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临床试验 NCT05854069 针对1型糖尿病目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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范德比尔特大学Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes 140
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05854069是一项针对1型糖尿病的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2023年4月30日，计划招募140名患者。该研究由范德比尔特大学主导，预计于2027年4月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年10月29日。
简要概括
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% usi...显示更多
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 rece...显示更多
官方标题
Adapting FAMS to Optimize CGM Use Among Emerging Adults With Type 1 Diabetes
疾病
1型糖尿病其他研究标识符
- 220847
- G-2203-05822 (其他拨款/资助编号) (The Leona M. and Harry B. Helmsley Charitable Trust)
NCT编号
实际开始日期
2023-04-30
最近更新发布
2025-10-29
预计完成日期
2027-04-30
计划入组人数
140
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
关键词
Continuous glucose monitor
Social support
Goal setting
Diabetes distress
Hemoglobin A1c
Time in range
Emerging adults
Family support
Text message
Mobile health
Social support
Goal setting
Diabetes distress
Hemoglobin A1c
Time in range
Emerging adults
Family support
Text message
Mobile health
主要目的
支持治疗
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性FAMS-T1D Participants will receive FAMS-T1D components (monthly phone coaching and text message support for goals) for 6 months. Support persons will receive text messages that are tailored to the goal set by the person with type 1 diabetes.
All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to ...显示更多 | FAMS-T1D FAMS-T1D involves monthly phone coaching that assists individuals in setting specific and time bound diabetes goals with automated text message support to the patient participant and less frequent automated text messages to their support person, if one is enrolled.
Behavioral: Diabetes Resources High quality digital materials about diabetes management will be provided upon enrollment and send to participants quarter...显示更多 Digital resources for diabetes Quality digital resources about diabetes management provided upon enrollment and during the study. |
安慰剂对照Digital resources for diabetes All persons with diabetes will receive text messages regarding how to access their HbA1c results and receive links providing information to assist them in self-care behaviors related to their diabetes. All support persons will also receive materials about type 1 diabetes and how to provide helpful support to the person with diabetes. | Digital resources for diabetes Quality digital resources about diabetes management provided upon enrollment and during the study. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
CGM frequency of use during the intervention period | Change in CGM frequency of use assessed by self-report on questionnaire; more frequent use/higher is better | Baseline and 6 months post-baseline |
CGM frequency of use during the intervention period | Change in CGM frequency of use assessed by objective CGM data (% of time; higher is better) | Baseline and 6 months post-baseline |
Gaps in CGM use | Length of gaps in CGM use as assessed by objective CGM data (measured in number of consecutive days without CGM data; higher is worse) | 6 months post-baseline |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
CGM behavioral responses during the intervention period | Change in frequency of making behavioral changes in response to CGM data assessed by self-report; higher scores indicate more frequent response (better) | Baseline and 6 months post-baseline |
Barriers to CGM use during the intervention period | Change in perceived influence of CGM on glycemic control scale assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) | Baseline and 6 months post-baseline |
Barriers to CGM use during the intervention period | Change in perceived influence of CGM on social complications assessed by Glucose Monitoring Survey; higher scores indicate more perceived problems with CGM use (worse) | Baseline and 6 months post-baseline |
CGM satisfaction during the intervention period | Change in CGM satisfaction assessed by Benefits of CGM scale; higher scores indicate more perceived benefits of CGM use (better) | Baseline and 6 months post-baseline |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
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
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
范德比尔特大学344 个活跃的临床试验可供探索研究责任方
Lindsay Mayberry, 主要研究者, Principle Investigator, Vanderbilt University Medical Center
没有联系数据。
2 位于 1 个国家/地区的研究中心
California
Children's Hospital of Los Angeles, Los Angeles, California, 90027, United States
Utah
University of Utah, Salt Lake City, Utah, 84112, United States