Oura Goes Clinical, Measuring Health Outcomes, Actionable Intelligence
From Fierce Healthcare:
Oura is pushing further into clinical healthcare research with its first clinical trial to study the link between smart ring data and obesity treatment outcomes.
The company is collaborating with UC San Diego Health on the clinical trial, called SMART-BMI. The multi-year study will investigate whether continuous data from the Oura Ring, including sleep, heart rate and activity, are associated with outcomes for patients receiving GLP-1 medications or bariatric surgery, the organizations said.
Researchers want to determine whether changes in sleep, recovery, activity and other physiological signals provide useful information about how patients are responding to obesity treatment.
The Oura Ring data will capture changes between care visits, and researchers plan to examine associations with outcomes including weight loss, HbA1c and treatment persistence. The study is registered at ClinicalTrials.gov, NCT07736729.
The trial aims to answer two questions, from the study website:
Do people lose more weight when their care team uses the ring's information? Does using the ring's information improve health measures like blood sugar and blood pressure?…
This study addresses a specific gap in the evidence for consumer wearable devices in obesity care. Prior trials that supplied wearable devices without integrating the resulting data into clinical decision-making have generally not improved weight outcomes. This trial is therefore designed to test not the device in isolation, but whether care teams acting on continuous biometric data achieve better outcomes than standard care.
Thera are more than 200 research publications that used Oura Ring to study various diseases, but this is only Oura’s second clinical trial (first for obesity), after the freshly completed hypertension tracking one.
If the trials are successful, Oura will have FDA-clearance for two features (Apple Watch has five), which won’t make it a medical device but it will open the doors to pharma and medtech eventually using Oura Rings to measure secondary endpoints in clinical trials.
What I find particularly interesting is the outcome measuring part.
On one hand, the difficult question with outcomes is that it’s hard to find a universal and easy to quantify metric to measure against. How do you objectively measure how much your life improved after you got that knee replacement? Here Oura can measure not just one but multiple metrics simultaneously and what’s better - benchmark them with each individual’s personal history and not just some population average. This makes for quite a unique moat and fits perfectly with the development of ever more personalised therapies.
On the other hand, the focus of this trial is not just proving that the data is accurate or relevant; it’s about whether the data is actionable and measuring that effect. This is the same logic behind the newly introduced tele-DiGAs and I think it’s very sensible. At the end of the day treatment success, especially for chronic conditions, is predicated on human actions, and influencing those actions is how you influence treatment outcomes.
Clinical trials are the biggest cost factor for the development of new therapies, because of the clinical operations around recruiting the patients, administering the treatment and monitoring the outcomes, which is currently done in the hospital. Oura may not just serve as a better measuring stick, but help move the trial location where the patient already is - at home.