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OpenTrials
Completed

NCT Number: NCT05668819

Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

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

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University Health Practice and Research Center Gaziosmanpasa Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TH-001

Device

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

Primary outcomes

  1. Change in HbA1c

    Time frame: 90 days

    The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.

  2. Change in FPG

    Time frame: 90 days

    The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.

  3. 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.

Secondary outcomes

  1. Change in weight

    Time frame: 90 days

    The difference in the mean change from baseline in weight (kg) at Day 90 between groups.

  2. 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.

  3. Change in WC

    Time frame: 90 days

    The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.

  4. 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.

Sponsors and collaborators

Lead sponsor

Tesu Saglik Teknolojileri A.S.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 30, 2022
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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