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Not Yet Recruiting
NCT05668819
Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
Conditions: PreDiabetes
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 56
Sponsor: Tesu Saglik Teknolojileri A.S.
Location: Turkey
Summary
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Eligibility Criteria
Inclusion Criteria:Being diagnosed with prediabetes according to the ADA Prediabetes Diagnostic Criteria (the presence of at least one of the following criteria is sufficient for diagnosis: FBG 100 - 125 mg/dL, OGTT 2 hour BG: 140 - 199 mg/dL, HbA1c: 5.7% - 6.4)Not using medication for the treatment of prediabetes, and if so, taking a break for at least two weeksHaving a smartphone with an iOS or Android operating systemBeing able to use a mobile applicationExclusion Criteria:Being diagnosed with diabetes mellitusHaving a disease that can cause prediabetesTaking medication that may cause prediabetes
Source: ClinicalTrials.gov (NCT05668819). StuddyBuddy aggregates publicly available trial information.