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Mind-Body Skills Training for Type 1 Diabetes

N/A

Waitlist Available

Led By Tamara S. Hannon, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Uncontrolled diabetes with A1c at least 9.0%

Age 15-17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will study if teaching mindfulness skills to adolescents with type 1 diabetes can improve their health, satisfaction, and mental wellness.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since the interventions involve educational sessions and mindfulness training, there are no direct medical side effects expected from participating in this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 15 and 17 years old.

Select...

My parent or guardian agrees to let me join the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of intervention in the study population.

Feasibility of intervention in the study population.

Secondary outcome measures

Glycosylated hemoglobin A

Other outcome measures

Child and Adolescent Social Support Scale (CASSS) questionnaire

Difficulties in Emotion Regulation Scale (DERS) questionnaire

Mindful Attention Awareness Scale (MAAS) questionnaire for adolescents

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mind-body skills + diabetes educationExperimental Treatment2 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 aloneActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diabetes education

2008

N/A

~110

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

983,131 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,201,028 Total Patients Enrolled

Tamara S. Hannon, MDPrincipal InvestigatorRiley Hospital for Children at Indiana University Health

Media Library

Diabetes education Clinical Trial Eligibility Overview. Trial Name: NCT05577169 — N/A

Type 1 Diabetes Research Study Groups: Mind-body skills + diabetes education, Diabetes education alone

Type 1 Diabetes Clinical Trial 2023: Diabetes education Highlights & Side Effects. Trial Name: NCT05577169 — N/A

Diabetes education 2023 Treatment Timeline for Medical Study. Trial Name: NCT05577169 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting geriatric participants?

"Patients between the ages of 15 and 17 are eligible for this clinical trial. There are 271 studies for minors and 932 for seniors aged 65 or above."

Answered by AI

Are new participants still being welcomed for this experiment?

"Clinicaltrials.gov reports that this clinical trial, which had its commencement on September 14th 2022, is actively enrolling patients. The study was recently updated on October 10th 2022."

Answered by AI

Is it possible to join this research trial?

"This research project is recruiting 30 adolescents between 15 and 17 with impaired glucose control. Applicants should have type 1 diabetes for at least one year, an A1c of 9% or more, and a parent/guardian who gives consent to participate."

Answered by AI

What is the participant count of this experiment?

"Affirmative. Clinicaltrials.gov specifies that this scientific trial is presently recruiting and was initially posted on the 14th of September 2022, with a recent update made October 10th 2022. The research necessitates 30 participants from 2 distinct sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes

Tamara S. Hannon 2022. "Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05577169.