Type 1 Diabetes (T1D)NCT07062887
Digital Mindfulness for Young Adults With Type 1 Diabetes
A study testing Mindfulness app in people with Type 1 Diabetes (T1D) and Diabetes Secondary to Pancreatitis, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Diabetes Secondary to Pancreatitis
- What is being tested?
- Mindfulness app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University School of Medicine
New Haven, Connecticut, 06520
Laura M Nally, MD, 203-785-5831, laura.nally@yale.edu
Laura M Nally, MD
About this study
Official title: A Digital Mindfulness and Biometric Feedback Application for Young Adults With Type 1 Diabetes
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.
- Being tested
- Mindfulness app
- Keywords
- mindfulness, stress, sleep, smartwatch, sensors
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness app usage
Minutes of usage per week
Measured: 6 weeks
Secondary outcomes (9)
Exit survey
Likert-style survey of usability, acceptability, appropriateness, and feasibility. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Measured: 6 weeks
T1D-related emotional distress
Problem Areas in Diabetes (PAID) scale. Responses are on a scale from 0 (Not a problem) to 4 (serious problem)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 weeks
Self-Compassion
Self-Compassion Scale. Participants rate frequency of behaviors. Scores range from 1 (almost always) to 5 (almost never).
Measured: 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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start4 Feb 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Calm.com, Inc.
- Responsible party
- Sponsor
- Investigators
- Laura M Nally, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062887
- Sponsor's protocol ID
- 2000039191
- Status last verified
- Feb 2026
- First submitted
- 3 Jul 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Survey scores, glucose, physical activity, sleep, heart rate, heart rate variability, respiratory rate
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Mindfulness and Biometric Feedback Application for Young Adults With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07062887
- Acronym / sponsor ID
- 2000039191
- Keywords
- mindfulness, stress, sleep, smartwatch, sensors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Calm.com, Inc.
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness App | Experimental | Behavioral: Mindfulness appUse 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness appMindfulness 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. | Behavioural | Mindfulness App |
Primary outcome
Mindfulness app usage
Time frame: 6 weeks
Minutes of usage per week
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Survey scores, glucose, physical activity, sleep, heart rate, heart rate variability, respiratory rate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura M Nally, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness app in people with Type 1 Diabetes (T1D) and Diabetes Secondary to Pancreatitis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura M Nally, MD (203-785-5831, laura.nally@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mindfulness app usage (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.