Here is an 3 March 2021 interview of Tidepool CEO Howard Look by podcaster Stacey Simms. The transcribed section below starts at 26:19.
Stacey Simms: So let’s go back to a bunch of questions about the targets because one of the things that people love so much about DIY, is that they can really set these target ranges for how they want and other things. Um, can you speak to that? What kind of flexibility as compared to what people understand with DIY Loop? May they experience the Tidepool Loop?
Howard Look: Yeah, it’s a super question. The first thing I will say is, we totally understand how the community loves having the flexibility of choosing their own target range set points. And we believe in that as well. That is definitely something that type schoolers [Tidepoolers] who use DIY lube [Loop], understand the value in that my daughter uses DIY Loop . I’ve been very public about that. We did in our submission to the agency proposed flexible set points. We are in review right now, that is something new, and most companies before us have submitted would fix set points or a limited set of set points. That is something that we are discussing with the agency, we’re not yet cleared. So I can’t tell you how that discussion will go. What I can tell you is the agency has been great. They have been so good. During this review. I know a lot of people like to dump on the FDA. I will not do that. Because my experience with the agency has been these are hard working really dedicated public servants that really want the best, safest and most effective solutions for the community. And the questions they have asked us about our clinical study day about how we built the product about cyber security is all completely reasonable. And so I know they are seriously considering it. And we’re hoping we will know the answer to how [emphasis added, I added my corrections to obvious transcription errors]
It looks like to me that Tidepool is doing its best to allow as much DIY Loop flexibility into Tidepool Loop as possible. I am curious, of course, as to what, exactly is meant by flexible set-points. I would be pleasantly surprised if these flexible set-points are made contingent on minimum variability thresholds.
I’m hoping that Tidepool’s unique perspective and good relationship with the FDA will lead to some breakthrough regulatory decisions. I think Howard Look, as a parent of a T1D child who uses DIY Loop, is well-positioned to thread this needle.
We shall see.