In this Fireside Chat, I sit down with Anand Iyer, Chief Strategy Officer at Welldoc. We discuss a myriad of different topics, including Anand’s work at Welldoc and his predictions for how the roles and types of digital health technologies will change in the post-COVID “new normal.” We also dissect topics such as how mobile prescription therapy works as a supplement to behavioral interventions and pharmacotherapy, and different ways to leverage healthcare data.
Below is a preview of our conversation:
Q: Tell us a little bit about the clinical trial dynamics [for BlueStar®, Welldoc’s FDA-cleared Software as a Medical Device (SaMD) digital health solution for type 1 and type 2 diabetes]?
A: There is a very simple answer to that, which is that in any clinical trial, you want to have a control group. So in this case, that’s standard of care. We recruited all of our patients from the community because the lion’s share of diabetes patients are actually seen by primary care or GPs; there are not enough endocrinologists in either Canada or the US and they usually focus on the more brittle type 1 patients. So we recruited patients and physicians from the community, and in the control group, you had standard of care: meters, strips, see your doctor every three months, the regular way of managing diabetes. In the intervention group, you had patients who got our BlueStar® product and you had physicians who got the smart visit report from the BlueStar® product.
A very important lesson learned here; when we designed our second clinical trial, the large one that was published in the Journal of the American Diabetes Association, we actually took the intervention group and split it into three, because we wanted to answer the business question: “where’s the value coming from?” Okay, I got it, you lowered A1c by two points; but what was causing it? Was it because the patient was doing what they were supposed to be doing? Was it because the doctor was titrating the medications? Where did the effect come from?
So in our first intervention arm, the patient got BlueStar® and the doctor got nothing. If the patient wanted to print their data off, they could have taken it into the office. In the second intervention arm, the patient got BlueStar® and the doctor just got the raw glucose logbook like they would get on the written piece of paper napkin. Then, of course, in the last intervention arm, the patients got BlueStar® and the doctor got that full analyzed report that told them, against clinical-based guidelines, what they should do with the patient, every three months. No surprises, it was the last group that had the biggest outcome. So in many ways, the clinical trial design follows exactly what you would do if you’re doing a clinical trial on a new drug or a new biologic, or a new vaccine…
For more of our discussion, you can watch the whole Fireside Chat with Anand Iyer, or listen to the podcast version, below.
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