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NCT Number: NCT06967701

Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes

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.

Recruiting

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Behavior Diabetes Mellitus Diabetes Mellitus, Type 1 Digestive System Diseases Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Latent Autoimmune Diabetes in Adult (LADA) Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale School of Medicine

New Haven, Connecticut, 06510, United States

Location status: Recruiting

Location contact

Garrett Ash, PhD, NSCA-CSCS

CONTACT

[email protected]

203-444-3079

Garrett Ash, PhD, NSCA-CSCS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Exercise Program

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.

Self-monitoring

Behavioral

Wear a fitness watch and keep daily health diary

Primary outcomes

  1. Weekly exercise duration

    Time frame: 20 weeks

    Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.

Secondary outcomes

  1. Weekly exercise volume

    Time frame: 20 weeks

    Kilocalories, determined by minutes and intensity. Measured by blinded hip watch and periodic interviews. A person achieving 150 minutes per week will achieve around 1,200 - 2,000 kilocalories per week.

  2. Weekly exercise days

    Time frame: 20 weeks

    Days/week. Measured by blinded hip watch and periodic interviews. 0 days/week is the lowest value, 3-7 days/week meets clinically recommended amounts.

  3. Glucose

    Time frame: 20 weeks

    The measurable range is 20-400 mg/dL. It is quantified by average levels, time above/within/below the target range of 70-180 mg/dL, and coefficient of variation.

  4. Body mass index

    Time frame: 20 weeks

    Calculated from body weight and height (kilograms per meters squared)

  5. Waist circumference

    Time frame: 20 weeks

    Measured in centimeters at umbilicus

  6. Blood pressure

    Time frame: 20 weeks

    Systolic and diastolic values in mmHg. Values above 130 / 85 are considered hypertensive range. Measured on home monitor in duplicate

  7. Sleep disturbance

    Time frame: 20 weeks

    NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance survey. Scores given in t-score reflecting value relative to population.

  8. Sleep-related impairment

    Time frame: 20 weeks

    NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep-related impairment survey. Scores given in t-score reflecting value relative to population.

  9. Affective motivation states

    Time frame: 20 weeks

    Cravings for Rest and Volitional Energy Expenditure (CRAVE) survey of motivation states for physical activity. Scores range from 0 (not at all) to 10 (more than ever).

  10. Fear of hypoglycemia

    Time frame: 20 weeks

    Survey with subscales of fear-related behavior and worry respectively. Scores range from 0 (never) to 4 (almost always).

  11. Fear of hyperglycemia

    Time frame: 20 weeks

    Survey with subscales of glucose decisions, lifestyle decisions, and worry. Scores range from 1 (never) to 5 (always).

  12. Exercise self-efficacy

    Time frame: 20 weeks

    Asks about confidence to achieve exercise goals. Scores range from 0 (not confident) to 10 (very confident).

  13. Exercise self-regulation

    Time frame: 20 weeks

    Survey of reasons for motivation to exercise. Participants rate possible reasons with scores ranging from 1 (not at all true) to 7 (very true).

Study contacts

Contact information is provided by the study sponsor or research team.

Garrett Ash, PhD, CSCS

CONTACT

[email protected]

203-444-3079

Yashvi Verma, BS

CONTACT

[email protected]

203-444-0678

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

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

Registry information

Official study title

Informatics-Based Digital Intervention to Promote Safe Exercise in Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes - A Pilot Efficacy Study

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 13, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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