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Using wearable devices to track daily health in primary biliary cholangitis

Studies wearable device data and symptom questionnaires in adults with primary biliary cholangitis.

Plain-language title generated from the registry record
Registry title: Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)

Key facts

Where
Redwood City, United StatesSee the site

Where in United States

  • Stanford University School of MedicineRedwood City, United StatesNo longer taking part

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Trial details

Who runs it
Stanford University
Trial code
NCT07631442
Record updated
11 June 2026
Original description
The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.Read full original descriptionShow less

Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology

The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.

Exclusion: Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results; Active malignancy requiring treatment.

Inclusion Criteria:; PBC diagnosis based on meeting 2 of 3 criteria:; Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT); Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40; Diagnostic or compatible liver biopsy; Ability to provide informed consent; Ability to complete digital questionnaires; Elevated alkaline phosphatase; Abbreviations:; alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100].

ClinicalTrials.gov NCT07631442