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

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About this study

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.

Condition
Type 1 Diabetes
Tested
T1D team, structured education, peer support , and diabetes technologies, Routine Management
Sponsor
Second Xiangya Hospital of Central South University

Who can join

Age
6 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 16

  • Minimum age: 6 years
  • Study condition: Type 1 Diabetes
  • 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.

Exclusion 15

  • Patients who plan to receive diabetes treatment at other hospitals.
  • Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
  • Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
  • 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 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 severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.
  • Patients with auditory or visual impairments.
  • Patients with alcohol or drug abuse.
  • Patients who plan to receive blood transfusions during the study period.
  • Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.
  • Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.
  • Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.
  • 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

10 sites, 10 recruiting

Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University

Changsha, Hunan, China

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 and Metabolism, Peking University People's Hospital

Beijing, Beijing Municipality, China

Recruiting

Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Recruiting

Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health

Hangzhou, Zhejiang, China

Recruiting

Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, China

Recruiting

and 4 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.