Digital Mindfulness for Young Adults With Type 1 Diabetes

NCT07062887 | Recruiting

• 1 other identifier: 2000039191
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes (T1D); Diabetes Secondary to Pancreatitis

Keywords

mindfulness; stress; sleep; smartwatch; sensors

Outcome Measures

Primary Outcomes (1)

• Mindfulness app usage

  Minutes of usage per week

  6 weeks

Secondary Outcomes (9)

• Exit survey

  6 weeks

• T1D-related emotional distress

  6 weeks

• Type 1 Diabetes Distress

  6 weeks

• Type 1 diabetes-specific health related quality of life

  6 weeks

• Anxiety

  6 weeks

Study Arms (1)

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.

Behavioral: Mindfulness app

Interventions

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.

Mindfulness App

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Calm.com, Inc.: collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laura M Nally, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura M Nally, MD

CONTACT

203-785-5831; laura.nally@yale.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 14, 2025
• Study Start: February 4, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Start date: Publication of primary manuscript End date: Indefinitely
• Access Criteria: 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.

Locations

US (1)