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NCT Number: NCT07281170

Xinqiao High-risk Cohort of Diabetes(NICE)

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.

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Key information

Age range

20 month–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The prevalence of diabetes in high-risk groups during the study

    Time frame: through study completion, an average of 5 year

Secondary outcomes

  1. FPG HbA1c and TIR changes from baseline in high-risk groups

    Time frame: through study completion, an average of 5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai General Hospital, China

Other

Registry information

Official study title

Xinqiao High-risk Cohort of Diabetes

Important dates

Study start
2019
Primary completion
2034
Study completion
2034
First posted
Dec 15, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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