Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT07097818
Status:
RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-07-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2
Sponsor:
Second Xiangya Hospital of Central South University
Organization:
Study Overview
Official Title:
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: