UPDATE: Great news! Late this afternoon, the FDA panel voted FOR changing Dexcom’s label to indicate that it can be used for making treatment decisions. Still has to be formally approved by the FDA, but this decision has a lot of positive implications for those living with type 1 diabetes!
I had the honor of attending today’s landmark FDA panel meeting to decide if Dexcom’s CGM can be used to make treatment decisions. I was there to provide a parent’s perspective by sharing Isabella’s story with the panel. I wanted to share my comments with all of you, as well.
The FDA will vote in a matter of hours and, I don’t know about you, but I’m waiting on the edge of my seat. This decision is a big deal; like a really big deal…one that has many implications for those living with type 1 diabetes. Stay tuned!
Thanks to the awesome peeps at DiaTribe, the link to the full video can be found here, which includes me getting choked up at the end of my comments! Feel free to watch the whole thing or at least start at ~15 minutes to see the awesome 10-year-old who spoke before me!
Good afternoon and thank you for the opportunity to speak today.
My name is Greg Dooley. My 5 year-old-daughter, Isabella, has type 1 diabetes and uses a Dexcom G5 CGM.
Before I get started, I’d like to disclose that Dexcom will be reimbursing my travel costs to attend this meeting.
Isabella was diagnosed with type 1 nearly four years ago…just two weeks before her 2nd birthday.
After four days in the hospital, we were sent home with a prescribed plan consisting of 4 insulin injections and 8-10 fingerpricks per day. We embraced our new reality and quickly became experts in managing type 1 diabetes in a small child.
In July 2014, Isabella began a Dexcom trial. This amazing technology has been a game changer for us and has significantly improved our ability to care for our daughter.
I’ll never forget that first night with Dexcom…
I was supposed wake up at 3am to check Isabella’s blood sugar using her meter, which had become my normal routine.
Unfortunately, I slept through my iPhone alarm.
Thankfully, the sound of a Dexcom alert, which was intentionally designed to be extremely loud and annoying, woke me up — alerting me to a severe low, which I was able to correct by giving her some glucose gel…..
I’m quite confident that Dexcom saved Isabella’s life that night.
Needless to say, we loved our initial experience with Dexcom and never turned back.
The real-time data and trends provided by Dexcom are extremely powerful. We are now able to see a blood glucose reading every 5 minutes compared to once every 2-3 hours.
To put that into perspective: that’s 288 readings per day with trend indicators….compared to only 8-10 snapshots using a glucose meter, each of which required that we prick Isabella’s finger with a lancing device. Prior to Dexcom she already had more than 7,000 finger pricks in only two years since diagnosis.
As our comfort level and confidence in Dexcom’s accuracy increased, we began using it to avoid dangerously high or low blood sugars….without confirming with a finger stick first. This method of treatment was supported and encouraged by Isabella’s endocrinologist.
Dexcom has become a very critical tool for my family. We use Dexcom to make treatment decisions every single day… despite the fact that the FDA currently considers this to be an “off-label” use.
For us, this “off label” use has — without a doubt — saved Isabella’s life countless times and has enabled us to more effectively manage her disease.
I’m hopeful that an approval by the FDA will ultimately put this very powerful tool in the hands of a lot more people and enable Dexcom to properly train patients and caregivers on how to effectively use the G5 to make better treatment decisions.
Thank you for your time.