Not_yet_recruitingNCT07386756

Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes

Sponsor: Peking Union Medical College Hospital

Trial Details

ConditionPrediabetes
StatusNot_yet_recruiting
Participants1,000
Est. Completion31 Dec 2027
Last Updated15 Apr 2026

Primary Outcome

oral glucose tolerance test

Eligibility Criteria

Inclusion 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.

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