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Recruiting NCT07097805

Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study

No phase Interventional Type 1 Diabetes (T1D)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: GLITTER comprehensive management.
Who it may be relevant to
Registry conditions: Type 1 Diabetes (T1D). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Change in HbA1c [Time frame: Trough study completion, an average of 1 year]
Secondary outcome measures (12)
  • Percentage of patients using continuous glucose monitors [Time frame: Trough study completion, an average of 1 year]
  • Percentage of patients using insulin pump [Time frame: Trough study completion, an average of 1 year]
  • Diabetes-related complications [Time frame: Trough study completion, an average of 1 year]
  • Urine Albumin-to-Creatinine Ratio [Time frame: Trough study completion, an average of 1 year]
  • Change in titer of autoantibodies [Time frame: Trough study completion, an average of 1 year]
  • Change in C-peptide [Time frame: Trough study completion, an average of 1 year]
  • Change in blood glucose [Time frame: Trough study completion, an average of 1 year]
  • Systolic blood pressure [Time frame: Trough study completion, an average of 1 year]
  • Diastolic blood pressure [Time frame: Trough study completion, an average of 1 year]
  • Change in lipid profiles [Time frame: Trough study completion, an average of 1 year]
  • Self-Management of Type 1 Diabetes for Chinese Adults [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 [Time frame: Trough study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

China · 10 centers
  • Department of Endocrinology and Metabolism, Peking University People's Hospital — Beijing
  • Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University — Beijing
  • Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen U — Guangzhou
  • Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospi — Shenzhen
  • Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinica — Luoyang
  • Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South Univers — Changsha
  • Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University — Nanjing
  • Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliat — Shenyang
  • … and 2 more centers

Identifiers

NCT: NCT07097805 · KYZ20240193

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗