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CompletedNCT05668819Updated Jan 10, 2025

Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

An interventional study of TH-001 in PreDiabetes, sponsored by Tesu Saglik Teknolojileri A.S.. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-10.

Sponsored by Tesu Saglik Teknolojileri A.S. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • PreDiabetes

Keywords

  • Prediabetic State
  • Digital Therapeutic
  • Mobile Health
  • Digital Health
  • Mobile Apps
  • Lifestyle Modification
  • mHealth
03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 68 is close to the median of 65 across 844 interventional studies indexed under Prediabetic State.

Browse Prediabetic State studies →

Lead sponsor

This is the only study on the registry with Tesu Saglik Teknolojileri A.S. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Being diagnosed with diabetes mellitus
  • Having a disease that can cause prediabetes
  • Taking medication that may cause prediabetes
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    TH-001

    Device: TH-001

  • No intervention
    Control

Interventions

  • DeviceTH-001

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

06

What researchers measure

Primary outcomes

  1. Change in HbA1c

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

    Time frame: 90 days

  2. Change in FPG

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

    Time frame: 90 days

  3. Change in PPG

    The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups.

    Time frame: 90 days

Secondary outcomes

  1. Change in weight

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

    Time frame: 90 days

  2. Change in BMI

    The difference in the mean change from baseline in BMI (kg/m\^2) at Day 90 between groups.

    Time frame: 90 days

  3. Change in WC

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

    Time frame: 90 days

  4. 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.

    Time frame: 90 days

07

Study locations

1 site
  • Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05668819
Lead sponsor
Tesu Saglik Teknolojileri A.S.
Responsible party
Sponsor
First posted
Dec 30, 2022
Start date
Feb 7, 2023
Primary completion
Dec 24, 2024
Completion
Dec 24, 2024
Last update
Jan 10, 2025

Study contacts

Ramazan Cakmak, MD
principal investigator · Istinye University Health Practice and Research Center Gaziosmanpasa Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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