Second Xiangya Hospital of Central South University
Phase
Not applicable
Started
2025-08-18
Last updated
2025-09-03
Condition(s) studied
Type 1 Diabetes
Investigational drug(s) / intervention(s)
T1D team, structured education, peer support , and diabetes technologiesRoutine Management
T1D team, structured education, peer support , and diabetes technologies: Patients with T1D will use insulin pumps and CGM , while undergoing structured education courses under the management of a specialized T1D team and engaging in peer support activities.
Routine Management: Patients with T1D will be managed according to the routine diagnosis and education model of each hospital.
Study summary
The GLITTER Study 2 is a cluster randomized trial that will evaluate the impact of comprehensive and intensive management, comprising a team, technology, education, and peer resources, on metabolic control and psychological outcomes in patients with type 1 diabetes.
Eligibility
Sex
ALL
Min age
6 Years
Max age
—
Healthy volunteers
No
Eligibility criteria for study hospitals:
1. Members of the China Diabetes Type 1 Study (CD1S).
2. Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.
3. Have type 1 diabetes educators.
Eligibility criteria of study participants:
1. Diagnosis of Type 1 Diabetes.
2. Age ≥6 years, regardless of gender.
3. Duration of disease \>3 months.
4. Planned to attend follow-up visits at this hospital within the next year.
5. Possess sufficient cognitive ability to operate all study-related devices.
6. Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring.
7. Willing to attend structured education sessions and camp activities on time (for the intervention group only).
8. Willing and able to adhere to the study protocol.
9. Willing to sign the informed consent form.
Exclusion Criteria of study participants:
1. Patients who plan to receive diabetes treatment at other hospitals.
2. Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
3. Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
4. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.
5. Patients diagnosed with hematologic or bleeding disorders.
6. Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening.
7. Patients who have used any oral, injectable, or intravenous corticosteroids within 8 weeks prior to screening, or who plan to use corticosteroids during the trial.
8. Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.
9. Patients with auditory or visual impairments.
10. Patients with alcohol or drug abuse.
11. Patients who plan to receive blood transfusions during the study period.
12. Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.
13. Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.
14. Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.
15. Patients who, in the investigator's opinion, are not suitable for participation in this clinical trial, such as those with a history of vision impairment, eating disorders, celiac disease, etc.
Primary outcome measure(s)
Change in HbA1c — Baseline, 13, 26, and 52 weeks The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c) before and after the 52 weeks intervention. HbA1c is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.
Trial sites (10)
Facility
City
Region
Status
Department of Endocrinology and Metabolism, Peking University People's Hospital
Beijing
Beijing Municipality
Not Yet Recruiting
Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou
Fujian
Not Yet Recruiting
Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University
Shenzhen
Guangdong
Not Yet Recruiting
Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital
Tangshan
Hebei
Not Yet Recruiting
Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang
Henan
Recruiting
Department of Endocrinology, Zhongnan Hospital of Wuhan University
Wuhan
Hubei
Not Yet Recruiting
Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University
Changsha
Hunan
Recruiting
Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University
Shenyang
Liaoning
Not Yet Recruiting
Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University
Chengdu
Sichuan
Not Yet Recruiting
Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health
Hangzhou
Zhejiang
Not Yet Recruiting
More Second Xiangya Hospital of Central South University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.