New study aims to predict type 1 diabetes before it strikes
NCT ID NCT07468474
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is working to create a system that can identify people at high risk for type 1 diabetes. Researchers will follow 340 people, including patients with type 1 diabetes and their close relatives, for four years. They will collect blood, urine, and stool samples each year to look for genetic markers, autoantibodies, and other clues that might predict who will develop the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to a reliable screening method to identify people at high risk for type 1 diabetes before symptoms appear.
- What could go wrong
- This is an observational study, not a treatment trial. It may not result in a practical screening tool, and findings may not apply to all populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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4 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
1. Inclusion and exclusion criteria for patients with type 1 diabetes: Inclusion criteria: * 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. Exclusion criteria: 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; (6) 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. (2) Inclusion and exclusion criteria for first-degree relatives of patients with type 1 diabetes: Inclusion criteria: * 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. Exclusion criteria: * 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: Inclusion criteria: * 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. Exclusion criteria: ①A definite diagnosis of type 1 diabetes in a first - or second-degree relative.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, China
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