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NCT Number: NCT07062887

Digital Mindfulness for Young Adults With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Secondary to Pancreatitis Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Location contact

Laura M Nally, MD

CONTACT

[email protected]

203-785-5831

Laura M Nally, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital.
  • Sign and date informed consent form we will provide
  • Willingness to complete procedures and availability for duration of the study
  • Aged 18-30 years
  • 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.
  • User of a continuous glucose monitor (CGM) in your routine clinical care for at least the past 2 weeks.
  • Able to use a smartphone.
  • Able to read and write English.

Exclusion criteria

  • Current meditation or mindfulness practice meeting or exceeding the study's recommended schedule
  • 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
  • New or unstable psychopharmaceutical treatment in past 2 months.
  • Current or planned pregnancy during study period.

Treatment and study plan

Mindfulness App

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.

Primary outcomes

  1. Mindfulness app usage

    Time frame: 6 weeks

    Minutes of usage per week

Secondary outcomes

  1. Exit survey

    Time frame: 6 weeks

    Likert-style survey of usability, acceptability, appropriateness, and feasibility. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)

  2. T1D-related emotional distress

    Time frame: 6 weeks

    Problem Areas in Diabetes (PAID) scale. Responses are on a scale from 0 (Not a problem) to 4 (serious problem)

  3. Type 1 Diabetes Distress

    Time frame: 6 weeks

    Type 1 Diabetes Distress Scale (T1-DDS). Consists of common distressing things about living with type 1 diabetes. Scores range from 1 (not a problem) to 6 (very serious problem).

  4. Type 1 diabetes-specific health related quality of life

    Time frame: 6 weeks

    Type 1 diabetes and life (T1DAL) scale. Aspects of life with type 1 diabetes. Scores range from 1 (no, not true at all) to 5 (yes, very true).

  5. Anxiety

    Time frame: 6 weeks

    Generalized anxiety disorder 7-question screener (GAD-7). Participants rate frequency of symptoms. Scores range from 0 (not at all) to 3 (nearly every day).

  6. Depression

    Time frame: 6 weeks

    Patient Health Questionnaire 9-question screener. Participants rate frequency of symptoms. Scores range from 0 (not at all) to 3 (nearly every day).

  7. Mindful attention awareness

    Time frame: 6 weeks

    Mindful attention awareness scale. Participants rate frequency of typical experiences. Scores range from 1 (almost always) to 6 (almost never).

  8. Self-Compassion

    Time frame: 6 weeks

    Self-Compassion Scale. Participants rate frequency of behaviors. Scores range from 1 (almost always) to 5 (almost never).

  9. Practice of mindfulness

    Time frame: 6 weeks

    Five-facet mindfulness questionnaire. Participants rate frequency of behaviors. Scores range from 1 (never or very rarely true) to 5 (very often or always true).

Study contacts

Contact information is provided by the study sponsor or research team.

Laura M Nally, MD

CONTACT

[email protected]

203-785-5831

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Calm.com, Inc.

Registry information

Official study title

A Digital Mindfulness and Biometric Feedback Application for Young Adults With Type 1 Diabetes

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 14, 2025
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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