Cakmak Ramazan, Tosun İlker, Avcu Hasan, Birer Gürkan Caner, Akgul Ozer, Saini Kamal S, Carnell Jonathan, Kutlu Orkide
Department of Endocrinology, Istinye University, İstanbul, Turkey.
Tesu Health, Cambridge, UK.
Digit Health. 2025 Sep 12;11:20552076251376260. doi: 10.1177/20552076251376260. eCollection 2025 Jan-Dec.
Prediabetes, characterized by elevated blood glucose levels below diabetes diagnostic thresholds, presents a significant global health challenge due to high prevalence and associated risks for developing type 2 diabetes. 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 validation. 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.
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 measures. User engagement metrics were also assessed.
The intervention significantly reduced HbA1c levels (mean difference -0.22%, .023) and body weight (-2.53 kg, .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 (.95, .001), demonstrating the critical role of sustained interaction with TH-001.
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.Efficacy and Safety of Digital Therapeutic in Adults with Prediabetes; https://clinicaltrials.gov/study/NCT05668819; ClinicalTrials.gov ID: NCT05668819.
糖尿病前期的特征是血糖水平升高但低于糖尿病诊断阈值，由于其高患病率以及发展为2型糖尿病的相关风险，给全球健康带来了重大挑战。传统的糖尿病预防计划（DPPs）在可扩展性和可及性方面常常面临挑战，尤其是在服务不足的社区。数字疗法（DTx），如TH - 001，提供了可能具有可扩展性的解决方案，但需要临床验证。这项随机、开放标签、对照、平行组临床试验旨在评估数字治疗应用TH - 001在90天干预期内降低糖尿病前期成年人糖化血红蛋白（HbA1c）的疗效和安全性。
68名符合条件的成年人被随机分配至仅接受标准护理或接受标准护理加TH - 001干预。测量的主要结局为血糖参数，包括HbA1c、空腹血糖、口服葡萄糖耐量试验的负荷后2小时血糖以及胰岛素水平，次要结局包括人体测量指标。还评估了用户参与度指标。
与对照组相比，干预显著降低了HbA1c水平（平均差异 - 0.22%，P = 0.023）和体重（- 2.53 kg，P = 0.001）。尽管空腹血糖和胰岛素水平呈现出积极趋势，但差异无统计学意义。用户参与度较高，与HbA1c降低密切相关（r = 0.95，P = 0.001），表明与TH - 001持续互动的关键作用。
TH - 001在降低HbA1c和体重方面显示出显著效果，且用户参与度较高，表明它可能有效克服糖尿病预防计划的传统障碍。需要进行长期研究以确认持续的益处。数字疗法对糖尿病前期成年人的疗效和安全性；https://clinicaltrials.gov/study/NCT05668819；ClinicalTrials.gov标识符：NCT05668819 。
