Type 1 Diabetes MellitusNCT07468474
Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Peking University First Hospital at 1 site in China.
Trial summary
This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Gene polymorphic detection
- How many people
- 340 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to Jul 2028
- How long will I take part?
- 4 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: It is planned to recruit 340 subjects meeting the inclusion criteria, including 40 healthy controls matching gender and age, 150 patients with T1D, and 150 first-degree relatives of T1D patients.
Who may be able to join
- Meet the WHO's diabetes diagnostic criteria, diagnosed as type 1 diabetes; ② Able and willing to participate in 12 hours of structured education training;
- Able and willing to undergo regular outpatient follow-up;
- Volunteer to participate in the study and sign informed consent.
- First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);
- Age ≥4 years old; ③ Able and willing to undergo regular outpatient follow-up; ④ Volunteer to participate in the study and sign informed consent.
- Age ≥40 years old;
- No history of diabetes; ③ Fasting blood glucose < 6.1mmol/L, 2-hour glucose load blood glucose < 7.8mmol /L, glycosylated hemoglobin < 5.7%; ④ Volunteer to participate in the study and sign informed consent.
Who cannot join
- ① Non-type 1 diabetic patients;
- Severe microvascular complications: proliferative retinopathy; Urinary albumin/urinary creatinine > 300mg/g, or 24-hour urinary protein quantity > 1g/d; Uncontrolled painful diabetic neuropathy and significant diabetic autonomic neuropathy; ③ Patients who had acute cerebrovascular accident, acute coronary syndrome, peripheral artery disease requiring hospitalization or underwent vascular intervention or amputation within 3 months before enrollment; Blood pressure is consistently higher than 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week; Serum creatinine clearance was less than 30ml/min/1.73m2(calculated according to CKDEPI formula), alanine aminotransferase ≥3 times the upper limit of normal, total bilirubin ≥2 times the upper limit of normal for more than 1 week;
- Have used drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, growth hormones, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc.; However, small doses of diuretics (hydrochlorothiazide < 25mg/d, indapamide ≤1.5mg/d) for antihypertensive purposes, and physiological dosages of thyroid hormones used for replacement therapy are not subject to this limit; (7) Systemic infection or serious concomitant disease; Patients with malignant tumors or chronic diarrhea; Other circumstances that cause the subjects to be unable to complete the study: such as serious cognitive dysfunction, mental illness, etc.;
- ⑨ The subject is uncooperative, unable to follow up, or the investigator judges that it may be difficult to complete the investigator;
- ⑩ Other conditions deemed unsuitable for inclusion by the investigator. The study physician will determine whether you are suitable for the study based on your actual condition and the inclusion and exclusion criteria in the study protocol.
- Inclusion and exclusion criteria for first-degree relatives of patients with type 1 diabetes:
Show all 9Show fewer
- Type 1 diabetes has been diagnosed;
- Second degree relatives of patients with type 1 diabetes; ③ Patients who could not complete regular outpatient follow-up. (3) Inclusion and exclusion criteria for healthy people:
- ①A definite diagnosis of type 1 diabetes in a first - or second-degree relative.
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
Peking University First Hospital
Beijing, Beijing Municipality
Nan Gu, +8613811135033, 13811135033@163.com
About this study
This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.
Read the detailed description
- For patients with type 1 diabetes, the intervention includes two aspects: Firstly, at the time of subject enrollment, a 12-hour structured course is conducted, covering various aspects such as diabetes diet, exercise, blood sugar monitoring, insulin injection, complication prevention, and psychological adjustment. Secondly, regular outpatient follow-ups are carried out, with a frequency of once every 3 months. The follow-up content includes routine outpatient visit-related items, such as blood sugar, islet function, liver and kidney function, blood lipid, etc., as well as screening for diabetes complications. Follow-ups are conducted regularly based on the time of type 1 diabetes diagnosis.
- For the first-degree relatives of patients with type 1 diabetes: At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination. Subsequently, follow-ups are conducted once a year, with blood sampling and collection of urine and stool samples for the same items as in the baseline follow-up.
- For healthy control populations, no follow-up arrangements are made. At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Gene polymorphic detection
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene polymorphic detectionGenetic
The follow-up visit period of T1D patients and their first-degree relatives was 4 years. Blood samples were collected every year for detection of gene polymorphism, determination of islet related autoantibodies, blood glucose, glycated hemoglobin, and islet function evaluation. Urine samples were collected for urinary proteomic determination. Stool samples were collected for the determination of stool intestinal flora.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in HbA1c in patients with type 1 diabetes
Changes in HbA1c in patients with type 1 diabetes at baseline and at 1, 2, 3, and 4 years of follow-up
Measured: From enrollment to the end of the study at 1,2,3,4 years
Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control
Albumin-to-Creatinine Ratio will be test in all of the participants
Measured: From enrollment to the end of the study at 1,2,3,4 years
Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control
Blood monitoring to assess genetic polymorphisms in all of the participants
Measured: From enrollment to the end of the study at 1,2,3,4 years
To establish screening and management paths for high-risk groups of type 1 diabetes patients
Establish an identification and screening system for high-risk groups of type 1 diabetes, as well as a standardized management pathway for these high-risk groups.
Measured: up to 4 years
Secondary outcomes (4)
Changes in disease self-management scores of patients with type 1 diabetes
use Adult Type 1 Diabetes Self-Management Scale to evaluate, the minimum value is 0, and the maximum value is 120, higher scores mean a better outcome.
Measured: From enrollment to the end of the study at 1,2,3,4 years
Changes of quality of life scores in patients with type 1 diabetes
use Diabetes-specific Quality of Life Measurement Scale to evaluate, This scale consists of 3 dimensions, namely satisfaction (15 items, with the lowest score being 15 and the highest score being 75), impact degree (20 items, with the lowest score being 20 and the highest score being 100), and anxiety level (11 items, with the lowest score being 11 and the highest score being 55). the lower scores mean a better outcome.
Measured: From enrollment to the end of the study at 1,2,3,4 years
Changes of mood scale scores in patients with type 1 diabetes
use Beck Depression Inventory Scale to evaluate, the minimum value is 0, and the maximum value is 63, lower scores mean a better outcome.
Measured: From enrollment to the end of the study at 1,2,3,4 years
The decline in C-peptide levels in patients with type 1 diabetes
the blood C-peptide will be test at baseline and at 1, 2, 3, and 4 years of follow-up
Measured: From enrollment to the end of the study at 1,2,3,4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Sep 2024
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe 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
- Prospective
- Enrolment
- 340 participants (estimated)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donghui Zhang, Principal investigator, Peking University First HospitalNan Gu, Study chair, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07468474
- Sponsor's protocol ID
- 2024-487-001
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07468474
- Acronym / sponsor ID
- 2024-487-001
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 12 Mar 2026 (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.
This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.
Detailed description
- For patients with type 1 diabetes, the intervention includes two aspects: Firstly, at the time of subject enrollment, a 12-hour structured course is conducted, covering various aspects such as diabetes diet, exercise, blood sugar monitoring, insulin injection, complication prevention, and psychological adjustment. Secondly, regular outpatient follow-ups are carried out, with a frequency of once every 3 months. The follow-up content includes routine outpatient visit-related items, such as blood sugar, islet function, liver and kidney function, blood lipid, etc., as well as screening for diabetes complications. Follow-ups are conducted regularly based on the time of type 1 diabetes diagnosis.
- For the first-degree relatives of patients with type 1 diabetes: At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination. Subsequently, follow-ups are conducted once a year, with blood sampling and collection of urine and stool samples for the same items as in the baseline follow-up.
- For healthy control populations, no follow-up arrangements are made. At the time of subject enrollment, blood samples are taken for genetic polymorphism testing, islet-related autoantibody determination, blood sugar, glycosylated hemoglobin, and islet function assessment; urine samples are collected for urine proteomics determination. Stool samples are collected for stool intestinal flora determination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It is planned to recruit 340 subjects meeting the inclusion criteria, including 40 healthy controls matching gender and age, 150 patients with T1D, and 150 first-degree relatives of T1D patients.
Key inclusion criteria (7 listed)
- First-degree relatives of patients with type 1 diabetes (including parents, children, siblings);
- Age ≥40 years old;
Key exclusion criteria (9 listed)
- ① Non-type 1 diabetic patients;
- Have used drugs that may affect blood sugar for more than 1 week within 12 weeks, such as oral/intravenous glucocorticoids, growth hormones, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc.; However, small doses of diuretics (hydrochlorothiazide < 25mg/d, indapamide ≤1.5mg/d) for antihypertensive purposes, and physiological dosages of thyroid hormones used for replacement therapy are not subject to this limit; (7) Systemic infection or serious concomitant disease; Patients with malignant tumors or chronic diarrhea; Other circumstances that cause the subjects to be unable to complete the study: such as serious cognitive dysfunction, mental illness, etc.;
- ⑨ The subject is uncooperative, unable to follow up, or the investigator judges that it may be difficult to complete the investigator;
- ⑩ Other conditions deemed unsuitable for inclusion by the investigator. The study physician will determine whether you are suitable for the study based on your actual condition and the inclusion and exclusion criteria in the study protocol.
- Inclusion and exclusion criteria for first-degree relatives of patients with type 1 diabetes:
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 |
|---|---|---|
| Gene polymorphic detectionThe follow-up visit period of T1D patients and their first-degree relatives was 4 years. Blood samples were collected every year for detection of gene polymorphism, determination of islet related autoantibodies, blood glucose, glycated hemoglobin, and islet function evaluation. Urine samples were collected for urinary proteomic determination. Stool samples were collected for the determination of stool intestinal flora. | Genetic | – |
Primary outcome
Changes in HbA1c in patients with type 1 diabetes
Time frame: From enrollment to the end of the study at 1,2,3,4 years
Changes in HbA1c in patients with type 1 diabetes at baseline and at 1, 2, 3, and 4 years of follow-up
Ther differences in Albumin-to-Creatinine Ratio between type 1 diabetic patients and first-degree relatives and healthy control
Time frame: From enrollment to the end of the study at 1,2,3,4 years
Albumin-to-Creatinine Ratio will be test in all of the participants
Ther differences in Genotype polymorphisms between type 1 diabetic patients and first-degree relatives and healthy control
Time frame: From enrollment to the end of the study at 1,2,3,4 years
Blood monitoring to assess genetic polymorphisms in all of the participants
To establish screening and management paths for high-risk groups of type 1 diabetes patients
Time frame: up to 4 years
Establish an identification and screening system for high-risk groups of type 1 diabetes, as well as a standardized management pathway for these high-risk groups.
4 secondary outcomes
Changes in disease self-management scores of patients with type 1 diabetes
Time frame: From enrollment to the end of the study at 1,2,3,4 years
Changes of quality of life scores in patients with type 1 diabetes
Time frame: From enrollment to the end of the study at 1,2,3,4 years
Changes of mood scale scores in patients with type 1 diabetes
Time frame: From enrollment to the end of the study at 1,2,3,4 years
The decline in C-peptide levels in patients with type 1 diabetes
Time frame: From enrollment to the end of the study at 1,2,3,4 years
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 12 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Donghui Zhang principal investigator
Peking University First Hospital
Nan Gu study chair
Peking University First Hospital
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 Type 1 Diabetes Mellitus, run by Peking University First Hospital 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 7 inclusion and 9 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 12 Mar 2026. 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?
Contact Nan Gu (+8613811135033, 13811135033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in HbA1c in patients with type 1 diabetes (time frame: From enrollment to the end of the study at 1,2,3,4 years). The study lists 4 primary outcomes in all. 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 12 Mar 2026.