Mind-Body Skills Training for Type 1 Diabetes

No longer recruiting at 1 trial location

Overseen By Lauren A. Ray, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Cognitive disabilities, Uncontrolled chronic diseases, others

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

Compensation: Varies

Number of Visits: 10

Duration: 10-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how mindfulness skills can help teens with type 1 diabetes manage their condition more effectively. Participants will attend either regular diabetes education sessions or sessions that include mindfulness practices such as deep breathing and meditation. The researchers aim to determine if these mind-body techniques improve blood sugar control, treatment satisfaction, and overall mental wellness. Teens who have had type 1 diabetes for at least a year and struggle with stable blood sugar levels might be suitable for this study. As an unphased trial, this study provides a unique opportunity for teens to explore innovative methods to enhance their diabetes management and overall well-being.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that mind-body skills training is safe for adolescents with type 1 diabetes?

Research shows that mindfulness and mind-body skills are generally safe for people with diabetes. Studies have found that mindfulness activities, like deep breathing and meditation, improve mental well-being without major side effects. For instance, a review of mindfulness-based stress reduction found it well-tolerated and beneficial for health, particularly in reducing stress and depression.

Additionally, research on teenagers with type 1 diabetes has shown that these methods are easy to follow and maintain, indicating their safety and effectiveness.

No reports of serious safety issues have emerged from these studies, meaning no major concerns have arisen. While these practices have been around for a while, combining them with diabetes education is a new approach. This combination is expected to enhance diabetes management without adding risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential benefits of combining mind-body skills with traditional diabetes education for people with Type 1 diabetes. Unlike standard treatments that primarily focus on medication and blood sugar monitoring, this approach incorporates deep breathing, self-reflection, and meditation to help manage stress. The innovative aspect here is the emphasis on self-awareness and stress reduction, which could complement existing treatments by addressing the emotional and mental health aspects of living with diabetes. This holistic approach could help improve overall well-being and diabetes management.

What evidence suggests that this trial's treatments could be effective for type 1 diabetes?

Research has shown that mindfulness practices can aid people with type 1 diabetes. These practices improve blood sugar management, as reflected in hemoglobin A1c (HbA1c) tests. They also reduce stress and depression, common among those with diabetes. Techniques such as deep breathing and meditation have been linked to better management and well-being in young people with type 1 diabetes. In this trial, one group of participants will receive both mind-body skills training and diabetes education, while another group will receive diabetes education alone. Evidence from several studies suggests that incorporating these skills into diabetes education can lead to better health outcomes. ^{1 2 5 6 7}

Who Is on the Research Team?

Tamara S. Hannon, MD

Principal Investigator

Riley Hospital for Children at Indiana University Health

Are You a Good Fit for This Trial?

This trial is for adolescents aged 15-17 with type 1 diabetes that's not well-controlled (A1c of at least 9.0%) and have been diagnosed for over a year. They need consent from a parent or guardian to participate, and must be able to attend all study visits.

Inclusion Criteria

I have been diagnosed with type 1 diabetes for over a year.

My diabetes is uncontrolled with an A1c level of 9.0% or higher.

I am between 15 and 17 years old.

Exclusion Criteria

My chronic conditions are under control.

I cannot attend visits because of my schedule.

You have been diagnosed with cognitive disabilities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo 10-12 weekly group sessions with diabetes education and mind-body skills training

10-12 weeks

10-12 virtual group sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Diabetes education
• Mind-body skills

Trial Overview The study aims to see if adding mind-body skills training to regular diabetes education helps improve blood sugar control, satisfaction with treatment, and mental health in teenagers with type 1 diabetes.

How Is the Trial Designed?

Group I: Mind-body skills + diabetes education Experimental Treatment 2 Interventions

Participants randomly assigned to this arm will undergo 20-30 minutes discussing a predetermined diabetes topic followed by 20-30 minutes working on a mind-body skills component. This mind-body skills component will be a combination of deep breathing, self-reflection, and meditation techniques focused on self-awareness to calm the stress-response. Participants will be assigned "homework" designed to encourage practice of the learned skill.

Group II: Diabetes education alone Active Control 1 Intervention

Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Eli Lilly and Company

Industry Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11430895/

Effectiveness of Mindfulness-Based Interventions with ... Effectiveness of mindfulness-based interventions with respect to psychological and biomedical outcomes in young people with type 1 diabetes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10534311/

The Effects of Mindfulness on Glycemic Control in People with ... Mindfulness interventions show potential for improving glycemic control as measured by hemoglobin A1c (HbA1c) levels, as well as reducing stress, depression, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05577169

Incorporating Mind-body Skills With Diabetes Education in ... This is a pilot study to learn if adding mind-body skills to diabetes education is useful in helping adolescents manage their type 1 diabetes. Specifically, the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002409

A self-management plus mind body intervention for ... Results suggest adolescents with confidence and skills to manage T2D have better outcomes than those with less, and that self-management interventions improve ...

5. diabetesjournals.org diabetesjournals.org/spectrum/article/14/4/213/697/Mind-Body-Interventions

Mind-Body Interventions | Diabetes Spectrum Many case and controlled studies using biofeedback-assisted relaxation training with type 1 diabetic patients showed significantly lower average ...

6. formative.jmir.org formative.jmir.org/2024/1/e45659

Acceptability of a Self-Led Mindfulness-Based Intervention for ... This study examined the feasibility and acceptability of a scalable self-led mindfulness-based intervention to reduce diabetes distress in adolescents with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2909138/

Mindfulness-Based Stress Reduction and Diabetes - PMC This review highlights the literature and research on Mindfulness-Based Stress Reduction to improve the health and well-being of individuals with diabetes.