Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Device: TH-001

• Registration Number: NCT05668819
• Lead Sponsor: Tesu Saglik Teknolojileri A.S.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-17
• Study First Submitted QC: 2022-12-24
• Study First Posted: 2022-12-30
• Study Start: 2023-02-07
• Primary Completion: 2024-12-24
• Study Completion: 2024-12-24
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TH-001	TH-001	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	90 days	The difference in the mean change from baseline in HbA1c (%) 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.
Change in FPG	90 days	The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.

Secondary Outcome Measures

Name	Time	Method
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 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.

Trial Locations

Locations (1)

Istinye University Health Practice and Research Center Gaziosmanpasa Hospital; 🇹🇷 Istanbul, Turkey