InvesT1D: Promoting Adolescent Investment in Diabetes Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Time In Range
研究概览
简要总结
The goal of this clinical trial is to see if a financial incentives program called InvesT1D is helpful to support diabetes management in adolescents with type 1 diabetes.
Adolescent participants will be randomized to usual care or receive financial incentives for meeting diabetes self-management and clinical outcomes goals during the study. Researchers will compare changes in glucose levels, as well as adolescent and caregiver person-reported outcomes between groups.
详细描述
Adolescents face many challenges as they transition from childhood to adulthood. For adolescents with type 1 diabetes, there are additional responsibilities that come with daily diabetes self-management.
The goal of this study is to find out whether financial incentives can help adolescents with their daily self-management. Adolescent participants will be assigned to one of 6 groups. Some participants will be asked to choose diabetes self-management goals such as increasing daily bolus insulin administration or increasing their continuous glucose monitoring system wear time, and then will be provided with financial incentives (money) when they meet their selected goals. Other participants will be asked to continue their diabetes management as usual.
Researchers will collect data from 96 adolescent participants and their caregivers to assess change in glucose levels, as well as adolescent and caregiver person-reported outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 1 diabetes ≥12 months
- •Utilize a continuous glucose monitor (CGM) to support diabetes management
- •Average daily CGM use is less than or equal to 70% of the time and/or their baseline average insulin bolus administration is less than or equal to 3 times a day
- •Are using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- •Cognitively able to participate in incentive program and complete surveys
- •Have access to a mobile phone to receive information about goal attainment and incentive updates
- •Have the ability to upload glucose and insulin administration data remotely per processes used by participant's diabetes care team
- •Caregivers are willing to participate in study and complete surveys
排除标准
- •At time of screening, average CGM wear is greater than 70% of the time or baseline average insulin bolus administration is greater than 3 times a day
- •Adolescent is not interested in using diabetes technology that allows for tracking of bolus insulin administration if participant wants to work on improving daily bolus insulin administration
- •Cognitively or physically unable to participate
- •Adolescent is a ward of the state
- •Severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
- •Caregivers are not willing to participate in study and complete surveys
结局指标
主要结局
Time In Range
时间窗: Change over 12-18 months
Continuous glucose monitor sensor glucose measurements collected during the intervention that are in range (70-180 mg/dL)
次要结局
- Time Above Range(Change over 12-18 months)
- Time Below Range(Change over 12-18 months)
- Hemoglobin A1c (HbA1c)(Change over 12-18 months)
- Diabetes Distress(Change over 12-18 months)
- Diabetes Family Conflict(Change over 12-18 months)
- Adolescent Quality of Life(Change over 12-18 months)
- Caregiver Quality of Life(Change over 12-18 months)
- Diabetic Ketoacidosis(12-18 months)
- Severe Hypoglycemia(12-18 months)
- Insulin Adminstration(Change over 12-18 months)
研究者
Davene R. Wright
Associate Professor
Harvard Pilgrim Health Care