Tokyo, Dec. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060090) titled 'Analysis of Blood Glucose Variation Patterns in Healthy Individuals under Free-Living Conditions' on Dec. 15.

Study Type: Observational

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - None (Healthy Individuals) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to record and analyze temporal changes in blood glucose levels during daily living by having Japanese healthy individuals wear an intermittently scanned continuous glucose monitoring device (isCGM) for a specified period. In particular, the study aims to calculate CGM metrics, including Time in Range (TIR), and to clarify characteristic glucose variability patterns in individuals with normal glucose tolerance. Additionally, the study will examine associations between glucose variability and physical characteristics such as body composition (visceral fat and muscle mass), obesity indices, age, sex, and height. By establishing reference ranges for healthy glucose profiles specific to the Japanese population, this study seeks to contribute to the development of diagnostic, preventive, and interventional indicators for diabetes. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Healthy volunteers aged 18 years or older who respond to recruitment advertisements, are able to undergo blood sampling, questionnaires, isCGM placement, and body composition analysis, and who provide written informed consent after adequate explanation. Key exclusion criteria - Individuals with diagnosed diabetes or impaired glucose tolerance, those receiving oral steroid therapy, those with significant internal medical disorders, those who are pregnant or breastfeeding, and those deemed inappropriate by the investigators. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 21 Day Date of IRB - 2025 Year 12 Month 02 Day Anticipated trial start date - 2025 Year 12 Month 08 Day Last follow-up date - 2031 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068724

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