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Digital Mindfulness for Young Adults With Type 1 Diabetes

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 30 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the Calm Health mindfulness app for young adults with type 1 diabetes or other diabetes in which the body cannot make insulin. Mindfulness means noticing your thoughts and feelings without judging them or reacting negatively. Everyone will get mindfulness guidance and personal feedback on how mindfulness, blood sugar, stress, and sleep are linked.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Get diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital.
  • Sign and date the study consent form.
  • Be willing to do study tasks and be available for the whole study.
  • Be 18 to 30 years old.
  • Have had type 1 diabetes or another form of diabetes in which the body cannot make insulin for at least 1 year.
  • Have used a continuous glucose monitor (CGM), a device that tracks blood sugar, for regular diabetes care for at least the past 2 weeks.
  • Be able to use a smartphone.
  • Be able to read and write English.

Who can't join

  • Already meditate or practice mindfulness as often as, or more often than, the study recommends.
  • Have a severe mental health condition that is not being treated, or currently have thoughts of suicide.
  • Have started a new mental health medicine or had unstable treatment with these medicines in the past 2 months.
  • Are pregnant now or plan to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

CT