An observational study in Pre Diabetic, sponsored by Shanghai General Hospital, China. Recruiting at 2 sites in China. Open to participants aged 20 Months to 79 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Shanghai General Hospital, China · Observational
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
793 studies on the registry are indexed under Glucose Intolerance; 115 are open to participants now.
This study's planned enrollment of 7,000 is above the median of 218 across 109 observational studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Shanghai General Hospital, China is the lead sponsor of 8 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Residents of the high-risk diabetes population who have been living in the Xinqiao community for a long time
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Exclusion Criteria:
The prevalence of diabetes in high-risk groups during the study
Time frame: through study completion, an average of 5 year
FPG HbA1c and TIR changes from baseline in high-risk groups
Time frame: through study completion, an average of 5 year
Plan to share: No
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Started Oct 2019 (actual). Primary completion is estimated for Oct 2034, 180 months after the start.
Of 33 observational studies under Glucose Intolerance, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 186. This study's planned 180 months is above that.
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Shanghai General Hospital, China