Mind-Body Skills Training for Type 1 Diabetes

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Adolescence presents a challenging time for type 1 diabetes management, and despite a multitude of studies aimed at increasing disease compliance in this age group, none have been deemed superior. The purpose of this study is to incorporate mindfulness skills in with diabetes education sessions for adolescents with type 1 diabetes and study if this translates to improved outcomes in glycemic control, patient satisfaction, and mental wellness.

Research Team

Tamara S. Hannon, MD

Principal Investigator

Riley Hospital for Children at Indiana University Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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