ACTIVATE: Physical Activity in Teens with Type 1 Diabetes

A Type 1 Diabetes Research Study

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Can you provide a bit of background to your study?

The primary project that we are working on with Labfront is using a two-arm RCT to test an intervention to increase physical activity in teens with type one diabetes. And so in that trial,  we're randomizing teens either to usual care, where they are just wearing a Garmin, or to the intervention program. The intervention program is an incentive-based behavioral training intervention where the teens receive incentives for increasing physical activity with the goal of trying to get to at least five days a week with 30 minutes of physical activity. They also have a health coach who's assigned to them who walks them through the study and provides problem-solving support when needed. For example, they can do video or phone call check-ins. All teens get weekday text messages from their health coaches with updates on their progress towards their goals. And so the teens in the intervention are getting much more contact points in support along with financial incentives for meeting goals, whereas the teens in the control arm are just wearing their watches without any goals or recommendations specific to their needs.

What were the broader goals of this project?

Our broader goal of this project was really grounded in two things: one is that after middle adulthood, the primary causes of morbidity and mortality for people with type one diabetes shift from being more immediate health events related to severe hypo and hyperglycemic to cardiovascular and other diabetes-related vascular disease. Thus, we need more research focused not just on immediate management of glycemic events but also cardio-protective interventions for adolescents with type 1 diabetes. We hope our scalable physical activity program can be combined with other glucose-focused interventions for adolescents with type 1 diabetes to improve cardiovascular outcomes.  Given the importance of better supporting cardiovascular health, our second main goal of this pilot study is to understand if we can use a scalable, internet delivered approach to safely increase physical activity in teens with type one diabetes.

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We hope our scalable physical activity program can be combined with other glucose-focused interventions for adolescents with type 1 diabetes to improve cardiovascular outcomes.

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Did you run the entire study remotely?‍

Yes, since it's a nationally-scalable intervention program with participants all over the country, everything is remote. In some ways, our lab was lucky across COVID because we’ve almost always done things remotely for our scalable health behavior interventions. For this study, we ship a small assessment box to the participants with their Garmins and some other assessment tools for a virtual baseline assessment, and then they ship it back to us at the end.

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Why did you choose to include Garmin wearables in your study?‍

Our primary goal was to measure physical activity, a key target for our intervention program. We moved to the Garmin wearables when we selected the Labfront platform for this study.  In the past we have used other physical activity assessment tools; however, for projects with a smaller budget we were always using workarounds to get low-cost access to the data stream we wanted from the device (or we were using devices that were discontinued during the course of the study). The Garmin + Labfront combination gave us a way to test our program with devices that have considerable market share and might be used by our teens in everyday life as well as easy to access data at a reasonable cost.  

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Overall, it's been very smooth. With the Garmins and Labfront and getting everything connected, it's gone really well and that's including our remote setup process.

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Which physiological wearable metrics are you collecting from the Garmins?

In terms of the primary data points for the intervention, what we're interested in is minutes of moderate to vigorous physical activity each day, which uses the heart rate sensor. This is the target behavior in the intervention. We are also planning to explore differences in moderate versus vigorous physical activity and steps as they predict changes in glucose regulation and cardiovascular disease risk outcomes to help guide future intervention development. . There's some emerging data on vigorous physical activity and teens showing that exercising vigorously at least 20 minutes a day may be a critical bar to hit in terms of cardio and respiratory fitness and exploring how that marker of activity predicts outcomes in our sample might help guide recommendations for activity in teens with type 1 diabetes in the future.

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Labfront’s dashboard has also been helpful; it makes it easier to quickly send out a reminder to certain participants that morning to sync their apps or check in to see if they’ve met their goals.

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What other devices did you use in this study?

Though it wasn’t a necessity, almost every participant enrolled in this study is using continuous glucose monitors (CGMs) and insulin pumps. I estimate we'll have it for 80% to 90% of our participants. This data will allow us to overlay daily glucose regulation, insulin basals and boluses, and physical activity data for most participants in the study to give a deeper look at how these factors are all interrelated in teens with type 1 diabetes. 

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Did you face any difficulties using the devices? 

I think we run into the usual things with teens, where they don’t charge their devices, for example. We've also had some of our participants who felt like they weren't getting credit when they were being active. And so we helped them turn on specific activities like bike riding, etc. to make sure the sensors were adequately activated and picking up every movement.

Overall, it's been very smooth. With the Garmins and Labfront and getting everything connected, it's gone really well and that's including our remote setup process.

Having affordable platforms like Labfront in the academic research on digital health space is a game-changer.

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How has the experience been using Labfront?

Both myself and your research coordinator have been really happy with how it's worked out in accessing the systems. We access Labfront to download the data almost daily. We're on the platform a lot.

The dashboard has also been helpful; it makes it easier to quickly send out a reminder to certain participants that morning to sync their apps or check in to see if they’ve met their goals. 

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Is there anything you’d like to see Labfront support in the future?

I think for us, if there was something that would have made our lives a bit easier, it would be just knowing at a quick glance what the participants’ minutes of activity yesterday were. Or, for example, if I could see for some people how many steps a participant walked on the dashboard, just to get a quick sense of whether they are wearing the band or not. They might be syncing the app, but if they are showing less than 1500 steps a day, then they probably aren't wearing it. So having some visuals for high-level data results without having to download the data would be nice. 

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Thanks for the feedback, and we’re actually in the process of creating a data visualizer that reports out user-friendly aggregates of participant data, but that feature won’t be released until 2023.

Speaking of the future, what are the next steps for this pilot study?

We still have another 12 months or so of this pilot study. We're shortly going to launch what we're calling a baseline visit, where we're taking in our teens who are ineligible for the RCT due to having too high of physical activity levels. They’ll do just the baseline visit, and then wear the Garmin for a week, plus provide CGM and pump data.

We want to have a broader sample of teens in terms of variability and physical activity to help us understand not only if our intervention is helpful for the teens that are not the most physically active, but how are physical activity levels overall linked to key glucose and cardiovascular disease risk outcomes. So our end number of study participants will be a little higher.  Then we’ll use this data to support a larger grant application to test a revised version of the intervention program in a larger sample at more sites across the US.

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Looking forward to learning more about those results! Finally, how do you see platforms like ours supporting future research in this field?

Having affordable platforms like Labfront in the academic research on digital health space is a game-changer. I’ve worked with other digital tech companies in the past who have had similar goals (streamlining data from multiple devices onto a singular platform) but they’ll sometimes charge 30 to 40 thousand dollars to use their system for a research trial! That kind of price on NIH exploratory grants or small pilot grants is just simply not feasible. 

I think cost has definitely been a limiting factor in how quickly research in this space can grow from the academic side. Having a lower-cost way to collect backend sensor data in the digital health space, and also have it presented in a simpler format just makes a huge difference in our research flow and how productive we can be across time.   I also want to acknowledge our funding source for this study, the Vermont Center on Behavior and Health, an NIH COBRE Center.