NCT07097818 Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2
| NCT ID | NCT07097818 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Xiangya Hospital of Central South University |
| Condition | Type 1 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-08-18 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Xia Li, MD, PhD
PRINCIPAL INVESTIGATOR
Second Xiangya Hospital of Central South University
Frequently Asked Questions
Who can join the NCT07097818 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Type 1 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07097818 currently recruiting?
Yes, NCT07097818 is actively recruiting participants. Contact the research team at lixia2014@vip.163.com for enrollment information.
Where is the NCT07097818 trial being conducted?
This trial is being conducted at Beijing, China, Quanzhou, China, Shenzhen, China, Tangshan, China and 6 additional locations.
Who is sponsoring the NCT07097818 clinical trial?
NCT07097818 is sponsored by Second Xiangya Hospital of Central South University. The principal investigator is Xia Li, MD, PhD at Second Xiangya Hospital of Central South University. The trial plans to enroll 400 participants.
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