The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
TH001 is a software program intended to treat adults with prediabetes.
Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
Istanbul, Turkey (Türkiye)
Change in HbA1c
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Time frame: 90 days
Change in FPG
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
Time frame: 90 days
Change in PPG
The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups.
Time frame: 90 days
Change in weight
The difference in the mean change from baseline in weight (kg) at Day 90 between groups.
Time frame: 90 days
Change in BMI
The difference in the mean change from baseline in BMI (kg/m\^2) at Day 90 between groups.
Time frame: 90 days
Change in WC
The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.
Time frame: 90 days
Change in WHR
The difference in the mean change from baseline in waist-to-hip ratio (WHR) (waist circumference and hip circumference measured in centimeters) at Day 90 between groups.
Time frame: 90 days
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