Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Sponsor

Tesu Saglik Teknolojileri A.S. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05668819

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

9.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
PreDiabetes	Device: TH-001	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Open-Label, Randomized, ControlledOpen-Label, Randomized, Controlled

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TH-001	Device: TH-001 TH001 is a software program intended to treat adults with prediabetes.
No Intervention: Control

Arm

Intervention/Treatment

Experimental: TH-001

Device: TH-001

TH001 is a software program intended to treat adults with prediabetes.

No Intervention: Control

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Change in weight [90 days]
The difference in the mean change from baseline in weight (kg) 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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