Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

February 1, 2024 updated by: Tesu Saglik Teknolojileri A.S.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Withdrawn
        • Fatih Sultan Mehmet Training and Research Hospital
      • Istanbul, Turkey
        • Recruiting
        • Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
        • Contact:
          • Ramazan Cakmak, MD
        • Principal Investigator:
          • Ramazan Cakmak, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: 90 days
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
90 days
Change in FPG
Time Frame: 90 days
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
90 days
Change in PPG
Time Frame: 90 days
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
Time Frame: 90 days
The difference in the mean change from baseline in weight (kg) at Day 90 between groups.
90 days
Change in BMI
Time Frame: 90 days
The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups.
90 days
Change in WC
Time Frame: 90 days
The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.
90 days
Change in WHR
Time Frame: 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.
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tesu Saglik Teknolojileri A.S.

Investigators

  • Principal Investigator: Ramazan Cakmak, MD, Istinye University Health Practice and Research Center Gaziosmanpasa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 17, 2022

First Submitted That Met QC Criteria

December 24, 2022

First Posted (Actual)

December 30, 2022

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TH001_1001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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