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

Background 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.