​Dexcom Agrees to Support T1D1 Human Factors Study!

Sept 1, 2024
​Author: Mike Mendelow, T1D1 Foundation (501(c)(3))
​
Over the last two years, we have been tirelessly working to complete T1D1's FDA premarket submission.  The final roadblock we have been trying to navigate was finding a way to fund and run a Human Factors Trial.  

Now, we're thrilled to announce that the team at Dexcom has stepped in and graciously offered to run the study for us!

This is no small undertaking.  Dexcom has committed their Human Factors resources to execute the study protocol on our behalf.  First they will run a pilot (formative) study to ensure that our protocol and technology are sound.  Then, after incorporating any findings from the results they will plan and execute the full (summative) study itself.   Each of these studies will require participant recruiting as well as data analysis and reporting.  Like we said, it's not a small undertaking!

Drew with Manu and Egemen @ Comerge in Zurich

Last but not least, the team at FDA understands the need and have been fantastic advisors in our pre-submission meetings.  What started with Drew coding alone in his bedroom has become an international effort with grassroots, corporate and foundational support.  All in all, this entire process is a great example of the T1D community coming together to improve the lives of the people we love!

If all goes to plan, we are hoping to have everything wrapped up and ready to submit to the FDA by the end of this year.   
​Let's do this!

We are incredibly grateful to the team at Dexcom, but there are many others who have supported Drew and T1D1 to get us to this point. ​Diabetes Centre Bern (DCB) and Comerge AG have been incredible partners and supporters in this mission for the past 18 months.  And, over 200 members of the community stepped up to support the creation of our HF Study Protocol earlier this year.  

Drew with Derek Brandt @ DCB in Bern