Xinqiao High-risk Cohort of Diabetes(NICE)

Shanghai General Hospital, China

Status: Enrolling

Conditions: Pre Diabetic

Study type: Observational

Funder types: Other

Identifiers

NCT07281170

NICE202508

Details and patient eligibility

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.

Enrollment: 7,000 estimated patients

Sex: All

Ages: 20 months to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Individuals who provide written informed consen
• Have access to a smartphone
• Hamily history of diabetes or abnormal microglucose level detected once
• Age ≥18 years at the time of consent

Exclusion criteria

• Diabetes mellitus
• Any other condition which, in the judgment of the investigator, would make the subject unsuitable for enrollment in the study
• recently surgical histories, trauma, acute cardiovascular complications, or infectious diseases

Trial design

7,000 participants in 1 patient group

High-risk population for diabetes