Publication of clinical trial results evaluating TH-001 (PreDiaWell®) in Digital Health

We are pleased to announce the publication of the results from our randomised controlled clinical trial (NCT05668819) TH001_1001 evaluating PreDiaWell® (TH-001) in the peer-reviewed journal Digital Health.

The study investigated the efficacy and safety of PreDiaWell®, a digital therapeutic designed for adults with prediabetes.

In this 90-day, randomised, open-label, controlled trial involving 68 adults, participants using PreDiaWell® in addition to standard care achieved:

• A statistically significant reduction in HbA1c (mean difference −0.22%, p=0.023)
• Clinically meaningful weight loss (−3.7 kg, p<0.001)
• Strong correlation between app engagement and glycaemic improvement (r=0.95, p<0.001)

Importantly, no adverse events or adverse device effects were reported, supporting the safety profile of the intervention.

These findings demonstrate the potential of PreDiaWell® to deliver clinically validated outcomes comparable to traditional diabetes prevention programmes, while offering a fully digital and scalable solution.

The article, entitled “A randomised clinical trial to evaluate a digital therapeutic (TH-001) for improving glycaemic control in adults with prediabetes”, is available open access in Digital Health.

Tesu Health would like to thank the study’s authors – Ramazan Cakmak, Ozer Akgul, Kamal S. Saini, Jonathan Carnell, and Orkide Kutlu – for their contributions to this important work.