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However, incorporating consumer wearables into clinical studies is not as straightforward as simply purchasing devices and providing them to participants. It requires engaging with a complex engineering ecosystem with multiple investigator decisions on device selection, associated data management practices, and patient\/participant engagement and technical support. This tutorial, based on experience running large clinical trials using consumer wearables, outlines the wearables market landscape across varying form factors and manufacturers as well as the data management software products supporting wearable use. It delineates the major decision processes involved in designing studies that incorporate wearables and presents a structured framework to guide the selection of devices and supporting data tools according to study objectives.<\/jats:p>","DOI":"10.1111\/cts.70693","type":"journal-article","created":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T05:00:43Z","timestamp":1785906043000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Device and Data Access Considerations for Digital Health Studies Using Consumer\u2010Grade Wearables: An Experience\u2010Based Tutorial"],"prefix":"10.1111","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0009-0004-4583-8162","authenticated-orcid":false,"given":"Mike","family":"Zhu","sequence":"first","affiliation":[{"name":"Department of Molecular Pharmacology and Experimental Therapeutics Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joshua D.","family":"Spencer","sequence":"additional","affiliation":[{"name":"Digital Technology Organization, Information Technology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sherry","family":"Chesak","sequence":"additional","affiliation":[{"name":"Department of Nursing Mayo Clinic  Rochester Minnesota USA"},{"name":"School of Nursing University of Minnesota  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Magdalena","family":"Romanowicz","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8848-4385","authenticated-orcid":false,"given":"Mohit","family":"Chauhan","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychology Mayo Clinic  Jacksonville Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liselotte N.","family":"Dyrbye","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Colorado School of Medicine  Denver Colorado USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul E.","family":"Croarkin","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Psychology Mayo Clinic  Rochester Minnesota USA"},{"name":"Mayo Clinic Children's Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William V.","family":"Bobo","sequence":"additional","affiliation":[{"name":"Department of Behavioral Sciences and Social Medicine Florida State University  Tallahassee Florida USA"},{"name":"Center for Medicine and Public Health Policy and Practice Florida State University  Tallahassee Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9764-1768","authenticated-orcid":false,"given":"Arjun P.","family":"Athreya","sequence":"additional","affiliation":[{"name":"Department of Molecular Pharmacology and Experimental Therapeutics Mayo Clinic  Rochester Minnesota USA"},{"name":"Department of Psychiatry and Psychology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,4]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.2196\/63879"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1017\/cts.2023.706"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-024-01030-x"},{"key":"e_1_2_9_5_1","unstructured":"Administration U.F.a.D \u201cDigital Health Technologies (DHTs) for Drug Development \u201d(2026)."},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.2217\/pme-2018-0044"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41746-025-02238-1"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40279-024-02077-2"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.3390\/s24020635"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.119.044126"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.2196\/52444"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0251975"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1038\/s44325-025-00082-6"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1145\/3131892"},{"key":"e_1_2_9_15_1","volume-title":"Garmin Vivosmart 5. 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