Recruiting

Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2

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.

ClinicalTrials.gov IDNCT07097818
PhaseNA
Enrollment400
SponsorSecond Xiangya Hospital of Central South University
Age6 Years
SexALL
I'm interested View official listing

Conditions studied

Type 1 Diabetes

About this study

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.

Interventions

Primary outcomes

Eligibility information

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.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.