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

ABSTRACT:

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 rand

SUBMITTER: Cakmak R 

PROVIDER: S-EPMC12432327 | biostudies-literature | 2025 Jan-Dec

REPOSITORIES: biostudies-literature