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L'essai clinique NCT07097805 pour Diabète de type 1 (DT1) est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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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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L'essai clinique NCT07097805 est une étude interventionnel pour Diabète de type 1 (DT1). Son statut actuel est : en recrutement. L'étude a débuté le 1 janvier 2025 et vise à recruter 3 000 participants. Dirigée par Second Xiangya Hospital of Central South University, l'étude devrait être terminée d'ici le 1 mars 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 31 juillet 2025.
Résumé succinct
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.
Description détaillée
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...Afficher plus
Titre officiel
Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study
Pathologies
Diabète de type 1 (DT1)Autres identifiants de l'étude
- KYZ20240193
Numéro NCT
Date de début (réel)
2025-01-01
Dernière mise à jour publiée
2025-07-31
Date de fin (estimée)
2028-03-01
Inscription (estimée)
3 000
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Type 1 diabetes
Comprehensive management
Comprehensive management
Objectif principal
Soins de soutien
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
AutreT1D 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. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
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 |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Enfant, Adulte, Adulte âgé
Sexes éligibles
Tous
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 UniversityPartie responsable de l'étude
Xia Li, Investigateur principal, Professor, Second Xiangya Hospital of Central South University
Contact central de l'étude
Contact: Xia Li, +86 13974885753, [email protected]
10 Centres de l'étude dans 1 pays
Beijing Municipality
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, Beijing Municipality, China
Xiaoling Cai, Contact
En recrutement
Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University, Beijing, Beijing Municipality, China
Chang Liu, Contact
En recrutement
Guangdong
Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
Jinhua Yan, Contact
En recrutement
Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China
Haiyan Li, Contact
En recrutement
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, Contact
En recrutement
Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan, 410011, China
Xia Li, Contact, +86 13974885753, [email protected]
En recrutement
Jiangsu
Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, 210029, China
Mei Zhang, Contact
En recrutement
Liaoning
Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Yanli Cao, Contact
En recrutement
Sichuan
Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Nanwei Tong, Contact
En recrutement
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, Contact
En recrutement