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Clinical Trial

Continuous Glucose Monitoring and Dietary Self-Management in Adults in Namwon

NCT: NCT07890740 · NOT_YET_RECRUITING

NCT IDNCT07890740
StatusNOT_YET_RECRUITING
Start Date2026-11-02
SponsorJi-Yeob Choi (OTHER)
First posted
Last updated

Brief Summary

This study will test whether adding a continuous glucose monitoring (CGM) device, which shows personal glucose patterns, improves dietary self-management over the first 6 weeks. Both groups receive the same digital health program, standardized education, and support for setting behavioral goals. It will include 860 residents of Namwon, Republic of Korea, aged 40 years or older who have elevated fasting glucose or documented type 2 diabetes diagnosis or treatment. After screening, participants will be assigned by chance to one of two groups of 430. Assignment is preferably on the first screening visit but may occur later. The actual assignment date is Day 0. The device group will use one CGM sensor for approximately 10 days after assignment. The wait-list control group will receive the same education and behavioral goal-setting support during the first 6 weeks, without a CGM device. Researchers will compare dietary self-management scores at week 6, before the control group receives a sensor. After the week 6 assessment and data lock, the control group will also be offered a sensor so that all eligible randomized participants have an opportunity to use the device. This later offer is not the main intervention comparison. Week 12 assessments provide exploratory follow-up after both groups have been offered a device. Researchers will also assess application use, body weight, waist circumference, blood pressure, and safety. The research team will not change medicines based on sensor readings, and usual medical care will continue.

Official Source

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