The key to thriving in this age of data appears to be learning to make the best use of all that information. What if really understanding how you slept could unlock new secrets around your blood glucose fluctuations and insulin needs?

Tidepool and Evidation Health are teaming up in an observational pilot study that hopes to help those with T1D do just that. The just-launched study, which is called the T1D Sleep Pilot, is currently gathering participants. It will use data collected overnight from patients’ diabetes tech along with sleep and activity trackers on smartphones and other sensors to explore linkages between nocturnal hypoglycemia, next-day behavior, sleep patterns, and heart rates.  

The intention is to complete a better portrait for type 1 patients of what happens with their diabetes overnight, how that correlates to their life the next day, and to gather ongoing research around how daily behavioral habits, sleep, and diabetes complications interact.

“People with diabetes can use their individual data to play a key role in improving health,” said Tidepool Founder and CEO Howard Look in a press release. “Our study with Evidation gives people with diabetes a new way to share their data with researchers, and contribute to a better understanding of dangerous low-blood sugar levels, which can often occur more frequently while sleeping.”

Tidepool is the open-source, not-for-profit company whose mission is making diabetes data more accessible and actionable for patients, their care teams, and researchers. The company identifies as data-agnostic, meaning it does not restrict itself to particular technology types or brands. What does that philosophy, and this sleep pilot, mean for those with type 1? It’s creating a whole new way of doing studies, claims the company.

That’s a bold statement.

Deborah Kilpatrick is CEO of Evidation Health, and she backs it.

“It’s a big claim,” she says. “And I think we stand up to it in a few ways. We're really passionate about bringing every day data into the clinical research equation, and we’re equally passionate in bringing clinical research ecosystems right to the patient.”

According to Kilpatrick and Look, that’s what this study seeks to do. Using the latest connected devices — including the Dexcom continuous glucose monitor, an Emfit sleep monitor, and a WHOOP activity tracker — researchers will gain access data about overnight low blood sugar events that has never previously been available.

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That approach presents a more egalitarian and opportunistic way of doing clinical research, reaching beyond the traditional confines of brick and mortar walls, and set geographical study locations, the organizers say.

 

A Clinical Study That Gives Patients Control

“When we can virtualize something, we do,” said Kilpatrick about Evidation’s mission. “We’re not asking the patient to go inside a clinic if they're unable to or if the protocol doesn't call for it. That doesn't mean, that they don't have interaction with caregivers because that too can be achieved in virtual medicine through data sharing and follow-ups.”

Under the pilot study, patients will retain control and ownership of all gathered data.

“The only way this works is by giving patients control,” Kilpatrick says.

Evidation seeks to analyze and process large-scale sensor and behavior data in clinically meaningful ways. Tidepool, by teaming with Evidation, becomes the latest in a list of more than 100 data sources that are currently linked to Evidation’s platform, including Apple Health, Blue Button, Dexcom, Epic and Fitbit. According to Evidation, there are currently more than 2 million individuals interfacing with that platform via the company’s Achievement app, which pays people for doing health-related things like tracking steps, sleep, and meals.

“The definition of ‘meaningful’ here is clinically meaningful,” says Kilpatrick. “The data users are tracking and sharing and that we’re compiling has to be meaningful to their care. It's the heart of why we do clinical research. To better care. In this case we're using direct data owned by patients and working with Tidepool to turn it into meaningful, actionable care for both caregivers the patient.”

Evidation and Tidepool are hoping, that by lowering the friction and the barriers to participation in clinical study, a more diverse pool of participants can be created. “That’s how we reduce the gap between clinical trial data and the real-world effectiveness of devices,” says Kilpatrick.

 

How to Enroll in the Study

The pilot is potentially open to anyone with type 1 diabetes, though a screening process to determine eligibility is in place. Those who wish to participate can visit a pre-screening website here. The site links into Evidation’s Achievement health app and acts as a homepage for the T1D Sleep pilot. Once there, one enters his or her email address to begin the eligibility screening process, answering a series of questions on age, sex, ethnicity, race, whether you currently live in the United States, and have access to a laptop or iPhone. After that questions about a patient’s type 1 and current tech and treatment start. Potential users answer questions until they are either alerted they are or are ineligible for the pilot study.

So what actually makes one eligible?

While Evidation didn’t reveal all the criteria for inclusion when contacted, it did say that those age 25 years or older who reside in the U.S.; are diagnosed with type 1 diabetes; currently use CGM, BGM, and insulin pump systems supported by Tidepool; are willing to share the connected device data for the study; are willing to use an activity tracker and sleep monitor for the study; and are willing to take vigilance tests by mobile phone at specific time periods during the study are being included at high levels.

After enrollment, all participants go through an informed consent process to share study data, complete study activities, and be contacted by study personnel as needed. Any individual can "opt out" anytime by simply withdrawing from the study.

The enrollment stage is currently underway.

In addition to volunteer enrollment, recruitment is also being targeted to both Tidepool members and Achievement members who meet certain criteria and have eligible device integrations: CGMs, BGMs, insulin pumps.

 

Sleep Matters, People!

Adam Brown, a senior editor at diaTribe and the author of Bright Spots & Landmines: The Diabetes Guide I Wish Someone Had Handed Me, is among the many who are optimistic about this T1D Sleep Pilot.

“I love remote online studies like this,” he says. “I feel like lack of sleep is the ultimate diabetes landmine because it affects every single aspect of diabetes. It affects things in a very direct way and also in an indirect way. That's pretty powerful. If you get less than seven hours of sleep per night, you're more insulin-resistant. At least for me, I have higher blood sugar the next day without fail with less sleep. Lack of sleep impacts hunger hormones in a really profound way, too, so you're hungrier when you don't get enough sleep. And you crave more sugar. I mean, those are all of the worst possible directions for someone with type 1.”

Brown has watched for years as few around him have talked about the role of sleep in managing and treating type 1 diabetes.  Many were surprised when he included getting a good night’s rest as one of the “four pillars of diabetes health” in his book.

“You don't hear sleep talked about,” he says. “I think, in a way, because it's not that sexy, you know? It's not like a new technology. It's not a fancy new insulin.”

He thinks the implications of this study could be massive just by increasing awareness around sleep. “Just just quantifying how poorly people with type 1 diabetes are sleeping is huge.”

 

Results We Can Act On

So what are the companies going to do with the data gathered?

The challenge and the hope, says Kilpatrick, is making data something that is actually informative. “We want to turn data into information that’s useable,” she said.

Brown, too, believes that what gives this study such importance is the focus on making things actionable.  

“Sleep is so hard for people to understand and control. When they can see what’s happening that might change. The biggest way to make a difference is to give people actionable data,” he says.

In addition to improving individual care and quality of life, Tidepol and Evidation are hopeful that the study will give researchers access to before-unseen levels of data on how sleep and type 1 diabetes correlate and interact. Compared to other lifestyle elements, the clinical research on the link between the two is thin, according to Brown.

“I think it's important to just give people some simple correlation through studies like this,” he says. “Like, when you sleep less than seven hours, your blood sugar is 20 percent higher the next day. Or, when you sleep less than seven hours, you need 30 percent more insulin. Things like that that are actionable. At the end of the day, the goal is to show people their own data so they realize, wow, sleep really matters and I should probably get more of it.”