Use of the Paradigm 722 System to Improve Glycemic Control in Adult and Adolescent Subjects With Type 1 Diabetes: A Multi-center, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 14
- 主要终点
- Change in A1c From Baseline to 26 Weeks
研究概览
简要总结
The purpose of this study is to determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only.
详细描述
Glycemic control remains a significant challenge for both adult and adolescent Type 1 diabetics. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements which aid in identification of glycemic excursion patterns. This data is then used to make therapy change recommendations for the future. The Paradigm 722 System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. This System will alert users to high and low glucose levels, and will allow subjects and their clinicians to treat to a therapeutic target HbA1c under monitored conditions.
Subjects wearing the Paradigm 722 System will be compared to subjects wearing the Paradigm 715 Insulin Pump over a 6 month period to evaluate changes in glycemic control (HbA1c).
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
- 12 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12 - 80 years
- •Type 1 Diabetes Mellitus diagnosed at least 1 year ago
- •Using insulin infusion pump for past 6 months minimum
- •Performing minimum 4 blood glucose tests per day
- •Agree to treat to A1c targets
- •Read and understand English
排除标准
- •Pregnant or planning pregnancy
- •History of unresolved tape allergy or skin conditions
结局指标
主要结局
Change in A1c From Baseline to 26 Weeks
时间窗: Baseline and 26 weeks
Change is defined as A1c at Week 26 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
次要结局
- Glucose Sensor Accuracy as Measured in the 722 Group(Baseline and 26 weeks)
- Difference in Frequency of Severe Hypoglycemia From Baseline to Week 26(Baseline and 26 weeks)
- Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 26(Baseline and 26 weeks)
- Problem Areas in Diabetes (PAID) Questionnaire Assessed and Compared Between Groups(Baseline and 26 weeks)
- Changes in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 26(Baseline and 26 weeks)