Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.

Official Title
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Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults

Conditions
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PreDiabetes

Intervention / Treatment
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* Device: TH-001


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-Label, Randomized, Controlled
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TH-001<br> | Device: TH-001<br>* TH001 is a software program intended to treat adults with prediabetes.<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c | The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups. | 90 days | 
| Change in FPG | The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups. | 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. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | The difference in the mean change from baseline in weight (kg) at Day 90 between groups. | 90 days | 
| Change in BMI | The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups. | 90 days | 
| Change in WC | The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups. | 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. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth