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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
  Luoyang, Henan, China Recruiting
• Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University
  Changsha, Hunan, China Recruiting
• 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

Study contacts

• Principal investigator: Xia Li, MD, PhD — Second Xiangya Hospital of Central South University
• Study coordinator: Xia Li
• Email: lixia2014@vip.163.com
• Phone: +86 13974885753

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.