Digital Mindfulness for Young Adults With Type 1 Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness app.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Diabetes Secondary to Pancreatitis. Basic parameters: 18 years — 30 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Digital Mindfulness and Biometric Feedback Application for Young Adults With Type 1 Diabetes
Overview
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
- Behavioral Mindfulness 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.
Primary outcome measures
- Mindfulness app usage [Time frame: 6 weeks]
Secondary outcome measures (9)
- Exit survey [Time frame: 6 weeks]
- T1D-related emotional distress [Time frame: 6 weeks]
- Type 1 Diabetes Distress [Time frame: 6 weeks]
- Type 1 diabetes-specific health related quality of life [Time frame: 6 weeks]
- Anxiety [Time frame: 6 weeks]
- Depression [Time frame: 6 weeks]
- Mindful attention awareness [Time frame: 6 weeks]
- Self-Compassion [Time frame: 6 weeks]
- Practice of mindfulness [Time frame: 6 weeks]
Eligibility criteria
Inclusion criteria
- Receiving diabetes care at Yale New Haven Children's Hospital or Yale New Haven Hospital.
- Sign and date informed consent form we will provide
- Willingness to complete procedures and availability for duration of the study
- Aged 18-30 years
- 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.
- User of a continuous glucose monitor (CGM) in your routine clinical care for at least the past 2 weeks.
- Able to use a smartphone.
- Able to read and write English.
Exclusion criteria
- Current meditation or mindfulness practice meeting or exceeding the study's recommended schedule
- 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
- New or unstable psychopharmaceutical treatment in past 2 months.
- Current or planned pregnancy during study period.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Yale University School of Medicine — New Haven
Identifiers
NCT: NCT07062887 · 2000039191