Type 1 Diabetes MellitusNCT04096794
Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
An observational study of Type 1 Diabetes Mellitus, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2016to Sep 2027
- How long will I take part?
- 3 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: type 1 diabetes patients
Who may be able to join
- Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
- Written informed consent from the patient or family representative;
- Individuals who own smartphone and are capable of using wechat or apps
Who cannot join
- Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease
- With mental disorders
- Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
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
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Zhiguang Zhou, MD/PhD, 86-731-85292154, zhouzg@hotmail.com
About this study
The China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.
Read the detailed description
- Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.
- observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.
- Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.
- By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.
- Conditions
- Type 1 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 1
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in serum hemoglobin A1c level
A1c reflects the average blood glucose level in the past 3 months.
Measured: Baseline and every up to 12 weeks afterwards
Secondary outcomes (11)
changes in Time in range (TIR)
TIR measures the time where the blood glucose remains within the proposed target range.
Measured: Baseline and every up to 12 weeks afterwards
C-peptide
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study
Measured: Baseline and every up to 12 weeks afterwards
Change in titer of autoantibodies
Measured: Baseline and every up to 12 weeks afterwards
Fasting blood glucose
the blood sugar level after fasting for eight hours
Measured: Baseline and every up to 12 weeks afterwards
Systolic blood pressure
Systolic blood pressure
Measured: Baseline and every up to 12 weeks afterwards
Diastolic blood pressure
Diastolic blood pressure
Measured: Baseline and every up to 12 weeks afterwards
Change in lipid profiles
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Measured: Baseline and every up to 12 weeks afterwards
Height in meters
Height in meters will be measured
Measured: Baseline and every up to 12 weeks afterwards
Weight in kilograms
Weight in kilograms will be measured
Measured: Baseline and every every up to 12 weeks afterwards
Stool samples
Measured: Baseline and every up to 12 weeks afterwards
Adverse effects
Adverse effects are recorded at each time-point of the follow-up
Measured: Baseline and every up to 12 weeks afterwards
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study startSep 2016
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 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
- NCT04096794
- Sponsor's protocol ID
- CAT1D2019CS0011
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2019
- Last updated
- 21 Apr 2023
- Results posted
- No
- 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 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
- ClinicalTrials.gov ID
- NCT04096794
- Acronym / sponsor ID
- CAT1D2019CS0011
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Sep 2019 (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 China Alliance for Type 1 Diabetes (CAT1D) is committed to exploring and implementing the model of graded diagnosis and treatment of type 1 diabetes and comprehensive management of outpatient service, carrying out a series of educational activities for patients, and cooperating in the development of multi-center prospective clinical research on type 1 diabetes.
Detailed description
- Through the CAT1D, expand the cohort construction of type 1 diabetes patients and first-level relatives in China, establish the electronic information database of type 1 diabetes, and lay a foundation for obtaining the research data of type 1 diabetes in China.
- observe and study the occurrence and development rules of acute and chronic complications of type 1 diabetes in China, analyze the influencing factors, and provide intervention means for reducing acute complications and preventing chronic complications.
- Through the established management platform and structured education system, verify and promote the comprehensive management mode based on structured education, and build a standard treatment plan and process based on evidence-based science and suitable for Chinese people and medical background.
- By using mobile health (mHealth) and Artificial Intelligence (AI) technologies, a new mode of intelligent structured education is established, which provides a new way to explore the individualized education management mode and improve the outcome of chronic diseases through modern technology.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- type 1 diabetes patients
Key inclusion criteria (3 listed)
- Individuals diagnosed with Type 1 Diabetes according to the 1999 World Health Organization report
- Written informed consent from the patient or family representative;
- Individuals who own smartphone and are capable of using wechat or apps
Key exclusion criteria (3 listed)
- Non-t1dm patients with autoimmune polyendocrine adenopathy syndrome (APS) are the first disease
- With mental disorders
- Have any other condition or disease that may hamper from compliance with the protocol or complication of the trial
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
changes in serum hemoglobin A1c level
Time frame: Baseline and every up to 12 weeks afterwards
A1c reflects the average blood glucose level in the past 3 months.
11 secondary outcomes
changes in Time in range (TIR)
Time frame: Baseline and every up to 12 weeks afterwards
C-peptide
Time frame: Baseline and every up to 12 weeks afterwards
Change in titer of autoantibodies
Time frame: Baseline and every up to 12 weeks afterwards
Fasting blood glucose
Time frame: Baseline and every up to 12 weeks afterwards
Systolic blood pressure
Time frame: Baseline and every up to 12 weeks afterwards
Diastolic blood pressure
Time frame: Baseline and every up to 12 weeks afterwards
Change in lipid profiles
Time frame: Baseline and every up to 12 weeks afterwards
Height in meters
Time frame: Baseline and every up to 12 weeks afterwards
Weight in kilograms
Time frame: Baseline and every every up to 12 weeks afterwards
Stool samples
Time frame: Baseline and every up to 12 weeks afterwards
Adverse effects
Time frame: Baseline and every up to 12 weeks afterwards
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 21 Apr 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Type 1 Diabetes Mellitus
Active, not recruiting
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
Type 1 Diabetes
Not yet recruiting
Outpatient Pramlintide Study
Type 1 Diabetes
Active, not recruitingPhase 2
Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)
Type 1 Diabetes Mellitus
Active, not recruitingPhase 2
Probiotics in Newly Diagnosed T1D
Type 1 Diabetes, Type1diabetes
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
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.
Institute of Metabolism and Endocrinology, Second Xiangya Hospital, Central South University
Changsha, China
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 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 3 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 21 Apr 2023. 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?
changes in serum hemoglobin A1c level (time frame: Baseline and every up to 12 weeks afterwards). 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 21 Apr 2023.