PreDiabetes
Conditions
Keywords
Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth
Brief summary
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Interventions
DEVICETH-001
TH001 is a software program intended to treat adults with prediabetes.
Sponsors
Tesu Saglik Teknolojileri A.S.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label, Randomized, Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c | 90 days | The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups. |
| Change in FPG | 90 days | The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups. |
| Change in PPG | 90 days | The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | 90 days | The difference in the mean change from baseline in weight (kg) at Day 90 between groups. |
| Change in WHR | 90 days | 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. |
| Change in BMI | 90 days | The difference in the mean change from baseline in BMI (kg/m\^2) at Day 90 between groups. |
| Change in WC | 90 days | The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups. |
Countries
Turkey (Türkiye)
Outcome results
None listed