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NOT YET RECRUITING
NCT07890740
NA

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

Sponsor: Ji-Yeob Choi

View on ClinicalTrials.gov

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 title: Community-Based Digital Health Management Intervention Study in Namwon

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

860

Start Date

2026-11-02

Completion Date

2028-09

Last Updated

2026-10-22

Healthy Volunteers

No

Interventions

DEVICE

Continuous Glucose Monitoring With Application-Based Biofeedback

One Dexcom G7 sensor is worn for approximately 10 days, with personal glucose patterns displayed through PASTA as biofeedback for lifestyle self-management. The device group starts on the actual randomization date (Day 0) or within 10 business days. The wait-list control group receives no device during the first 6 weeks and is offered the sensor after the week 6 assessment and data lock, on that day or within 7 business days, to provide access for all eligible participants. Both groups receive the same standardized education and behavioral goal setting during the first 6 weeks. The primary contrast is the incremental device effect during that period. Sensor placement, connection, and safety instructions accompany actual use. Research staff do not adjust medicines based on readings.

BEHAVIORAL

Common Standardized Education and Behavioral Goal Setting

Both randomized groups receive the same standardized education and behavioral goal-setting support during the first 6 weeks, regardless of whether a CGM device has been provided. Education covers interpretation of glucose patterns, relationships of meals, activity and sleep with glucose responses, differences in responses to foods, and safe behavioral goals. Safety guidance includes not changing medicines, insulin or food intake solely on the basis of sensor readings. This is a common component, not the randomized difference; it is not postponed until sensor provision in the wait-list control group. Instructions for actual sensor placement, application connection, and device safety are distinguished from this common education.

BEHAVIORAL

Common Digital Health Program and Basic Health Counseling

Both randomized groups receive the same background program beginning at the first screening visit, which may precede randomization: PASTA application guidance, the commercially available AI Diet dietary assessment and feedback provided through Kakao Healthcare's PASTA application, using the existing 10 dietary categories and risk-stage table without modification, CancerFree prevention information, assistance with digital skills, and basic health counseling. Standardized education and behavioral goal setting are also common to both groups during the first 6 weeks. Personal glucose-linked functions become available only when a sensor is provided; actual placement, connection, and device safety instructions accompany device use. The common background program has no separate untreated comparator in this study.

Locations (4)

Namwon City Hall

Namwon, Jeollabuk-do, South Korea

Namwon Medical Center

Namwon, Jeollabuk-do, South Korea

Namwon Public Health Center

Namwon, Jeollabuk-do, South Korea

Namwon Senior Welfare Center

Namwon, Jeollabuk-do, South Korea