Dexcom gets FDA Approval
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.
Labels: announcements, CGM, Dexcom, diabetes
posted by Bernard @ 10:36 PM
8 Comments:
Great writeup Bernard. This is an interesting device, I'll have to look more into it.
I like the post-operative tight glycemic control market myself. There's been some good research lately that points out the opportunity to prevent recurrent visits to the hospital by closely monitoring glucose levels including those of non-diabetics! Dex is well positioned. They just have to improve the user experience.
Kevin
I agree with you, that market could be very hot for Dexcom and other providers. But the user experience is so appalling it's hard to describe. If it weren't for the fact they're the only player besides Medtronic, Dexcom would be doing no business.
And you know that others will start nipping at their heels.
It will be interesting to see whether Dexcom can pull this off.
Thanks for the info Bernard. I hope that the new sensor is also more reliable. I have decided that I really can't rely on my dexcom, which is too bad. It has some outstanding periods, which are great when they happen. For me, the performance is inconsistent. When I was testing out the Guardian RT, my conclusions were the same.
Thanks for all the information you posted on Dexcom Bernard.
I just want to apologize to you for not getting back to you earlier regarding your questions related to C-peptide from an previous posting of mine. I was having "Technical Problems."
Medicine as you probably know, is a very political ballpark. There are many Egos and personalities involved.
Sometimes things get approved and Grants issued depending on not only "Merit" but all the politics within the System.
As far as C-peptide is concerned. those w/IRD(aka Type 2 Diabetes) have a sufficient amount of it already circulating within their blood.
The question most overlooked Bernard is, how to prevent Complications from both Autonomic and Peripheral occurring in T1DM? This problem involves both the micro-vascular and macro-vascular parts within the body.
Now, most Physicians will "automatically" come out with their glib answer, "just keep your blood sugars within normal values."
There is some truth to this, but it is a superficial answer not based on reality. the reality is for a person with T1DM, Complication can still develop even with "good blood sugar numbers." It is the nature of the Disease as well as Longevity which contributes to that. Of course, if a person is Hyperglycemic most of the time rather than normoglycemic, than the risk of Complications will be expedited.
My concern is with the Treatment and Prevention of Complications. It is very easy with the use of available technology as well as determination to keep blood sugars within good numbers.
The other part of the equation has not been addressed, as you are aware.
That is why C-peptide, from everything I have read(a lot) seems most promising.
Hi Bernard,
Great writup! Your's was the first useful blog I found to help me learn some about DexCom STS as I was searching for more information on CGMS systems on web.
I have created a blog which starts with my experiences with DexCom STS. I think this is a bit more detailed then what I have seen on the web, so it might help others.
It can be accessed from the following link:
www.sanjay-mehrotra.blogspot.com
Please feel free to delete this comment, if you think it is inappropriate for your blog.
Best wishes -- and thank you for the information you provide.
Just a quick question. I have been looking forward to FDA approval of the Abbott CGM system (just got approved in EU so maybe soon here too). Anyhow, I was interested in that one because of a presentation i saw by my Endocrinologist who has been evaluating all of these systems.
What struck me about all of them was how appalling they were at picking up overnight hypoglycemic episodes. Do you know if there is any data out on the 2nd generation dexcom in thix regard? Thanks.
I have not yet seen ANY data on overnight lows for the next gen machine.
But I get (rudely) awakened by the current one when my BG runs low. I've set it at 80 so I can correct before it gets too low. Now I'm thinking I should reset it to 70 before bedtime and back to 80 when I wake up. Because at night it generally drops very gradually.
And sometimes you get readings like 90-95-95-78-92-90 and the 78 (or whatever it is) triggers an alarm. And I HATE those in the middle of the night.
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