NCT05668819
Completed
Not Applicable
Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults
Tesu Saglik Teknolojileri A.S.1 site in 1 country68 target enrollmentFebruary 7, 2023
ConditionsPreDiabetes
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- PreDiabetes
- Sponsor
- Tesu Saglik Teknolojileri A.S.
- Enrollment
- 68
- Locations
- 1
- Primary Endpoint
- Change in HbA1c
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Investigators
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 weeks
- •Having a smartphone with an iOS or Android operating system
- •Being able to use a mobile application
Exclusion Criteria
- •Being diagnosed with diabetes mellitus
- •Having a disease that can cause prediabetes
- •Taking medication that may cause prediabetes
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: 90 days
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Change in PPG
Time Frame: 90 days
The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups.
Change in FPG
Time Frame: 90 days
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
Secondary Outcomes
- Change in BMI(90 days)
- Change in WC(90 days)
- Change in weight(90 days)
- Change in WHR(90 days)
Study Sites (1)
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