NCT02003898已完成不适用
Post Approval Study of the TS (Threshold Suspend) Feature With a Sensor-Augmented Pump System Supplemented With Commercial Patient Data
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 372
- 试验地点
- 43
- 主要终点
- Mean Change in A1C From Baseline to 1 Year
研究概览
简要总结
The purpose of this study is to evaluate the Threshold Suspend (TS) feature of the Medtronic MiniMed® 530G insulin pump in patients 16 and older with insulin requiring diabetes.
详细描述
Multi-center trial is initiated to observe the Threshold Suspend (TS) feature with a sensor-augmented insulin pump (Medtronic MiniMed® 530G insulin pump) in patients 16 and older with insulin requiring diabetes over a period of one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is age 16 or older at time of screening
- •Subject has been diagnosed with diabetes mellitus for at least one year prior to screening.
- •Subject is currently on pump therapy.
- •Subject is transitioning to the 530G insulin pump system with the TS feature turned ON.
- •Subject is willing to complete all study related activities
- •Subject is willing to upload data every 21 days from the study pump
- •Subject must have Internet access and access to a computer system that meets the requirements for uploading the pumps. This may include use of family or friend's computer system with Internet access.
- •Subject is able (by insurance or financial means) to cover the initial investment and ongoing cost of the 530G insulin pump and consumables, CGM, Bayer CONTOUR Next Link RF enabled meter and supplies for the length of the study- 1 year.
排除标准
- •Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study devices in the last 2 weeks.
- •Subject is a woman of child-bearing potential who has a positive pregnancy test at screening or plans to become pregnant during the course of the study
- •Subject is being treated for hyperthyroidism at time of screening
- •Subject has an abnormality (>1.8mg/dL) in creatinine at time of screening visit
- •Subject has an abnormality (out of reference range) in thyroid-stimulating hormone (TSH) at time of screening visit. If TSH is out of range, Free T3 and Free T4 will be tested. Subject may be included with TSH out of range as long as Free T3 and Free T4 are in normal reference range.
- •Subject has taken any oral, injectable, or IV steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study
- •Subject is currently abusing illicit drugs
- •Subject is currently abusing prescription drugs
- •Subject is currently abusing alcohol
- •Subject has sickle cell disease or hemoglobinopathy
- •Subject has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening or plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- •Subject diagnosed with current eating disorder such as anorexia or bulimia
- •Subject has been diagnosed with chronic kidney disease that results in chronic anemia
- •Subject is on dialysis
研究组 & 干预措施
Medtronic MiniMed 530G Insulin Pump
Experimental
All subjects received diabetes treatment using the Medtronic MiniMed 530G insulin pump.
干预措施: Medtronic MiniMed 530G Insulin Pump (Device)
结局指标
主要结局
Mean Change in A1C From Baseline to 1 Year
时间窗: 1 year
Comparison of A1C measurement from baseline to end of study in the CEP266 study population. The overall mean change in A1C from baseline will be estimated and compared by a non-inferiority test with an A1C margin of 0.4% and a significance level of 0.025 (one-sided) with the CEP 266 study population.
次要结局
- Mean Change in A1C From Baseline to 1 Year, Baseline A1c of 7% to 9%(1 year)
- Mean Change in A1C From Baseline to 1 Year, Baseline A1c Below 7%(1 year)
- Mean Change in A1C From Baseline to 1 Year, Baseline A1c > 9%(1 year)
研究者
研究点 (43)
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