Evidence map›Paper›PMID 39826619›Full record

Observational studyGastroenterology2025

Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares.

Robert P Hirten, Matteo Danieletto, Milagros Sanchez-Mayor, Jessica K Whang, Kyung Won Lee, Kyle Landell, Micol Zweig, Drew Helmus, Thomas J Fuchs, Zahi A Fayad and 4 more

2 registry-linked trialsAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Gastroenterology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 32 papers.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07159776 not yet recruitingnot on this map

Multiple Digital Biomarkers for Optimization of IBD Care

TypeobservationalSponsorImelda GI Clinical Research CenterRan2025 to 2026Enrolled80ConditionsCrohn Disease (CD), Ulcerative Colitis (UC), Inflammatory Bowel Disease (IBD)Armsmonitoring of wearable data, shopping data, biomarkers and patient reported outcomes
NCT07647640 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study

TypeobservationalSponsorMaastricht University Medical CenterRan2026 to 2027Enrolled600ConditionsInflammatory Bowel Disease (IBD), Ulcerative Colitis (UC), Crohn Disease (CD)ArmsWearing their own wearable device.
3 · Its place in the literature

Who cites it

32 citing papers in PubMed.

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  18. Smart Ring in Clinical Medicine: A Systematic Review.Biomimetics (Basel, Switzerland) · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Robert P HirtenThe Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York; The Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York; Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: robert.hirten@mountsinai.org.
Matteo DanielettoThe Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York; Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Milagros Sanchez-MayorDepartment of Population Health Science and Policy, Center for Biostatistics, Icahn School of Medicine at Mount Sinai, New York, New York.
Jessica K WhangThe Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Kyung Won LeeDepartment of Population Health Science and Policy, Center for Biostatistics, Icahn School of Medicine at Mount Sinai, New York, New York.
Kyle LandellThe Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York; Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Micol ZweigThe Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York; Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Drew HelmusThe Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Thomas J FuchsThe Hasso Plattner Institute for Digital Health at Mount Sinai, Icahn School of Medicine at Mount Sinai, New York, New York; Windreich Department of Artificial Intelligence and Human Health, Icahn School of Medicine at Mount Sinai, New York, New York.
Zahi A FayadBiomedical Engineering and Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Girish N NadkarniDivision of Data-Driven and Digital Medicine, Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York; The Charles Bronfman Department of Personalized Medicine, Icahn School of Medicine at Mount Sinai, New York, New York.
Laurie KeeferThe Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Mayte Suarez-FarinasDepartment of Population Health Science and Policy, Center for Biostatistics, Icahn School of Medicine at Mount Sinai, New York, New York.
Bruce E SandsThe Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.

Funding

Digital Biomarkers of Ulcerative Colitis FlareK23DK129835 · NIDDK · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HIRTEN, ROBERT · 2021 to 2025
$812k
NIDDK NIH HHS K23 DK129835
6 · The paper itself

Abstract

BACKGROUND &

aimsWearable devices capture physiological signals noninvasively and passively. Many of these parameters have been linked to inflammatory bowel disease (IBD) activity. We evaluated the associative ability of several physiological metrics with IBD flares and how they change before the development of flare.

methodsParticipants throughout the United States answered daily disease activity surveys and wore an Apple Watch (Apple), Fitbit (Google), or Oura Ring (Oura Health). These devices collected longitudinal heart rate (HR), resting heart rate (RHR), heart rate variability (HRV), steps, and oxygenation. C-reactive protein, erythrocyte sedimentation rate, and fecal calprotectin were collected as standard of care. Linear mixed-effect models were implemented to analyze HR, RHR, steps, and oxygenation, and cosinor mixed-effect models were applied to HRV circadian features. Mixed-effect logistic regression was used to determine the predictive ability of physiological metrics.

resultsThree hundred and nine participants were enrolled across 36 states. Circadian patterns of HRV differed significantly between periods of inflammatory flare and remission and symptomatic flare and remission. Marginal means for HR and RHR were higher during periods of inflammatory flare and symptomatic flare. There were fewer daily steps during inflammatory flares. HRV, HR, and RHR differentiated whether participants with symptoms had inflammation. HRV, HR, RHR, steps, and oxygenation were significantly altered up to 7 weeks before inflammatory and symptomatic flares.

conclusionsLongitudinally collected physiological metrics from wearable devices can identify and change before IBD flares, suggesting their feasibility to monitor and predict IBD activity.

Indexed as

Inflammatory Bowel DiseasesSymptom Flare UpWearable Electronic DevicesAdultBiomarkersBlood SedimentationCircadian RhythmC-Reactive ProteinFecesFemaleHeart RateHumansLeukocyte L1 Antigen ComplexMaleMiddle AgedPredictive Value of TestsBiomarkersC-Reactive ProteinLeukocyte L1 Antigen ComplexCrohn’s DiseaseInflammatory Bowel DiseasePredictionUlcerative ColitisWearable Devices

Identifiers

PMID39826619
PMCPMC12206379

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.