Digital Mindfulness for Young Adults With Type 1 Diabetes

Not Applicable

Not yet recruiting

• Conditions: Type 1 Diabetes (T1D); Diabetes Secondary to Pancreatitis

• Registration Number: NCT07062887
• Lead Sponsor: Yale University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-03
• Last Update Submitted: 2025-07-03
• Study First Posted: 2025-07-14
• Last Update Posted: 2025-07-14
• Primary Completion: 2025-12
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Mindfulness app usage	6 weeks	Minutes of usage per week

Secondary Outcome Measures

Name	Time	Method
Exit survey	6 weeks	Likert-style survey of usability, acceptability, appropriateness, and feasibility. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
T1D-related emotional distress	6 weeks	Problem Areas in Diabetes (PAID) scale. Responses are on a scale from 0 (Not a problem) to 4 (serious problem)
Type 1 Diabetes Distress	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).
Type 1 diabetes-specific health related quality of life	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).
Anxiety	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).
Depression	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).
Mindful attention awareness	6 weeks	Mindful attention awareness scale. Participants rate frequency of typical experiences. Scores range from 1 (almost always) to 6 (almost never).
Self-Compassion	6 weeks	Self-Compassion Scale. Participants rate frequency of behaviors. Scores range from 1 (almost always) to 5 (almost never).
Practice of mindfulness	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).

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States