NCT00675311已完成不适用
A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LifeScan
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations
研究概览
简要总结
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.
详细描述
To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 64 years of age as of January 1, 2008
- •Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
- •Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
- •Able to provide written informed consent for study participation
排除标准
- •Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
- •Selected cancers (one or more claims in the most recent 12-month period)
- •HIV/AIDS (one or more claims in the most recent 12-month period)
- •Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
- •Cirrhosis of the liver (one or more claims in the most recent 12-month period)
- •Current participation in another LifeScan study or other diabetes-related clinical trials
- •Medicare is primary source of insurance coverage
- •Unable to understand written and spoken English
结局指标
主要结局
The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations
时间窗: 1 Year
次要结局
- Secondary measures include diabetes-related health-care utilization and physiologic data.(1 Year)
研究者
研究点 (1)
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