Mindfulness App for Type 1 Diabetes

Overseen By Garrett I Ash, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must not be taking: Psychopharmaceuticals

Disqualifiers: Severe psychiatric illness, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a mindfulness app called Calm Health to determine its effectiveness for young adults with type 1 diabetes or similar types of diabetes. Mindfulness involves being aware of thoughts and feelings without judgment, and the app will guide users on how this practice relates to blood sugar, stress, and sleep. Participants will use the app for six weeks, wear a special watch to track activity, and share data from their glucose monitors. The trial seeks individuals aged 18-30 who have had type 1 diabetes for at least a year and are already using a continuous glucose monitor. As an unphased trial, this study offers a unique opportunity to explore new ways to manage diabetes and improve 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. However, if you have started a new or unstable psychiatric medication in the past 2 months, you may not be eligible to participate.

What prior data suggests that this mindfulness app is safe for young adults with type 1 diabetes?

Studies have shown that meditation apps, such as Calm Health, are generally easy to use. Research indicates that these apps can help reduce stress for individuals with type 1 diabetes. Previous studies have reported no major negative effects, making them a safe option for stress management. Additionally, health plans already use the Calm Health app to provide mental health support, suggesting it is considered safe and effective. Overall, using a mindfulness app like Calm Health is seen as a low-risk way to improve well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mindfulness App for Type 1 Diabetes because it offers a fresh approach to managing the condition. Unlike traditional treatments that primarily focus on insulin therapy and blood sugar monitoring, this app aims to improve patients' mental well-being through mindfulness practices. By integrating mindfulness techniques, the app may help users better manage stress, which is known to affect blood sugar levels. Additionally, the app's use of actigraphy watches and continuous glucose monitoring data provides a more personalized health management experience, offering insights that could lead to improved diabetes control.

What evidence suggests that the Calm Health app is effective for type 1 diabetes?

Studies have shown that meditation apps like Calm Health, which participants in this trial will use, can help reduce stress for people with type 1 diabetes. Research indicates that these apps might improve mental health, sleep, and resilience. Although Calm Health hasn't been specifically tested for its impact on blood sugar levels, mindfulness practices can help manage stress, which is important for diabetes care. Early findings suggest that people find these apps easy to use and engaging, though about 38% may stop using them over time. Overall, Calm Health appears promising as a tool to support mental well-being in people with type 1 diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Garrett Ash, PhD

Principal Investigator

Yale University

Laura M Nally, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 Diabetes or similar conditions where the body can't make insulin. Participants should be interested in using a mindfulness app to manage their condition.

Inclusion Criteria

Receiving diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital

Sign and date informed consent form provided

Willingness to complete procedures and availability for duration of the study

Exclusion Criteria

Current severe untreated psychiatric illness (e.g., bipolar disorder, schizophrenia, major depression, panic disorder, borderline personality disorder, organic mood or mental disorders) or active suicidal ideation

Current or planned pregnancy during study period

I regularly practice meditation or mindfulness as per the study's guidelines.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the mindfulness app for 6 weeks, wear an actigraphy watch, share data from their continuous glucose monitor, and complete surveys and interviews.

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Calm Health

Trial Overview The study tests the Calm Health app, which provides mindfulness guidance and personalized feedback on how mindfulness affects blood sugar levels, stress, and sleep in participants.

How Is the Trial Designed?

Group I: Mindfulness App Experimental Treatment 1 Intervention

Use the mindfulness app for 6 weeks, wear an actigraphy watch, share the data from your own continuous glucose monitor (CGM), answer surveys and interviews about the app.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

Calm.com, Inc.

Industry Sponsor

Trials

8

Recruited

1,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11527505/

Acceptability and Scalability of a Meditation App Among ... Meditation apps may help reduce some of the stress associated with living with T1DM. This study explores the acceptability and scalability of a ...

2. mhealth.jmir.org mhealth.jmir.org/2019/6/e14273/citations

Efficacy of the Mindfulness Meditation Mobile App “Calm” to ... Exploring the views of adolescents with type 1 diabetes on digital mental health interventions: What functionality and content do they want?.

3. researchgate.net researchgate.net/publication/385392612_Acceptability_and_Scalability_of_a_Meditation_App_Among_Adolescents_With_Type_1_Diabetes_Mellitus

(PDF) Acceptability and Scalability of a Meditation App ... Meditation apps may help reduce some of the stress associated with living with T1DM. This study explores the acceptability and scalability of a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0005796723001699

Rates of attrition and engagement in randomized ... Future large efficacy trials should factor in an expected attrition rate of around 38% for those allocated to the mindfulness app arm.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9557765/

Testing the Pragmatic Effectiveness of a Consumer-Based ... The results suggest that the Calm app is an effective workplace intervention for improving mental health, sleep, resilience, and productivity.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209764/

Technology Use and Mindfulness in Adolescents with Type ... The study explores the relationship among technology, mindfulness, and the health management experiences of adolescents with T1D.

7. health.calm.com health.calm.com/health-plans/

Digital Mental Health App for Health Plans Calm Health helps health plans offer scalable, clinically validated mental health care that enhances member engagement and outcomes. Request a demo.