I know what the FDA will say and I don't care
Wednesday, October 3, 2012 at 9:08AM 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.
Advocacy, DexCom, FDA, Pharma, Sick Day, technology in Daddy's Blog, DexCom Blog, OmniPod Blog
Reader Comments (14)
BRAVO!!!!!! My husband and I completely agree with you. He has been saying it for a long time... he wants an app on his phone where he can see Tristan's blood sugar so that even if we aren't with him, we can react to it. We have DexCom in a glass at night so that it will vibrate against the cup and wake us up (he's 8 and we have to have a baby monitor in his room and ours).... but a lot of time it doesn't. The alarms are just not loud enough! Period! They need to do something better.... I'm 100% behind you and hopefully we will see something soon.
Amazingly powerful post, Scott. So important.
Thanks for all of the great responses! I heard from many of you not just here but on FaceBook and even in Instagram comments. This is obviously an issue that resonates with all of us. Let's think about how to make our voices heard in Pharma and with device manufacturers. Tell them that we need them to be bold for us.
Just a couple of weeks ago, I had a conversation with my endocrinologist about a super-bolus which somehow morphed into a discussion about Low-Glucose Suspend technology. He told me that they (I wish I could remember who "they" is) did a test where they would randomly suspend people's pumps for two hours, without warning, regardless of BG levels or anything else. The intent was to prove that LGS was safe, even if CGM technology was imperfect. NONE of the trial participants came anywhere close to DKA.
That's enough to convince me that LGS warrants approval by the FDA. The next steps (fully closed-loop) can be handled later, but let's get the life-saving stuff out of the bureaucracy and into the hands of the people who need it. Well written!
I know this is not ideal but have you thought about getting a baby monitor? You could create a cradle to hold the cgm in a position and point the camera at it. This would give you the ability to see the glucose reading and hear when it alarms?
I definitely agree that CGMs could use a dock, or blaring alarms and whistles. My T1 father is 67 years old, and has hypoglycemia unawareness. All of our family worries about the overnight lows, I will stay over at night if my Mom is out of town.
There's a lot to desire in the world of CGM and pumping - that is for sure. Yet, when it comes to preventing overnight lows - I know of a food product that has helped our family (still not perfect) - but I really don't want to "spam" your comments with a sales pitch. I put my email, so if you'd like info on that product, just let me know. Thanks for sharing your story - I really think this is one of the scariest parts of T1 diabetes, and needs attention.
I have an answer for you!!! It's not FDA approved but it is a short term solution until there is something better. Like you, the lack of sleep made me sleep through a very bad low and I just knew I had to do something! Being in the technology business, we found our alarm system- literally. I purchased an alarm system with vibration sensor which I place on top of Nates dexcom every night. When it vibrates it sets off an alarm in my bedroom which I have to get up and reset. We even bought a siren for it but have not needed it (yet). It has been a prefect solution for us- feel free to contact me if you want more details or need a parts list. I know it is not the solution you are looking for, we all could scream at the FDA for the way they drag things out, but it may help you get a few good nights sleep :)
So many imaginative ideas from some very loving people!
We tried a baby monitor with no luck, Arden's receiver seems to need to be in the bed with her to maintain a connection so it moves throughout the night. (A little bird told me that the next generation will have more range).
This alarm system sounds amazing Amber. Nate is super lucky to have you guys!
Have a great day!
Love your ideas what good does an alarm do if you can't hear the darn thing we put Jared's Dexcom in a glass bowl with marbles and a baby monitor but the range is so bad it goes out of range if he sleeps at the wrong end of the bed. Oh how many time I have gone to his room to check on an alarm only to discover him sleeping on the end of the bed and Dexcom screaming out of range.
Hi
Medtronics VEO pump with cgm stop insulin delivery for two hours if bg drops below a certain value (you can set the shutoff bg yourself) and you don't react to the alarm, the point at which you want the insulin delivery to stop can ofcourse be much lower than your normal low bg alarms, such that you'll first get loads of low bg alarms before the bg goes below the point at which the pump stops delivery. Further the pump also have alarms you can set for fast dropping bg's. I believ the VEO pump have been available for the past two years in Europe not sure if it's FDA approved though. I'm really sattisfyed with the pump, its been litteraly lifesaving on a coupple of occasions...
Louise - That sounds fantastic!!! I did a little searching and it seems they aren't available in the US but have been submitted for approval. http://diatribe.us/issues/44/new-now-next/3
Let' hope it doesn't take forever to reach here. Thanks for the info!
Scott
Has anyone tried My Sentry? We are currently using a Dexcom and get up every two hours at night. Medtronic is offering a discount for My Sentry unil October 26th. It is normally $2400, but they are selling it for $1700 with a $400 credit if you fill out trial information. We not know what to do because it is expensive still, we are in a warranty with Dexcom for a year with insurance, and they say the stomach sensor for Medtronic's is more painful. I am tempted to get it while it is discounted and save it for when our Dexcom warranty is up. We have had way too many dangerous lows in the middle of the night!
Maureen,
We've never tried the MySentry but I know that Leighann (http://www.d-mom.com) used one and then opted for a DexCom. I think she wrote about their experience on her site.
Not sure how far your bedroom is from your child's but the new DexCom (shipping the end of this month) is touting a much improved range from sensor to receiver, a smaller sensor wire and a number of other improvements. More info here - http://www.ardensday.com/main/2012/10/8/dexcom-g4-platinum-overview.html
Can I ask, is your child using a pump or MDI?
Scott
NEW DEXCOM FDA APPROVED- Taking orders! www.dexcom.com
Maureen- We tried the Medtronic pump/ CGM combo- doesnt compare to dexcom. VERY VERY painful insertion (my son bawled where he doesnt flinch with Dex- plus it bled a LOT). Range was not as good (lost signal 3ft away), accuracy was comparable. I was considering the MySentry as well- but definitely not worth putting him through the pain of sensor changes every 3 days...