Recruiting

Calm Health

Sponsor:

Yale University

Code:

NCT07062887

Conditions

Type 1 Diabetes (T1D)

Diabetes Secondary to Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Mindfulness app

Study Details

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 ID

NCT07062887

Start date

Feb 4, 2026

Status verified date

Feb, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Mindfulness app usage [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Principal Investigator:

Laura M Nally, MD

More Information

Sponsor

Yale University

Last update posted

Feb 9, 2026

Last verified

Feb, 2026

Keywords

  • mindfulness
  • stress
  • sleep
  • smartwatch
  • sensors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-02-09.