Intervention to Thrive With Type 1 Diabetes 2026
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Multidimensional sleep health composite score
研究概览
简要总结
This study aims to learn whether a cognitive behavioral intervention can improve lifestyle and glucose targets for adults with type 1 diabetes.
详细描述
Type 1 diabetes (T1D), a common yet understudied chronic condition in young adulthood, is a life-shortening disorder leading to beta-cell destruction and absolute insulin deficiency. Suboptimal glucose diabetes self-management is associated with a higher risk for premature vascular complications, both macrovascular (e.g., coronary artery disease, peripheral arterial disease, and stroke) and microvascular (retinopathy, nephropathy, neuropathy) through accelerated vascular aging. Yet a majority of adults with T1D do not achieve recommended glycemic targets (A1C <7%) or blood pressure targets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 31 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 31 to 75 years
- •Type 1 Diabetes for at least 1 year
- •One or more sleep health dimensions are out of range
排除标准
- •Non-English speaking
- •Recent night shift work or transmeridian travel
- •Life-limiting illness
研究组 & 干预措施
Transdiagnostic Intervention for Sleep and Circadian (TranS-C) Dysfunction Intervention Arm
Participants will work with a health coach to aim for 7-9 hours of sleep per night, at least 85% sleep efficiency, and less than 60 minutes' variation in bed and wake times.
干预措施: TranS-C Intervention Arm (Behavioral)
Enhanced Usual Care (EUC) Arm
Participants will work with a health coach focused on enhanced usual care.
干预措施: Attention Control Enhanced Usual Care (EUC) Arm (Behavioral)
结局指标
主要结局
Multidimensional sleep health composite score
时间窗: Baseline and post-intervention (14 weeks from baseline)
The multidimensional sleep health composite score assesses six domains: regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep regularity, timing, efficiency, and duration will be measured using a non-dominant wrist-worn research-grade actigraph (Ametris CentrePoint Insight Watch) worn 24/7 during the monitoring period. Sleep satisfaction will be assessed using the global score of the 19-item Pittsburgh Sleep Quality Index (PSQI; range 0-21; scores \<5 coded as 1, indicating good sleep). Alertness will be assessed using the Epworth Sleepiness Scale (ESS; range 0-24; scores \<8 coded as 1, indicating good daytime alertness). Each component will be scored according to predefined criteria and summed to create a composite score ranging from 0 to 6, with higher scores indicating better overall sleep health over the 1-week monitoring period at each time point. The composite score (unitless) will be assessed at baseline and post-intervention.
Glycated hemoglobin (HbA1C)
时间窗: Baseline and post-intervention (14 weeks from baseline)
HbA1C will be measured by the FDA-approved A1C Now Self-Check. HbA1C reflects the average blood glucose level over the preceding approximately 2-3 months and will be reported as a percentage (%). Changes in glycemia will be assessed by comparing HbA1C values measured at baseline and post intervention. Units = percent (%).
次要结局
- Glucose variability(Baseline and post-intervention (14 weeks from baseline))
- Time in range(Baseline and post-intervention (14 weeks from baseline))
研究者
Stephanie Griggs
Associate Professor
Emory University