A Randomized Clinical Trial to Assess the Efficacy and Safety of Real-Time Continuous Glucose Monitoring in the Management of Type 1 Diabetes in Young Children (4 to <10 Year Olds)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 10
- 主要终点
- Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
研究概览
简要总结
The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.
详细描述
On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a physical examination by a study investigator.
The subject will return for a second visit about 6 weeks after the enrollment visit. At this visit, quality of life questionnaires will be completed and a CGM sensor will be inserted. The monitor will be blinded so that the glucose values cannot be seen. The parent will be instructed on insertion, calibration, and care of the CGM.
The subject will return for a randomization visit 14 to 28 days after the blinded CGM was initiated.
- Subjects who have been compliant with use of the CGM and HGM will be randomized to one of two treatment groups: CGM Group or Control Group
- For the CGM Group, the CGM, HGM, and pump data (if applicable) will be reviewed and changes will be made to diabetes management as needed. Parents will be taught to use the protocol-developed instructions for changes to diabetes management to be used in real time based on CGM and HGM data. Instructions for downloading the CGM and HGM will be provided to subjects with a home computer.
- For the Control Group, a HGM and test strips will be provided. The HGM and pump data (if applicable) will be reviewed and changes will be made in diabetes management as needed. The blinded CGM data will be downloaded but will not be reviewed by study personnel until the end of the first 6 months of the study. Parents will be taught to use the protocol-developed instructions for how to make changes to diabetes management based on HGM data.
Both groups will have follow-up visits at 1,4,8,13,19, and 26 weeks (+/- 1 week) plus one contact between each visit (including one phone contact between the second visit and the one week visit) to review their diabetes management.
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
- 4 Years 至 9 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 twelve months
- •Age >4.0 to <10.0 years
- •HbA1c >= 7.0%
- •Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)
排除标准
- •Diabetes diagnosed <6 months of age
- •Use of a medication such as oral/inhaled glucocorticoids 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 or another disease that the investigator believes to be a contraindication to participation in the protocol:
- •Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
- •Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
- •Home use of CGM in past 6 months.
- •Participation in an intervention study (including psychological studies) in past 6 weeks.
- •Another member of the same household is participating in this study.
结局指标
主要结局
Number of Participants With a Decrease >=0.5% HbA1c With no Severe Hypoglycemic Events
时间窗: 26 weeks
次要结局
- Number of Severe Hypoglycemic Events Experienced by Participants(26 weeks)
- Measures of Variability: Mean Amplitude of Glycemic Excursions (MAGE)(26 weeks)
- Parental Quality of Life Measures: Blood Glucose Monitoring System Rating Scale(26 weeks)
- Biochemical Hypoglycemia (Percentage of Sensor Values </= 70 mg/dL)(26 weeks)
- Parental Quality of Life Measures: PAID (Problem Areas in Diabetes)(26 weeks)
- CGM Glucose Values (mg/dL)(26 weeks)
- Measures of Variability: Standard Deviation (SD)(26 weeks)
- Measures of Variability: Mean Absolute Rate of Change(26 weeks)
- Parental Quality of Life Measures: Hypoglycemia Fear Survey(26 weeks)
- Parental Quality of Life Measures: CGM Satisfaction Scale(26 weeks)