Tokyo, Aug. 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062479) titled 'Effectiveness of an ICT-Based Regional Collaboration System Combined with an AI-Enabled Personal Health Record for Glycemic Management in Individuals with Impaired Glucose Tolerance' on Aug. 5.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - University of Nagasaki

Condition: Condition - People with type 2 diabetes mellitus or impaired glucose tolerance (Excluding non-obese individuals) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The aim of this study is to evaluate the effectiveness of AI-based remote nutritional support compared with conventional face-to-face support using a Personal Health Record (PHR) system in diabetes care. Furthermore, we aim to identify factors associated with improvements in clinical outcomes to develop more effective and personalized support strategies. In addition, we will investigate whether automated feedback and reminder functions provided by AI can contribute to reducing the burden on healthcare professionals and establish a framework for continuous support under limited medical resources. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Only participants in the intervention group will receive AI messages. The AI message intervention will start 2 weeks after the index date and continue for 6 months. Interventions/Control_2 - Participants in the control group will not receive AI message-based intervention and will receive usual care.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients who have been using the Health2Sync application for at least 6 months at the time of enrollment. 2.Patients who are 18 years of age or older at the time of informed consent. 3.No restriction on sex. 4.Patients with a body weight change of less than 5% during the 6 months before enrollment. 5.Patients with an HbA1c change of less than 0.5% during the 6 months before enrollment. 6.Patients who have received sufficient information about the study, fully understood the study, and provided written informed consent voluntarily. Key exclusion criteria - 1.Patients who had an addition or change in antidiabetic medications during the study period 2.Patients who were judged by the attending physician to be inappropriate for participation in the study Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 31 Day Anticipated trial start date - 2026 Year 08 Month 17 Day Last follow-up date - 2027 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071509

Disclaimer: Curated by HT Syndication.