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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12+
SponsorStanford University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Insul-In This Together

    Behavioral

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: Waitlisted ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Adolescent diabetes-related quality of life

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).

Time frame
From Baseline (post enrollment) to 12-month post-baseline
2

Percent time-in-range (TIR)

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.

Time frame
From baseline (post enrollment) to 12-month post-baseline

Secondary outcomes

1

Hemoglobin A1c

HbA1c results will be gathered based on at-home test kits provided and analyzed by University of Minnesota.

Time frame
From baseline (post enrollment) to 12-month post-baseline
2

Adolescent diabetes distress

The Problem Areas in Diabetes questionnaire (PAID) is a 20-item scale of emotional responses related to diabetes distress among adolescents.

Time frame
From baseline (post enrollment) to 12-month post-baseline
3

Parent diabetes distress

The Parent Diabetes Distress Scale (P-DDS) is a 20-item measure of diabetes related distress among parents of teens with diabetes.

Time frame
From Baseline (post enrollment) to 12-month post-baseline

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: