PreDiabetesNCT05668819
Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
A study testing TH-001 in people with PreDiabetes, run by Tesu Saglik Teknolojileri A.S. at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- PreDiabetes
- What is being tested?
- TH-001
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Feb 2023to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Being diagnosed with diabetes mellitus
- Having a disease that can cause prediabetes
- Taking medication that may cause prediabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
Istanbul
About this study
Official title: 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.
- Conditions
- PreDiabetes
- Being tested
- TH-001
- Keywords
- Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-001Device
TH001 is a software program intended to treat adults with prediabetes.
| Study group | Role | What they receive |
|---|---|---|
| TH-001 | Experimental | Not described Receives: Device: TH-001 |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Measured: 90 days
Change in FPG
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
Measured: 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.
Measured: 90 days
Secondary outcomes (4)
Change in weight
The difference in the mean change from baseline in weight (kg) at Day 90 between groups.
Measured: 90 days
Change in BMI
The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups.
Measured: 90 days
Change in WC
The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.
Measured: 90 days
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.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start7 Feb 2023
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-Label, Randomized, Controlled
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tesu Saglik Teknolojileri A.S.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramazan Cakmak, MD, Principal investigator, Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668819
- Sponsor's protocol ID
- TH001_1001
- Status last verified
- Jan 2025
- First submitted
- 17 Dec 2022
- Last updated
- 10 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40949672
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomized, Controlled, Parallel Group Study Evaluating Efficacy and Safety of Digital Therapeutic (TH-001) for the Treatment of Prediabetes in Adults
- ClinicalTrials.gov ID
- NCT05668819
- Acronym / sponsor ID
- TH001_1001
- Conditions
- PreDiabetes
- Keywords
- Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Tesu Saglik Teknolojileri A.S.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-Label, Randomized, Controlled
| Arm | Type | Receives |
|---|---|---|
| TH-001 | Experimental | Device: TH-001 |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Being diagnosed with diabetes mellitus
- Having a disease that can cause prediabetes
- Taking medication that may cause prediabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH-001TH001 is a software program intended to treat adults with prediabetes. | Device | TH-001 |
Primary outcome
Change in HbA1c
Time frame: 90 days
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Change in FPG
Time frame: 90 days
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
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.
4 secondary outcomes
Change in weight
Time frame: 90 days
Change in BMI
Time frame: 90 days
Change in WC
Time frame: 90 days
Change in WHR
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 40949672Cakmak 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.
- Individual participant dataSharing planned: No
Related trials for PreDiabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Cakmak, MD principal investigator
Istinye University Health Practice and Research Center Gaziosmanpasa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TH-001 in people with PreDiabetes, run by Tesu Saglik Teknolojileri A.S. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.