NCT00467675已完成不适用
Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator CGM System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making: Phase 2-Establishing Ambulatory Glucose Profiles for Individuals Without Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
研究概览
简要总结
In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female
- •Within normal range for two hour OGTT glucose level (<140 mg/dl)
- •Within normal range for fasting glucose level (<100 mg/dl)
- •Within normal range for total insulin level as measured by radioimmunoassay
- •BMI <30kg/m2
- •Age 21-75 years of age, inclusive (15 subjects in the 21-49 years of age group, 15 subjects in the 50-75 years of age group)
- •Willing to give informed consent
- •Capable of following the protocol and instructions of study staff
- •Available for scheduled visits
- •Access to telephone communications
排除标准
- •Under 21 years of age or over 75 years of age
- •Abnormal OGTT
- •Previous history of diabetes
- •Outside of normal insulin range
- •BMI > 30kg/m2
- •Unable to follow protocol
- •Unable to read and write in English
- •Skin abnormalities at insertion sites
- •Allergy to adhesives
- •Any concomitant medical condition that would likely affect the evaluation of device performance
- •Taken prednisone or cortisone medications in the previous 30 days
- •Blood transfusion within the past 90 days
- •Blood donation within the past 30 days
- •Metabolic syndrome (NCEP ATP III guidelines)
- •Any medical condition that would affect glucose (per investigator decision)
研究者
研究点 (1)
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