A Pilot Study to Evaluate the Navigator Continuous Glucose Sensor in the Management of Type 1 Diabetes in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 12
- 主要终点
- Navigator Accuracy
研究概览
简要总结
This study is being done to find out how accurate the Navigator continuous glucose monitor is in children. It is also being done to see if use of the Navigator can improve blood sugar control and help prevent low blood sugar events. This study has three basic parts: Use of the Navigator at home for one week without being able to see the blood sugar readings; a Baseline visit or a 24-hour admission to a research unit of the hospital to find out how well the Navigator measures the blood sugar; and then 3 months use of the Navigator at home as an aid to diabetes care.
详细描述
Approximately 60 children will be recruited from five centers in the United States to participate in this study. The information gained from this study will be used to plan a larger study in which half of the patients will use the Navigator and half will not. Children who participate in this study will not be eligible to take part in the larger study.
The Navigator provides a glucose reading every 60 seconds (or 1440 readings a day). Each sensor is designed to provide readings for up to 120 hours. It has alarms for hypoglycemia and hyperglycemia and for projected high and low glucose values. The alarm set points can be adjusted by the user. The Navigator also has a trend arrow indicating the glucose rate of change (>-2 mg/dL/min, -2 to -1 mg/dL/min, -1 to 1 mg/dL/min, 1 to 2 mg/dl/min, and >2 mg/dl/min). Subjects can enter events, such as when they took insulin, ate, or exercised. The sensor requires calibration values to be entered 3 times during the first day of wear at 1-hour, 3-hours, and 24-hours and does not require additional calibration values. The values are entered directly into the Navigator which has a TheraSense Freestyle home glucose meter built into the unit. The Navigator has not yet been approved by the FDA. The Navigator currently under review by the FDA will limit sensor wear to 3 days.
Beginning the Study
When a child enters the study, the following will be done:
- Questionnaires will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Age 3.0 years to less than 18.0 years
- •Subject has used a downloadable insulin pump or Lantus with MDI of a short-acting insulin (e.g. Humalog or Novolog) for at least 6 months
- •Parent/guardian and subject understand the study protocol and agree to comply with it
- •Subjects >9.0 years old and primary care giver (i.e., parent or guardian) comprehend written English
- •Subject has a home computer with email access
- •For females, subject not intending to become pregnant during the next 3 months
- •No expectation that subject will be moving out of the area of the clinical center during the next 3 months
- •Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
排除标准
- •The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
- •The presence of any of the following diseases:
- •Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
- •Cystic fibrosis
- •Other major illness that in the judgment of the investigator might interfere with the completion of the protocol (Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment)
- •Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
- •Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
结局指标
主要结局
Navigator Accuracy
Feasibility of using the Navigator sensor on a daily basis (Average number of sensors used per week, Average number of hours of use per sensor, Number of sensors per week that fail to calibrate)
次要结局
- Psychosocial Questionnaires
- Exploratory assessment of impact of Navigator on HbA1c