Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in Patients With Type 2 Diabetes Mellitus Using Multiple Daily Injections or Insulin Pumps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- HbA1c (%) changes
研究概览
简要总结
Multicenter, Open-label, Randomized Trial to Compare the Effectiveness of Structured Education and Safety of FreeStyle Libre or Self-Monitoring of Blood Glucose (SMBG) in patients with type 2 Diabetes Mellitus using Multiple Daily Injections or Insulin Pumps
详细描述
All subjects must participate in Blind Continuous Glucose Monitoring(CGM) for two weeks prior to Visit 2 visit (random assignment).
Subjects who meet the selection/exclusion criteria in Visit 2 visits are randomly assigned to the test group (personal in-depth education and FreeStyle Libre) or control 1 (standard education and FreeStyle Libre) or control 2 (standard education and SMBG) at a 1:1:1 ratio.
In the test group, personal in-depth education is conducted at baseline (Visit 2), 4 weeks (Visit 3), 8 weeks (Visit 4), 12 weeks (Visit 5), and 18 weeks (Visit 6), and the time required for education and preparation time required for patient education are checked.
Control groups 1 and 2 conduct routine insulin basic injection training as standard education at baseline (Visit 2) and 12 weeks (Visit 5).
After randomization, FreeStyle Libre is applied to the test group and control group 1 for 24 weeks, and SMBG is performed for 22 weeks and Blind CGM is applied for 2 weeks at 22 weeks (Visit 7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes patients aged 19 and under 75 years.
- •Multiple insulin injections at the time of screening (at least one base insulin and two or more fast-acting insulin. However, one insulin aspart/insulin degludec + one insulin aspart or two or more insulin aspart/insulin degludec can be included.) or those who have been using an insulin pump for at least 12 weeks.
- •HbA1c of not less than 7.5% and not more than 12.0% at the time of screening
- •patients who agree to use FreeStyle Libre for medical care and research
- •patients who voluntarily signed a written consent form
排除标准
- •Those who have difficulty in education due to severe systemic diseases (e.g., terminal renal failure requiring dialysis, cirrhosis above Child-Pugh Class C), cognitive impairment, and mental illness.
- •Those who are taking drugs that may affect metabolism per screening time (e.g., adrenocortical hormones, immunosuppressants, etc.) (However, those who have taken the same dose for more than 12 weeks until screening time and who are not scheduled to change drug dose can participate in this study.)
- •Those with clinically significant cardiovascular diseases (heart failure, angina, myocardial infarction, cerebral infarction, etc.) within 24 weeks of screening.
- •Those who have a glomerular filtration rate (eGFR) of <15 mL/min.
- •A person with severe diabetes complications that deteriorate or newly occur within 3 months of screening and require emergency treatment.
- •Pregnant or lactating persons.
- •Pregnancy is planned during the study period, effective contraception (if condoms, oral contraceptives, intrauterine contraceptives, injections, transplants, contraceptives, or absolute abstinence, such as periodic abstinence (e.g., Krenda, ovulation, symptom body temperature) and resection are not considered as recognized contraceptives) for women or men.
- •Those who find other researchers inappropriate for participation in research.
结局指标
主要结局
HbA1c (%) changes
时间窗: 24 weeks
HbA1c (%) changes at 24 weeks compared to baseline
次要结局
- HbA1c (%) changes(12 weeks)
- Percentage of time in range (70 - 180mg/dL)(24 weeks)
- Percentage of time in level 1 hypoglycemia (> 180 mg/dL)(24 weeks)
- Diabetes Treatment Satisfaction Questionnaire (DTSQ) changes(24 weeks)
- Mean glucose changes(24 weeks)
- Percentage of time in level 2 hypoglycemia (<54 mg/dL)(24 weeks)
- Percentage of time in level 1 hypoglycemia (<70- 54 mg/dL)(24 weeks)
- Coefficient of variation(CV) changes(24 weeks)
- Percentage of time in level 2 hypoglycemia (> 250 mg/dL)(24 weeks)