NCT07097805

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
22mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Jan 2025Mar 2028

Study Start

First participant enrolled

January 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

July 31, 2025

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

Type 1 diabetesComprehensive management

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (19)

  • Percentage of patients using continuous glucose monitors

    Trough study completion, an average of 1 year

  • Percentage of patients using insulin pump

    Trough study completion, an average of 1 year

  • Diabetes-related complications

    Trough study completion, an average of 1 year

  • Urine Albumin-to-Creatinine Ratio

    Trough study completion, an average of 1 year

  • Change in titer of autoantibodies

    Trough study completion, an average of 1 year

  • +14 more secondary outcomes

Study Arms (1)

T1D Patients

OTHER

All patients diagnosed with type 1 diabetes of all ages.

Behavioral: GLITTER comprehensive management

Interventions

The GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support.

T1D Patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Department of Endocrinology and Metabolism, Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University

Shenzhen, Guangdong, China

RECRUITING

Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology

Luoyang, Henan, China

RECRUITING

Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University

Changsha, Hunan, 410011, China

RECRUITING

Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

RECRUITING

Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University

Chengdu, Sichuan, China

RECRUITING

Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

January 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

July 31, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations