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 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. 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 measures. User engagement metrics were also assessed. Results: The intervention significantly reduced HbA1c levels (mean difference -0.22%, 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.Efficacy and Safety of Digital Therapeutic in Adults with Prediabetes; https://clinicaltrials.gov/study/NCT05668819; ClinicalTrials.gov ID: NCT05668819.