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Insul-In This Together Program for Type 1 Diabetes (IITT Trial)

N/A

Waitlist Available

Led By Korey K Hood, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a family intervention for teens with type 1 diabetes and their parents to see if it can help manage the risks of the disease.

Who is the study for?

This trial is for teens aged 12-19 with Type 1 Diabetes, diagnosed for at least 6 months. They must have a parent willing to participate and both should be able to use a smartphone or Wi-Fi-enabled computer. Teens with developmental, cognitive, or psychiatric conditions affecting study participation are excluded.

What is being tested?

The 'Insul-In This Together' program is being tested to see if it helps teenagers with Type 1 Diabetes and their parents manage the psychosocial challenges and self-care requirements of diabetes more effectively.

What are the potential side effects?

Since this intervention focuses on family-based education and support rather than medication, there may not be direct medical side effects; however, participants might experience emotional discomfort during discussions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date)

This trial's timeline: 3 weeks for screening, Varies for treatment, and average percent time in range based on two weeks of glucose monitoring data at 6-month follow-up (plus or minus 2 weeks around target data collection date) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adolescent quality of life

Glucose levels percent time in target range based on glucose monitoring

Secondary study objectives

Adolescent depression

Adolescent distress

Hemoglobin A1c (HbA1c)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Waitlisted Control GroupExperimental Treatment1 Intervention

The waitlisted control group will receive the same intervention as the intervention group, but at the 6-month follow-up mark. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week from baseline. Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.

Group II: Intervention GroupExperimental Treatment1 Intervention

The intervention group will participated in the The Insul-In This Together intervention, which consists of 6 weekly 30-minute online family sessions to discuss topics related to diabetes distress and parent-teen communication. Sessions include structured education, discussions, and skill-building activities related to parental involvement, parental monitoring, and parent-adolescent conflict. The intervention will be conducted by the PI or clinically trained research staff via Zoom. Online surveys, and glucose monitoring data will be captured at baseline and 3,6 and 12-month follow-ups. Brief surveys will also be conducted at 2-, 4-, and 6-week follow-ups (after every 2 sessions for the intervention group and later the control group). Participants will be asked to provide A1C test results that will be collected via chart review or from participants sharing their test results at baseline, 6-month, and 12-month follow-up.

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