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Insul-In This Together: Leveraging Family Support and Diabetes Technology for Adolescents Living With Type 1 Diabetes (IITT)

2026年9月28日 更新者：Jessie Wong、Stanford University

The goal of this clinical trial is to learn if the "Insul-In This Together" family program works to improve outcomes for adolescents living with type 1 diabetes. It will also learn about how the program influences diabetes-related factors, including parenting. The main questions it aims to answer are:

Does this program improve glycemic (blood glucose) outcomes? Does this program improve adolescent quality of life related to diabetes? Researchers will offer the program to all participating families, with one group receiving the program right after enrollment and another group receiving the program 6 months later.

Adolescent and parent participants will:

Attend 8 weekly 30-minute videoconference sessions with an interventionist Complete online surveys, share diabetes device data, and conduct at-home A1c tests 3-5 times over a 12-month period

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The proposed study is a nationwide randomized controlled trial with 200 adolescents ages 12-17 living with type 1 diabetes for at least six months who are US residents and their parents. Participants will be randomized 1:1 to either the intervention condition (offered the intervention immediately post-baseline) or the waitlisted control condition (offered the intervention after completing the 6-month follow-up). The primary outcome endpoint will be 3-month post-baseline, based on prior findings. This cross-over design will support recruitment and retention and offer all participants the opportunity to receive this empirically supported program, while maintaining an experimental comparison group. The revised intervention includes eight 30-minute weekly sessions to be delivered to each parent-adolescent dyad by a trained interventionist. Didactic and interactive content targets parental monitoring, involvement strategies, collaborative problem-solving, and communication across six sessions with two glycemic sessions that focus on glucose monitoring, data interpretation, and strategies to increase/optimize technology use. Data will be gathered via adolescent and parent report, continuous glucose monitoring (CGM) and other device data, and at-home HbA1c test kits. We will assess intervention outcomes, differential intervention responses, and key drivers of change.

研究类型

介入性

注册 (估计的)

200

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Palo Alto、California、美国、94305
        • Stanford University
        • 接触：
        • 首席研究员：
          • Jessie J Wong, PhD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • For adolescent participants: ages 12-17, diagnosed with type 1 diabetes for at least 6 months, US resident, English proficiency, and resides with the participating parent/caregiver.
  • For parent participants: residing with eligible and participating adolescent, US resident, and English proficiency.

Exclusion Criteria:

  • Severe or pervasive physical or mental health condition that would limit participation in data collection or the intervention (e.g., pervasive developmental delays).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Intervention

Offered the intervention immediately after Baseline data collection
行为的：Insul-In This Together

The "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use.
其他：Waitlisted Control

Offered the intervention after 6-Month Post-Baseline data collection
行为的：Insul-In This Together

The "Insul-In This Together" intervention consists of eight weekly 30-minute sessions. Each adolescent-parent dyad (an adolescent with corresponding parent/caregiver) meets remotely with an interventionist (not in groups). The structure of adolescents and parents receiving the intervention as a single dyad (not in groups) offers space to discuss sensitive topics and flexibility to accommodate variability in families' schedules. Intervention content targets diabetes-related parental monitoring, involvement, and conflict with a focus on communication and problem-solving skills. Diabetes technology use is addressed related to shared goals, expectations, and communication based on each family's current use.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Adolescent diabetes-related quality of life
大体时间：From Baseline (post enrollment) to 12-month post-baseline

The Type 1 Diabetes and Life (T1DAL) survey is a 23-item scale with a teen version (ages 12-17) and a young adult version (ages 18-25) that capture quality of life related to living with diabetes (for those who turn 18 during the study).
From Baseline (post enrollment) to 12-month post-baseline
Percent time-in-range (TIR)
大体时间：From baseline (post enrollment) to 12-month post-baseline

TIR is strongly linked to risk of health complications and offers valuable insights beyond hemoglobin A1c, particularly.13 Percent time spent in target range (70-180mg/dL) will be calculated based on continuous glucose monitoring (CGM) data captured in a 14-day window. At least 10 days of data will be required within the 14-day window to be included in analyses.
From baseline (post enrollment) to 12-month post-baseline

次要结果测量

结果测量
措施说明
大体时间
Hemoglobin A1c
大体时间：From baseline (post enrollment) to 12-month post-baseline

HbA1c results will be gathered based on at-home test kits provided and analyzed by University of Minnesota.
From baseline (post enrollment) to 12-month post-baseline
Adolescent diabetes distress
大体时间：From baseline (post enrollment) to 12-month post-baseline

The Problem Areas in Diabetes questionnaire (PAID) is a 20-item scale of emotional responses related to diabetes distress among adolescents.
From baseline (post enrollment) to 12-month post-baseline
Parent diabetes distress
大体时间：From Baseline (post enrollment) to 12-month post-baseline

The Parent Diabetes Distress Scale (P-DDS) is a 20-item measure of diabetes related distress among parents of teens with diabetes.
From Baseline (post enrollment) to 12-month post-baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Stanford University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2028年1月1日

初级完成 (估计的)

2031年12月1日

研究完成 (估计的)

2032年6月1日

研究注册日期

首次提交

2026年9月28日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月5日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 88772

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data may be shared with qualified researchers upon reasonable request after publication of the primary results. Requests will be reviewed by the study team and will require a scientifically sound proposal, institutional approvals as applicable, and a data use agreement that prohibits re-identification or onward sharing. Data sharing will be limited to information that can be provided without compromising participant privacy or confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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