Dr. David Rubin Discusses Initial Results of Takeda-Sponsored and Litmus-Powered Research at DDW
Last week at the 2019 Digestive Disease Week meeting, Dr. David Rubin, leading expert on inflammatory bowel disease and Professor of Medicine at the University of Chicago, discussed the results of a multi-year trial focused on the use of wearables and real-life data to better understand how factors like sleep and activity affect IBD.
Two years after announcing a research partnership with Takeda Pharmaceuticals powered by Litmus Health, the early results are in.
Dr. Rubin’s study found that passive biosensor monitoring can be used to predict elevated biomarkers indicative of inflammation in IBD, effectively tracking flares as they relate to everyday activities like patient activity and heart rate.
These new results have the potential to inform disease monitoring and management strategies, granting patients a deeper understanding over their illness.
You can read the abstract in full here.
Dr. Rubin’s medical student, Philip Sossenheimer, presented the group’s work in greater detail as an oral presentation titled “Wearable Devices Can Predict Disease Activity in Inflammatory Bowel Disease.” You can also read this article about the presentation in Healio.
“Disease activity in IBD is negatively correlated with physical activity, positively correlated with resting heart rate and not clearly correlated in sleep quality,” Sossenheimer explained. “It is possible to predict disease activity in IBD moderately well using data from biosensors and basic clinical characteristics alone.”
For the study, Dr. Rubin and his team turned to Litmus to help them collect real-world data.
Driven by our belief that data collected at the point of experience can enable clinicians to better understand patients’ behavior and environment, we were engaged partners and research collaborators from the start. We’ve seen how the insights derived from these novel data help us understand quality of life and discover new correlations and digital biomarkers related to their chronic disease. Knowing the particular challenges of IBD, we wanted to leverage our platform to bring more clarity to a disease known for its unpredictability.
“IBD is both a very personal and a very demanding disease to live with, making it the perfect candidate to benefit from these rich new data we are constantly collecting through wearables and other devices,” said Dr. Samuel Volchenboum, practicing physician and CMO of Litmus Health. “As with other chronic diseases, we are just beginning to understand the influence of the day-to-day activities on the disease, and how we can better manage quality of life. Designing research around data collected at the point of experience has allowed Dr. Rubin to uncover new insights with significant implications for the management of a disease that affects over a million people. We were honored to be able to partner with Dr. Rubin to advance IBD research.”
Elsewhere in industry, patient-reported outcomes are usually collected through surveys that require a high degree of compliance and recall from patients. Data collected at the point of experience from Fitbits and other wearables like Actigraphs transforms our ability to track patient outcomes throughout the trial. The ability to align these data with traditional endpoints and creates a holistic, longitudinal representation of the patient’s course.
The study run by Dr. Rubin at the University of Chicago, funded by Takeda, and powered by Litmus has enrolled 292 patients to-date, and plans to enroll up to 500 overall. Over the course of the study, the trial has recorded 24,262,425 steps, 9,747,017 sleep minutes, and 36,849 survey events.
“There’s never been a study like this in IBD, where we collect this much data in real time, continuously,” Rubin said of the trial when it first started. “It would be great if we could get ahead of the curve, because with chronic diseases like Crohn’s disease and ulcerative colitis, if we can predict if someone is going to have a problem, we have the opportunity to intervene to prevent it.”
Dr. Rubin’s team is now developing models capable of predicting flares in IBD based on heart rate, sleep, and physical activity.
With early prediction, it is possible that an intervention could be designed and tested that would allow patients to modify their habits or begin therapy in order to manage and reduce flares and allow physicians to more accurately personalize their care.
“The reality of a chronic disease like IBD is that it doesn’t just exist when you go to the doctor. It is something that both impacts and is affected by your everyday activities, and understanding that dynamic is the key to an improved system of care,” said Rubin. “At the end of the day, it’s about quality of life. It’s about managing the day-to-day of chronic disease so that there can be more prevention and prediction, as well as better care.”
In addition to the abstract presented at DDW, the partnership has resulted in eight other published research papers, abstracts, and posters. Each discusses the role of wearables in monitoring and measuring patient quality of life as influenced by IBD.
The full list is as follows:
- Andersen MJ, Lei D, Golan MA, Yvellez O, Rodriquez R, Zmeter N, Rubin DT. Simplified daily assessments of sleep quality, pain and quality of life in IBD patients correlate with validated measures. (Poster Presentation). Advances in IBD 2017, Orlando, Florida.
- Yvellez O, Andersen MJ, Golan MA, Rodriquez R, Zmeter N, El Jurdi K, Rubin DT. IBD patient compliance with mobile technologies used for monitoring sleep quality, pain and quality of life. (Poster Presentation). Crohn’s & Colitis Congress 2018, Las Vegas, Nevada.
- Sofia MA, Yvellez O, Zmeter N, El Jurdi K, Ollech J, Andersen MJ, Golan MA, Rodriquez R, Rubin DT. Sleep fragmentation measured by wearable device is an indicator of clinical disease activity in inflammatory bowel disease. (Poster Presentation). DDW 2018, Washington, DC.
- Ollech J, Yvellez O, Zmeter N, El Jurdi K, Andersen MJ, Golan MA, Rodriquez R, Rubin DT. Assessment of continuous heart rate monitoring using wearable devices as an instrument to predict disease activity. (Poster Presentation). GUILD 2018, Maui, Hawaii.
- Andersen MJ, Yvellez O, El Jurdi K, Lei D, Pearl T, Zmeter N, Rubin DT. Simplification of Validated Patient-Reported Outcome Instruments in Inflammatory Bowel Disease. (Poster Presentation). ACG 2018, Philadelphia, Pennsylvania.
- Yvellez O, Sossenheimer PH, Andersen MJ, El Jurdi K, Mayampurath A, Rubin DT. Using Wearable Health Devices to Assess Pain in Inflammatory Bowel Disease. (Poster Presentation). ECCO 2019, Copenhagen, Denmark
- Sossenheimer PH, Yvellez O, Andersen MJ, Pearl T, El Jurdi K, Rubin D, Mayampurath A, Rubin DT. Using Wearable Health Devices to Predict Disease Activity in Inflammatory Bowel Disease. (Poster Presentation). ECCO 2019, Copenhagen, Denmark
- Sossenheimer PH, Yvellez O, Andersen MJ, Pearl T, El Jurdi K, Rubin D, Mayampurath A, Rubin DT. Wearable Devices Can Predict Disease Activity in Inflammatory Bowel Disease Patients. (Oral Presentation). DDW 2019, San Jose, California
- Sossenheimer PH, Yvellez O, Mayampurath A, Volchenboum S, Rubin DT. A structured approach to working with wearable health data: lessons learned from the University of Chicago IBD biosensor study.(Abstract Submitted). AMIA Annual Symposium 2019, Washington, D.C.