Insul-In This Together Program for Type 1 Diabetes

(IITT Trial)

Overseen By Haley Linzmeyer, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: No smartphone, No English, Cognitive limitations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 15

Duration: 6 weeks

366 Participants Needed

Trial Summary

What is the purpose of this trial?

The "Insul-In This Together" intervention is designed for teens with Type 1 Diabetes and their parents. This study seeks to evaluate an evidence-based family intervention for teens with type 1 diabetes and their parents to offset the psychosocial and diabetes self-management risks. This information will provide a more in-depth understanding of family-based program efficacy for teens with adolescents and provide more judicious and streamlined intervention options to be offered in diabetes clinics in the future.

Research Team

Korey Hood, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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.

Inclusion Criteria

Participation of at least one cohabitating parent/caregiver.

I am a teenager diagnosed with type 1 diabetes for at least 6 months.

I am a teenager aged 12-19.

Exclusion Criteria

Subject has pervasive developmental, cognitive, or psychiatric limitations that compromise participation in study

Subject lacks access to a smartphone or Wi-Fi via computer

Subject has restricted or no English proficiency

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 6-week psychosocial intervention consisting of weekly 30-minute online family sessions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with surveys and glucose monitoring data collected at 3, 6, and 12-month follow-ups

12 months

3 visits (virtual)

Waitlisted Control Group Treatment

Waitlisted control group receives the same intervention at the 6-month follow-up mark

6 weeks

6 visits (virtual)

Treatment Details

Interventions

• Insul-In This Together

Trial Overview 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.

Participant Groups

Group I: Waitlisted Control Group Experimental Treatment 1 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 Group Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+