GO TEAM INTERVENTION PROTOCOL: GLUCOSE OPTIMIZATION THROUGH TECHNOLOGY ASSISTED MANAGEMENT: Use of a Diabetes Dashboard and Community Health Worker to Decrease Disparities in Technology Use in Pediatric T1D
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
研究概览
简要总结
Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Self-reported as Non-Hispanic Black
- •Clinical diagnosis of T1D requiring treatment with insulin at the time of consent
- •Not currently (within the past 3 months) using an automated insulin delivery system \
- •Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor
排除标准
- •Clinical diagnosis of Type 2 or monogenic diabetes
- •Completed high school
- •Non-English speaking guardians
- •Automated insulin delivery system use within the past 3 months
- •Custody of children and family services
研究组 & 干预措施
Standard of Care
Participants in this arm follow standard of care procedures.
Diabetes Dashboard and Community Health Worker
Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.
干预措施: Glucosano (Other)
Diabetes Dashboard and Community Health Worker
Participants diabetes technology devices will be linked to a remote patient monitoring dashboard and will have access to a Smartphone application, as well as scheduled and as needed visits with a community health worker.
干预措施: Community Health Worker diabetes technology coach (Behavioral)
结局指标
主要结局
Change in percentage of participants who start on automated insulin delivery (AID) as measured by medical records review
时间窗: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
Change in percentage of participants who remain on AID as measured by medical record review
时间窗: Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months
次要结局
- Change in percentage of CGM wear time as measured by CGM data(Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months)
- Change in percentage of participants using an insulin pump as measured by chart review(Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months)
- Change in barriers to technology as measured by Barriers to Technology Checklist(Baseline, 12 months)
- CGM satisfaction as measured by the CGM satisfaction scale(12 months)
- Change in diabetes management self-efficacy as measured by the Self-Efficacy for Diabetes Self-Management scale short version(4 weeks, 12 months)
- Episodes of Diabetic Ketoacidosis as measured by chart review(up to 12 months)
- Change in time glucose >250 mg/dL as measured by continuous glucose monitoring(4 weeks, 6 months, 12 months)
- Benefits and Burdens of CGM as measured by Benefits and Burdens of CGM scale(12 months)
- Change in patient endorsement of intervention as measured by the Acceptability of Intervention Measure (AIM)(3 months and 12 months)
- Number of times patient reached out to team as measured by medical record review(Up to 12 months)
- Number of alerts as measured by dashboard review(Up to 12 months)
- Number of phone calls initiated by patients as measured by dashboard review(Up to 12 months)
- Change in patient endorsement of intervention as measured by Feasibility of Intervention Measure (FIM)(3 months and 12 months)
- Change in patient endorsement of intervention as measured by Intervention Appropriateness Measure (IAM)(3 months and 12 months)
- Number of automatically generated alerts as measured by dashboard/app review(Up to 12 months)
- Number of times a physician or diabetes nurse interacted with patient as measured by dashboard review(Up to 12 months)
- Number of downloads of the app(Up to 12 months)
- Number of days of patient/family use interaction with the app as measured by dashboard review(Up to 12 months)
- Change in time in range as measured by continuous glucose monitoring(4 weeks, 6 months, 12 months)
- Change in percentage of participants using continuous glucose monitor (CGM) with at least 80% wear time as measured by CGM data(Baseline, 4 weeks, 3 months, 6 months, 9 months, 12 months)
- Change in capillary HbA1c(Baseline, 3 months, 6 months, 9 months, 12 months)
- Change in time glucose is <70 mg/dL as measured by continuous glucose monitoring(4 weeks, 6 months, 12 months)
- Change in diabetes family conflict, as measured by the Diabetes Family Conflict Scale(4 weeks, 12 months)
- Change in parental burden related to diabetes, as measured by Problem Areas in Pediatric Diabetes - Parent Revised Version(4 weeks, 12 months)
- Change in child/adolescent quality of life, as measured by PedsQL Type 1 diabetes module by parent-proxy(4 weeks, 12 months)
- Change personal frequency of discrimination in healthcare, as measured by the Racism in Healthcare Index(Baseline, 12 months)
- Psychosocial functioning of children/adolescents, as measured by the strengths and difficulties questionnaire given to parents(Baseline)
- Change in medical distrust, as measured by the Group Based Medical Distrust Scale(Baseline, 12 months)
- Change in perceptions of racism in healthcare, as measured by the Racism in Healthcare Index(Baseline, 12 months)
- Change in diabetes specific attitudes towards technology as measured by the Diabetes Specific Technology Attitudes Scale(Baseline, 12 months)
- Episodes of severe hypoglycemia as measured by chart review(up to 12 months)
研究者
Sarah MacLeish
Associate Professor of Pediatrics
Case Western Reserve University