NCT07097818

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Aug 2025

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%
Aug 2025Apr 2027

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
18 days until next milestone

Study Start

First participant enrolled

August 18, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

September 3, 2025

Status Verified

July 1, 2025

Enrollment Period

1.5 years

First QC Date

July 24, 2025

Last Update Submit

September 1, 2025

Conditions

Type 1 Diabetes

Keywords

Type 1 diabetesComprehensive managementT1D teamsStructured educationPeer resourcesDiabetes technologiesGlycemic control

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    The primary outcome is the Change in Glycated Hemoglobin A1C (HbA1c) before and after the 52 weeks intervention. 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.

    Baseline, 13, 26, and 52 weeks

Secondary Outcomes (23)

  • Percentage of patients in each group with HbA1c <7.0%

    52 weeks

  • Percentage of patients in each group with HbA1c <7.5%

    52 weeks

  • CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L)

    Baseline, 13, 26, and 52 weeks

  • CGM-measured Percentage Time >180 mg/dL (>10.0 mmol/L)

    Baseline, 13, 26, and 52 weeks

  • CGM-measured Percentage Time >250 mg/dL (>13.9 mmol/L)

    Baseline, 13, 26, and 52 weeks

  • +18 more secondary outcomes

Other Outcomes (3)

  • Severe hypoglycemic episodes

    52 weeks intervention period

  • Diabetes ketoacidosis

    52 weeks intervention period

  • Serious Adverse Events

    52 weeks intervention period

Study Arms (2)

Intervention group

EXPERIMENTAL

Patients with T1D in the intervention group will undergo comprehensive management.

Behavioral: T1D team, structured education, peer support , and diabetes technologies

Control group

OTHER

Patients with T1D in the control group will receive routine management.

Behavioral: Routine Management

Interventions

T1D team, structured education, peer support , and diabetes technologiesBEHAVIORAL

Patients with T1D will use insulin pumps and CGM , while undergoing structured education courses under the management of a specialized T1D team and engaging in peer support activities.

Intervention group
Routine ManagementBEHAVIORAL

Patients with T1D will be managed according to the routine diagnosis and education model of each hospital.

Control group

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients who plan to receive diabetes treatment at other hospitals.
  • Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.
  • Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.
  • Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.
  • Patients diagnosed with hematologic or bleeding disorders.
  • Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening.
  • Patients who have used any oral, injectable, or intravenous corticosteroids within 8 weeks prior to screening, or who plan to use corticosteroids during the trial.
  • Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.
  • Patients with auditory or visual impairments.
  • Patients with alcohol or drug abuse.
  • Patients who plan to receive blood transfusions during the study period.
  • Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.
  • Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.
  • Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.
  • Patients who, in the investigator's opinion, are not suitable for participation in this clinical trial, such as those with a history of vision impairment, eating disorders, celiac disease, etc.

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

NOT YET RECRUITING

Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, China

NOT YET RECRUITING

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

Shenzhen, Guangdong, China

NOT YET RECRUITING

Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital

Tangshan, Hebei, China

NOT YET RECRUITING

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

Luoyang, Henan, 471003, China

RECRUITING

Department of Endocrinology, Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

NOT YET RECRUITING

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

Changsha, Hunan, 410011, China

RECRUITING

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

Shenyang, Liaoning, China

NOT YET RECRUITING

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

Chengdu, Sichuan, China

NOT YET RECRUITING

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

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

  • Xia Li, MD, PhD

    Second Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Li

CONTACT

+86 13974885753lixia2014@vip.163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
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

August 18, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

September 3, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(10)