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The study aims to evaluate the efficacy and safety of a digital therapeutic (TH-001) for adult individuals with prediabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TH-001 | Experimental |
| |
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TH-001 | Device | TH001 is a software program intended to treat adults with prediabetes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | The difference in the mean change from baseline in weight (kg) at Day 90 between groups. | 90 days |
| Change in BMI | The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramazan Cakmak, MD | Istinye University Health Practice and Research Center Gaziosmanpasa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istinye University Health Practice and Research Center Gaziosmanpasa Hospital | Istanbul | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40949672 | Derived | 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. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Open-Label, Randomized, Controlled
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| 90 days |
| Change in WC | The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups. | 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. | 90 days |
| D004700 | Endocrine System Diseases |