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| Name | Class |
|---|---|
| Calm.com, Inc. | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness App | Experimental | Use the mindfulness app for 6 weeks, wear an actigraphy watch, share the data from your own continuous glucose monitor (CGM), answer surveys and interviews about the app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Mindfulness app usage | Minutes of usage per week | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Exit survey | Likert-style survey of usability, acceptability, appropriateness, and feasibility. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied) | 6 weeks |
| T1D-related emotional distress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laura M Nally, MD | Contact | 203-785-5831 | laura.nally@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Laura M Nally, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University School of Medicine | Recruiting | New Haven | Connecticut | 06520 | United States |
Survey scores, glucose, physical activity, sleep, heart rate, heart rate variability, respiratory rate
Start date: Publication of primary manuscript End date: Indefinitely
The data will be available immediately following publication, with no end dates. The data will be shared with researchers who provide a methodologically sound proposal to achieve the aims of the approved proposal. The proposals should be directed to Dr. Garrett Ash at Yale University (garrett.ash@yale.edu). To gain access, data requesters must sign a data access agreement.
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
Problem Areas in Diabetes (PAID) scale. Responses are on a scale from 0 (Not a problem) to 4 (serious problem)
| 6 weeks |
| Type 1 Diabetes Distress | 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). | 6 weeks |
| Type 1 diabetes-specific health related quality of life | 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). | 6 weeks |
| Anxiety | 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 weeks |
| Depression | Patient Health Questionnaire 9-question screener. Participants rate frequency of symptoms. Scores range from 0 (not at all) to 3 (nearly every day). | 6 weeks |
| Mindful attention awareness | Mindful attention awareness scale. Participants rate frequency of typical experiences. Scores range from 1 (almost always) to 6 (almost never). | 6 weeks |
| Self-Compassion | Self-Compassion Scale. Participants rate frequency of behaviors. Scores range from 1 (almost always) to 5 (almost never). | 6 weeks |
| Practice of mindfulness | 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). | 6 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |