# Digital Biomarkers of Ulcerative Colitis Flare

> **NIH NIH K23** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2021 · $162,118

## Abstract

This project will evaluate longitudinally collected physiological metrics, with a focus on autonomic nervous
system function (heart rate variability [HRV]), using wearable devices. It will investigate the ability of these
physiological metrics to identify and predict symptomatic ulcerative colitis (UC) flares. It will explore the
modifiability of these metrics through a HRV directed biofeedback intervention and its impact on UC symptoms.
Candidate: The primary objective of this application is to support the development of Dr. Robert Hirten into an
independent patient-oriented researcher in the field of digital health and inflammatory bowel disease (IBD)
research. Dr. Hirten’s career goal is to be an independent researcher and leader in leveraging the dense
physiological data acquired through novel wearable technologies in IBD research. Dr. Hirten’s proposed training
activities are in five areas: (1) Advanced statistical methodology, (2) Digital health, (3) Clinical trial design, (4)
Behavioral intervention science, (5) Career development. To achieve these goals Dr. Hirten has assembled a
mentorship team led by Dr. Bruce Sands, Chief of Gastroenterology at The Mount Sinai Hospital who has
expertise in longitudinal and clinical trial research in IBD. Environment: The Icahn School of Medicine at Mount
Sinai has a strong tradition of research and is a top 20 medical school in NIH funding. The Mount Sinai Division
of Gastroenterology is a top 10 division in the country by US News and World Report and is a leader in IBD
research and clinical care. The Hasso Plattner Institute for Digital Health at Mount Sinai is an international
institute with expertise in data science, biomedical and digital engineering. Research: UC is a chronic
inflammatory disease affecting the colon with symptomatic flares characterized by diarrhea, blood per rectum
and abdominal pain. Flares are frequent, occurring in at least 30% of patients per year, and are associated with
morbidity and impaired quality of life. Current methods to identify and predict flare are suboptimal and limited. If
flares can be identified earlier and predicted strategies for mitigation or prevent could be instituted. Advances in
digital and wearable technology allow for collection of continuous, non-invasive physiological parameters
potentially linked with disease activity. Therefore, our specific aims are to (1) To determine the association of
physiological metrics, including HRV, with symptomatic flare in UC, (2) To assess the predictive ability of
physiological metrics, with a focus on HRV, for the development of symptomatic flare in UC, (3) Determine the
feasibility, acceptability, and effect size of a HRV biofeedback intervention in subjects with symptomatic UC. To
accomplish this we will perform a longitudinal cohort study enrolling 160 subjects with UC in remission and follow
them for 12 months or until flare, collecting physiological indices from a wearable device (Apple Watch) and
survey metric...

## Key facts

- **NIH application ID:** 10283677
- **Project number:** 1K23DK129835-01
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Robert Hirten
- **Activity code:** K23 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $162,118
- **Award type:** 1
- **Project period:** 2021-09-01 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10283677

## Citation

> US National Institutes of Health, RePORTER application 10283677, Digital Biomarkers of Ulcerative Colitis Flare (1K23DK129835-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10283677. Licensed CC0.

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