The Efficacy, Short and Long Term Effects of Regular Home Use Vs Diabetic Team - Supported Use of the Medtronic CareLink Therapy Management System in Patients With Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- HbA1c
研究概览
简要总结
Randomized, two arms, controlled, open study comprised of two consecutive segments. At the first segment that will last during the first 4 months of the study, patients will be randomized to the Care link treated group or non Care link treated group. At this segment of the study the usage of the Care link system will be accompanied by the diabetic team, through at least monthly contact via the Internet initiated by the diabetic team. At the second segment of the study, during the following 4 months, both groups will use the Care link System, home-use, without support initiated by the diabetic team.
详细描述
A randomized, two arms, controlled, open study in order to compare the efficacy, short and long term effects of regular home-use Vs diabetic team- supported use of the Medtronic CareLink therapy management system in patients with diabetes.
Primary objective:
To assess the efficacy, short term (4 months) and long term (8 months) effects of using the Medtronic CareLink® Therapy Management System for Diabetes on the following parameters:
- Metabolic control as expressed by HbA1c.
- Hypoglycemic events- number and severity of episodes.
- DKA and ketosis events- number and severity of episodes.
- Patient's satisfaction and quality of life measured by treatment satisfaction and quality of life questionnaires.
- 7 points glucose profile.
Secondary objective:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes diagnosed at least 6 months prior to study entry
- •Current treatment with Medtronic 722 /712 external insulin pump systems
- •Treatment with insulin pump at least 3 month prior to study entry
- •An internet access from patient's home
- •Age 0-35 years old
- •Signing inform consent forms
排除标准
- •Any significant disease or conditions, including psychiatric disorders that in the opinion of the investigator are likely to effect his compliance or ability to complete the study
- •Patients participating in other device or drug studies
研究组 & 干预措施
2
Regular treated group in the first segment and CareLink treated group in the second segment
干预措施: regular home use and Medtronic CareLink Therapy Management (Other)
1. CareLink team supported group
CareLink team supported group
干预措施: Medtronic CareLink therapy management system (Other)
结局指标
主要结局
HbA1c
时间窗: At Baseline and every 4 month after
次要结局
- Hypoglycemic events(will be recorded through the whole study period)
- DKA and ketosis events(will be recorded through the whole study period)
- 7 points glucose profile(Will be recorded 2 days before baseline visit and every 4 months after)
- Patient's satisfaction and quality of life questionnaire(At baseline visit and every 4 months after)