CGM, and the importance of working hard on better insurance reimbursement. He mentioned five letters from Congress that endorsed CGM and looking for better coverage (I wonder whether these could be obtained under Freedom of Information). And that Dexcom has a dedicated reimbursement team, but that reimbursement is still spotty.
Interestingly Andy also talked about the needs of intensive patient monitoring post surgery. This is to move the use of Dexcom technology from just ambulatory to in-hospital use. There is 'compelling clinical evidence' to show intensive management reduced mortality and morbidity by 50%, and not all of these folks (only 13%) had diabetes. I think he mentioned a Dr. Vandenburg who had done these studies.
Dexcom sees this as a large market opportunity. There are over 110,000 critical care beds and Dexcom estimates that over 25% of hospitals have implemented intensive regimes with 12-24 finger sticks per day.And that at $3-$5 per stick, the CGM systems might be more cost effective, as well as less stressful to the patient.
This is also a more focused and effective distribution channel instead of selling to individual patients. That would clearly reduce the cost of sales for Dexcom and presumably increase profitability. Dexcom is also building in the capabilities to interface with any monitoring systems.
They see partnering with other devices makers as being significant in the future. He mentioned not just combining with an insulin pump, but perhaps also with an insulin pen. This would mean several million new users, over the several thousand already using insulin pumps.
My Final Thoughts
I think this will put more competitive pressure on Medtronic Minimed, and may also have implication for the (as yet unapproved) FreeStyle Navigator. I'm excited for the folks at Dexcom, but I'll reserve judgment on the new system until I get one in my hands.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I'll say about the company or its products.
...there is no current consensus on how to compare CGM devices, how to define the appropriate level of agreement given the time lag between blood and interstitial fluid levels, or how to display and interpret data. The guideline being co-developed by CLSI and DTS will address these issues by reaching consensus on how CGM data should be presented and compared between different devices and different glucose methodologies.
I've been trying to promote a standard just to represent the data values themselves. This agreement seems to go far beyond this.
It will take some time and hard work to agree on this guideline but I see it as an important development in the acceptance of CGM technology.
I was talking with someone in support at Dexcom last week. We were discussing some fluctuations in my numbers and how to control these. And he offered to send me this guide that might help.
It arrived in the mail yesterday, and it's 38-pages about how to use CGM effectively to control your blood sugars. It's written by Dr. Steven Edelman (from TCOYD) and Dr. Timothy Bailey (co-author of Using Insulin). Dexcom supported this book by providing a grant, and there are graphs taken from the Dexcom STS system throughout the book.
From reading it, I think that anyone using any CGM system will benefit from reading this short book.
After the Introduction, there are three main sections:
Blood Glucose Levels on the Rise
Blood Glucose Levels on the Way Down
Blood Glucose Levels During the Night
The book has a total of ten scenarios. Each one describes a situation that happened with details about insulin dosage, food eaten, etc., and then shows a graph of what happened to BG levels. You then get to answer a question choosing from 3-4 answers per question.
The book helped me think about how to best interpret what was happening and decide what alternate actions I could take to improve a given situation.
Now here's the best news. You don't have to be a Dexcom customer to get this book. You can get a PDF version here courtesy of the Taking Control of your Diabetes site.
What might this mean? Well here's the problem for those of us with diabetes.
How many diabetes data devices do you use? Glucose meters? Continuous glucose meters? Insulin pumps? Each of these typically collects some amount of data related to your diabetes treatment.
Have any of you got an easy way to collect this data into a single piece of software to that you can do some analysis on it?
Now imagine a future where all of the various pieces of software that come with your devices each exports the data in a common format. What might that mean?
If that format was shared and freely useable by anyone, then it allows different people to create software to collect the data and make logbooks out of it, or analyze it in different ways.
To get device makers to think about this, I've sent e-mails to various companies that are currently working on new blood glucose monitoring devices. Companies like Biosign Technologies who are developing a new wrist-worn monitor; and Nilimed who is working on a new continuous glucose monitor. I'm also trying to interest the Artificial Pancreas project in supporting standard data formats as part of that effort.
Would you like to get involved? If you've got any experience with programming, especially how to use XML and process XML, then you may be able to help.
Leave a comment, or send me an e-mail (mail address on the wiki), and I'll drop you a note.
The authors did a comparison between the FreeStyle (reading every 1 minute) and a system to measure venous blood glucose (reading every 15 minutes).
And the conclusion?
Measurements with the FreeStyle Navigator system were found to be consistent and accurate compared with venous measurements made using a laboratory reference method over 5 days of sensor wear (82.5% in the A zone on day 1 and 80.9% on day 5).
This article also contains pointers to two interesting FDA summary of safety and effectiveness documents. One for the Dexcom STS system(PDF), and one for the Medtronic Guardian RT system(PDF).
Has anyone out there used this system and can post about it? I'm especially interested in what the software does.
Update: They've finally received FDA approval for the Navigator. I've posted on my blog with the details.
Warning for those of you who are faint-hearted. This is not good software. So this is a very critical review
After some pestering, I finally received the download software for my Dexcom CGM system. I paid for the system on March 30th, and received the software today April 10th. It wasn't worth waiting for.
In a nutshell, this is extremely poor software. According to the Dexcom Help About screen, this is version 9.0.2.18. Why they would use a complicated numbering scheme is just an indication of how little they're thinking of the user.
To me this feels like beta software. There was no attempt made to give the user any level of control.
You can only do three slightly useful things with the software. Download the readings from the Dexcom receiver, view up to seven days worth of readings at a time, and print a report showing the readings over an extended period, with seven days of readings summarized on each page.
The screen to view the readings is shown below. You can see strong correlation between the Dexcom readings (blue circles) and the Ultra meter readings (red X marks). If you hold the mouse over a symbol you can see the summary value in mg/dL.
Later in the review, I show an example of the Modal Day view for the data. This is valuable for doctors and, with some help, patients.
I believe that software like this is unusable for the average patient. It doesn't provide information that they can readily act on. At the end of this review I've outlined some areas for improvement.
The rest of this article is a screen by screen description of what I found in the Dexcom software.
Dexcom Software Details
When I loaded the CD that the software arrived on, it immediately started installing. I was given no installation choices about where to put the software. This was the only screen that I saw.
The whole feeling I got during thw install was the lack of control I was given. Notice how the screen above only has a Cancel button? And there's no option to indicate where to install the software.
The next screen below warned me to remove any attached Dexcom receivers. Now this is written all over the box that contains the software and cable, but I understand the need to be cautious.
So after pressing OK, the next screen tells me to connect the Dexcom receiver using the supplied cable.
I connect the cable to a USB port on my computer and to the Dexcom receiver. After pressing OK, I get the obligatory legalese screen.
Now I'm ready to download data from my Dexcom receiver....but the software isn't.
First I've got to fill in some details to get the download going. On the screen below, I click the New button (picture is after I filled in my details).
Then I fill out this form. You could leave it blank. But then if you exported the data, it wouldn't have your name. I added the minimal amount of information.
Then I press the Start button to get the transfer going. I had data from March 23rd to April 10th, about 18 days worth. While the data is transferring I see the following screen. It takes about four minutes to transfer all the data across.
After that I can finally see the data, up to seven days at a time. Apart from the Glucose Trend view (shown at the start of my review), there is also a Modal Day view that shows up to seven days worth of data superimposed over a single 24-hour time period.
I think this is the most valuable aspect of the Dexcom software. You can select for example three days worth of data and then use the arrows to see successive days. That gives me some idea of the trends.
Minor Points
The Dexcom software was almost hidden on my PC. I had to use a special tool to find it buried under the following area:
C:\Documents and Settings\Bernard Farrell\Local Settings\Apps\2.0
After a good deal of investigation, I could not figure out which file in this area is holding the data itself. So for a technical person like me, I couldn't figure out how to extract my own data from their software so I could look at it in more detail.
Areas for Improvement
I could write several pages here. Let me just make a few points.
First. Make two versions of the software. One for patients and one for doctors. An individual doesn't need to track patients. This same criticism is true for software from OneTouch and Minimed. I think they're using the same group of consultants!
Second. Let us get at our data. Better yet, make it available in a standard format. That way we can build software to combine this with data about food, insulin, and other useful information.
Finally. Add some basic statistics. How about the average (mean) blood glucose value for the displayed time period? Or the percentage of time between a range of values. This could really help.
Other stuff. I'd like to compare what happens over different time periods. Show me the trend for a 14-day period. Give me the modal view for a selected set of weekends. Allow me to mark a range of readings with additional data to indicate sickness, menses, etc.
Your Assignment
Have you any experience with diabetes-related software? Are there things that you like or don't like? How about providing some comments that might help in the development of the next version of this software.
Have you used the Minimed software for this CGM? How about posting a review somewhere for that.
Codes for insurance coverage of Dexcom devices may be issued later this year.
According to this Forbes article, there will be a public hearing in May and the codes may be available before the end of the year.
I'm hoping that this means insurance companies will actually get a bit more flexible before final approval.
Dexcom shares have increased significantly as a result of this. I wonder if folks were just using it as a chance to cash out. Let's see what happens to the share price over the next few weeks. That'll indicate what the market really thinks about Dexcom and its future prospects.
In the batch of photos that I published earlier about the Dexcom, one of the photos shows a trace of the redness left after using a shower cover. Now this was after I'd worn the sensor for about 4 days. So I'd have at least 3 shower covers applied in the same place.
Here's that picture again. And if you jump to Flickr, you'll see where the red mark from the shower cover is visible.
I'd read somewhere (don't remember I'm afraid) that the Press n' Seal food wrap worked pretty well for shower covering. So I decided to invest in a box and try it out. Here's a picture of the results before a shower.
Overall it's worked pretty well for me, and I've tried this three times so far.
Now this isn't a perfect alternative to the Dexcom shower covers (about $0.60 each). First of all, you need to trim the wrap because it's too wide. And I've found that even with a sharp scissors this is difficult. Also it's hard to get a tight seal all around the edge. You'll probably get some amount of water in behind the wrap.
But it is much easier on my skin. The last time I used the shower cover it was really sore to take it off. I've heard that the Dexcom shower cover does seem to work in swimming pools, so that's a benefit for those.
I've also tried showering without any cover over the transmitter. After I'm done I've found that sometimes there's very little water behind it. Sometimes there's a lot. Immediately after the shower, I take the transmitter off the sensor and dry carefully both the transmitter and the sensor. Then I reattach the transmitter. I try to do this at some distance from the Dexcom receiver so that I don't send it strange readings that might throw it off. So far that's worked fairly well the 3-4 times I've tried it.
Can I point out another CGM benefit? My wife likes that she can see where things are by simply looking at the CGM. Sometimes when my blood sugar gets low I get very uncooperative. I think in situations like that it'll be nice to have something where she can quickly see what the number is right now and where it's been for the last hour or so.
The way I've described it to people that I meet (I love yakking about this thing) is that it gives me a much better feeling of control. I hope that my A1C will actually reflect that.
I'm meeting with my endo on Wednesday and I'm going to start the paperwork for the insurance reimbursement after that.
I have two minor issues with Dexcom support. First of all, I still haven't received the download software. It's been over a week since I paid for all this and I can't download readings and see what the software's like. That's really irritating.
Second, I tried to call the Dexcom support number on Friday morning to talk about getting an extended period of "---" results. I wanted to see if they had any suggestions for resolving this. I spoke to someone (after about 5 minutes on hold) who took my number and said that a support person would call me back shortly. In the end, I got the callback over 90 minutes later, when I wasn't there to talk with them. If the Dexcom sales take off substantially, how will they deal with the likely increase in support calls? I'm hoping this is a once-off issue.
I wanted to post on what it took to change the Dexcom sensor. This is a small amount of text and a lot of photos. You can click on any of them to see larger versions.
If you've any questions, let me know.
First of all, here's a picture of the old site.
And here's what the sensor looks like after it was removed. It's quite long, but not painful while it's in place.
After choosing a new location where there isn't scarring from insulin pump sets, I used an alcohol swab to clean the new site.
Then I positioned the new Dexcom sensor.
After making sure it's stuck in place, I remove the safety lock.
Then I can push the plunger to get the needle and sensor inserted. This is probably the worst part of the entire process, thought it's really only a small pinch.
Then I pull back on the collar, which remove the needle and leaves the sensor wire in place. Once I've had a little discomfort doing this.
I remove the applicator. The blue pad sometimes swings out a little. The first time I saw this I thought it was broken.
Finally I use the transmitter latch to lock the transmitter into place. This takes a little practice. You can also do it just by pressing with your fingers.
And here's the finished result. You can also see the trace of the old sensor location.
One part of this animation shows the sensor being worn on the back of the arm. That's a very different location that is currently recommended for CGM sensors.
