Virtual Group for Type 1 Diabetes

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Western Michigan University School of Medicine

Disqualifiers: Chronic condition, Mental health, others

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

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help young adolescents with type 1 diabetes (T1D) manage the emotional challenges of their condition. The goal is to teach emotion regulation skills to prevent risky behaviors and mood problems, especially when managing T1D conflicts with social goals, such as taking insulin in front of new friends. Participants will join virtual group sessions, called "The T1D Talks: A Virtual Group for Teens and Tweens with T1D," to learn these skills. The trial seeks adolescents aged 12-14 who have had T1D for at least a year and can access virtual meetings. As an unphased trial, this study offers a unique opportunity to gain valuable skills and support in managing T1D.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on emotional support rather than medication changes.

What prior data suggests that this intervention is safe for adolescents with T1D?

Past studies have shown promise in programs that help young teens manage their emotions. These programs teach skills to better handle feelings, which can lower stress and prevent mood problems. Research shows that group sessions, like the T1D Talks Virtual Group, can help reduce stress related to managing diabetes.

These programs are generally considered safe. They focus on teaching practical emotional skills instead of using medications, so there are usually no physical side effects. Feedback from similar programs has been positive, with participants often feeling more supported and less stressed.

This study is in the early testing phase, focusing on how participants respond to the program. This helps researchers understand how well the program is received and if any changes are needed. Although extensive safety data is not yet available, the approach is based on proven methods that have been safe in the past. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about "The T1D Talks" because it offers a unique way of supporting teens and tweens with Type 1 Diabetes (T1D) by creating a virtual community. Unlike traditional treatments that primarily focus on managing blood sugar through insulin therapy, this virtual group intervention aims to improve the emotional and social aspects of living with T1D. By fostering peer support and shared experiences, it addresses the psychological challenges of the condition, potentially leading to better overall well-being and disease management.

What evidence suggests that this virtual group intervention is effective for managing emotional distress in adolescents with type 1 diabetes?

Research has shown that teaching young adolescents to manage their emotions can improve their ability to handle feelings and reduce risky behaviors. These programs have successfully prevented unhealthy habits and mood issues, particularly for those facing social and emotional challenges. The T1D Talks virtual group, which trial participants will join, is designed to teach these skills specifically to young people with Type 1 diabetes. Although direct data on this specific program is limited, similar methods have shown promise in aiding young people with chronic conditions like T1D. The aim is to help adolescents better cope with the emotional challenges of managing their diabetes. ^{3 4 6 7 8}

Who Is on the Research Team?

Rachel Wasserman, PhD

Principal Investigator

Western Michigan University Homer Stryker MD School Of Medicine

Are You a Good Fit for This Trial?

This study is for young adolescents aged 12-14 with Type 1 Diabetes (T1D) who may experience emotional distress due to managing their condition, especially in social situations. The goal is to help them develop skills to handle these challenges.

Inclusion Criteria

Reliable internet connection and a virtual meeting capable device (tablet or laptop)

T1D for at least 1 year

The ability to read/write and converse in English

Exclusion Criteria

A chronic medical condition that requires intensive daily management

A significant mental health or cognitive disability that would prevent them from participating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in an emotion regulation intervention through 11 virtual group sessions

11 weeks

11 virtual group sessions

Follow-up

Participants are monitored for feedback and effectiveness of the intervention

1 week

What Are the Treatments Tested in This Trial?

Interventions

• The T1D Talks: A Virtual Group for Teens and Tweens with T1D

Trial Overview The trial tests 'The T1D Talks,' an emotion regulation intervention consisting of 11 virtual group sessions designed specifically for teens and tweens with T1D. It aims to improve their ability to manage the emotional aspects of living with diabetes.

How Is the Trial Designed?

Group I: The T1D Talks Virtual Group Intervention for Teens and Tweens with T1D Experimental Treatment 1 Intervention

Experimental: The T1D Talks Group Intervention. This is the intervention, as this is a proof of concept pilot study, we will only have an intervention arm.

Who Is Running the Clinical Trial?

Western Michigan University School of Medicine

Lead Sponsor

Trials

6

Recruited

560+

Nemours Children's Health System

Collaborator

Trials

11

Recruited

17,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12450109/

Efficacy of the Online Interactive Podcast Program “Living With ... Aim: The aim was to design a study protocol for evaluating the efficacy of an interactive podcast program to assist Type 1 diabetes patients ...

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-1-2024-a3807

Virtual Group for Type 1 Diabetes · Info for Participants Trial Overview The trial tests 'The T1D Talks,' an emotion regulation intervention consisting of 11 virtual group sessions designed specifically for teens and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12449673/

Insights Into How Digital Health Interventions Shape ... Initial hypothesis 3: type 1 diabetes (T1D) self-management information and suggestions (intervention) may contribute to improved outcomes by ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425000651

Design of the type 1 diabetes and life (T1DAL) pilot ... This pilot study will generate preliminary data about a brief intervention targeting HRQOL for youth and adult PWDs and family members.

5. diabetesjournals.org diabetesjournals.org/spectrum/article/35/1/26/144551/Peer-Support-Interventions-on-Digital-Platforms

Peer Support Interventions on Digital Platforms for Children ... A growing number of studies have evaluated the effectiveness of implementing such interventions in people with T1D and their caregivers to bring ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07109128

Study Details | NCT07109128 | The T1D Talks Pilot Study The investigators aimed to pilot the novel emotion regulation intervention (11 virtual group sessions) with 3 sequential groups of 6-8 young ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07109128?aggFilters=status%3A

The T1D Talks Pilot Study A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized. ... A ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9631532/

Virtual Group Appointments Reduce Distress and Improve ... Virtual group attendance in CoYoT1 Clinic was associated with significant improvements in diabetes-related distress.