Tokyo, Feb. 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060579) titled 'Efficacy of a Diabetes Onset Prevention App System Utilizing Continuous Glucose Monitoring and Artificial Intelligence in Individuals at High Risk for Type 2 Diabetes' on Feb. 13.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Niigata University

Condition: Condition - Prediabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - As existing evidence is limited to improvements in surrogate markers, this study will conduct a 1-year randomized controlled trial using an improved system, with diabetes incidence as the primary endpoint, to establish empirical evidence for the prevention of type 2 diabetes. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Intervention using a continuous glucose monitoring function + AI-powered disease prevention application system Interventions/Control_2 - Standard diabetes prevention guidance

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Individuals with HbA1c = 6.0 percent and fasting blood glucose >= 103 mg/dL or condition 2 HbA1c >= 6.2 percent or condition 3 fasting blood glucose >= 112 mg/dL 3. Individuals aged 20 years or older and 70 years or younger at the time of consent acquisition 4. Individuals with a BMI >= 25 kg/m2 and < 40 kg/m2 5.Individuals capable of using the smartphone application employed in the research 6. Individuals who have received an explanation of the research content and have provided consent to participate in the study Key exclusion criteria - 1.Individuals currently receiving treatment for diabetes 2.Individuals deemed inappropriate for participation by the attending physician Target Size - 660

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 04 Day Anticipated trial start date - 2026 Year 02 Month 13 Day Last follow-up date - 2028 Year 02 Month 28 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069291

Disclaimer: Curated by HT Syndication.