Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

NCT ID: NCT06967701

Last Updated: 2025-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-10

Study Completion Date

2027-07-31

Brief Summary

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The challenges of living with type 1 diabetes often stand in the way of getting enough exercise. Continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. This remote participation-based research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently. You do not need to live in Connecticut to participate, as there will be no required in-person visits during the study.

Detailed Description

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Conditions

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Type 1 Diabetes (T1D) Latent Autoimmune Diabetes in Adult (LADA) Pancreatitis

Keywords

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exercise physical activity mobile phone health coaching fitness watch

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Self-Monitoring

Wear a fitness watch and keep daily health diary

Group Type ACTIVE_COMPARATOR

Self-monitoring

Intervention Type BEHAVIORAL

Wear a fitness watch and keep daily health diary

Exercise program

Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.

Group Type EXPERIMENTAL

Exercise program

Intervention Type BEHAVIORAL

Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.

Interventions

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Exercise program

Participants will receive a free Garmin smartwatch and a free program membership providing exercise coaching + personalized feedback about the relationship among their insulin, carbohydrates, exercise, sleep, and blood sugar.

Intervention Type BEHAVIORAL

Self-monitoring

Wear a fitness watch and keep daily health diary

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 30-65 years old inclusive
* Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
* Less than 1.0 exercise sessions per week
* Smartphone ownership
* English literacy
* Under regular care by a healthcare provider (1+ appointments per year)
* Home Broadband wireless Internet or cell phone network
* Using continuous glucose monitor (CGM) and sharing data with medical record for at least 6 weeks
* Using insulin pump or pen and sharing data with medical record for at least 6 weeks

Exclusion Criteria

* Diabetic ketoacidosis not clearly related to pump site failure in past 6 months
* \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months
* A1c ≥10.0%
* Resting blood pressure \>160mmHg systolic or \>100 mmHg diastolic.
* Myocardial infarction or angina in past 12 months
* Uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms)
* Congestive heart failure (stage 3 or 4)
* Exercise-induced asthma (not controlled on inhalers)
* Chronic obstructive pulmonary disease (requiring home oxygen)
* Renal failure
* Pregnancy
* Cognitive impairment
* Severe retinopathy or neuropathy.
* Other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Garrett I Ash, PhD

Assistant Professor of Medicine, Biomedical Informatics, and Data Science

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Garrett Ash, PhD, CSCS

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yashvi Verma, BS

Role: CONTACT

Phone: 203-444-0678

Email: [email protected]

Garrett Ash, PhD, CSCS

Role: CONTACT

Phone: 203-444-3079

Email: [email protected]

Facility Contacts

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Garrett Ash, PhD, NSCA-CSCS

Role: primary

Other Identifiers

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K01DK129441

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000039977

Identifier Type: -

Identifier Source: org_study_id