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

Central South University

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Behavioral: Routine Management; Behavioral: T1D team, structured education, peer support , and diabetes technologies

Study type: Interventional

Funder types: Other

Identifiers

NCT07097818

KYZ20250019

Details and patient eligibility

About

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.

Full description

Type 1 diabetes (T1D) is a lifelong metabolic disease with an increasing disease burden. Despite continuous advancements in diagnostic and treatment technologies, patients of all age groups fail to meet the glycemic targets. Currently, there is a common deficiency in the management of T1D both domestically and internationally, which is specifically manifested as: the disconnection between blood glucose monitoring and insulin adjustment, low utilization rate of new technologies, insufficient patient self-management training, and the absence of psychological intervention, etc.

This GLITTER Study 2 extends the GLITTER Study (Glycemic Improvement with Team, Technology, Education and Peer Resources in type 1 diabetes) by implementing its philosophy (Team, Technology, Education, Peer Resources) to develop a comprehensive T1D management model, integrating these components to enhance management and evaluate effectiveness.

This multicentre, cluster-randomized controlled trial will be conducted across 10 hospitals. It aims to enroll patients with T1D aged ≥6 years who have had the disease for >3 months. Five hospitals were randomly assigned to the comprehensive management intervention group, and five to the usual care group. A total of 400 individuals were recruited into the study. The intervention for the intervention group includes: T1D team (dedicated T1D physicians, certified diabetes educators, registered dietitians), centralized structured education (courses, short videos, and structured educational materials), peer support (volunteer matching, camp, volunteer peer live streaming), and diabetes technologies (insulin pumps and continuous glucose monitoring). The control group received usual care, with the five assigned hospitals continuing their clinical practice. This 52-week trial includes assessments at the following timepoints: screening, week 13 (visit 2), week 26 (visit 3), week 39 (visit 4), and week 52 (visit 5). Throughout the study period, we will evaluate the model's impact on glycemic control and psychosocial outcomes, aiming to establish an evidence-based clinical practice paradigm for T1D management.

Enrollment: 400 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

400 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients with T1D in the intervention group will undergo comprehensive management.

Treatment:

Behavioral: T1D team, structured education, peer support , and diabetes technologies

Control group

Other group

Description:

Patients with T1D in the control group will receive routine management.

Treatment:

Behavioral: Routine Management