Evidation Health is teaming up with Tidepool to launch a connected device-powered study of nocturnal hypoglycemic events in people with Type 1 diabetes.
The research is novel in that connected devices — including Dexcom continuous glucose monitors, an Emfit sleep monitor, and a WHOOP activity tracker — will allow researchers to access data about overnight low blood sugar events that previously hasn't been available. Participants will be recruited online through Evidation's Achievement platform, and they'll also complete daily brain games, adding another source of data.
"We’re curious about measuring or observing nocturnal hypoglycemia, and then taking a look at how these events that might happen overnight effect next-day behavior, sleep patterns, heart rates — just understanding some of the symptoms that appear in these different disease or therapy areas and the impact of these events on their quality of life daily," Christine Lemke, president and cofounder of Evidation Health, told MobiHealthNews. "The hypothesis is if people are having these at night, they’re having a miserable next day and perhaps even a miserable couple of days, and it’s just helpful to be able to objectively measure that rather than to have patients walk into their doctor and anecdotally saying that. This is one of those things that’s really difficult to measure unless you’re looking at things on an every day continual basis."
Tidepool's role in the partnership is to collect the data from the patient's CGM and send it to Evidation. The non-profit's mission is to make CGM, insulin pump, and glucometer data interoperable so people with diabetes can see all their data in one app.
"They’ve done all the hard work of integrating with all the different CGMs in order to put the data that’s typically been closed on those devices into the patients’ hands," Lemke said. "Now all the devices are starting to make shifts toward sharing the data back to individuals, but Tidepool really [put] it together and then put that data back into patients’ hands. We’re just really philosophically aligned from that perspective. And they’ve done it in a rigorous way. They’ve built these connectors. They’ve shown the FDA what they’re doing to make sure the data that comes out of their connectors is rigorous and valid and accurate, and so we’ve been impressed with them on a number of levels."
Tidepool is one of the nine companies participating in the FDA's Pre-Cert Program and has been transparent about the efforts.
Lemke said the study will yield information about both the impact nocturnal effects have on daytime behavior and vice-versa. Hopefully the information will be useful to treating physicians and empowering to patients. It's a short observation study, so Evidation expects to have data to work with in Q4.
"We’re excited about this because our platform and our partnerships allow us to ask really different questions about human health," Lemke said. "And this is one example of being able to ask really interesting questions about human health that haven’t really been measured or seen before."