Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Gaps in CGM use
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy of an adapted FAMS (Family/friend Activation to Motivate Self-care) intervention on CGM use among study participants who are CGM users. We will leverage the infrastructure of an NIDDK-funded RCT evaluating FAMS-T1D among N=280 emerging adults with T1D who have elevated hemoglobin A1c or elevated diabetes distress (NCT05820477). We anticipate at least 50% using CGM to be included in these analyses.
详细描述
FAMS (Family/friend Activation to Motivate Self-care) is a mobile phone-delivered intervention, based on Family Systems Theory, which helps adults with diabetes set behavioral goals and improve support received from friends and family for goal success. FAMS includes monthly phone coaching and text message support by FAMS coaches for the person with diabetes (PWD) and the option to enroll a support person (SP) to receive automated texts tailored to the self-care goals the person with T1D sets in coaching sessions. Adaptations specific to CGM include the option to set CGM use goals in coaching (and receive associated text support) and skill-building exercises during coaching to support data sharing relationships (e.g., establishing, setting and adjusting ground rules about communication).
Within the FAMS-T1D RCT (NCT05820477), we will test effects of FAMS-T1D on CGM use use relative to enhanced treatment as usual. We will evaluate effects on CGM use from baseline to post-intervention (6 months) as the primary endpoint. Study start date for the nested trial (NCT05854069) is the enrollment date of the first participant using a CGM. Since the goal of this trial is to assess effects of the adapted FAMS intervention on CGM use, the date participant CGM usage was confirmed is considered the enrollment date.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PERSONS WITH DIABETES
- •Ages 18-24
- •Have a diagnosis of T1D and has been taking insulin for at least one year
- •Comfortable sending and receiving texts
- •Can speak, read, and write in English
- •Meets one of the following two criteria: 1) has a most recent A1c value in the EHR that is 7.5% or higher (or missing) OR 2) screen positive for diabetes distress on the two-item Diabetes Distress Screen (DDS-2)
- •Using a continuous glucose monitor (CGM)
- •SUPPORT PERSONS
- •Age 18 or older
- •Can speak, read, and write in English or Spanish
- •Comfortable sending and receiving texts
排除标准
- •PERSONS WITH DIABETES
- •Has a condition that would prohibit study completion (intellectual disability, blindness or auditory limitations, severe mental illness)
- •Plans to live outside the country during the study period
- •SUPPORT PERSONS
- •Shares a phone with the person with diabetes
- •Plans to live outside of the country during the study period
结局指标
主要结局
Gaps in CGM use
时间窗: 6 months post-baseline
Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse)
CGM frequency of use during the intervention period
时间窗: Baseline and 6 months post-baseline
Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better
次要结局
- CGM behavioral responses during the intervention period(Baseline and 6 months post-baseline)
- CGM satisfaction during the intervention period(Baseline and 6 months post-baseline)
- Barriers to CGM use during the intervention period(Baseline and 6 months post-baseline)
研究者
Lindsay Mayberry
Principle Investigator
Vanderbilt University Medical Center