Type 1 Diabetes (T1D)NCT07097805
Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study
A study testing GLITTER comprehensive management in people with Type 1 Diabetes (T1D), run by Second Xiangya Hospital of Central South University at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- GLITTER comprehensive management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 10 sitesChina
- Study dates
- 1 Jan 2025to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- 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:
- Initiation and continuation of insulin therapy after diagnosis (excluding pancreas or islet transplantation) B. Positive for islet cell antibodies
Who cannot join
None listed.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Department of Endocrinology and Metabolism, Peking University People's Hospital
Beijing, Beijing Municipality
Xiaoling Cai
- Recruiting
Department of Endocrinology, Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
Chang Liu
- Recruiting
Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University
Changsha, Hunan, 410011
Xia Li, +86 13974885753, lixia2014@vip.163.com
- Recruiting
Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University
Chengdu, Sichuan
Nanwei Tong
- Recruiting
Department of Endocrinology and Metabolism, the Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Jinhua Yan
- Recruiting
Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health
Hangzhou, Zhejiang
Junfen Fu
- Recruiting
Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology
Luoyang, Henan
Hongwei Jiang
- Recruiting
Department of Endocrinology, The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Mei Zhang
- Recruiting
Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University
Shenyang, Liaoning
Yanli Cao
- Recruiting
Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University
Shenzhen, Guangdong
Haiyan Li
About this study
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.
Read the 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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- GLITTER comprehensive management
- Keywords
- Type 1 diabetes, Comprehensive management
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLITTER comprehensive managementBehavioural
The GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support.
| Study group | Role | What they receive |
|---|---|---|
| T1D Patients | Other | All patients diagnosed with type 1 diabetes of all ages. Receives: Behavioral: GLITTER comprehensive management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Trough study completion, an average of 1 year
Secondary outcomes (19)
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.
Measured: Trough study completion, an average of 1 year
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:
- Device data download demonstrating functional use; or
- Clinician-verified patient logbook records with corroborating evidence.
Measured: Trough study completion, an average of 1 year
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).
Measured: Trough study completion, an average of 1 year
Urine Albumin-to-Creatinine Ratio
Normal: <30 mg/g；Microalbuminuria: 30-300 mg/g；Macroalbuminuria: >300 mg/g
Measured: Trough study completion, an average of 1 year
Change in titer of autoantibodies
Islet autoantibodies represent serological markers of autoimmune destruction targeting pancreatic β-cell antigens, serving as pivotal biomarkers for T1D pathogenesis.
Measured: Trough study completion, an average of 1 year
Change in C-peptide
C-peptide are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
Measured: Trough study completion, an average of 1 year
Change in blood glucose
Blood glucose are measured before and 2-hour after a mixed meal tolerance test at each follow-up of this study.
Measured: Trough study completion, an average of 1 year
Systolic blood pressure
Systolic blood pressure
Measured: Trough study completion, an average of 1 year
Diastolic blood pressure
Diastolic blood pressure
Measured: Trough study completion, an average of 1 year
Change in lipid profiles
Including triglyceride, total cholesterol, HDL-cholesterol and LDL-cholesterol
Measured: Trough study completion, an average of 1 year
Self-Management of Type 1 Diabetes for Chinese Adults
The Self-Management of Type 1 Diabetes for Chinese Adults (SMOD-CA) scale is a validated instrument specifically designed to assess the self-management behaviors and capabilities of adults with type 1 diabetes in the Chinese population. The SMOD-CA consists of 30 items. Responses are rated on a five-point scale, with higher scores indicating better self-management ability. The total score ranges from 0 to 120.
Measured: 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
The 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents (C-SMOD-A-23) is a validated and simplified instrument designed to assess the self-management behaviors and capabilities of adolescents with type 1 diabetes.
Measured: Trough study completion, an average of 1 year
Chinese version of the Diabetes Quality of Life for Youth Scale Short Form
The Chinese version of the Diabetes Quality of Life for Youth Scale Short Form (C-DQOLY-SF) is a psychometrically tested instrument designed to assess the quality of life in adolescents with type 1 diabetes. The scale consists of 25 items that measure various aspects of life satisfaction, diabetes impact, and diabetes-related worry.
Measured: Trough study completion, an average of 1 year
Athens Insomnia Scale
The Athens Insomnia Scale (AIS) is a self-assessment tool used to evaluate the presence and severity of insomnia symptoms. The total score provides a quantitative measure of insomnia severity, with higher scores indicating more significant sleep disturbances.
Measured: Trough study completion, an average of 1 year
Depression Self-Rating Scale for Children
The Depression Self-Rating Scale for Children (DSRSC) is a standardized psychological assessment tool designed to measure depressive symptoms in children and adolescents. This self-report inventory allows young individuals to rate the frequency and severity of various depressive feelings and behaviors they may be experiencing.
Measured: Trough study completion, an average of 1 year
Diagnosis and measurement of the severity of depression: Patient Health Questionnaire
The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression.
Measured: Trough study completion, an average of 1 year
Generalized Anxiety Disorder 7-item scale
The Generalized Anxiety Disorder 7-item scale (GAD-7) consists of seven items. Each item asks respondents to rate how often they have been bothered by specific anxiety-related symptoms over the past two weeks.
Measured: Trough study completion, an average of 1 year
WHO-5 Well-Being Index
The WHO-5 Well-Being Index (WHO-5) is a brief, self-report questionnaire designed to assess subjective well-being. The WHO-5 consists of five simple and straightforward items. Each item is rated on a 6-point Likert scale, ranging from 0 (not present) to 5 (constantly present). The total score is calculated by summing the responses to all five items, resulting in a score that ranges from 0 to 25. Higher scores indicate better well-being.
Measured: Trough study completion, an average of 1 year
Mini-EAT
The Mini-Eating Assessment Tool, is a brief dietary assessment scale designed to evaluate the quality of an individual's diet. It is a concise tool that aims to provide a quick yet effective measure of dietary habits and nutrition intake.
Measured: Trough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xia Li, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097805
- Sponsor's protocol ID
- KYZ20240193
- Status last verified
- Sep 2024
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study
- ClinicalTrials.gov ID
- NCT07097805
- Acronym / sponsor ID
- KYZ20240193
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 diabetes, Comprehensive management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| T1D Patients | Other | Behavioral: GLITTER comprehensive managementAll patients diagnosed with type 1 diabetes of all ages. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Meet any one of the following criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLITTER comprehensive managementThe GLITTER comprehensive management represents a management approach that effectively combines multidisciplinary professional team care, diabetes technology empowerment, structured education steering, and peer support. | Behavioural | T1D Patients |
Primary outcome
Change in HbA1c
Time frame: Trough study completion, an average of 1 year
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.
19 secondary outcomes
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
Chinese version of the Diabetes Quality of Life for Youth Scale Short Form
Time frame: Trough study completion, an average of 1 year
Athens Insomnia Scale
Time frame: Trough study completion, an average of 1 year
Depression Self-Rating Scale for Children
Time frame: Trough study completion, an average of 1 year
Diagnosis and measurement of the severity of depression: Patient Health Questionnaire
Time frame: Trough study completion, an average of 1 year
Generalized Anxiety Disorder 7-item scale
Time frame: Trough study completion, an average of 1 year
WHO-5 Well-Being Index
Time frame: Trough study completion, an average of 1 year
Mini-EAT
Time frame: Trough study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLITTER comprehensive management in people with Type 1 Diabetes (T1D), run by Second Xiangya Hospital of Central South University at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Li (+86 13974885753, lixia2014@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c (time frame: Trough study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.