NCT07097818Recruiting
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial
Source: ClinicalTrials.gov · Last updated 3 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- First submitted
- 24 Jul 2025
- Start date
- 18 Aug 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07097818
What you commit to
- Study type: Interventional
- Planned participants: 400
- From 18 Aug 2025 to the primary completion date, 1 Mar 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
- Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening.
- 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.
- Patients with alcohol or drug abuse.
- Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.
- Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.
Other illness
- Patients who plan to receive diabetes treatment at other hospitals.
- Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.
- Patients diagnosed with hematologic or bleeding disorders.
- 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.
Lab values
- Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
- Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.
Other
- Patients with auditory or visual impairments.
- Patients who plan to receive blood transfusions during the study period.
- Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.
Criteria the registry did not label
- Eligibility criteria for study hospitals:
- Members of the China Diabetes Type 1 Study (CD1S).
- Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.
- Have type 1 diabetes educators.
- Eligibility criteria of study participants:
- Diagnosis of Type 1 Diabetes.
- Age ≥6 years, regardless of gender.
- Duration of disease \>3 months.
- Planned to attend follow-up visits at this hospital within the next year.
- Possess sufficient cognitive ability to operate all study-related devices.
- Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring.
- Willing to attend structured education sessions and camp activities on time (for the intervention group only).
- Willing and able to adhere to the study protocol.
- Willing to sign the informed consent form.
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Endocrinology and Metabolism, Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University Coordinator of this site? Confirm its status | Changsha | China | Recruiting |
| Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health Coordinator of this site? Confirm its status | Hangzhou | China | Not yet recruiting |
| Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology Coordinator of this site? Confirm its status | Luoyang | China | Recruiting |
| Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University Coordinator of this site? Confirm its status | Quanzhou | China | Not yet recruiting |
| Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University Coordinator of this site? Confirm its status | Shenzhen | China | Not yet recruiting |
| Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital Coordinator of this site? Confirm its status | Tangshan | China | Not yet recruiting |
| Department of Endocrinology, Zhongnan Hospital of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.