Assessing Effectiveness of a Diabetes Navigator in Increasing Progression (Improving Uptake and/or Optimization) of Advanced Diabetes Technologies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)
研究概览
简要总结
The goal of this randomized control trial is to determine if the support of a Diabetes Navigator is more effective than standard care in improving uptake and use of advanced diabetes technology among patients with type 1 diabetes.
详细描述
This study will recruit 148 individuals, 74 adults (ages 21-75) and 74 youth (ages 5-20) with type 1 diabetes. Participants will be randomized to standard care (usual diabetes care) or the intervention arm in which the participants will receive additional support from a Diabetes Navigator. Participants in the intervention group will receive assistance from a Diabetes Navigator who will help the participants address challenges in acquiring and optimally using advanced diabetes technology. The investigators will compare the group receiving Diabetes Navigator support with the standard care group to see if the additional support improves progression (increases uptake and/or optimization) in use of advanced diabetes technology and, consequently, improves glycemic control among patients.
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
- Single (Outcomes Assessor)
盲法说明
Patients will be masked until randomization. Outcomes Assessor will be masked.
入排标准
- 年龄范围
- 5 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 5 to 75 years.
- •Diagnosis of type 1 diabetes
- •Patient of Johns Hopkins Medicine adult or pediatric diabetes clinics
- •Not using or not optimally using diabetes technology.
- •Planned Diabetes technology intensification by diabetes provider.
- •If already on diabetes technology - must be using the specific device for a minimum of 14 days.
排除标准
- •Optimally using Diabetes Technology
- •Pregnancy or lactation or planned pregnancy in the next 12 months.
- •Other types of diabetes (type 2 diabetes, Maturity Onset Diabetes in Youth, cystic fibrosis-related diabetes, steroid-induced diabetes, post total pancreatectomy, transplant-related diabetes)
- •Active participant of any other research study that may interfere with diabetes management.
结局指标
主要结局
Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (based on review of last 14 days of CGM and insulin pump data)
时间窗: Baseline, 3 months
Diabetes Technology Utilization Score is calculated based on CGM and Insulin pump use ranging from 0-4, 4 indicating optimal technology use and 0 indicating no use of technology. Measured from baseline to 3 months as a binary outcome (yes/no question)
次要结局
- HbA1c change(Baseline, 3 months, 6 months)
- Change in the Diabetes Technology Use Score (DTUS)(Baseline, 3 months and 6 months)
- Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases (90 days of data)(Baseline, 3 months)
- Changes in continuous glucose monitor (CGM) "Time in Range"(Baseline, 3 months, 6 months)
- Percent of participants whose Diabetes Technology Utilization Score (DTUS) increases at 3 months and stays the same or increases at 6 months.(Baseline, 3 months, 6 months)