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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial targets teens with Type 1 Diabetes and their parents to explore how a family-based program, "Insul-In This Together," can aid in diabetes management and reduce stress. The program consists of six weekly online sessions that address diabetes challenges and aim to improve communication between teens and parents. Participants are divided into two groups: one begins the program immediately, while the other starts six months later. Teens who have lived with Type 1 Diabetes for at least six months and reside with a parent or caregiver are well-suited for this trial. As an unphased trial, this study provides a unique opportunity for families to enhance their diabetes management skills and improve family communication.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on family-based interventions rather than medication changes.

What prior data suggests that the "Insul-In This Together" program is safe for teens with Type 1 Diabetes and their parents?

Research shows that the "Insul-In This Together" program is designed for teens with Type 1 Diabetes and their parents. As a family-based program, it aims to improve communication and manage stress related to diabetes.

Focusing on behavior and education, the program avoids physical side effects that drug treatments might cause. Participants join online sessions to learn and practice skills, complete surveys, and share glucose levels to track progress.

While direct safety data from other studies is lacking, the program's design suggests it is well-tolerated. Trained staff lead the sessions, emphasizing support and education, which reduces the risk of negative effects.

Overall, the program appears safe, with the primary goal of helping families manage diabetes more effectively together. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Insul-In This Together program because it offers a fresh approach to managing Type 1 diabetes by focusing on family dynamics and communication. Unlike standard treatments that primarily address blood sugar control through medication and lifestyle changes, this program zeroes in on reducing diabetes-related stress within families. By conducting interactive online sessions, it aims to improve how parents and teens communicate and work together in managing the condition, potentially leading to better health outcomes and quality of life. This innovative strategy could complement existing medical treatments, providing a more holistic approach to diabetes care.

What evidence suggests that the "Insul-In This Together" program is effective for teens with Type 1 Diabetes?

Research shows that family-based programs can help teens with Type 1 Diabetes. In this trial, participants in the "Insul-In This Together" program will engage in organized sessions with their families. Studies have found that when both teens and their parents participate in such sessions, diabetes management improves and stress decreases. These sessions typically involve learning, discussions, and activities to enhance communication and support between parents and teens. Early results suggest that when families collaborate, teens may manage their diabetes more effectively. This team approach aims to simplify and improve diabetes management for families. ^{1 2 6 7 8}

Who Is on the Research Team?

Korey Hood, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/phase-diabetes-mellitus-11-2020-01f6c

Insul-In This Together Program for Type 1 Diabetes 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 ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/89/NCT04589689/Prot_000.pdf

Optimizing Family-based Interventions for Adolescents ... Page 1. Insul-In This Together Program: Optimizing Family-based. Interventions for Adolescents With Type 1 Diabetes and. Their Parents.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9047817/

Effectiveness of video consultations in type 1 diabetes patients ... The purpose of the study is to assess the effectiveness of video consultations in patients with type 1 diabetes mellitus (DM) treated with insulin pumps in ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dme.14741

Real‐world evidence on clinical outcomes of people with ... Real-world evidence on clinical outcomes of people with type 1 diabetes using open-source and commercial automated insulin dosing systems: A ...

5. stanfordhealthcare.org stanfordhealthcare.org/trials/i/NCT04589689.html

Insul-In This Together Program for Adolescents With Type ... 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 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8080922/

Outcomes from the International Diabetes Closed-Loop Trial Conclusions: CLC use for 6 months was substantial and associated with improved TIR and reduced hypoglycemia in adolescents and young adults with type 1 diabetes ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03040414

NCT03040414 | Fuzzy Logic Automated Insulin Regulation The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) ...

8. liebertpub.com liebertpub.com/doi/full/10.1089/dtom.2025.0005

Real-World Clinical Outcomes of a Virtual Integrated ... Results: A total of 230 patients (36.1% with type 1 diabetes; 45.6% taking insulin; median baseline A1C 8.0%) were included. Over a median ...