Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 10
- 主要终点
- Change in HbA1c
研究概览
简要总结
The GLITTER study is comprised of four key components: Team, Technology, Education, and Peer Resources. The aim of the GLITTER Study is to improve the metabolic control rate in patients with type 1 diabetes through a comprehensive management approach.
详细描述
Patients with type 1 diabetes (T1D) face significant glycemic fluctuations, posing substantial challenges in disease management. Current clinical evidence indicates that although interventions such as structured education programs, peer support, and novel diabetes technologies demonstrate positive outcomes when applied individually, the glycemic target attainment rate remains suboptimal, with fewer than 30% achieving this benchmark. To address this clinical dilemma, the investigators has proposed the GLITTER (Glycemic Improvement with Team, Technology, Education and Peer Resources in type 1 diabetes) study, which aims to establish a four-in-one integrated management model combining multidisciplinary collaborative teams, structured educational frameworks, peer support systems, and diabetes technologies. The research team comprises T1D-specialized physicians and diabetes educators. Structured education is delivered through dedicated T1D specialty clinics and by local clinicians. Technological support involves informing patients about access to continuous glucose monitors (CGM) and insulin pumps without mandating their use, while peer support is established through patient communication groups (volunteer matching mechanisms are not yet implemented). This GLITTER study seeks to achieve dual objectives: population-wide coverage and whole-disease-course management for individuals with T1D.
This is a multicenter, prospective, cohort study. This longitudinal investigation systematically collects multidimensional clinical datasets encompassing glycemic control parameters, pancreatic β-cell function, and complication risk profiles through regular follow-up visits. This study explores the metabolic control, psychological outcomes, and their associated influencing factors among patients with T1D.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with type 1 diabetes of all age groups, regardless of disease duration.
- •The diagnosis criteria for type 1 diabetes are met by fulfilling any one point from the first two criteria plus any one point from the third criterion.
- •Clinically diagnosed as Type 1 Diabetes by a specialist physician.
- •Meet any one of the following criteria:
- •A. Age of onset <15 years B. No obesity at the time of onset C. diabetic ketoacidosis onset D. Maximum random C-peptide <200 pmol/L
- •Meet any one of the following criteria:
- •A. Initiation and continuation of insulin therapy after diagnosis (excluding pancreas or islet transplantation) B. Positive for islet cell antibodies
排除标准
- 未提供
结局指标
主要结局
Change in HbA1c
时间窗: Trough study completion, an average of 1 year
The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c). HbA1c is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.
次要结局
- Percentage of patients using continuous glucose monitors(Trough study completion, an average of 1 year)
- Diabetes-related complications(Trough study completion, an average of 1 year)
- Percentage of patients using insulin pump(Trough study completion, an average of 1 year)
- Urine Albumin-to-Creatinine Ratio(Trough study completion, an average of 1 year)
- Change in titer of autoantibodies(Trough study completion, an average of 1 year)
- Diastolic blood pressure(Trough study completion, an average of 1 year)
- Change in blood glucose(Trough study completion, an average of 1 year)
- Systolic blood pressure(Trough study completion, an average of 1 year)
- Change in C-peptide(Trough study completion, an average of 1 year)
- Change in lipid profiles(Trough study completion, an average of 1 year)
- Self-Management of Type 1 Diabetes for Chinese Adults(Trough study completion, an average of 1 year)
- 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents(Trough study completion, an average of 1 year)
- Chinese version of the Diabetes Quality of Life for Youth Scale Short Form(Trough study completion, an average of 1 year)
- Athens Insomnia Scale(Trough study completion, an average of 1 year)
- Depression Self-Rating Scale for Children(Trough study completion, an average of 1 year)
- Diagnosis and measurement of the severity of depression: Patient Health Questionnaire(Trough study completion, an average of 1 year)
- Generalized Anxiety Disorder 7-item scale(Trough study completion, an average of 1 year)
- WHO-5 Well-Being Index(Trough study completion, an average of 1 year)
- Mini-EAT(Trough study completion, an average of 1 year)
研究者
Xia Li
Professor
Second Xiangya Hospital of Central South University