Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07386756
Eligibility Criteria:
Inclusion Criteria:
* Voluntarily participate in this study, sign a written informed consent form, and be able to adhere to the study protocol for regular follow-up visits;
* Age≥35 years and Chinese Diabetes Risk Score≥25 points (i.e., individuals at high risk for diabetes based on traditional factors); ③Normal blood glucose levels at baseline, as determined by fasting blood glucose, HbA1c, or OGTT testing (i.e., fasting blood glucose \< 6.1 mmol/L AND HbA1c \< 5.7% AND 2-hour OGTT glucose \< 7.8 mmol/L).
Exclusion Criteria:
* Diagnosed with diabetes or prediabetes: History of diabetes or meeting diagnostic criteria for diabetes at baseline screening (fasting blood glucose ≥7.0 mmol/L or HbA1c ≥6.5%) or prediabetes criteria (i.e., impaired fasting glucose: 6.1-6.9 mmol/L; and/or impaired glucose tolerance: 7.8-11.0 mmol/L; and/or HbA1c 5.7%-6.5%);
* Conditions severely affecting blood glucose control: severe cardiac, hepatic, or renal insufficiency (e.g., NYHA Class III-IV heart failure, cirrhosis, renal failure with eGFR \<30 mL/min/1.73 m²);
* Severe complications or comorbidities: recent (within 6 months) macrovascular events (e.g., myocardial infarction, stroke);
* Malignancy currently active or undergoing treatment;
* Severe psychiatric or cognitive impairment preventing study compliance;
* Pregnant women, lactating women, or women planning pregnancy within the next year; ⑦ Severe allergy or intolerance to the CGM sensor patch; ⑧ Plans to relocate outside the study center's coverage area within the next year, preventing completion of follow-up; ⑨ Inability or unwillingness to use a smartphone or smart device, which would impair data collection.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT07386756
Study Brief:
Protocol Section:
NCT07386756