Sensor Augmented Pump Therapy Versus Multiple Daily Injection Therapy for Hospitalized Patients in China With Type 2 Diabetes; Time to Target
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 118
- 试验地点
- 2
- 主要终点
- Time to Target
研究概览
简要总结
This is a prospective, randomized (open label), multi-center and post-market study. The study is to compare effectiveness of sensor-augmented pump (SAP) therapy versus multiple daily injection (MDI) therapy in hospitalized patients with insulin treating type 2 diabetes in China
详细描述
Primary objective:
To compare the length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus MDI
Secondary Objectives:
To compare glycemic variability (using CGM as reference method) with the 722 Paradigm Real-Time insulin pump versus MDI
This is a prospective, randomized (open label), multi-center study. The clinical study staff will conduct screening tests according to inclusion/exclusion criteria in order to verify the subject's eligibility for the study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is 18 to 65 years old at time of screening
- •A clinical diagnosis of type 2 diabetes > 6 months prior to the screening as determined by the Investigator,
- •Treating with insulin at least one injection per day prior to participate in the study
- •Glycosylated hemoglobin (A1C) > 8% at screening
- •Subject needs to be hospitalized to receive treatment for glucose management according to Endocrinologists' discretion
- •Subject is willing to follow protocol and underdo all study procedures
- •Subject is willing and able to provide informed written consent personally or by legal proxy
排除标准
- •Subject has known hypersensitivity to insulin or insulin infusion set
- •Subject has been treated with drugs with a known effect on BG within 8 weeks before enrollment other than diabetes medications such as insulin or oral agents.
- •random blood glucose is above 33 mmol/L
- •Subject is currently using real time CGM therapy prior to screening
- •Subject is currently using insulin pump therapy prior to screening
- •Female subject who is pregnant, or plans to become pregnant during the course of the study
- •Patients who are critically ill that must go to intensive critical care unit per Investigator discretion
- •Subject has any systemic disease or medical condition found on the screening tests that may interfere with the safety of the patient and efficacy of the study treatment, in the opinion of the Investigator, may preclude him/her from participating in the study. The following includes, but not limited to, those conditions:
- •Female subject has a positive serum pregnancy screening test
- •Subject has visually impaired or disability limits the use of RT-CGM.
- •Subject has any unresolved adverse skin condition in the area of sensor placement or device replacement (e.g., psoriasis, rash, Staphylococcus infection)
- •Subject has disease with a known effect on BG such as Active Graves' disease
- •Subject has a history of alcohol abuse
- •Any other condition, which may not be suitable for the study at physician's discretion.
研究组 & 干预措施
Pump
Paradigm 722 insulin pump used for insulin infusion and continuous glucose monitoring
干预措施: Pump (Device)
MDI
Multiple daily insulin injections used for treatment
干预措施: CGMS Gold (Other)
结局指标
主要结局
Time to Target
时间窗: Up to 14 days in hospital
length of time to achieve target glucose range using Self-Monitoring Blood Glucose (SMBG), as reference method, with the 722 Paradigm Real-Time insulin pump versus Multiple Daily Injection
次要结局
- Glycemic Variability(Up to 14 days in hospital)