Pre DiabeticNCT07281170
Xinqiao High-risk Cohort of Diabetes(NICE)
An observational study of Pre Diabetic, run by Shanghai General Hospital, China at 2 sites in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 months to 79 years
- Conditions the study is for
- Pre Diabetic
- How many people
- 7,000 participants
- Where
- 2 sitesChina
- Study dates
- 8 Oct 2019to 31 Dec 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 months to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Residents of the high-risk diabetes population who have been living in the Xinqiao community for a long time
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200000
- Recruiting
Shanghai 6th People's Hospital
Shanghai, Shanghai Municipality, 200233
Jian Zhou, 02164369181, zhoujian@sjtu.edu.cn
About this study
Official title: Xinqiao High-risk Cohort of Diabetes
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.
- 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.
Read more
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
- Establish a new standardized diabetes high-risk population research cohort with large sample size.
- Observe the metabolic characteristics, blood glucose fluctuation, ophthalmic conditions and bone density of high-risk groups with diabetes.
- Find effective interventions to reduce the annual conversion rate of diabetes.
- Conditions
- Pre Diabetic
- Keywords
- xinqiao, Pre Diabetic, NICE
- Medical subject headings
- Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk population for diabetes | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of diabetes in high-risk groups during the study
Measured: through study completion, an average of 5 year
Secondary outcomes (1)
FPG HbA1c and TIR changes from baseline in high-risk groups
Measured: through study completion, an average of 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start8 Oct 2019
- Primary completion20 Oct 2034 (estimated)
- Study completion31 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Responsible party
- Principal investigator, Yufan Wang, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281170
- Sponsor's protocol ID
- NICE202508
- Status last verified
- Dec 2025
- First submitted
- 17 Sep 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinqiao High-risk Cohort of Diabetes
- ClinicalTrials.gov ID
- NCT07281170
- Acronym / sponsor ID
- NICE202508
- Conditions
- Pre Diabetic
- Keywords
- xinqiao, Pre Diabetic, NICE
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, ChinaUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- 20 Oct 2034 (estimated)
- Study completion
- 31 Dec 2034 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Establish a new standardized diabetes high-risk population research cohort with large sample size.
- Observe the metabolic characteristics, blood glucose fluctuation, ophthalmic conditions and bone density of high-risk groups with diabetes.
- Find effective interventions to reduce the annual conversion rate of diabetes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk population for diabetes | – | – |
Who may qualify
- Ages
- 20 months to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Residents of the high-risk diabetes population who have been living in the Xinqiao community for a long time
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of diabetes in high-risk groups during the study
Time frame: through study completion, an average of 5 year
1 secondary outcome
FPG HbA1c and TIR changes from baseline in high-risk groups
Time frame: through study completion, an average of 5 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre Diabetic, run by Shanghai General Hospital, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LI WEN (+8618701835861, li_winfield@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The prevalence of diabetes in high-risk groups during the study (time frame: through study completion, an average of 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.