Actively Recruiting

Age: 20Months - 79Years
All Genders
NCT07281170

Xinqiao High-risk Cohort of Diabetes(NICE)

Led by Shanghai General Hospital, China · Updated on 2025-12-15

7000

Participants Needed

1

Research Sites

794 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Objective: 1. To systematically screen the high-risk population of diabetes in Xinqiao area, understand the characteristics of early glucose metabolism changes and pancreatic islet function changes in the high-risk population and patients with prediabetes, and establish the first standardized research cohort of high-risk patients and prediabetes patients in Songjiang area. 2\. Use CGM monitoring technology to identify the high-risk groups of diabetes and the fluctuation of blood glucose in pre-diabetes, understand their ophthalmology and bone density, observe the annual conversion rate of diabetes, find effective interventions, move forward the management of diabetes, and create a new model for the management of high-risk groups of diabetes. Research content: Part I: Establishing the first standardized diabetes high-risk population research cohort in Songjiang area The initiative focuses on early screening for high-risk populations with diabetes, shifting the focus downward and advancing prevention measures to detect diabetes at an earlier stage and initiate timely intervention. In Xinqiao District, all high-risk screening cases will undergo medical history documentation, anthropometric measurements, laboratory testing, and regular follow-ups. Standard oral glucose tolerance test (OGTT) methods will be employed to assess fasting blood glucose levels, insulin sensitivity, 2-hour postprandial glucose and insulin levels after a 75g glucose load, and glycated hemoglobin levels. Beyond evaluating glucose metabolism, the screening will also detect other metabolic disorders through routine blood tests including urinalysis, liver/kidney function tests, uric acid levels, lipid profiles, thyroid function, and urine protein/creatinine ratio. The establishment of this premium high-risk screening program in Xinqiao Community will create Songjiang District's first standardized research cohort for diabetes mellitus (DM) and prediabetes patients, carrying significant strategic importance. Part II: By integrating Clinical Monitoring (CGM) technology with ophthalmological evaluations and bone density ultrasound examinations, we identify characteristics of high-risk diabetic populations and track their disease progression. The CGM system (with auxiliary devices such as the Shansheng Dynamic Glucose Monitoring System) is utilized to monitor blood glucose fluctuations in these individuals. Concurrently, comprehensive ophthalmic assessments-including visual acuity tests, intraocular pressure measurements, fundus photography, OCT scans, OCTA imaging, and SLO examinations-are conducted alongside bone density testing. Annual follow-up evaluations are performed to track clinical outcomes. Research innovation points and expected results: Research innovation points: Establish the first standardized research cohort of high-risk and pre-diabetic patients in Songjiang area; move forward the management of diabetes, and create a new management model for high-risk groups of diabetes. anticipated results 1. Establish a new standardized diabetes high-risk population research cohort with large sample size. 2. Observe the metabolic characteristics, blood glucose fluctuation, ophthalmic conditions and bone density of high-risk groups with diabetes. 3. Find effective interventions to reduce the annual conversion rate of diabetes.

CONDITIONS

Official Title

Xinqiao High-risk Cohort of Diabetes(NICE)

Who Can Participate

Age: 20Months - 79Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals who provide written informed consent
  • Have access to a smartphone
  • Family history of diabetes or abnormal blood sugar level detected once
  • Age 18 years or older at the time of consent
Not Eligible

You will not qualify if you...

  • Diabetes mellitus
  • Any condition that the investigator judges would make the subject unsuitable for enrollment
  • Recent surgery, trauma, acute cardiovascular complications, or infectious diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Shanghai General Hospital

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

Loading map...

Research Team

L

LI WEN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here