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임상시험 NCT07097818은(는) 제1형 당뇨병에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2 400 무작위 배정
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07097818은(는) 제1형 당뇨병에 대해 알아보는 중재연구입니다. 현재 상태는 모집중이며, 연구는 2025년 8월 18일에 시작되어 400명의 참여자를 모집하고 있습니다. Second Xiangya Hospital of Central South University이(가) 진행하며, 2027년 4월 1일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2025년 9월 3일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
Type 1 diabetes (T1D) is a lifelong metabolic disease with an increasing disease burden. Despite continuous advancements in diagnostic and treatment technologies, patients of all age groups fail to meet the glycemic targets. Currently, there is a common deficiency in the management of T1D both domestically and internationally, which is specifically manifested as: the disconnection between blood glucose monitoring and...더 보기
공식 제목
Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial
질환명
제1형 당뇨병기타 연구 식별자
- KYZ20250019
NCT 번호
실제 연구 시작일
2025-08-18
최신 업데이트 게시
2025-09-03
예상 연구 완료일
2027-04-01
계획된 등록 인원
400
연구종류
중재연구
단계/상
해당 없음
상태
모집중
키워드
Type 1 diabetes
Comprehensive management
T1D teams
Structured education
Peer resources
Diabetes technologies
Glycemic control
Comprehensive management
T1D teams
Structured education
Peer resources
Diabetes technologies
Glycemic control
주요 목적
지지요법
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Intervention group Patients with T1D in the intervention group will undergo comprehensive management. | T1D team, structured education, peer support , and diabetes technologies 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. |
기타Control group Patients with T1D in the control group will receive routine management. | Routine Management Patients with T1D will be managed according to the routine diagnosis and education model of each hospital. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Percentage of patients in each group with HbA1c <7.0% | HbA1c serves as a crucial physiological marker for assessing average blood sugar levels over the preceding three months. Values below 7.0 are deemed optimal for long-term health. Consequently, a higher number or percentage of individuals achieving an HbA1c level below 7.0 is indicative of a positive outcome, reflecting better glycemic control and reduced risk of complications. | 52 weeks |
Percentage of patients in each group with HbA1c <7.5% | HbA1c serves as a crucial physiological marker for assessing average blood sugar levels over the preceding three months. Values below 7.5 are deemed optimal for long-term health. Consequently, a higher number or percentage of individuals achieving an HbA1c level below 7.5 is indicative of a positive outcome, reflecting better glycemic control and reduced risk of complications. | 52 weeks |
CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L) | The CGM-measured percentage time 70-180 mg/dL (3.9-10.0 mmol/L) refers to the proportion of time during which an individual's blood glucose levels, as continuously monitored by a CGM device. This metric is crucial for assessing glycemic control in individuals with diabetes. Maintaining blood glucose within this target range is associated with better health outcomes and reduced risk of complications. | Baseline, 13, 26, and 52 weeks |
CGM-measured Percentage Time >180 mg/dL (>10.0 mmol/L) | Smaller percentages of CGM-measured time above 180 mg/dL is considered a positive outcome. | Baseline, 13, 26, and 52 weeks |
CGM-measured Percentage Time >250 mg/dL (>13.9 mmol/L) | CGM measured blood sugar values above 250 mg/dL are considered to be undesirable. Thus, less time spent above 250mg/dL is considered a positive outcome. | Baseline, 13, 26, and 52 weeks |
CGM-Measured Percentage Time <70 mg/dL (<3.9 mmol/L) | Blood sugar values measured by CGM that fall below 70 mg/dL are considered potentially hazardous, as they may lead to unconsciousness and, in severe cases, even death. Therefore, minimizing the time spent below 70 mg/dL is regarded as a highly positive outcome, reflecting better management of low blood sugar episodes and enhanced safety for the individual. | Baseline, 13, 26, and 52 weeks |
CGM-Measured Percentage Time <60 mg/dL (<3.3 mmol/L) | Blood sugar values measured by CGM that fall below 60 mg/dL are considered potentially hazardous, as they may lead to unconsciousness and, in severe cases, even death. Therefore, minimizing the time spent below 60 mg/dL is regarded as a highly positive outcome, reflecting better management of low blood sugar episodes and enhanced safety for the individual. | Baseline, 13, 26, and 52 weeks |
CGM-measured Glucose Standard Deviation (SD) | Standard Deviation represents how much glucose levels fluctuate over time from a given average. | Baseline, 13, 26, and 52 weeks |
CGM-Measured Glucose Coefficient of Variation | The Coefficient of Variability (CV) is calculated as the ratio of the standard deviation to the mean of blood sugar values for each participant, as measured by CGM. The reported CV value is derived by multiplying the ratio of the standard deviation to the mean by 100, providing a percentage that reflects the degree of variability in blood sugar levels across the population. A higher CV value, which can range up to 100, signifies greater dispersion of CGM values, indicating more significant fluctuations in blood sugar levels. This increased variability is generally considered an unfavorable outcome, as it may suggest less stable glucose control. Conversely, the minimum CV value is 0, which would indicate no variability in blood sugar levels, representing perfect stability. | Baseline, 13, 26, and 52 weeks |
CGM-Measured Glucose Risk Index (GRI) | The CGM-Measured Glucose Risk Index (GRI) is a comprehensive metric derived from CGM data, designed to quantify the overall risk associated with blood glucose variability. It integrates multiple aspects of glucose levels, including the frequency and severity of both hypo- and hyperglycemic events, as well as the duration of time spent outside the target glucose range. A lower GRI score indicates better glucose stability and lower risk of adverse outcomes related to blood sugar fluctuations. | Baseline, 13, 26, and 52 weeks |
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. | Baseline and 52 weeks |
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. | Baseline and 52 weeks |
Assessment of sleep quality: Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire comprising seven component scores (subjective sleep quality, sleep latency, duration of sleep, sleep efficiency habits, sleep disturbances, use of sleeping medication, and daytime dysfunction), is used to evaluate sleep quality over the last month. | Baseline and 52 weeks |
Hypoglycemic Fear Scale | The Hypoglycemic Fear Scale is a widely used and validated assessment tool designed to measure the level of fear and anxiety that individuals with diabetes, particularly those with type 1 diabetes, experience in relation to hypoglycemia (low blood sugar). | Baseline and 52 weeks |
Diabetes Technology Attitude Scale | The Diabetes Technology Attitude Scale is a specialized assessment tool designed to evaluate individuals' attitudes toward diabetes-related technologies.
Tool lists statement and participants reports how much they agree with the statement. | Baseline and 52 weeks |
Barriers to Technology | The Barriers to Technology Questionnaire typically consists of several key sections, each designed to capture different aspects of technology adoption and use. | Baseline and 52 weeks |
Diabetes Treatment Satisfaction Questionnaire | The Diabetes Treatment Satisfaction Questionnaire (DTSQ) is a comprehensive and widely utilized tool designed to assess the level of satisfaction that individuals with diabetes have with their current treatment regimens. The DTSQ is usually administered as a self-report questionnaire, allowing patients to rate their responses on a Likert scale, typically ranging from "very dissatisfied" to "very satisfied." The total score is calculated by summing the responses to all relevant items, with higher scores indicating greater satisfaction with the treatment. | Baseline and 52 weeks |
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. | Baseline and 52 weeks |
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. | Baseline and 52 weeks |
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. | Baseline and 52 weeks |
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. | Baseline and 52 weeks |
Evaluation of the perception of hypoglycemia in the population tested with Clarke score | Clarke Hypoglycemia Awareness Scores (0-7 score with higher scores associated with impaired awareness). | Baseline and 52 weeks |
Evaluation of the perception of hypoglycemia in the population tested with Gold score | The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia. | Baseline and 52 weeks |
참여 도우미
적격성 기준
Eligibility criteria for study hospitals:
- Members of the China Diabetes Type 1 Study (CD1S).
- Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.
- Have type 1 diabetes educators.
Eligibility criteria of study participants:
Diagnosis of Type 1 Diabetes.
Age ≥6 years, regardless of gender.
Duration of disease >3 months.
Planned to attend follow-up visits at this hospital within the next year.
Possess sufficient cognitive ability to operate all study-related devices.
Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring.
Willing to attend structured education sessions and camp activities on time (for the intervention group only).
Willing and able to adhere to the study protocol.
Willing to sign the informed consent form.
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.
Second Xiangya Hospital of Central South University연구 책임자
Xia Li, 책임연구자, Professor, Second Xiangya Hospital of Central South University
연구 대표 연락처
연락처: Xia Li, +86 13974885753, [email protected]
10 1개국에 임상시험 장소
Beijing Municipality
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, Beijing Municipality, China
Xiaoling Cai, 연락처, [email protected]
대상자모집전
Fujian
Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, Fujian, China
Yi Zhang, 연락처, [email protected]
대상자모집전
Guangdong
Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, Guangdong, China
Haiyan Li, 연락처, [email protected]
대상자모집전
Hebei
Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital, Tangshan, Hebei, China
Hui Fang, 연락처, [email protected]
대상자모집전
Henan
Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology, Luoyang, Henan, 471003, China
Hongwei Jiang, 연락처, [email protected]
모집중
Hubei
Department of Endocrinology, Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Zhe Dai, 연락처, [email protected]
대상자모집전
Hunan
Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South University, Changsha, Hunan, 410011, China
Xia Li, MD, PhD, 연락처, +86 13974885753, [email protected]
모집중
Liaoning
Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliated Hospital of China Medical University, Shenyang, Liaoning, China
Yanli Cao, 연락처, [email protected]
대상자모집전
Sichuan
Department of Endocrinology and Metabolism, Laboratory of Diabetes and metabolism research, West China Hospital, Sichuan University, Chengdu, Sichuan, China
Nanwei Tong, 연락처, [email protected]
대상자모집전
Zhejiang
Department of Endocrinology, Children's Hospital of Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, Zhejiang, China
Junfen Fu, 연락처, [email protected]
대상자모집전