Efficacy and Safety of Digital Therapeutic in Adults With Prediabetes

Tesu Saglik Teknolojileri

Status: Completed

Conditions: PreDiabetes

Treatments: Device: TH-001

Study type: Interventional

Funder types: Industry

Identifiers

NCT05668819

TH001_1001

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

TH-001

Experimental group

Treatment:

Device: TH-001

Control

No Intervention group