Glycemic Improvement Project (GLITTER) for Type 1 Diabetes: a comprehensive management program

Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial

This project will test whether combining dedicated T1D care teams, diabetes technology, structured education, and peer support helps people with type 1 diabetes aged 6 and older improve blood sugar control and psychological well-being.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 6 Years and up
• Sex: All
• Sponsor: Second Xiangya Hospital of Central South University (other)
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT07097818 on ClinicalTrials.gov

What this trial studies

GLITTER Study 2 is a multicenter, cluster-randomized trial conducted across 10 hospitals in China that enrolled 400 people with type 1 diabetes aged ≥6 years. Five hospitals deliver a comprehensive intervention package—dedicated T1D teams (physicians, certified educators, dietitians), centralized structured education (courses, videos, camps), peer resources, and diabetes technologies such as continuous glucose monitoring and insulin pumps—while five hospitals provide usual care. Participants must be able to use study devices, upload data for remote monitoring, and attend follow-up visits at the enrolling hospital. The trial measures metabolic outcomes (glycemic control) and psychological outcomes to determine whether the integrated model yields better clinical and psychosocial results than routine management.

Who should consider this trial

Good fit: Ideal candidates are people with diagnosed type 1 diabetes aged 6 years or older with disease duration over 3 months who can attend follow-up at a participating hospital and are willing and able to use continuous glucose monitoring/insulin pumps and participate in education and remote monitoring.

Not a fit: Patients unlikely to benefit include those unable or unwilling to use the required diabetes technologies or attend local follow-up and education sessions, or those lacking the cognitive ability to operate study devices.

Why it matters

Potential benefit: If successful, this model could improve blood glucose control and mental health for people with type 1 diabetes by increasing appropriate use of technology, structured self-management skills, and team-based support.

How similar studies have performed: Previous programs combining multidisciplinary teams, structured education, and diabetes technology have shown improvements in glycemic control and quality of life, but fully integrated cluster-randomized evaluations of all four components together remain limited.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 9 other locations

• Department of Endocrinology and Metabolism, Peking University People's Hospital — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)
• Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University — Quanzhou, Fujian, China (NOT_YET_RECRUITING)
• Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University — Shenzhen, Guangdong, China (NOT_YET_RECRUITING)
• Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital — Tangshan, Hebei, China (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, China (RECRUITING)
• Department of Endocrinology, Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University — Changsha, Hunan, China (RECRUITING)
• Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (NOT_YET_RECRUITING)
• Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Xia Li, MD, PhD — Second Xiangya Hospital of Central South University
• Study coordinator: Xia Li

Conditions: Type 1 Diabetes, Type 1 diabetes, Comprehensive management, T1D teams, Structured education, Peer resources, Diabetes technologies, Glycemic control