Type 1 DiabetesNCT05577169
Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
A study testing Mind-body skills and Diabetes education in people with Type 1 Diabetes and Adolescent Behavior, run by Indiana University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 17 years
- Conditions the study is for
- Type 1 Diabetes, Adolescent Behavior
- What is being tested?
- Mind-body skills and Diabetes education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Sep 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 15-17 years
- Diagnosis of type 1 diabetes for at least 12 months
- Uncontrolled diabetes with A1c at least 9.0%
- Parent or guardian agrees for adolescent to participate
Who cannot join
- Diagnosed cognitive disabilities
- Other uncontrolled chronic diseases as assessed by PI
- Inability to attend visits due to individual schedules
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
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 investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c >9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.
- Conditions
- Type 1 Diabetes, Adolescent Behavior
- Being tested
- Mind-body skills, Diabetes education
- Keywords
- Type 1 diabetes, Adolescents, Mind-body skills
- Medical subject headings
- Diabetes Mellitus, Type 1, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mind-body skillsBehavioural
The purpose of mind-body medicine is to use conscious thoughts and actions to positively impact autonomic responses from the brain as well as coping mechanisms for life's stresses. Examples of mind-body skills include deep breathing exercises, meditation, drawing, guided imagery, journaling, affirmations, and biofeedback.
Diabetes educationBehavioural
When children and adolescents are diagnosed with diabetes, education is typically focused on the parents; as our older adolescents prepare to transition to adult care with full responsibility of their health, the goal of short education sessions is to review the basics of T1D along with addressing each individual's needs and questions as they make this transition.
| Study group | Role | What they receive |
|---|---|---|
| Mind-body skills + diabetes education | Experimental | 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. Receives: Behavioral: Mind-body skills; Behavioral: Diabetes education |
| Diabetes education alone | Active comparator | Participants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group. Receives: Behavioral: Diabetes education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of intervention in the study population.
Feasibility of recruitment, retention of participants, and intervention completion. This will be measured by considering study participation rate, time to recruit, attendance, study retention rate, study completion rate, participant burden, and data completeness.
Measured: 12 months
Acceptability of intervention in the study population.
This will be measured by participant satisfaction surveys.
Measured: 12 months
Secondary outcomes (1)
Hemoglobin A1c (HbA1c, %)
The change in HbA1c will be measured from baseline to 12 months.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start14 Sep 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention will have two arms - one group will receive diabetes education with the addition of mind-body skills, and the other group will receive only diabetes education.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Tamara S. Hannon, Indiana University
- Investigators
- Tamara S. Hannon, MD, Principal investigator, Riley Hospital for Children at Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577169
- Sponsor's protocol ID
- 15268
- Status last verified
- Apr 2025
- First submitted
- 7 Oct 2022
- Last updated
- 7 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating Mind-body Skills With Diabetes Education in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05577169
- Acronym / sponsor ID
- 15268
- Conditions
- Type 1 Diabetes, Adolescent Behavior
- Keywords
- Type 1 diabetes, Adolescents, Mind-body skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 investigators will be studying adolescents aged 15-17 years old with uncontrolled diabetes defined by an A1c >9.0% who have also had the diagnosis of diabetes for at least 12 months. This study combines the teaching of mind-body skills with short virtual diabetes education sessions, in order to address both the direct needs of good diabetes management and the indirect needs of coping with diabetes-related stress and other external factors. The investigators will have two arms of the study - one receiving diabetes education with the addition of mind-body skills, and the other arm receiving only diabetes education. Sessions will be conducted virtually with 20-30 minutes of diabetes education, followed by 20-30 minutes of mind-body skills teaching in the respective arm. The study will consist of 10-12 weekly group sessions, with pre- and post-study questionnaires to evaluate mental and physical health. Participants will continue to attend their regular diabetes clinic appointments every three months. At the end of the study, participants will also partake in a short interview to gather feedback about their experience. The goals of this study are to evaluate the effect of mind-body skills as well as pilot test the feasibility and acceptability of such a project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The intervention will have two arms - one group will receive diabetes education with the addition of mind-body skills, and the other group will receive only diabetes education.
| Arm | Type | Receives |
|---|---|---|
| Mind-body skills + diabetes education | Experimental | Behavioral: Mind-body skills, Behavioral: Diabetes educationParticipants 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. |
| Diabetes education alone | Active comparator | Behavioral: Diabetes educationParticipants randomly assigned to this arm will similarly undergo 20-30 minutes discussing the same predetermined diabetes topic as the intervention group. |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age 15-17 years
- Diagnosis of type 1 diabetes for at least 12 months
- Uncontrolled diabetes with A1c at least 9.0%
- Parent or guardian agrees for adolescent to participate
Key exclusion criteria (3 listed)
- Diagnosed cognitive disabilities
- Other uncontrolled chronic diseases as assessed by PI
- Inability to attend visits due to individual schedules
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mind-body skillsThe purpose of mind-body medicine is to use conscious thoughts and actions to positively impact autonomic responses from the brain as well as coping mechanisms for life's stresses. Examples of mind-body skills include deep breathing exercises, meditation, drawing, guided imagery, journaling, affirmations, and biofeedback. | Behavioural | Mind-body skills + diabetes education |
| Diabetes educationWhen children and adolescents are diagnosed with diabetes, education is typically focused on the parents; as our older adolescents prepare to transition to adult care with full responsibility of their health, the goal of short education sessions is to review the basics of T1D along with addressing each individual's needs and questions as they make this transition. | Behavioural | Diabetes education alone, Mind-body skills + diabetes education |
Primary outcome
Feasibility of intervention in the study population.
Time frame: 12 months
Feasibility of recruitment, retention of participants, and intervention completion. This will be measured by considering study participation rate, time to recruit, attendance, study retention rate, study completion rate, participant burden, and data completeness.
Acceptability of intervention in the study population.
Time frame: 12 months
This will be measured by participant satisfaction surveys.
1 secondary outcome
Hemoglobin A1c (HbA1c, %)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamara S. Hannon, MD principal investigator
Riley Hospital for Children at Indiana University Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind-body skills and Diabetes education in people with Type 1 Diabetes and Adolescent Behavior, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention in the study population. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2025.