Early Precise Identification and Intervention Strategies for Individuals at High Risk of Prediabetes
Trial ID: NCT07386756
Status: NOT_YET_RECRUITING
Study type: OBSERVATIONAL
Start date: 2026-04-30
Completion date: 2027-12-31
Sponsor: Peking Union Medical College Hospital
Conditions: Prediabetes
Enrollment: 1000
Age range: 35 Years - 75 Years
Sex: ALL

Summary:
Prediabetes significantly increases the risk of developing diabetes, cardiovascular and cerebrovascular diseases, tumors, and dementia. Early identification and intervention have become a leading focus in current diabetes prevention and control research. Currently, prediabetes screening primarily relies on methods such as fasting blood glucose, oral glucose tolerance tests, and glycated hemoglobin. These approaches suffer from limitations including single-point assessment, static nature, cumbersome procedures, poor reproducibility, delayed diagnosis, and limited accuracy. Continuous glucose monitoring (CGM) technology offers advantages such as ease of use, dynamic continuous monitoring, and round-the-clock surveillance. It comprehensively captures glucose fluctuation patterns, enabling identification of occult hyperglycemia and glucose variability. Integrating artificial intelligence (AI) to perform deep analysis on CGM-generated big data holds promise for pioneering new pathways toward earlier and more precise identification of prediabetes.

This project aims to establish a prospective prediabetes cohort integrating multidimensional data-including CGM parameters, body composition analysis, clinical indicators, and biomarkers-to develop novel diagnostic models for prediabetes. Building upon this foundation, we will construct an AI-driven prediabetes intervention management platform with intelligent decision support. This platform will generate personalized intervention strategies based on risk stratification, providing scientific evidence and practical support for advancing diabetes prevention and enabling precision management.

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.

Outcomes:
oral glucose tolerance test