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.
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.
“Longitudinal and surgical management of obesity can unlock the power of continuous monitoring and precision medicine offered by wearables,” said Jeff Reeves, M.D., UC San Diego Health.
“UC San Diego Health is precisely where innovative technology and subject matter experts come together to advance human health,” said Alexander Khalessi, neurosurgeon and chief innovation officer at UC San Diego Health in a statement. “We are proud of the thought leadership of Dr. Reeves and Oura’s engagement to take on these important clinical questions for our patients.”
The smart ring maker and health tracking company has ambitions to build an artificial intelligence-powered clinical health platform. Founded in Finland in 2013, Oura's smart rings continuously track more than 50 health metrics, including heart rate, sleep, daily movement and activity, stress, fertility windows and metabolic health. The company was gearing up to go public, filing an initial public offering in late September with plans to raise $2.2 billion in a U.S. IPO by offering 50 million shares priced at $40 to $44 per share.
In October, the company announced it was postponing its IPO due to "uncertainty in the IPO market." The company said it was delaying its public listing "despite strong demand."
The multi-year obesity outcomes study is part of a broader clinical push being coordinated through Oura's Office of Regulatory and Clinical Affairs (ORCA), which was built over the past year under Chief Medical Officer Ricky Bloomfield, M.D. ORCA combines scientific and medical evidence, regulatory and quality work, outcomes research and clinical informatics.
"Since I started at Oura, my focus has been on formalizing the clinical rigor behind the trust people already place in their ring,” Bloomfield said. "As we take on a bigger role in healthcare with new use cases, partnerships, and levels of clinical evidence, that trust has to be earned at every step. We do that by ensuring the right measurement, the right validation, the right outcomes data at every layer. ORCA is how we hold ourselves to that standard, alongside the researchers and institutions we work with."
Oura Ring has been included in more than 200 peer-reviewed publications spanning sleep, cardiovascular health, women’s health, metabolic health, mental health, pregnancy, and other areas.
The company is pursuing other outcomes-focused studies to examine how continuous Oura data relates to health outcomes, healthcare utilization and cost of care. Oura is working with Maven Clinic on a study of fertility and pregnancy outcomes. The study will look at both Oura-only and Oura-plus-Maven experiences and is designed to enroll at least 5,000 participants. It's also working with Johns Hopkins School of Medicine to investigate whether wearable data can identify changes associated with rehospitalization and recurrent acute kidney injury following hospitalization.
The company recently completed a large-scale blood pressure study through Oura Labs to explore how Oura data could inform future regulated features related to blood pressure.
Separately, researchers at hospital systems and academic medical centers have independently used Oura Ring in more than 150 studies. Researchers at institutions including NYU Langone, Mount Sinai, Cornell Tech, Weill Cornell and the University of Central Florida are using Oura data to study areas such as depression, heart failure and inflammatory arthritis.
Health systems are also beginning to bring Oura data into care delivery. Mount Sinai Doctors–Concierge Care’s Healthspan Membership is integrating Oura Ring 5 data to give physicians a continuous view of biometric trends between visits.
“The real opportunity is to understand what’s happening between visits, how a patient is sleeping, recovering, moving and responding to changes in their daily life,” said Fiorina Kyritsi, M.D., of Mount Sinai Doctors–Concierge Care. “By bringing those insights into the care relationship, we can have a much more informed conversation with our members.”