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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSecond Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinically diagnosed as Type 1 Diabetes by a specialist physician.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • GLITTER comprehensive management

    Behavioral

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

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: T1D PatientsOther 1 intervention

Trial outcomes

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.

Time frame
Trough study completion, an average of 1 year

Secondary outcomes

1

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.

Time frame
Trough study completion, an average of 1 year
2

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.

Time frame
Trough study completion, an average of 1 year
3

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).

Time frame
Trough study completion, an average of 1 year
4

Urine Albumin-to-Creatinine Ratio

Normal: \<30 mg/g;Microalbuminuria: 30-300 mg/g;Macroalbuminuria: \>300 mg/g

Time frame
Trough study completion, an average of 1 year

Other outcomes

Sponsors and contacts

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