Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2

Официальное название

Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial

Обзор

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.

Подробное описание

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 insulin adjustment, low utilization rate of new technologies, insufficient patient self-management training, and the absence of psychological intervention, etc.

This GLITTER Study 2 extends the GLITTER Study (Glycemic Improvement with Team, Technology, Education and Peer Resources in type 1 diabetes) by implementing its philosophy (Team, Technology, Education, Peer Resources) to develop a comprehensive T1D management model, integrating these components to enhance management and evaluate effectiveness.

This multicentre, cluster-randomized controlled trial will be conducted across 10 hospitals. It aims to enroll patients with T1D aged ≥6 years who have had the disease for \>3 months. Five hospitals were randomly assigned to the comprehensive management intervention group, and five to the usual care group. A total of 400 individuals were recruited into the study. The intervention for the intervention group includes: T1D team (dedicated T1D physicians, certified diabetes educators, registered dietitians), centralized structured education (courses, short videos, and structured educational materials), peer support (volunteer matching, camp, volunteer peer live streaming), and diabetes technologies (insulin pumps and continuous glucose monitoring). The control group received usual care, with the five assigned hospitals continuing their clinical practice. This 52-week trial includes assessments at the following timepoints: screening, week 13 (visit 2), week 26 (visit 3), week 39 (visit 4), and week 52 (visit 5). Throughout the study period, we will evaluate the model's impact on glycemic control and psychosocial outcomes, aiming to establish an evidence-based clinical practice paradigm for T1D management.

Вмешательства

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

Первичные конечные точки

• Change in HbA1c [Срок оценки: Baseline, 13, 26, and 52 weeks]

Вторичные конечные точки (12)

• Percentage of patients in each group with HbA1c <7.0% [Срок оценки: 52 weeks]
• Percentage of patients in each group with HbA1c <7.5% [Срок оценки: 52 weeks]
• CGM-measured Percentage Time 70-180 mg/dL (3.9-10.0 mmol/L) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-measured Percentage Time >180 mg/dL (>10.0 mmol/L) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-measured Percentage Time >250 mg/dL (>13.9 mmol/L) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-Measured Percentage Time <70 mg/dL (<3.9 mmol/L) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-Measured Percentage Time <60 mg/dL (<3.3 mmol/L) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-measured Glucose Standard Deviation (SD) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-Measured Glucose Coefficient of Variation [Срок оценки: Baseline, 13, 26, and 52 weeks]
• CGM-Measured Glucose Risk Index (GRI) [Срок оценки: Baseline, 13, 26, and 52 weeks]
• Self-Management of Type 1 Diabetes for Chinese Adults [Срок оценки: Baseline and 52 weeks]
• 23-item Chinese Version of Self-Report Measure of Self-Management of Type 1 Diabetes for Adolescents [Срок оценки: Baseline and 52 weeks]

Критерии участия

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.

Exclusion Criteria of study participants:

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Китай · 10 центров

• Department of Endocrinology and Metabolism, Peking University People's Hospital — Пекин
• Department of Endocrinology, Quanzhou First Hospital Affiliated to Fujian Medical Universi — Quanzhou
• Department of Endocrinology, Shenzhen Second People's Hospital, The First Affiliated Hospi — Шэньчжэнь
• Second Department of Endocrinology and Metabolism, Tangshan Gongren Hospital — Tangshan
• Endocrinology and Metabolism Center, The First Affiliated Hospital, and College of Clinica — Luoyang
• Department of Endocrinology, Zhongnan Hospital of Wuhan University — Ухань
• Institute of Metabolism and Endocrinology, Second Xiangya Hospital of Centra South Univers — Чанша
• Department of Endocrinology and Metabolism, Institute of Endocrinology, The First Affiliat — Шэньян
• … и ещё 2 центра

Идентификаторы

NCT: NCT07097818 · KYZ20250019

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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