The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- glycemic control assessed by HbA1C level.
研究概览
简要总结
The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with T1D,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.
详细描述
Managing Type 1 Diabetes requires daily checks of blood glucose and medication adjustments. Children and adolescents are known to have more difficulty with this than adults. Parents/legal guardians also face the task of helping with this self-management. A weekly text message regarding Type 1 Diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their Type 1 Diabetes.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
- •Have a diagnosis of Type 1 diabetes for ≥ one year.
- •Be aged 8 to 18 years old.
- •Be on insulin therapy for ≥ one year.
- •Have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older).
- •Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT&T, or Virgin Mobile.
- •The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study.
- •The parent/legal guardian must be able to read English OR the parent/legal guardian and the adolescent must be able to read English.
排除标准
- •Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control.
- •Individuals who are unable to undertake blood glucose testing during the study period
- •Individuals who are deemed unable or unlikely to comply with the protocol.
结局指标
主要结局
glycemic control assessed by HbA1C level.
时间窗: up to one year after randomization occurs
review of lab value
次要结局
- number of hospitalizations related to T1D(up to one year after randomization occurs)
- number of episodes of severe hypoglycemia(up to one year after randomization occurs)
- number of episodes of Diabetic Ketoacidosis (DKA)(up to one year after randomization occurs)
- number of patient contacts to the diabetes educator(up to one year after randomization occurs)
研究者
Gwendolyn Pierce
Research Nurse
University of Louisville