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

Korábbi kezelés

• 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.
• 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.

Más betegség

• 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.
• Type 1 diabetes. Insulin treatment alone does not establish type 1 diabetes.

Laborértékek

• Pregnancy or a need for a separate pregnancy-related glucose-management pathway.

Egyéb

• Unable to understand study-related information or express a choice, or unable to provide valid consent.

• 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.