A randomised clinical trial to evaluate a digital therapeutic (TH-001) for improving glycaemic control in adults with prediabetes

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dc.authorid0000-0003-3815-7444
dc.authorid0000-0002-3710-4706
dc.authorid0009-0003-0597-5173
dc.authorid0000-0001-7236-5613
dc.authorid0000-0002-3802-3270
dc.authorid0000-0001-6301-3309
dc.authorid0009-0000-4856-1999
dc.authorid0000-0002-4402-2231
dc.contributor.authorÇakmak, Ramazan
dc.contributor.authorTosun, İlker
dc.contributor.authorAvcu, Hasan
dc.contributor.authorBirer, Gürkan Caner
dc.contributor.authorAkgül, Özer
dc.contributor.authorSaini, Kamal S.
dc.contributor.authorCarnell, Jonathan
dc.contributor.authorKutlu, Orkide
dc.date.accessioned2025-09-26T11:30:57Z
dc.date.available2025-09-26T11:30:57Z
dc.date.issued2025
dc.departmentFakülteler, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü, Tıbbi Mikrobiyoloji Ana Bilim Dalı
dc.description.abstractBackground and Aims: Prediabetes, characterized by elevated blood glucose levels below diabetes diagnostic thresh olds, presents a significant global health challenge due to high prevalence and associated risks for developing type 2 dia betes. Traditional diabetes prevention programs (DPPs) often face challenges in scalability and accessibility, particularly in underserved communities. Digital therapeutics (DTx), like TH-001, offer potential scalable solutions requiring clinical val idation. This randomized, open-label, controlled, parallel-group clinical trial aimed to evaluate the efficacy and safety of TH-001, a digital therapeutic application, reducing hemoglobin A1c (HbA1c) among adults with prediabetes over a 90-day intervention period. Methods: 68 eligible adults were randomly assigned to either standard care alone or standard care plus the TH-001 intervention. Primary outcomes measured were glycaemic parameters including HbA1c, fasting glucose, 2-h post-load glucose from an oral glucose tolerance test, and insulin levels, while secondary outcomes included anthropometric mea sures. User engagement metrics were also assessed. Results: The intervention significantly reduced HbA1c levels (mean difference −0.22%, p = .023) and body weight (−2.53 kg, p < .001) compared to the control group. Although fasting glucose and insulin levels showed positive trends, differences were not statistically significant. User engagement was high, correlating strongly with HbA1c reduction (r = .95, p < .001), demonstrating the critical role of sustained interaction with TH-001. Conclusions: TH-001 demonstrates significant effectiveness in HbA1c reduction and body weight, with strong user engagement suggesting it may effectively overcome traditional barriers of DPPs. Long-term studies are needed to confirm sustained benefits.
dc.description.sponsorshipThe study is funded by Tesu Health. Tesu Health is the sole spon sor of the study. No external grants were utilized for this research. The digital therapeutic software application used in this study was provided by Tesu Health. Tesu Health reviewed the manuscript before submission, but the co-authors maintained the authority of final approval of the manuscript to submit for publication. Çalışma Tesu Health tarafından finanse edilmektedir. Tesu Health, çalışmanın tek sponsorudur. Bu araştırma için herhangi bir dış hibe kullanılmamıştır. Bu çalışmada kullanılan dijital terapötik yazılım uygulaması Tesu Health tarafından sağlanmıştır. Tesu Health, makaleyi göndermeden önce incelemiş, ancak ortak yazarlar makalenin yayına gönderilmesi için nihai onay yetkisini elinde tutmuştur.
dc.identifier.citationÇakmak, R., Tosun, İ., Avcu, H., Birer, G. C., Akgül, Ö., Saini, K. S., Carnell, J., & Kutlu, O. (2025). A randomised clinical trial to evaluate a digital therapeutic (TH-001) for improving glycaemic control in adults with prediabetes. Digital Health, 11, pp. 1-14. https://doi.org/10.1177/20552076251376260
dc.identifier.doi10.1177/20552076251376260
dc.identifier.endpage14
dc.identifier.issn2055-2076
dc.identifier.issn2055-2076
dc.identifier.pmidPMID: 40949672
dc.identifier.scopusqualityQ2
dc.identifier.startpage1
dc.identifier.urihttps://doi.org/10.1177/20552076251376260
dc.identifier.urihttps://hdl.handle.net/20.500.13055/1120
dc.identifier.volume11
dc.identifier.wosWOS:001571579500001
dc.identifier.wosqualityQ1
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakTR-Dizin
dc.indekslendigikaynak.otherSCI-E - Science Citation Index Expanded
dc.indekslendigikaynak.otherSSCI - Social Science Citation Index
dc.institutionauthorAkgül, Özer
dc.institutionauthorid0000-0002-3802-3270
dc.language.isoen
dc.publisherSAGE Publications
dc.relation.ispartofDigital Health
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectPre-Diabetic State
dc.subjectDiabetes Mellitus
dc.subjectType 2/Prevention and Control
dc.subjectHealthy Lifestyle
dc.subjectGlycemic Control
dc.subjectDigital Health
dc.titleA randomised clinical trial to evaluate a digital therapeutic (TH-001) for improving glycaemic control in adults with prediabetes
dc.typeArticle
dspace.entity.typePublication

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