DiabetesPDCNCT06320600
Precision Medicine of Diabetes Program in China
An observational study of Diabetes, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes
- How many people
- 120,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Dec 2028
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The retrospective cohort includes patients diagnosed with diabetes according to WHO 1999 criteria, and the prospective cohort enrolls precisely classified diabetic patients according to "Classification of diabetes mellitus in China: an expert consensus statement".
Who may be able to join
- Patients diagnosed with diabetes according to WHO 1999 criteria
Who cannot join
- with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital
Changsha, Hunan, 410010
Shuting Yang, 15200863137, yang_shting@163.com
About this study
The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.
- Conditions
- Diabetes
- Being tested
- no intervention
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
It's an observational study, no intervention included
| Study group | Role | What they receive |
|---|---|---|
| Retrospective PDC cohort | The study will include diabetes patients diagnosed within 1 year (including 1 year) from both inpatient and outpatient medical record systems between January 2022 and December 2022. Each center enrolls approximately 1000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 30,000 participants. Receives: Other: no intervention | |
| Prospective PDC cohort | The study centers will enroll diabetes patients diagnosed within 1 year (including 1 year) from both outpatient and inpatient services between January 2024 and December 2024. Each center sees approximately 3000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 90,000 participants. The patients will be followed up for a period of 5 years. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The currency analysis of diabetes classification
To assess the accuracy rate of diabetes classification diagnoses according to "Classification of diabetes mellitus in China: an expert consensus statement" and explore variations across centers in different regions and hospital levels.
Measured: July 1st 2023 to December 31th 2023
Secondary outcomes (3)
To establish a model for predicting diabetic retinopathy
To establish a model for diabetic retinopathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the retinopathy outcome of patients.
Measured: January 1st 2024 to December 31th 2028
To establish a model for predicting diabetic kidney disease
To establish a model for diabetic kidney disease (DKD) prediction, and calculate the sensitivity and specificity of the model were by comparing with the DKD outcome of patients.
Measured: January 1st 2024 to December 31th 2028
To establish a model for predicting diabetic neuropathy
To establish a model for diabetic neuropathy prediction, and calculate the sensitivity and specificity of the model were by comparing with the outcome of patients.
Measured: January 1st 2024 to December 31th 2028
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Jul 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 120,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06320600
- Sponsor's protocol ID
- PDC
- Acronym
- PDC
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine of Diabetes Program in China
- ClinicalTrials.gov ID
- NCT06320600
- Acronym / sponsor ID
- PDC / PDC
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Mar 2024 (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.
The prevalence of diabetes has been increasing year by year. According to the International Diabetes Federation (IDF) statistics in 2021, the global number of people with diabetes has reached 537 million. The patient population is large and heterogeneous, and precise diagnosis and treatment of diabetes patients have been a focus of attention. The objective of this study is to clarify the current status of precision classification and diagnosis of diabetes patients through retrospective and prospective cohort studies, and to establish a model for precision classification and diagnosis of diabetes, improving the accuracy of diabetes classification and diagnosis; based on big data of precision medicine for diabetes patients and follow-up cohorts, to establish precise diagnostic, therapeutic, and predictive methods for diabetes; and through multi-omics data analysis, to explore the potential pathogenesis of diabetes, explaining the heterogeneity of patients, and guiding individualized treatment for patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective PDC cohort | – | Other: no interventionThe study will include diabetes patients diagnosed within 1 year (including 1 year) from both inpatient and outpatient medical record systems between January 2022 and December 2022. Each center enrolls approximately 1000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 30,000 participants. |
| Prospective PDC cohort | – | Other: no interventionThe study centers will enroll diabetes patients diagnosed within 1 year (including 1 year) from both outpatient and inpatient services between January 2024 and December 2024. Each center sees approximately 3000 new diabetes patients annually, and it is planned to include 30 centers, with an estimated total of 90,000 participants. The patients will be followed up for a period of 5 years. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The retrospective cohort includes patients diagnosed with diabetes according to WHO 1999 criteria, and the prospective cohort enrolls precisely classified diabetic patients according to "Classification of diabetes mellitus in China: an expert consensus statement".
Key inclusion criteria (1 listed)
- Patients diagnosed with diabetes according to WHO 1999 criteria
Key exclusion criteria (1 listed)
- with duration more than 1 year; Diabetes has not been diagnosed by WHO standards in 1999; Absence of medical history data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionIt's an observational study, no intervention included | Other | Prospective PDC cohort, Retrospective PDC cohort |
Primary outcome
The currency analysis of diabetes classification
Time frame: July 1st 2023 to December 31th 2023
To assess the accuracy rate of diabetes classification diagnoses according to "Classification of diabetes mellitus in China: an expert consensus statement" and explore variations across centers in different regions and hospital levels.
3 secondary outcomes
To establish a model for predicting diabetic retinopathy
Time frame: January 1st 2024 to December 31th 2028
To establish a model for predicting diabetic kidney disease
Time frame: January 1st 2024 to December 31th 2028
To establish a model for predicting diabetic neuropathy
Time frame: January 1st 2024 to December 31th 2028
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 20 Mar 2024.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Second Xiangya Hospital of Central South University at 1 site 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 1 inclusion and 1 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 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The currency analysis of diabetes classification (time frame: July 1st 2023 to December 31th 2023). 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 20 Mar 2024.