Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

PreDiabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668819
• Other study ID #: TH001_1001
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2023
• Est. completion date: May 2024

Study information

• Verified date: February 2024
• Source: Tesu Saglik Teknolojileri A.S.
• Contact: Hasan Avcu, MD
• Phone: +905334158378
• Email: hasan.avcu[@]tesuhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Device:
• TH-001
TH001 is a software program intended to treat adults with prediabetes.

Locations

Country	Name	City	State
Turkey	Fatih Sultan Mehmet Training and Research Hospital	Istanbul
Turkey	Istinye University Health Practice and Research Center Gaziosmanpasa Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Tesu Saglik Teknolojileri A.S.

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c	The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.	90 days
Primary	Change in FPG	The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.	90 days
Primary	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	Change in weight	The difference in the mean change from baseline in weight (kg) at Day 90 between groups.	90 days
Secondary	Change in BMI	The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups.	90 days
Secondary	Change in WC	The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.	90 days
Secondary	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