Digital Mindfulness for Young Adults With Type 1 Diabetes

NCT ID: NCT07062887

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-09-30

Brief Summary

The purpose of this research study is to test a mindfulness app called Calm Health among young adults with type 1 diabetes or other absolute insulin deficiency diabetes. Mindfulness is the practice of being aware of your thoughts and feelings in the moment without judgment or negative reaction. All participants will receive mindfulness guidance and personalized feedback about the relationship among your mindfulness, blood sugar, stress, and sleep.

Conditions

Type 1 Diabetes (T1D); Diabetes Secondary to Pancreatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mindfulness App

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.

Group Type: EXPERIMENTAL

Mindfulness app

Intervention Type: BEHAVIORAL

Mindfulness app called Calm Health. It has mindfulness guidance modules related to different aspects of physical and mental health, including type 1 diabetes. It also provides a final report to help you track the relationship between mindfulness and your blood sugar, stress, and sleep.

Interventions

Mindfulness app

Mindfulness app called Calm Health. It has mindfulness guidance modules related to different aspects of physical and mental health, including type 1 diabetes. It also provides a final report to help you track the relationship between mindfulness and your blood sugar, stress, and sleep.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

2. Sign and date informed consent form we will provide

3. Willingness to complete procedures and availability for duration of the study

4. Aged 18-30 years

5. Diagnosed with type 1 diabetes (T1D) or other absolute insulin deficiency diabetes (latent autoimmune diabetes of adulthood, diabetes secondary to pancreatitis) for at least 1 year.

6. User of a continuous glucose monitor (CGM) in your routine clinical care for at least the past 2 weeks.

7. Able to use a smartphone.

8. Able to read and write English.

Exclusion Criteria

1. Current meditation or mindfulness practice meeting or exceeding the study's recommended schedule

2. 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

3. New or unstable psychopharmaceutical treatment in past 2 months.

4. Current or planned pregnancy during study period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Calm.com, Inc.

INDUSTRY

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laura M Nally, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Central Contacts

Laura M Nally, MD

Role: CONTACT

laura.nally@yale.edu

203-785-5831

Facility Contacts

Laura M Nally, MD

Role: primary

laura.nally@yale.edu

203-785-5831

Other Identifiers

2000039191

Identifier Type: -

Identifier Source: org_study_id