Type 1 Diabetes MellitusT1DNCT07144696
Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients
A study testing structured education and regular follow-up in people with Type 1 Diabetes Mellitus, run by Peking University First Hospital at 1 site in China.
Trial summary
In this study, type 1 diabetes patients from the outpatient department of Peking University First Hospital were selected as the research objects. The investigators plan to recruit 150 participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- structured education and regular follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old;
- It meets the WHO diagnostic criteria for diabetes and is diagnosed as type 1 diabetes;
- Capable and willing to participate in a 12 hour structured education course training;
- Capable and willing to accept regular outpatient follow-up visits;
- Voluntarily participate in this study and sign informed consent.
Who cannot join
- Non adult type 1 diabetes, type 2 diabetes and other special types of diabetes;
- Severe microvascular complications: proliferative retinopathy; Urinary albumin/creatinine\>300mg/g, or 24-hour urinary protein quantification\>1g/d; Uncontrolled painful diabetes neuropathy and significant diabetes autonomic neuropathy;
- Individuals who have undergone vascular intervention or amputation due to acute cerebrovascular accidents, acute coronary syndrome, or peripheral arterial disease requiring hospitalization within the first 3 months of selection;
- Blood pressure remains above 180/110mmHg and cannot be controlled within 160/110mmHg within one week;
- Blood creatinine clearance rate is less than 30ml/min/1.73m2 (calculated according to CKDEPI formula), alanine aminotransferase is ≥ 3 times the normal upper limit, total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week;
- Have used drugs that may affect blood sugar for more than one week within the past 12 weeks, such as oral/intravenous glucocorticoids, growth hormone, estrogen/progesterone, high-dose diuretics, antipsychotic drugs, etc; However, low-dose diuretics for blood pressure lowering purposes (hydrochlorothiazide\<25mg/d, indapamide ≤ 1.5mg/d), as well as physiological doses of thyroid hormones used for replacement therapy, are not subject to this restriction;
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- Systemic infection or severe accompanying diseases; Patients with malignant tumors or chronic diarrhea;
- Other situations that cause participants to be unable to cooperate in completing the study, such as severe cognitive impairment, mental illness, etc.
- The subject is uncooperative, unable to follow up, or the researcher determines that they may have difficulty completing the study.
- Other situations deemed unsuitable for inclusion by researchers. The research doctor will determine whether you are suitable to participate in this study based on your actual situation and the inclusion and exclusion criteria in the research plan.
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
Nan Gu, 8601083575103, nan.gu@pkufh.cn
About this study
Official title: Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients by Structured Education
In this study, type 1 diabetes patients from the outpatient department of Peking University First Hospital were selected as the research objects. The investigators plan to recruit 150 participants. Using the course and teaching plan of \"Take Control of My Life - Structured Education for Type 1 diabetes\" issued by the China Type 1 diabetes Alliance, offline teaching is carried out regularly for type 1 diabetes patients, aiming to improve participants' knowledge and skills of disease self-management and improve participants' self-management behavior. The course content includes diabetes diet, exercise, blood glucose monitoring, insulin injection, complication prevention, psychological adjustment, etc. The training will take place at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up will be further carried out for patients to standardize their treatment behavior, improve their blood sugar compliance rate and delay the occurrence and development of diabetes complications. The subject visit is conducted on-site at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time is determined by medical staff based on the subject\'s condition. Each visit lasts 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting and postprandial blood glucose, C-peptide, glycosylated hemoglobin, islet autoantibodies, blood lipids, liver and kidney functions), and screen diabetes complications. At the time of enrollment and after 1 year of follow-up, diabetes related questionnaires mainly related to diabetes self-management behavior and psychological emotions.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- structured education and regular follow-up
- 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.
structured education and regular follow-upBehavioural
Regularly carry out structured diabetes courses for patients with type 1 diabetes and offline teaching at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up visits will be conducted for patients, with on-site visits conducted at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time nodes will be determined by medical staff based on the patient\&#39;s condition. Each visit will last 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting
| Study group | Role | What they receive |
|---|---|---|
| structured education and regular follow-up | Experimental | education and regular follow-up Receives: Behavioral: structured education and regular follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated hemoglobin
Glycated hemoglobin between 4%~6% is normal
Measured: At baseline and 1-year follow-up
Secondary outcomes (3)
self-management scale of type 1 diabetes for Chinese adults, SMOD-CA
the minimum and maximum values is 0 and 120, and higher scores means better outcome
Measured: At baseline and 1-year follow-up
adjusted diabetes quality of life，A-DQOL
the minimum and maximum values is 46 and 230, and higher scores means better outcome
Measured: At baseline and 1-year follow-up
Beck Depression Inventory, BDI
the minimum and maximum values is 0 and 40, 0-5 points means healthy,6-15 points means mild depressive,16-25 points means has symptoms of depression,26-40 points means severe or severe depressive symptoms
Measured: At baseline and 1-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start5 Aug 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Aug 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gu Nan, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144696
- Sponsor's protocol ID
- 2024-447-002
- Acronym
- T1D
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Improvement of Metabolic Indicators in Type 1 Diabetes Patients by Structured Education
- ClinicalTrials.gov ID
- NCT07144696
- Acronym / sponsor ID
- T1D / 2024-447-002
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 27 Aug 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.
In this study, type 1 diabetes patients from the outpatient department of Peking University First Hospital were selected as the research objects. The investigators plan to recruit 150 participants. Using the course and teaching plan of \"Take Control of My Life - Structured Education for Type 1 diabetes\" issued by the China Type 1 diabetes Alliance, offline teaching is carried out regularly for type 1 diabetes patients, aiming to improve participants' knowledge and skills of disease self-management and improve participants' self-management behavior. The course content includes diabetes diet, exercise, blood glucose monitoring, insulin injection, complication prevention, psychological adjustment, etc. The training will take place at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up will be further carried out for patients to standardize their treatment behavior, improve their blood sugar compliance rate and delay the occurrence and development of diabetes complications. The subject visit is conducted on-site at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time is determined by medical staff based on the subject\'s condition. Each visit lasts 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting and postprandial blood glucose, C-peptide, glycosylated hemoglobin, islet autoantibodies, blood lipids, liver and kidney functions), and screen diabetes complications. At the time of enrollment and after 1 year of follow-up, diabetes related questionnaires mainly related to diabetes self-management behavior and psychological emotions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| structured education and regular follow-up | Experimental | Behavioral: structured education and regular follow-upeducation and regular follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years old;
- It meets the WHO diagnostic criteria for diabetes and is diagnosed as type 1 diabetes;
- Capable and willing to participate in a 12 hour structured education course training;
- Capable and willing to accept regular outpatient follow-up visits;
- Voluntarily participate in this study and sign informed consent.
Key exclusion criteria (10 listed)
- Non adult type 1 diabetes, type 2 diabetes and other special types of diabetes;
- Severe microvascular complications: proliferative retinopathy; Urinary albumin/creatinine\>300mg/g, or 24-hour urinary protein quantification\>1g/d; Uncontrolled painful diabetes neuropathy and significant diabetes autonomic neuropathy;
- Individuals who have undergone vascular intervention or amputation due to acute cerebrovascular accidents, acute coronary syndrome, or peripheral arterial disease requiring hospitalization within the first 3 months of selection;
- Blood pressure remains above 180/110mmHg and cannot be controlled within 160/110mmHg within one week;
- Blood creatinine clearance rate is less than 30ml/min/1.73m2 (calculated according to CKDEPI formula), alanine aminotransferase is ≥ 3 times the normal upper limit, total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week;
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 |
|---|---|---|
| structured education and regular follow-upRegularly carry out structured diabetes courses for patients with type 1 diabetes and offline teaching at Peking University First Hospital. On the basis of structured courses, regular outpatient follow-up visits will be conducted for patients, with on-site visits conducted at the Endocrinology Clinic of Peking University First Hospital. The usual visit period is once every 1-3 months, and the specific follow-up time nodes will be determined by medical staff based on the patient\&#39;s condition. Each visit will last 1-3 hours, and each subject is expected to be followed up for 1 year. During each visit, collect the medical history and some personal information of the subjects, complete the routine physical examination, draw blood to test diabetes related indicators (including the determination of fasting | Behavioural | structured education and regular follow-up |
Primary outcome
Glycated hemoglobin
Time frame: At baseline and 1-year follow-up
Glycated hemoglobin between 4%~6% is normal
3 secondary outcomes
self-management scale of type 1 diabetes for Chinese adults, SMOD-CA
Time frame: At baseline and 1-year follow-up
adjusted diabetes quality of life，A-DQOL
Time frame: At baseline and 1-year follow-up
Beck Depression Inventory, BDI
Time frame: At baseline and 1-year follow-up
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 4 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing structured education and regular follow-up in people with 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 5 inclusion and 10 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 4 Sep 2025. 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 Donghui D Zhang (+8613811135033, 13811135033@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated hemoglobin (time frame: At baseline and 1-year follow-up). 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 4 Sep 2025.