Patient Enrolment Completed in TH001_1001

Tesu Health is pleased to announce the completion of patient enrolment in the clinical trial (NCT05668819) TH001_1001. The trial evaluates TH-001 (PreDiaWell®) in combination with standard care versus standard care alone in adult patients with prediabetes over a 90-day treatment period. The primary outcome measures assess the mean change from baseline in HbA1c (%), fasting plasma glucose (FPG, mg/dL), and 2-hour glucose levels from a 75 g oral glucose tolerance test (OGTT, mg/dL) at day 90 between groups.

In October 2022, the Turkish Medicines and Medical Devices Agency of the Ministry of Health granted Tesu Health approval to conduct this prospective, randomised, controlled clinical trial. The study is designed to generate safety and effectiveness data to support a CE Mark certification of TH-001 as a medical device upon completion.

Led by Principal Investigator Ramazan Çakmak, MD, Endocrinologist at Istinye University Hospital in Istanbul, Türkiye, the trial marks a significant step in advancing digital therapeutics for prediabetes. A key milestone was achieved when the first patient was enrolled by the Principal Investigator, initiating the study’s journey towards evaluating TH-001’s clinical impact.

The successful enrolment of participants represents another important milestone in Tesu Health’s clinical programme. We are proud to collaborate with the Istinye University Hospital research team in evaluating TH-001 as a potential solution for a condition with significant unmet medical need.

For more details about the TH001_1001 clinical trial, please visit ClinicalTrials.gov.