Hey FDA, what about diabetes!?

Please take a moment to read diaTribe's message (below) to the FDA and then click on the link to their petition that asks the FDA to include diabetes in their upcoming 'patient meetings'.

Lend your voice and help to push this petition to 5,000 signatures so that our children's needs can be considered at the highest levels of decision making.

I hope you have a fantastic holiday weekend, thank you for your support!

Best,

Scott

From diaTribe:

"The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.

But not diabetes. That is unacceptable.

Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.

According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes, and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.

No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.

New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.

We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.

Our voices need to be heard.

Please sign this petition to urge the FDA to sponsor a patient meeting focused on diabetes – and the sooner, the better.

Thank you very much."

BREAKING NEWS: Smaller OmniPods approved by FDA!

From Insulet

"The new OmniPod System, comprised of a smaller Pod and an updated PDM, has received clearance from the U.S. Food and Drug Administration (FDA). This means Insulet can begin manufacturing and selling the new OmniPod in the U.S. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features."

more from Insulet here

Insulet's investor statement is here

More statements of interest from Insulet/OmniPod

"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," said Mr. DeSisto. "We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013..."

"If you are currently an OmniPod wearer, you don't have to do anything right now. We will reach out to you when it's time for you to convert to the new OmniPod and give you all the information you'll need. Converting to the new OmniPod will be EASY! And you can be confident that we'll give you plenty of notice before your new OmniPod is shipped."

Well, it took wayyyyy longer then any of use could have predicted or hoped but all of that is behind us now! Whose excited?!?! I for one can not wait to tell Arden, she is going to be so happy. 

Update on Friday, December 14, 2012 at 12:45PM by Scott Benner

@diaTribeNews is reporting via their twitter feed about the new OmniPod:

"Insulet upgrading all current OmniPod users free! New PDM/pods come 2 US early '13. New pod rocking in EU, upgrades done in next 60 days"

"For people new to OmniPod - very nice that the new PDM will cost exactly the same as old one - no price increases for a better product."

If you've never visted http://diatribe.us you should!

Update on Friday, December 14, 2012 at 2:55PM by Scott Benner

Check out my latest post about the NEW OmniPod complete with information and pictures I bet you haven't seen before!

http://www.ardensday.com/main/2012/12/14/new-omnipod-pictures-and-information.html

FDA Approves DexCom G4 Platinum CGM

Arden has been using the DexCom 7+ for over two years and I don't remember how we did all of this without it. That's why I'm so excited to say that DexCom just announced that their newest version, the "G4 Platinum" has been APPROVED by the FDA. A review of the press release tells me that the company has made improvements in accuracy exactly where they were needed most. The release says in part:

Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.

"Improved accuracy in the critical hypoglycemic range is most important from a life-saving point of view," said Terrance H. Gregg, DexcomCEO. "The Dexcom G4 PLATINUM fulfills the promise of CGM for people with diabetes by providing accurate and reliable real-time performance."

In addition to accuracy improvements the release also highlights these new capabilities:

• Longest transmission range, enabling improved patient flexibility and convenience
• A smaller, discrete profile that fits busy lifestyles
• A first-of-its-kind color LCD display for easy viewing
• Customizable alerts with specific tones
• "Hypo alert" setting at 55 mg/dl that provides an increased level of safety — a feature that no other device has.

You can read the entire press release here.

Crossing my fingers that they thought about remote monitoring... 

* I was able to find images from a site used to register for a recent DexCom symposium in Berlin, but they are low res. I'm working on finding better ones and will let you know when I do.

Update on Monday, October 8, 2012 at 10:35AM by Scott Benner

There are better images and a video in my new post here.

I know what the FDA will say and I don't care

I've been sick since last weekend. It's mostly a head cold but it tried really hard to get into my lungs, I was able to fight it off and am feeling better today, but that's not the story.

Three nights ago it hit me the worst, I wanted, no I needed to sleep, but Arden's BG was high and being very stubborn so I wasn't able to until about 2:30 am. On a day when I wasn't sick I'd take 2:30 with a smile, but like I said, I wasn't feeling good and so it was tough. But I survived. With about five hours of sleep under my belt, the next day drug on. I was a bit of a wreck if I'm being honest and my cold was doing it's best to advance into my chest. I needed sleep badly now, so I guess you can imagine what happened.

Arden got the cold too, now I knew why her BGs were so stubborn. She stayed home from school and we were sick together. But that night, that second night of my three night tale of woe, it was rough. BGs fought me like a bull and I wasn't able to lay my head down for good until 4:38 am, but I still had to get up at 7:15 the next morning. Now my ass was officially dragging. Every time I tried to sit down yesterday my eyes would close so I stayed busy doing household chores. When the evening came Arden was feeling much better, she didn't get it as badly as I did thankfully and I was hopeful about her BGs and my chances for some overdue rest. 

Before bed last night Arden's BG was a respectable 123 on her CGM, 140 with a finger stick and I was smelling sleep. I stayed up for another two hours to make sure she wasn't going to drop unexpectedly and sometime around 12:30 am I set a temp basal restricting her overnight basal rate because I knew I was going to fall to sleep and stay that way. It makes me nauseous to admit this, but I was happy to trade a waking 190 for seven hours of sleep.

This is what I woke up to.

Now I know what the FDA will say to my next statement and I don't care. We need something to help us. After a while you stop hearing the beeps and feeling the vibrations. Other days you may just be too tired or sick to react. For all that continuous glucose monitoring brings to the daytime, it just doesn't cut it after we lay our heads to rest.

Arden's DexCom receiver, your DexCom receiver should come with a dock, maybe it's an alarm clock too. I should be able to buy a companion clock for my room, for our living room, there should be an app. F&%king alarms and whistles and lights should blare in my ears and shine in my face. Hell I'd wear a bracelet that shocked me when Arden's BGs fell too low. Give me a Rube Goldberg that bashes me in the face, give us something... anything.

Now I am quite sure that the manufacturers of CGMs understand how much an alert system of some kind is necessary and this isn't the first time that I or others have ranted on the subject, but I am tired of hearing that, "the FDA won't allow that". I don't give a damn that each piece of tech that you add to a process makes getting clearance nearly impossible, just someone get the nerve to try. Walk defiantly forward and try to break new ground. Please.

Do it before I die of exhaustion, do it before Arden dies in her sleep. Do it before it decimates another life, another family. Be bold so we can not just live, but live better. Look closely at the next picture. Study the graph and then look at Arden's little face in the shadows. Imagine all of the people living with diabetes that are tired, battling a cold or just would love, absolutely f&%king love, a decent nights rest and then do something to help them.

I know what the FDA will say, they may say that if the signal is carried by my home WiFi for example then my home WiFi would need to be verified so it's not possble. They may say any number of a thousand things, but I don't care. Tell me where to sign my rights away. I promise I won't sue anyone if my router happens to stop working on the night my daughter's BG gets so low that it harms her. I'll take the chance, it's mine to take. Stop restricting great ideas from seeing the light of day because of what might go wrong. Something is better then nothing. Right? 

Seat belts aren't 100% effective, I still wear one. Condoms can't promise we won't get sick or pregnant, but we wear them because it gives us a better chance. This isn't just an issue for young children and their parents. This is also about husbands and wives, boyfriends, college kids, it's an issue that effects every person with diabetes and all we want is a fighting chance. 

Medtronic found a way around the problem with MySentry. Sanofi figure out how to link an app with iBGStar. It can be done.

Here is my unsolicited message to every company that has an idea that they are afriad to move forward with because of government regulations: I know you are scared to approach the FDA with innovation, I get it, I really do understand. But I'm afraid to sleep. I'm afriad that my daughter is going to die. People are scared that their wives, friends, mothers, sons will fall to sleep one night and never wake up. We win, our fear is worse then yours. Help us.

FDA clears Freestyle test strips for use with OmniPod

 

"The FDA has notified the company that the new Abbott Freestyle test strip has been cleared for use with the OmniPod," Insulet confirmed in an email to MassDevice. "The companies are in the midst of updating the product label and will be communicating with customers once that has been completed, hopefully next week."

It's official, after more then a year and I can only imagine how much cost to taxpayers, the FDA finally has said that we can use Abbott's butterfly test strips in our OmniPod PDMs.

I'm not all that excited and am about to be a bit snarky about this announcement because I figured this out over a year ago for free and it only took me two days.

I completely understand and support that medical devices, equipment and the like need to be safe, accurate and durable but come on - test strips? I asked myself last year, "why would Abbott develop and manufacture a test strip that wouldn't work with their business partner's testing devices". I found the common sense answer to simply be, "of course they wouldn't do that". Then I conducted my own test and began using the strips with Arden's PDM in December of 2010, we have never looked back.

I'd like to congratulate the FDA on once again turning something simple into a train wreck, you guys are nothing if not consistent. Maybe now they'll (FDA) have time to clear Insulet's latest OmniPod design, from what I understand it's being held up because the "documentation can be confusing". To be clear, I've seen the documentation, used the new pods and not only couldn't the documentation be any simpler but it's about 99% the same as the current generation's instructions. In my opinion the new OmniPod design is being held up because of bureaucratic and political BS.

Our representatives in D.C. love to say that business should allowed to thrive but they'll take any chance to stand in it's way. Insulet is not a huge or rich company. They make a wonderful product that every day helps countless people live easier and more healthy lives. I'd very much like to see the FDA give them a chance to make a profit so that their amazing insulin pump can be around until type I diabetes is cured. Hopefully that cure, when discovered, won't be held up by the FDA forever...

I assume that most of you, because of necessity, have already implemented the "new" strips but just in case you were waiting for official word, you can find it here it's entirety.

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Update on Thursday, January 12, 2012 at 10:38AM by Scott Benner

Insulet has posted a link to updated information.