Community-Based digital health management intervention study in namwon
NCT ID NCT07890740
First seen Oct 22, 2026 · Last updated Oct 23, 2026 · Updated 1 time
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 860 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Resident of Namwon, Republic of Korea, aged 40 years or older. * Able to understand the study, express a choice, and provide voluntary written informed consent. * Able to participate in questionnaires, health-record review, dietary assessment, counseling, and basic measurements, with research-team assistance for smartphone or application use when needed. * At least one of the following glycemic-risk criteria: documented type 2 diabetes diagnosis or treatment with glucose-lowering medication or insulin; no documented diagnosis or treatment with the most recent fasting glucose at least 126 mg/dL; or no documented diagnosis or treatment with the most recent fasting glucose from 100 through 125 mg/dL. * Eligibility is verified at the first screening visit. Randomization preferably occurs that day but may occur later, without a separate maximum interval, after required consent and pre-allocation assessments. Before allocation, willingness to participate, treatment, safety status, and sensor-use changes are rechecked. The actual randomization date is Day 0. If it differs from screening, the four dietary self-management items are repeated before allocation; other baseline measures remain those from the first screening visit. Participants without a qualifying fasting glucose result or objective type 2 diabetes diagnosis or treatment documentation at that visit are not randomized. For fasting-glucose-based eligibility, the result must be from within two years before the first screening visit. The most recent available national health-screening result is used, unless a more recent medical-facility result explicitly identified as fasting glucose is provided. Existing diagnosis or treatment must be supported by objective documentation such as a prescription record, medication package or medication itself, or a medical certificate; self-report alone is insufficient. Documented type 2 diabetes diagnosis or treatment permits eligibility without an available fasting glucose result. Relevant partial copies or on-site review of application screens or paper records may be used; submission of the whole health-record file is not required. * Provides additional written consent for continuous glucose monitoring (CGM), application linkage, data collection, and week 6 and week 12 assessments. * Provides the separate consents required for transfer of PASTA personal and health data and provision of consent-confirmation information to Kakao Healthcare. * Investigator judges that CGM can be used safely and follow-up procedures can be completed with assistance when needed. Exclusion Criteria: * Unable to understand study-related information or express a choice, or unable to provide valid consent. * Acute illness, severe symptoms, or another condition that makes study procedures unsafe in the investigator's judgment. * Severe skin disease at the sensor site, severe adhesive allergy, or a history of serious contact dermatitis. * Recent acute cardiovascular event, severe infection, active anticancer treatment, or another condition making participation clinically inappropriate. * Pregnancy or a need for a separate pregnancy-related glucose-management pathway. * Severe anxiety about sensor readings or concern that CGM use could compromise safe medication or dietary management. * Any previous or current CGM sensor use, regardless of product, purpose, or duration, or planned non-study CGM use before the week 6 assessment. Clinically necessary CGM use will not be stopped for study participation. * Type 1 diabetes. Insulin treatment alone does not establish type 1 diabetes. * Previous participation in the Namwon public health center employee pilot program. Receiving information or making a reservation alone does not constitute prior participation. Welfare-center participants who have not used a sensor may enter the main study within the 860-participant target only after approval of the amendment, new informed consent, and confirmation of all eligibility criteria. Previously collected welfare-center data are handled only within the scope permitted by ethics review; public health center pilot data are excluded from the main study analysis.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Namwon City Hall
Namwon, Jeollabuk-do, South Korea
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Namwon Medical Center
Namwon, Jeollabuk-do, South Korea
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Namwon Public Health Center
Namwon, Jeollabuk-do, South Korea
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Namwon Senior Welfare Center
Namwon, Jeollabuk-do, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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