Digital mindfulness program for young adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–30 with type 1 diabetes or other absolute insulin deficiency who receive care at Yale will use the Calm Health mindfulness app and receive personalized feedback linking their mindfulness practice with continuous glucose monitor (CGM) and wearable sleep/stress sensor data. The intervention delivers guided mindfulness content and tailored insights about relationships among mindfulness, blood glucose patterns, stress, and sleep. All enrolled participants receive the app-guided program and feedback rather than being randomized to a non-treatment arm. Outcomes will be measured using participant-reported stress and sleep measures together with CGM and wearable-derived physiologic data over the study period. Participants must be CGM users, able to use a smartphone, and able to read English to take part.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale University School of Medicine
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Laura M Nally, MD — Yale University
• Study coordinator: Laura M Nally, MD
• Email: laura.nally@yale.edu
• Phone: 203-785-5831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.