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.

Tesu Health