Effects of Real-time Continuous Glucose Monitoring System on Hospital-to-home Transitional Blood Glucose Control and Self-efficacy Among Patients With Type 2 Diabetes Treated With Insulin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time in range (3.9~10.0mmol/L, %)
研究概览
简要总结
Glucose monitoring is an important part of self-management for patients with diabetes. The results of glucose monitoring not only help to assess the degree of glucose metabolism disorders in patients, but also help physicians to make clinical decisions and guide patients in self-management. Despite extensive efforts and advances in diabetes management during hospitalization, glucose control after patients is discharged home remains a challenge. This trial aims to explore the effect of real-time continuous glucose monitoring (RT-CGM) system compared to self-monitoring of blood glucose (SMBG) group on glucose and self-efficacy of type 2 diabetes patients treated with insulin after discharge from the hospital.
详细描述
Glycemic management of patients with diabetes after discharge home is extremely challenging, especially for those requiring insulin therapy. The use of a real-time continuous glucose monitoring (RT-CGM) system may improve glycemic control and self-efficacy in patients with type 2 diabetes treated with insulin after discharge from the hospital.
One hundred and fifty insulin-treated adults with type 2 diabetes were randomly assigned to receive either RT-CGM or self-monitoring of blood glucose (SMBG) at hospital discharge for a 12-week monitoring intervention and a 36-week follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old ≤ age ≤ 80 years old.
- •Type 2 diabetes admitted to Department of Endocrinology and Metabolism.
- •8% ≤ HbA1c ≤ 12% in the last 1 month.
- •Insulin therapy within 1 month of planned discharge from hospital.
- •Frequency of self-monitoring of blood glucose <4 times per week and no use of real-time continuous glucose monitoring system in the 3 months prior to hospitalisation.
- •Willing and able to provide written informed consent and comply with the requirements of this study.
排除标准
- •Oral steroid hormone therapy.
- •Patients with acute complications of diabetes (including Diabetic ketoacidosis, hyperglycemia and hyperosmolality, Lactic acidosis)
- •Patients with severe liver disease (alanine aminotransferase or glutamine aminotransferase exceeding more than three times the upper limit of normal).
- •Patients with severe kidney injury or end-stage renal disease (eGFR < 30 mL/min/1.73 m2).
- •Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period.
结局指标
主要结局
Time in range (3.9~10.0mmol/L, %)
时间窗: 12 weeks
Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
次要结局
- HbA1c (%)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Time in range (3.9~10.0mmol/L, %)(4weeks, 8weeks, 24weeks, 48 weeks)
- Time above range (>10.0mmol/L, %)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Time below range (<3.9mmol/L, %)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Coefficient of variation (CV)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Standard deviation (SD)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Mean amplitude of glycemic excursions (MAGE)(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Diabetes management self-efficacy(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
- Diabetes Self Care Activities(4weeks, 8weeks, 12 weeks, 24weeks, 48weeks)
研究者
Jian Zhou
Professor, Chief Physician, Deputy Director, Department of Endocrinology and Metabolism
Shanghai 6th People's Hospital