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
- 1
- 主要终点
- 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.
研究组 & 干预措施
Standard of Care
Standard care provided by the healthcare staff during routine diabetes clinic visits.
Diabetes Navigator
Support and guidance of Diabetes Navigator in addition to standard care
干预措施: Diabetes Navigator (Behavioral)
结局指标
主要结局
Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data)
时间窗: From baseline to 3 months
Participants whose DTUS increased from baseline to 3 months as a binary outcome (yes/no question)
次要结局
- Participants Whose Diabetes Technology Utilization Score (DTUS) Increases (90 Days of Data)(From baseline to 3 months)
- Participants Whose Diabetes Technology Utilization Score (DTUS) Stays the Same or Increased at 6 Months Among Those Whose DTUS Increased at 3 Months(From 3 months to 6 months)
- Participants Whose Diabetes Technology Use Score (DTUS) Increases (Based on Review of Last 14 Days of CGM and Insulin Pump Data) at 6 Months(From baseline to 6 months)
- Changes in Continuous Glucose Monitor (CGM) Percent Time Active(From baseline to 3 months)
- Change in Glycated Hemoglobin (HbA1c)(From baseline to 6 months)