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%, 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. Efficacy and Safety of Digital Therapeutic in Adults with Prediabetes; https://clinicaltrials.gov/study/NCT05668819 ; ClinicalTrials.gov ID: NCT05668819