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Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Primary Purpose

PreDiabetes

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TH-001
Sponsored by
Tesu Saglik Teknolojileri A.S.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PreDiabetes focused on measuring Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fatih Sultan Mehmet Training and Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TH-001

Control

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Change in FPG
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
Change in PPG
The difference in the mean change from baseline in 2-hour 75 g OGTT (mg/dL) at Day 90 between groups.

Secondary Outcome Measures

Change in weight
The difference in the mean change from baseline in weight (kg) at Day 90 between groups.
Change in BMI
The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups.
Change in WC
The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.
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.

Full Information

First Posted
December 17, 2022
Last Updated
February 14, 2023
Sponsor
Tesu Saglik Teknolojileri A.S.
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1. Study Identification

Unique Protocol Identification Number
NCT05668819
Brief Title
Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tesu Saglik Teknolojileri A.S.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PreDiabetes
Keywords
Prediabetic State, Digital Therapeutic, Mobile Health, Digital Health, Mobile Apps, Lifestyle Modification, mHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Open-Label, Randomized, Controlled
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TH-001
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
TH-001
Intervention Description
TH001 is a software program intended to treat adults with prediabetes.
Primary Outcome Measure Information:
Title
Change in HbA1c
Description
The difference in the mean change from baseline in HbA1c (%) at Day 90 between groups.
Time Frame
90 days
Title
Change in FPG
Description
The difference in the mean change from baseline in FPG (mg/dL) at Day 90 between groups.
Time Frame
90 days
Title
Change in PPG
Description
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 Outcome Measure Information:
Title
Change in weight
Description
The difference in the mean change from baseline in weight (kg) at Day 90 between groups.
Time Frame
90 days
Title
Change in BMI
Description
The difference in the mean change from baseline in BMI (kg/m^2) at Day 90 between groups.
Time Frame
90 days
Title
Change in WC
Description
The difference in the mean change from baseline in Waist Circumference (centimeters) at Day 90 between groups.
Time Frame
90 days
Title
Change in WHR
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hasan Avcu, MD
Phone
+905384158378
Email
havcu@tesu.com.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Ilker Tosun, MD
Phone
+905334158378
Email
itosun@tesu.com.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seda Sancak, MD
Organizational Affiliation
Fatih Sultan Mehmet Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fatih Sultan Mehmet Training and Research Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seda Sancak, MD
First Name & Middle Initial & Last Name & Degree
Seda Sancak, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

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