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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
3,000
The GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support.
Department of Endocrinology and Metabolism, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGDepartment of Endocrinology, Beijing Tongren Hospital, Capital Medical University
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.
Time frame: Trough study completion, an average of 1 year
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.
Time frame: 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.
Time frame: 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).
Time frame: Trough study completion, an average of 1 year
Urine Albumin-to-Creatinine Ratio
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Beijing, Beijing Municipality, China
Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGDepartment of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong, China
RECRUITINGEndocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGInstitute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University
Changsha, Hunan, China
RECRUITINGDepartment of Endocrinology, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGDepartment of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
RECRUITINGDepartment of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGDepartment of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health
Hangzhou, Zhejiang, China
RECRUITINGNormal: \<30 mg/g；Microalbuminuria: 30-300 mg/g；Macroalbuminuria: \>300 mg/g
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Trough study completion, an average of 1 year
Systolic blood pressure
Systolic blood pressure
Time frame: Trough study completion, an average of 1 year
Diastolic blood pressure
Diastolic blood pressure
Time frame: Trough study completion, an average of 1 year
Change in lipid profiles
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Trough study completion, an average of 1 year