Getting started — Part 13: Wearables for Sleep, Stress, Heart Rate and more

Background

If you're interested in collecting real-world data (RWD) from wearables, Trialflare has integrations with Garmin devices through our Garmin Partnership. With the partnership, you're able to collect ongoing metrics on sleep, stress, heart rate, respiration, activity, calories and more.

How Trialflare handles this is a little different to traditional forms and stages. Since wearables will be constantly transmitting data to the cloud, these will be fed to Trialflare sporadically as and when they are being pushed over the cloud.

Enabling the Garmin Integration (admin-led)

Under the Settings tab, click on Integrations and check the Garmin tickbox. What happens next? When participants log in to the Trialflare app (whether this is on web or smartphone), there will be an option to login to Garmin Connect. Participants will need:

  • An existing Garmin device (some study organisers can provision these, and Trialflare is able to potentially broker discounts on bulk-purchases if required).
  • A Garmin Connect account (tied to them, for example, through a personal email address). Garmin Connect accounts are free to create.

Reminding participants to connect

Participants don't always connect their account straight away. Tick Send Garmin reminders to participants, underneath the Garmin settings, and anyone who hasn't connected yet will receive a message and push notification each morning and afternoon — around 10am and 4pm in their own timezone — until they do.

Connection reminders only go to participants who are using the app: someone who has never logged in, or who hasn't opened the app in the last two weeks, isn't chased.

The same setting also looks after participants who have connected. If no Garmin data has arrived from a participant for two days — usually because the watch is flat, not being worn, or has lost its connection to the Garmin Connect app on their phone — they receive a message and push notification once a day, around 4pm in their own timezone, asking them to make sure their device is charged, that they are wearing it, and that it can connect to Garmin Connect. These continue until their data starts arriving again, for up to two weeks: after a fortnight without data the reminders stop, and it is over to the study team. Someone who has only just connected is given two days for their first data to come through before they are reminded, and no sync reminders are sent while the study database is locked, since Trialflare doesn't accept Garmin data then.

Neither kind of reminder goes to anyone who has completed the study or who has been withdrawn or archived. If you've restricted the Garmin integration to selected groups, only participants in those groups are reminded.

To help you keep on top of it, whether or not reminders are switched on, any participant whose Garmin hasn't sent data for two days or more is marked with a small orange dot on their Garmin Connect logo in the Participants tab (hover over it to see how long; a green dot there instead means data arrived in the last 12 hours), and is listed, with how long it has been, in the daily and weekly trial updates you can subscribe to under Settings. These keep listing them for as long as the data is missing. Participants who have completed the study, been withdrawn or archived aren't included, and nothing is flagged while the study database is locked.

Synchronising Garmin wearables (participants-led)

Once your Garmin integration is enabled in the study settings, your participants will see an option when they login to connect a Garmin Connect account. The account needs to be tied to a device already. If participants are using their smart watch already, they will have already done this. To connect, the participant will need to click on the Connect button on the Trialflare web or smartphone app.

Once the participant has logged into their Garmin Connect account, they will be asked to agree to link this to Trialflare to collect data.

If the participant wishes to disconnect their account, they can also do this in the Trialflare app.

Accessing wearables data on Trialflare

You'll want to confirm that your participants have connected their Garmin Connect account and are therefore able to send data to your study. Trialflare can show you this in the Participants tab where the blue box indicates that a Garmin account is connected. When you click into the Participant record you can see when this happened, too. All Garmin connections and disconnections are audit logged and can also be seen in the participant's Information tab.

When you're in the participant's records, you can then click on the Wearables Responses tab. As data comes in, you'll see this compiled into tabs.

Important: Depending on the hardware / device, there will be limitations on what can be collected.

Full capabilities (as detailed by Garmin) include:

  • Steps
  • Intensity minutes
  • Sleep
  • Calories
  • Heart rate
  • Stress
  • Pulse Ox
  • Body battery
  • Body composition
  • Respiration
  • Blood pressure
  • Enhanced beat-to-beat interval
  • Running data
  • Cycling data
  • Swimming data
  • Yoga data
  • Strength training data
  • Activity details