{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T15:51:05Z","timestamp":1793029865731,"version":"4.5.0"},"reference-count":32,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T00:00:00Z","timestamp":1782777600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"Perfood GmbH"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Cephalalgia"],"published-print":{"date-parts":[[2026,7]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Low-glycaemic diet may alleviate migraine; however, individual blood glucose variability can affect efficacy. In this open-label randomised controlled trial in Germany, we assessed whether the digital therapeutic (DTx) sinCephalea, which delivers personalised low-glycaemic nutritional recommendations supported by intermittent continuous glucose monitoring (CGM), reduces migraine frequency compared with a design-matched control application.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This open-label trial in Germany assessed the DTx sinCephalea for migraine prevention. Adults aged 18\u201365 years with episodic migraine were randomised 1:1 (in addition to standard treatment) to the digital therapeutic (intervention) or a design-matched control application. Patients completed a daily headache and medication diary, and 4-weekly patient-reported outcome questionnaires. Adherence to nutritional recommendations was monitored. Primary endpoint (Week 12): change from baseline in monthly migraine days (every 4 weeks) for intervention versus control. Secondary endpoints: change from baseline in monthly migraine days in patients with \u226550% adherence to nutritional recommendations, 30% response rates, migraine- and headache-related impairment, quality-of-life, and acute medication use for intervention versus control. Adverse events were recorded.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>842 patients were randomised between July 2021 and August 2023 (full analysis set: intervention\u2009=\u2009416; control\u2009=\u2009419). There were significantly greater reductions in monthly migraine days at week 12 for intervention versus control (mean [SD] change: 1.7 [3.4] versus 1.2 [3.2] days; between-group difference estimate: \u22120.53 [95% CI \u22120.98 to \u22120.09]; p\u2009=\u20090.0195) with similar monthly migraine days reductions observed in adherent patients (p\u2009=\u20090.0062; adjusted \u03b1\u2009=\u20090.05). Response rate was 54.9% (185\/337) in intervention versus 42.9% (168\/392) in control (odds ratio: 1.63 [95% CI 1.21\u20132.19]; p\u2009=\u20090.0012; adjusted \u03b1\u2009=\u20090.0125). Migraine- and headache-related impairment were lower at week 12 for intervention versus control (p\u2009=\u20090.0247, adjusted \u03b1\u2009=\u20090.0167and p\u2009=\u20090.0001, adjusted \u03b1\u2009=\u20090.01, respectively). There was no significant difference in quality-of-life or acute medication use and no digital therapeutic-related adverse events.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Personalised nutrition, supported by intermittent CGM, via the DTx sinCephalea, was efficacious for migraine prevention without DTx-related adverse events. This study provides evidence in support of the link between diet and migraine frequency and symptoms. Additionally, as this is a non-pharmacological treatment with no DTx-related side effects, it may be an attractive option for patients. DTx could also reduce the burden of migraine on healthcare systems by providing a scalable, remote, non-invasive and convenient treatment option.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/03331024261459744","type":"journal-article","created":{"date-parts":[[2026,6,30]],"date-time":"2026-06-30T13:51:53Z","timestamp":1782827513000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Efficacy of digital therapeutic sinCephalea for personalised nutrition versus control for migraine prevention: A 12-week open-label randomised clinical trial"],"prefix":"10.1177","volume":"46","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4460-3244","authenticated-orcid":false,"given":"Stefan","family":"Evers","sequence":"first","affiliation":[{"name":"Medical Faculty of the University of M\u00fcnster, M\u00fcnster, Germany"},{"name":"Department of Neurology, Lindenbrunn Hospital, Coppenbr\u00fcgge, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3179-7895","authenticated-orcid":false,"given":"Hanna C.B.","family":"Grube","sequence":"additional","affiliation":[{"name":"University of L\u00fcbeck, University Medical Centre Schleswig-Holstein"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9884-3158","authenticated-orcid":false,"given":"Astrid","family":"Gendolla","sequence":"additional","affiliation":[{"name":"Practice for Neurology and Pain Therapy, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9362-3711","authenticated-orcid":false,"given":"Charly","family":"Gaul","sequence":"additional","affiliation":[{"name":"Headache Centre Frankfurt, Frankfurt am Main, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-3735-4952","authenticated-orcid":false,"given":"Kristian","family":"Ewald","sequence":"additional","affiliation":[{"name":"Perfood GmbH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-8665-9137","authenticated-orcid":false,"given":"Oliver","family":"Witt","sequence":"additional","affiliation":[{"name":"Perfood GmbH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9120-2203","authenticated-orcid":false,"given":"Jenny","family":"Voggel","sequence":"additional","affiliation":[{"name":"Perfood GmbH"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-9182-9165","authenticated-orcid":false,"given":"Matthias","family":"Nitschke","sequence":"additional","affiliation":[{"name":"University of L\u00fcbeck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7640-1220","authenticated-orcid":false,"given":"Christian","family":"Sina","sequence":"additional","affiliation":[{"name":"Institute for Nutritional Medicine, University Medical Centre Schleswig-Holstein, Campus L\u00fcbeck & University of L\u00fcbeck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8513-550X","authenticated-orcid":false,"given":"Diamant","family":"Tha\u00e7i","sequence":"additional","affiliation":[{"name":"Institute and Comprehensive Centre for Inflammation Medicine, University of L\u00fcbeck"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0504-6465","authenticated-orcid":false,"given":"Inke R.","family":"K\u00f6nig","sequence":"additional","affiliation":[{"name":"University of L\u00fcbeck, University Medical Centre Schleswig-Holstein"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4897-1481","authenticated-orcid":false,"given":"Torsten","family":"Schr\u00f6der","sequence":"additional","affiliation":[{"name":"Perfood GmbH"},{"name":"Institute for Nutritional Medicine, University Medical Centre Schleswig-Holstein, Campus L\u00fcbeck & University of L\u00fcbeck"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,6,30]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.3390\/nu14142927"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1007\/s13410-022-01111-1"},{"key":"e_1_3_3_4_2","first-page":"954","article-title":"Global, regional, and national burden of migraine and tension-type headache, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016","volume":"17","author":"GBD 2016 Headache Collaborators","unstructured":"GBD 2016 Headache Collaborators. 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