Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults
1 other identifier
interventional
68
1 country
1
Brief Summary
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2022
CompletedFirst Posted
Study publicly available on registry
December 30, 2022
CompletedStudy Start
First participant enrolled
February 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 24, 2024
CompletedJanuary 10, 2025
January 1, 2025
1.9 years
December 17, 2022
January 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in HbA1c
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
90 days
Change in FPG
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
90 days
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 Outcomes (4)
Change in weight
90 days
Change in BMI
90 days
Change in WC
90 days
Change in WHR
90 days
Study Arms (2)
TH-001
EXPERIMENTALControl
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Being diagnosed with diabetes mellitus
- Having a disease that can cause prediabetes
- Taking medication that may cause prediabetes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
Istanbul, Turkey (Türkiye)
Related Publications (1)
Cakmak R, Tosun I, Avcu H, Birer GC, Akgul O, Saini KS, Carnell J, Kutlu O. A randomised clinical trial to evaluate a digital therapeutic (TH-001) for improving glycaemic control in adults with prediabetes. Digit Health. 2025 Sep 12;11:20552076251376260. doi: 10.1177/20552076251376260. eCollection 2025 Jan-Dec.
PMID: 40949672DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ramazan Cakmak, MD
Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2022
First Posted
December 30, 2022
Study Start
February 7, 2023
Primary Completion
December 24, 2024
Study Completion
December 24, 2024
Last Updated
January 10, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share