Supporting Medtronic 780G Insulin Pump Adoption in Latino Patients: A Spanish - Language Training Initiative
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months
研究概览
简要总结
This study plans to learn more about whether a support program delivered in Spanish or both English and Spanish for bilingual families helps Latino youth with Type 1 Diabetes (T1D) successfully use the Medtronic MiniMed 780G system.
The main question it aims to answer is:
Does a linguistically and culturally tailored onboarding model for an automated insulin delivery system close the gap in technology adoption and improve health outcomes?
Participants will:
- Use the Medtronic MiniMed 780G Automated Insulin Delivery system for eight months
- Attend one in-person nutrition support and insulin pump start class
- Participate in regular virtual check-ins with native Spanish-speaking study team members
详细描述
This interventional, single-group study will assess the effectiveness of a structured, culturally tailored onboarding and support program designed to promote initiation and sustained use of the Medtronic MiniMed 780G system among Latino/Hispanic youth with type 1 diabetes. Participants will transition to the Medtronic MiniMed 780G system and receive ongoing education and support over an 8-month period. The primary outcome is the proportion of participants continuing use of the system at 6 months. Secondary outcomes include clinical measures derived from routine care (HbA1c, time in range, hypoglycemia) and participant-reported satisfaction and confidence with diabetes technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 10 - 20 years old
- •Diagnosis of type 1 diabetes
- •Self-identify as Latino/Hispanic (determined via self-report and/or electronic health record)
- •Currently managing diabetes using any regimen, including multiple daily injections (MDI) or any non-Medtronic automated insulin delivery system
- •Willing to transition to and use the Medtronic MiniMed 780G system for the duration of the study
排除标准
- •Current use of any Medtronic technology
- •More than 1 episode of diabetic ketoacidosis (DKA) within 12 months of study enrollment
- •Current pregnancy (self-reported), due to limited safety data for use of the Medtronic MiniMed 780G system during pregnancy
- •Presence of any significant medical condition that, in the opinion of the investigator, would interfere with study participation or data interpretation
- •Inability or unwillingness to use the Medtronic MiniMed 780G system for the duration of the study
研究组 & 干预措施
Intervention - Medtronic Pump Onboarding Program
干预措施: Medtronic MiniMed 780G Insulin Pump System (Device)
Intervention - Medtronic Pump Onboarding Program
干预措施: Culturally and linguistically tailored onboarding and support program (Other)
结局指标
主要结局
Proportion of Participants Continuing Use of the Medtronic MiniMed 780G System at 6 Months
时间窗: 6 months
Adoption will be defined as continued use of the Medtronic MiniMed 780G insulin pump system at 6 months following initiation. The outcome will be calculated as the proportion of enrolled participants who remain actively using the system at the 6-month time point.
次要结局
- Change from Baseline in Hemoglobin A1c(Baseline and 8 months)
- Proportion of Participants Achieving Time in Range (70-180 mg/dL) greater than 60 percent(Baseline and 8 months)
- Change from Baseline in Participant Diabetes Treatment Satisfaction(Baseline and 8 months)
- Change from Baseline in Participant Confidence in Diabetes Technology Use(Baseline through Month 8)
- Change from Baseline in Caregiver Diabetes Treatment Satisfaction(Baseline and 8 months)
- Change from Baseline in Caregiver Confidence in Diabetes Technology Use(Baseline through Month 8)