RecruitingNot ApplicableNCT06810986

Cohort Study Evaluating Glycaemic Control in Individuals with Type 2 Diabetes Mellitus Through Digital Therapeutics (DM DTx)

Phase 2 Research Study for Type 2 Diabetes Mellitus Through Digital Therapeutics

Sponsor

EVYD Technology

Enrollment

500 participants

Start Date

Aug 20, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes Mellitus (T2DM)

Summary

This study is conducted to evaluate the effectiveness of Digital therapeutics (DTx) in managing patients with Type 2 Diabetes Mellitus (T2DM) by delivering digital lifestyle interventions through a national health application (BruHealth).

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a digital app-based therapy program can help people with type 2 diabetes manage their blood sugar levels better. Participants use a digital tool on their phone or device to support lifestyle changes and treatment adherence. **You may be eligible if...** - You are between 18 and 70 years old - You have type 2 diabetes managed with oral medications, insulin (up to 2 injections daily), diet alone, or a GLP-1 medication (started at least 6 months ago) - You have a smartphone or tablet **You may NOT be eligible if...** - You have type 1 diabetes - You require more than 2 insulin injections per day - You are pregnant or breastfeeding - You have had a recent heart attack or stroke (within 6 months), heart failure, liver failure, or active cancer - You have severe kidney disease (stage 4 or 5) - You have active serious complications such as advanced foot disease or diabetic eye disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORAL16-week digital intervention

Participants will be enrolled in a 16-week programme with the aim to manage T2DM through lifestyle adjustments. Participants will be given online support by their personal health coach with additional support from a dietitian or clinician in the study if required. Each participant will receive personalised recommendations for blood glucose monitoring schedule, diet and physical activity. Participants are required to log their blood glucose, diet and physical activity in the BruHealth application. Participants will review their progress with their health coach via video consultation on a regular basis. Additionally, participants will also participate in a structured diabetes self-management education course.