Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 14
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •of study participants:
- •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.
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 13, 26, and 52 weeks
The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c) before and after the 52 weeks intervention. 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.
Change in HbA1c
时间窗: Baseline, 13, 26, and 52 weeks
The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c) before and after the 52 weeks intervention. 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 in each group with HbA1c <7.0%(52 weeks)
- Percentage of patients in each group with HbA1c <7.5%(52 weeks)
- CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-measured Percentage Time >180 mg/dL (>10.0 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-measured Percentage Time >250 mg/dL (>13.9 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Percentage Time <70 mg/dL (<3.9 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Percentage Time <60 mg/dL (<3.3 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-measured Glucose Standard Deviation (SD)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Glucose Coefficient of Variation(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Glucose Risk Index (GRI)(Baseline, 13, 26, and 52 weeks)
- Self-Management of Type 1 Diabetes for Chinese Adults(Baseline and 52 weeks)
- 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents(Baseline and 52 weeks)
- Assessment of sleep quality: Pittsburgh Sleep Quality Index(Baseline and 52 weeks)
- Hypoglycemic Fear Scale(Baseline and 52 weeks)
- Diabetes Technology Attitude Scale(Baseline and 52 weeks)
- Barriers to Technology(Baseline and 52 weeks)
- Diabetes Treatment Satisfaction Questionnaire(Baseline and 52 weeks)
- Diagnosis and measurement of the severity of depression: Patient Health Questionnaire(Baseline and 52 weeks)
- Depression Self-Rating Scale for Children(Baseline and 52 weeks)
- Generalized Anxiety Disorder 7-item scale(Baseline and 52 weeks)
- WHO-5 Well-Being Index(Baseline and 52 weeks)
- Evaluation of the perception of hypoglycemia in the population tested with Clarke score(Baseline and 52 weeks)
- Evaluation of the perception of hypoglycemia in the population tested with Gold score(Baseline and 52 weeks)
- Evaluation of the perception of hypoglycemia in the population tested with Gold score(Baseline and 52 weeks)
- Percentage of patients in each group with HbA1c <7.0%(52 weeks)
- Percentage of patients in each group with HbA1c <7.5%(52 weeks)
- Hypoglycemic Fear Scale(Baseline and 52 weeks)
- CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-measured Percentage Time >250 mg/dL (>13.9 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Percentage Time <70 mg/dL (<3.9 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Percentage Time <60 mg/dL (<3.3 mmol/L)(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Glucose Coefficient of Variation(Baseline, 13, 26, and 52 weeks)
- CGM-Measured Glucose Risk Index (GRI)(Baseline, 13, 26, and 52 weeks)
- Self-Management of Type 1 Diabetes for Chinese Adults(Baseline and 52 weeks)
- 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents(Baseline and 52 weeks)
- Assessment of sleep quality: Pittsburgh Sleep Quality Index(Baseline and 52 weeks)
- Diabetes Technology Attitude Scale(Baseline and 52 weeks)
- Diabetes Treatment Satisfaction Questionnaire(Baseline and 52 weeks)
- Diagnosis and measurement of the severity of depression: Patient Health Questionnaire(Baseline and 52 weeks)
- Depression Self-Rating Scale for Children(Baseline and 52 weeks)
- Generalized Anxiety Disorder 7-item scale(Baseline and 52 weeks)
- WHO-5 Well-Being Index(Baseline and 52 weeks)
- Evaluation of the perception of hypoglycemia in the population tested with Clarke score(Baseline and 52 weeks)
研究者
Xia Li
Professor
Second Xiangya Hospital of Central South University