Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Genetic: Gene polymorphic detection

Detailed Description

1. 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.
2. 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.
3. 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 Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Nan Gu; Phone Number: +8613811135033; Email: 13811135033@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China
      • Recruiting
      • Peking University First Hospital
      • Contact: Nan Gu; Phone Number: +8613811135033; Email: 13811135033@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	up to 4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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	From enrollment to the end of the study at 1,2,3,4 years

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Investigators: Principal Investigator: Donghui Zhang, Peking University First Hospital; Study Chair: Nan Gu, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2024-487-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No