NCT00782496已完成不适用
A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients
Ascensia Diabetes Care8 个研究点 分布在 1 个国家目标入组 211 人开始时间: 2008年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 211
- 试验地点
- 8
- 主要终点
- Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
研究概览
简要总结
The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with type 1 or type 2 diabetes
- •Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
- •Persons at least 21 years of age
- •Persons willing to complete all study visits and study procedures including:
- •Using the meal-marker + reminder feature regularly (Group 2 subjects only)
- •Using the paper logbook provided (both Groups)
- •Testing their BG at least 3 times a day during the entire study.
- •Persons who are able to speak, read and understand English
- •Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more
排除标准
- •Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
- •Persons who test over 6 times/day regularly
- •Persons who wear a BG sensor 2 weeks or more during each month.
- •Persons with home heath aides who assist with their BG testing.
- •Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
- •Significant visual impairment
- •Significant hearing impairment
- •Cognitive disorder
- •Significant unstable co-morbidity (with notable change within the past 3 months)
- •Any other condition as per investigator's discretion
结局指标
主要结局
Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features
时间窗: 6 months
次要结局
- Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2(Over six month period)
研究者
研究点 (8)
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