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 2012-10-08 14:36 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'sBG 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.

Emojis for texting DexCom data: A New School Plan Update

We are three weeks into the 2012 school year and I am back to report some amazing news. I'm not even sure I believe this, but Arden has yet to visit the school nurse for anything diabetes related. Not once, nada, zero times!

Our New Plan is working even better then I imagined due in large part to how smooth technology has made the transition. Apple's latest upgrade to the iPhone software included the addition of an emoji keyboard and we are making good use of it in our conversations about type I.

We try to keep our interactions as short as possible to minimize the time Arden is distracted from her school work. I estimate that our plan saves Arden from missing between forty-five minutes and an hour each day of class time, but there is always room for improvement. So when I noticed that our texting conversations were taking more time then I thought they should, I wondered why. Arden and I spoke and it turned out that she was struggling to spell some of the words that we use to discuss her DexCom CGM data. Words like, diagonal and horizontal. Other issues were less to do about spelling and more about word count. For example, "189 diagonal up" or "143 straight across". That's when I thought, "if there is an emoji of a heart, dress, shoe and dog pooh there must be arrows".

and there was...

So now we are speaking to each other with even more economy of time and our texting conversations have been trimmed in half, which makes more time for learning.

Emoji can be activated on Apple devices running iOS 6 like so. Settings>General>Keyboard>Keyboards>Add New Keyboard>Emoji. If you talk to your child about their DexCom data via text message this is more then worth your time to set up.

Another nice feature to check out is 'Send Read Receipts'. This one is great not just for diabetes, but for every parent/child texting conversation. Send Read Receipts allows you to see when the person on the other end of your conversation has read your message. It looks like this...

This setting is accessible by taking these steps. Settings>Messages>Send Read Receipts. Changing the setting to on "Allows others to be notified when you have read their messages". No more wondering if the person you are texting with has seen your message. Turning this feature on is a no-brainer for parents, but if you are trying to avoid someone... that's a whole other consideration.

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Day one of our New School Plan

Arden went back to school today to begin the third grade so it's time to put our new plan into action and see what happens. I had a nice 45 minute meeting with Arden's teacher and school nurses yesterday so we could discuss how the shift in care was going to happen. Having interested, committed and kind people on the other side of the table is such a pleasure, I wish I could thank them everyday for being so wonderful and adventurous.

I say adventurous because today Arden became the first child in the history of our school district to manage their type I diabetes without being required to do so in the nurse's office. I say wonderful because even though we are forging into uncharted waters, no one at the school is freaking out or getting cold feet. I suggested yesterday that we just begin down our new path together and let the process grow and adapt at it's own pace. I was thrilled when everyone agreed even though what I was asking for is covered by state laws protecting children with diabetes and Arden's Endo backed 504 Plan. What I hear from so many of you is that most schools get scared and put up walls when you try something different. For that reason alone I feel very lucky today that I have the relationship that I do with these amazing educators.

What is this New Plan all about? How does it work?

In the past Arden visited the nurse for every diabetes related decision but now she will only be going to their office if an emergency situation arises. We are going to try and limit the visits to unexpected low blood glucose readings, dizziness and other such moments that feel like they aren't manageable over the phone.

I began my day by visiting Arden's class to explain that this year would be different then last. Arden's entire class moved from second to third grade together this year and their teacher stayed with them so everyone understands the nuts and bolts of Arden's nurse visits and testing. This short talk was to take a bit of the excitement away as I don't want the exuberance of the children to cause the teacher or Arden to feel uncomfortable. You may be wondering how seeing something that they all witnessed last year as Arden's nurse visit companion will be exciting? Well, Arden will be communicating with me from her desk with her iPhone. We will be using text messages whenever we can but Arden also has carte blanche to call me and I her as we need/see fit. Talk about progressive, right?! 

I'll be right back... she's texting now...

We just set a temp basal via text and she is going to test in 30 mins and then text me. This is working!!!

Anyway, there are snacks in her class (see above) plus juice boxes in a small refrigerator. She will be carrying her OmniPod PDM as well as a juice box with her from class to class and every room that she visits (Gym, library, etc.) also have snacks stashed with the teacher. I've tried to set the school day up so that her experience in the building mimics the one that she has every other day. Arden doesn't make her bolusing decision autonomously yet so with the exception of the texting/calling, this won't be any different then when we are at home. Actually, sometimes we do text about BGs from room to room so I guess this is almost exactly the same.

Why is this so different?

Arden's school district teaches a number of children with type I diabetes. Many of them test and bolus without supervision, especially the older kids, but they all do it in the nurses office and then record their actions into a log. The school can claim what they want but the log is mainly kept to protect the school from litigation. The kids may use it for reference but make no mistake, it's there to cover asses. Arden doesn't have to submit logs to the school and unless she ends up in with the nurse for care, they won't be apprised of the steps we take throughout the day. It's a different approach then most take but I think it will go a long way toward giving Arden more confidence and independence. Perhaps best of all Arden won't be leaving class so much throughout the day. I found myself so concerned with type I related safety at school that at times I was willing to ignore that so much of the education day was being missed.

typos: Daddy 1 - Arden 0

Day one wrap-up:

Our new plan worked well on the first day. There was one instant where Arden didn't hear her text message alert so I waited for a few moments and then called her. I received texts during class, library and from the bus. There was a bussing issue in the afternoon that caused Arden to be stuck on the bus for much longer then we plan for and her BG did begin to fall during the ride. The entire event was handled by Arden with one text and a phone call.

Later in the day I received a phone call from Arden's teacher, she just wanted to reach out to say that everything felt smooth on her end and the addition of the testing and phone to the room was never an issue. She praised Arden for being so mature with the phone, we chatted for a few minutes and agreed that day one was a success. On to day two...

Special Request

I held this post back for one day so that I could write about the 'Unfathomable Loss' that one of our fellow DOC members recently experienced when her husband was taken suddenly by cancer. I hope that you can take the time to read my post about Meri and her family.

Update on 2012-10-02 12:30 by Scott Benner

The first follow up to this post, 'New School Plan UPDATE: Emojis and texting DexCom data' is located here

Good morning from Chincoteague Island, VA

Good morning from Chincoteague Island, VA, we are are more then half way through our family vacation and i thought today would be a good time to check in with all of you and say hello. This morning around five Arden's DexCom CGM woke me when her BG dropped just below 90. I set a temp basal for an hour and snuck outside to take some pictures of the beautiful sunrise that the island enjoys. We are having a great week and I hope you are too! Lots of relaxing, fishing (we don't catch much), beach bumming and enjoying downtime together. I'm mixing in the last bit of writing I have before handing in my book, 'Life is Short, Laundry is Eternal' that is due to the publisher in a few days. Here are a few pictures from my sunrise photo walk that I just shared on Instagram... I guess that we'll be back to life before we know it, the kids just received their school schedules so they are beginning to countdown the days. Be well, I'll be back (too) soon.