Diabetes Secondary to Pancreatitis, Type 1 Diabetes (T1D)
Conditions
Keywords
mindfulness, stress, sleep, smartwatch, sensors
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.
Interventions
BEHAVIORALMindfulness app
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.
Sponsors
Yale University
Calm.com, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mindfulness app usage | 6 weeks | Minutes of usage per week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
CONTACTLaura M Nally, MD
PRINCIPAL_INVESTIGATORLaura M Nally, MD
Yale University
Outcome results
None listed