Digital mindfulness program for young adults with type 1 diabetes

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

This program will test the Calm Health mindfulness app to see if guided digital mindfulness and personalized feedback can help 18–30-year-olds with type 1 diabetes better manage stress, sleep, and blood sugar.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 30 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT07062887 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are 18–30-year-olds with type 1 diabetes (or other absolute insulin deficiency) who use a continuous glucose monitor, own a smartphone, receive diabetes care at Yale New Haven hospitals, and are not already following a regular mindfulness practice at the study-recommended level.

Not a fit: People with severe untreated psychiatric illness, active suicidal ideation, those already practicing mindfulness at or above the study's recommended schedule, or those unable/unwilling to use a CGM or smartphone are unlikely to benefit from this program.

Why it matters

Potential benefit: If successful, the program could reduce stress-related glucose variability and improve sleep and overall wellbeing for young adults with type 1 diabetes.

How similar studies have performed: Prior mindfulness programs for diabetes have shown modest benefits for stress and self-care, but app-based mindfulness combined with CGM and wearable feedback is a relatively new and less-tested approach.

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.

Where this trial is running

New Haven, Connecticut

• 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

Conditions Type 1 Diabetes; Diabetes Secondary to Pancreatitis; mindfulness; stress; sleep; smartwatch; sensors