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临床试验 NCT07097805 针对1型糖尿病 (T1D)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study 3,000
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临床试验NCT07097805是一项针对1型糖尿病 (T1D)的干预性研究试验，目前试验状态为招募中。试验始于2025年1月1日，计划招募3,000名患者。该研究由Second Xiangya Hospital of Central South University主导，预计于2028年3月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年7月31日。
简要概括
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...显示更多
官方标题
Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study
疾病
1型糖尿病 (T1D)其他研究标识符
- KYZ20240193
NCT编号
实际开始日期
2025-01-01
最近更新发布
2025-07-31
预计完成日期
2028-03-01
计划入组人数
3,000
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
关键词
Type 1 diabetes
Comprehensive management
Comprehensive management
主要目的
支持治疗
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他T1D Patients All patients diagnosed with type 1 diabetes of all ages. | GLITTER comprehensive management The GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Change in HbA1c | 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. | Trough study completion, an average of 1 year |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Percentage of patients using continuous glucose monitors | The percentage of participants who initiate and maintain active use of a continuous glucose monitor (CGM) trough study completion. Active use is defined as wearing the CGM sensor and having recorded glucose data available. Confirmation will be based on CGM device data download or patient self-reported daily wear logs verified by research staff or electronic adherence monitoring from the CGM cloud platform. | Trough study completion, an average of 1 year |
Percentage of patients using insulin pump | Proportion of enrolled patients maintaining active insulin pump use during follow-up, defined as consistent pump utilization confirmed by either:
1. Device data download demonstrating functional use; or
2. Clinician-verified patient logbook records with corroborating evidence. | Trough study completion, an average of 1 year |
Diabetes-related complications | Diabetes-related complications encompass microvascular disorders (diabetic retinopathy, nephropathy, neuropathy), macrovascular complications (coronary artery disease, cerebrovascular disease, peripheral arterial disease), neuropathic complications (peripheral neuropathy, autonomic neuropathy), diabetic foot syndrome, and acute metabolic events (severe hypoglycemia, ketoacidosis, hyperosmolar hyperglycemic state, diabetic lactic acidosis). | Trough study completion, an average of 1 year |
Urine Albumin-to-Creatinine Ratio | Normal: \<30 mg/g；Microalbuminuria: 30-300 mg/g；Macroalbuminuria: \>300 mg/g | Trough study completion, an average of 1 year |
Change in titer of autoantibodies | Islet autoantibodies represent serological markers of autoimmune destruction targeting pancreatic β-cell antigens, serving as pivotal biomarkers for T1D pathogenesis. | Trough study completion, an average of 1 year |
Change in C-peptide | C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study. | Trough study completion, an average of 1 year |
Change in blood glucose | Blood glucose are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study. | Trough study completion, an average of 1 year |
Systolic blood pressure | Systolic blood pressure | Trough study completion, an average of 1 year |
Diastolic blood pressure | Diastolic blood pressure | Trough study completion, an average of 1 year |
Change in lipid profiles | Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol | Trough study completion, an average of 1 year |
Self-Management of Type 1 Diabetes for Chinese Adults | The Self-Management of Type 1 Diabetes for Chinese Adults (SMOD-CA) scale is a validated instrument specifically designed to assess the self-management behaviors and capabilities of adults with type 1 diabetes in the Chinese population. The SMOD-CA consists of 30 items. Responses are rated on a five-point scale, with higher scores indicating better self-management ability. The total score ranges from 0 to 120. | 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 | The 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents (C-SMOD-A-23) is a validated and simplified instrument designed to assess the self-management behaviors and capabilities of adolescents with type 1 diabetes. | Trough study completion, an average of 1 year |
Chinese version of the Diabetes Quality of Life for Youth Scale Short Form | The Chinese version of the Diabetes Quality of Life for Youth Scale Short Form (C-DQOLY-SF) is a psychometrically tested instrument designed to assess the quality of life in adolescents with type 1 diabetes. The scale consists of 25 items that measure various aspects of life satisfaction, diabetes impact, and diabetes-related worry. | Trough study completion, an average of 1 year |
Athens Insomnia Scale | The Athens Insomnia Scale (AIS) is a self-assessment tool used to evaluate the presence and severity of insomnia symptoms. The total score provides a quantitative measure of insomnia severity, with higher scores indicating more significant sleep disturbances. | Trough study completion, an average of 1 year |
Depression Self-Rating Scale for Children | The Depression Self-Rating Scale for Children (DSRSC) is a standardized psychological assessment tool designed to measure depressive symptoms in children and adolescents. This self-report inventory allows young individuals to rate the frequency and severity of various depressive feelings and behaviors they may be experiencing. | Trough study completion, an average of 1 year |
Diagnosis and measurement of the severity of depression: Patient Health Questionnaire | The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression. | Trough study completion, an average of 1 year |
Generalized Anxiety Disorder 7-item scale | The Generalized Anxiety Disorder 7-item scale (GAD-7) consists of seven items. Each item asks respondents to rate how often they have been bothered by specific anxiety-related symptoms over the past two weeks. | Trough study completion, an average of 1 year |
WHO-5 Well-Being Index | The WHO-5 Well-Being Index (WHO-5) is a brief, self-report questionnaire designed to assess subjective well-being. The WHO-5 consists of five simple and straightforward items. Each item is rated on a 6-point Likert scale, ranging from 0 (not present) to 5 (constantly present). The total score is calculated by summing the responses to all five items, resulting in a score that ranges from 0 to 25. Higher scores indicate better well-being. | Trough study completion, an average of 1 year |
Mini-EAT | The Mini-Eating Assessment Tool, is a brief dietary assessment scale designed to evaluate the quality of an individual's diet. It is a concise tool that aims to provide a quick yet effective measure of dietary habits and nutrition intake. | Trough study completion, an average of 1 year |
参与助手
资格标准
适龄参与研究
儿童, 成人, 老年人
适龄性别
全部
1. 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
Second Xiangya Hospital of Central South University研究责任方
Xia Li, 主要研究者, Professor, Second Xiangya Hospital of Central South University
研究中心联系人
联系人: Xia Li, +86 13974885753, [email protected]
10 位于 1 个国家/地区的研究中心
Beijing Municipality
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, Beijing Municipality, China
Xiaoling Cai, 联系人
招募中
Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Chang Liu, 联系人
招募中
Guangdong
Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Jinhua Yan, 联系人
招募中
Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China
Haiyan Li, 联系人
招募中
Henan
Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, China
Hongwei Jiang, 联系人
招募中
Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan, 410011, China
Xia Li, 联系人, +86 13974885753, [email protected]
招募中
Jiangsu
Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China
Mei Zhang, 联系人
招募中
Liaoning
Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Yanli Cao, 联系人
招募中
Sichuan
Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Nanwei Tong, 联系人
招募中
Zhejiang
Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, China
Junfen Fu, 联系人
招募中