Organization Program of DiabEtes INsulIN ManaGement: An Open, Multi-center, Prospective, Randomized, 16-week, Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
Diabetes is a common, costly condition associated with significant morbidity and mortality. Diabetes self-management education, the process of teaching individuals to manage their diabetes, has been considered an important part. The intensive education has the capacity to deliver effective interventions to a large number of people. The investigators may be able to redirect our efforts to diabetes care and education strategies that will have a positive impact on the optimization of glycemic control and the prevention of long-term complications of diabetes, reducing the subsequent human and health care costs.
详细描述
This is a prospective, randomized, open-label, controlled clinical study. 1500 subjects with Type 2 DM will be enrolled and be randomized into Structured Education Group and Conventional Education Group in 1:1 ratio. Subjects in both of the groups will be treated with Scilin®M30 twice daily (30 minutes before breakfast and dinner). All the previous oral antidiabetic drugs (OAD(s)) will be discontinued except metformin and alpha-Glucosidase Inhibitors. The physician will determine the starting dose (0.3 IU/kg～0.4IU/kg), as well as later changes to dose according to insulin titration algorithm. The treatment duration will last 16 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written Informed Consent obtained before any trial-related activities Type 2 DM subjects;
- •Age > 18 years old,male or female;
- •Continuous treated with two or more oral antidiabetic drugs (OADs) for the last 3 months,and the current HbA1c>7.5%;
- •Cooperative with structured management;
排除标准
- •Subjects with type 1 diabetes;
- •Gestational diabetes mellitus and other specific types DM;
- •Those who are unwilling to sign in ICF;
- •Subjects with repeated hypoglycemia;
- •Subjects with BMI>30kg/m2;
- •Impaired liver function,defined as alanine aminotransferase (ALAT)>= 2.5 or alkaline phosphatase (ALP)>= 2 times upper referenced limit times upper normal limit;
- •Females of childbearing age who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods throughout the trial (adequate contraceptive measures as required by local law or practice);
- •Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation;
- •Any other clinically significant condition or major systemic diseases, including serious coronary heart disease, cardiovascular disease, myocardial infarction within the past 12 months; severe neurology or psychology or psychiatric diseases; serious infection; actively disseminated intravascular coagulation;
- •Malignant neoplastic diseases (except carcinoma in situ);
- •Current addiction to alcohol or other addictive substances;
研究组 & 干预措施
Structured Education Group
Subjects received structured diabetes education
干预措施: Scilin®M30 (Drug)
Structured Education Group
Subjects received structured diabetes education
干预措施: Structured Education (Behavioral)
Conventional Care Group:
Subjects received conventional diabetes education
干预措施: Conventional Diabetes Education (Behavioral)
Conventional Care Group:
Subjects received conventional diabetes education
干预措施: Scilin®M30 (Drug)
结局指标
主要结局
HbA1c
时间窗: Screen,16weeks
Investigate glycemic control as measured by HbA1c change
次要结局
- Diabetes self-management skills Diabetes self-management skills Assess diabetes self-care ability by Diabetes Self-Management (SDSCA)(Screen,16weeks)
- Assess diabetes self-management ability by Diabetes Management Self-Efficacy (C-DMSES)(Screen,16weeks)
- The satisfaction degree of structured management(Screen,2weeks,4weeks,8weeks,12weeks,16weeks)
- total daily insulin dose(1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks)
- 7-points of glucose(Screen,16weeks)
- body weight(baseline,2weeks,4weeks,8weeks,12weeks,16weeks)
- Medication compliance(Screen,16weeks)
- The incidence of Hypoglycemia(1week,2weeks,3weeks,4weeks,6weeks,8weeks,12weeks,16weeks)