Tokyo, July 25 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062325) titled 'Multifaceted verification for the practical application of an aggravation prevention program for type 2 diabetes using ICT' on July 24.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Tokio Marine & Nichido Fire Insurance Co., Ltd.

Condition: Condition - Type 2 diabetes, Prediabetes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - In this clinical study, with the cooperation of health insurance societies, we will conduct a practical program evaluation involving 300 participants, aiming for social implementation. Specifically, the objectives are to evaluate the following: 1) Rationalization of intervention costs while maintaining effectiveness in high-risk subjects. 2) Program composition at an appropriate cost-effectiveness level for medium-risk subjects. 3) Construction of approaches for low-risk individuals and young generations. 4) Reaching the indifferent demographic in collaboration with health insurance societies and occupational physicians. 5) Establishment of a scheme for sending/receiving health checkup/receipt data and extracting target individuals using existing systems. Through this study, we aim to optimize individualized guidance by risk tier using biological information obtained from FreeStyle Libre 2 and the dietary management app "glucose flight," thereby realizing effective and sustainable glycemic control. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Depending on the participant's risk tier (high, medium, low, youth), participants will wear the FreeStyle Libre 2 and record data in the dietary management app "glucose flight" for a period (up to 12 weeks), and receive online nutritional guidance by a registered dietitian (up to 8 times).

Eligibility: Age-lower limit - 18 years-old = 6.5% or currently undergoing treatment for type 2 diabetes) and fall into albuminuria categories A1 and A2. 3) Individuals who are not diabetic but met the criteria for specific health guidance based on health checkup results within the past year. 4) Individuals who can comply with the necessary procedures according to the research protocol. 5) Individuals from whom informed consent to participate in the study has been obtained. Key exclusion criteria - 1) Participants undergoing dialysis. 2) Participants unable to continuously wear the Libre sensor for the specified period. 3) Other participants deemed inappropriate for participation in this study by the principal investigator. Target Size - 300

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 06 Month 23 Day Anticipated trial start date - 2026 Year 08 Month 01 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071294

Disclaimer: Curated by HT Syndication.