Improving Glycemia & Reducing Diabetes Distress in Adolescents & Young Adults With T1D: Healthy And Positive Pathways for Young People With Type 1 Diabetes (HAPPY T1D)
概览
- 阶段
- 不适用
- 干预措施
- Psychoeducation to reduce diabetes distress and improve glycemic outcomes
- 疾病 / 适应症
- Type 1 Diabetes
- 发起方
- Joslin Diabetes Center
- 入组人数
- 217
- 试验地点
- 2
- 主要终点
- Time in Range (TIR)
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
In this 2-year randomized clinical trial, we will implement and assess the impact of a behavioral/psychoeducational intervention to reduce diabetes distress and improve glycemic outcomes in adolescents and young adults, aged 14-25 years, with T1D in order to optimize their short-term and long-term health.
详细描述
In this study, we will recruit 180 adolescents and young adults (ages 14-25) with type 1 diabetes for at least 1 year and suboptimal diabetes control (A1c 7-13%) to participate in a 2-year randomized clinical trial aimed at reducing diabetes distress and improving glycemic outcomes. Adolescents and young adults with type 1 diabetes represent a population that often has uncontrolled diabetes with elevated A1c levels and experiences diabetes distress, making such patients ideal for this study. Participants will be randomly assigned to one of two groups (control or intervention). The intervention group will participate in monthly intervention sessions with a research assistant during the first year of the study. Four sessions will focus on improving glycemic outcomes and 8 sessions will focus on reducing diabetes distress. The sessions will be conducted face-to-face or remotely. To ensure adequate recruitment and retention, the control group will participate in the intervention sessions during the second year of the study. Participants in both groups will use continuous glucose monitoring (CGM), with CGM data downloaded every 3 months. Participants in both groups will complete surveys and have A1c measured every 6 months. We will compare the two groups on percent time in target glucose range (70-180 mg/dL), A1c, and diabetes distress from baseline to 1 year. We hypothesize that the intervention group will have an improvement in percent time in range, A1c, and diabetes distress, compared with the control group.
研究者
入排标准
入选标准
- •Age 14-25 years
- •Diagnosis of type 1 diabetes (according to ADA criteria)
- •Type 1 diabetes duration ≥12 months
- •A1c 7-13%
- •Smartphone or regular access to wifi via computer
- •Fluency in English at a 5th grade level or higher (based on investigator assessment of grade level in school or highest grade level achieved and presence in mainstream academic classes)
排除标准
- •Physical or mental health condition that in the determination of the investigators may limit the ability to fully participate in the study (e.g., autism)
- •Participation in another intervention study within the last 3 months
- •Currently pregnant or intending to become pregnant during the study (assessed by self-report)
研究组 & 干预措施
Intervention Group
The Intervention Group will receive the monthly intervention sessions during the first year of the study.
干预措施: Psychoeducation to reduce diabetes distress and improve glycemic outcomes
Control Group
The Control Group will receive the monthly intervention sessions during the second year of the study (after assessment of primary outcomes at 1 year).
结局指标
主要结局
Time in Range (TIR)
时间窗: 0, 3, 6, 9, 12, 15, 18, 21, and 24 months (months 0-12 reported for primary outcome analysis)
CGM data will be downloaded every 3 months to assess percent time in range (TIR) (70-180 mg/dL). The primary outcome will be change in TIR from 0 to 12 months for intervention group vs. control group.
次要结局
- A1c(0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis))
- Diabetes Distress(0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis))
- Attitudes Toward Diabetes Device Use(0, 6, 12, 18, and 24 months (months 0-12 reported for secondary outcome analysis))