Type 1 Diabetes (T1D)NCT06967701
Building and Sustaining Exercise Habits for Adults With Type 1 Diabetes
A study testing Exercise program and Self-monitoring in people with Type 1 Diabetes (T1D) and Latent Autoimmune Diabetes in Adult (LADA), run by Yale University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Type 1 Diabetes (T1D), Latent Autoimmune Diabetes in Adult (LADA), Pancreatitis
- What is being tested?
- Exercise program and Self-monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2025to Oct 2027
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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)
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- 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)
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 School of Medicine
New Haven, Connecticut, 06510
Garrett Ash, PhD, NSCA-CSCS, 203-444-3079, garrett.ash@yale.edu
Garrett Ash, PhD, NSCA-CSCS
About this study
Official 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
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.
- Being tested
- Exercise program, Self-monitoring
- Keywords
- exercise, physical activity, mobile phone, health coaching, fitness watch
- Medical subject headings
- Diabetes Mellitus, Type 1, Pancreatitis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise programBehavioural
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-monitoringBehavioural
Wear a fitness watch and keep daily health diary
| Study group | Role | What they receive |
|---|---|---|
| Self-Monitoring | Active comparator | Wear a fitness watch and keep daily health diary Receives: Behavioral: Self-monitoring |
| Exercise program | Experimental | 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. Receives: Behavioral: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly exercise duration
Minutes/week. Measured by blinded hip watch and periodic interviews. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Measured: 20 weeks
Secondary outcomes (13)
Weekly exercise volume
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.
Measured: 20 weeks
Weekly exercise days
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.
Measured: 20 weeks
Glucose
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.
Measured: 20 weeks
Body mass index
Calculated from body weight and height (kilograms per meters squared)
Measured: 20 weeks
Waist circumference
Measured in centimeters at umbilicus
Measured: 20 weeks
Blood pressure
Systolic and diastolic values in mmHg. Values above 130 / 85 are considered hypertensive range. Measured on home monitor in duplicate
Measured: 20 weeks
Sleep disturbance
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance survey. Scores given in t-score reflecting value relative to population.
Measured: 20 weeks
Sleep-related impairment
NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep-related impairment survey. Scores given in t-score reflecting value relative to population.
Measured: 20 weeks
Affective motivation states
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).
Measured: 20 weeks
Fear of hypoglycemia
Survey with subscales of fear-related behavior and worry respectively. Scores range from 0 (never) to 4 (almost always).
Measured: 20 weeks
Fear of hyperglycemia
Survey with subscales of glucose decisions, lifestyle decisions, and worry. Scores range from 1 (never) to 5 (always).
Measured: 20 weeks
Exercise self-efficacy
Asks about confidence to achieve exercise goals. Scores range from 0 (not confident) to 10 (very confident).
Measured: 20 weeks
Exercise self-regulation
Survey of reasons for motivation to exercise. Participants rate possible reasons with scores ranging from 1 (not at all true) to 7 (very true).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start10 Jul 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Garrett I Ash, PhD, Yale University
- Investigators
- Garrett Ash, PhD, CSCS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967701
- Sponsor's protocol ID
- 2000039977
- Other IDs
- K01DK129441
- Status last verified
- Jul 2026
- First submitted
- 3 May 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06967701
- Acronym / sponsor ID
- 2000039977
- Keywords
- exercise, physical activity, mobile phone, health coaching, fitness watch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 10 Jul 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 13 May 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Monitoring | Active comparator | Behavioral: Self-monitoringWear a fitness watch and keep daily health diary |
| Exercise program | Experimental | Behavioral: Exercise programParticipants 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Exercise programParticipants 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. | Behavioural | Exercise program |
| Self-monitoringWear a fitness watch and keep daily health diary | Behavioural | Self-Monitoring |
Primary outcome
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.
13 secondary outcomes
Weekly exercise volume
Time frame: 20 weeks
Weekly exercise days
Time frame: 20 weeks
Glucose
Time frame: 20 weeks
Body mass index
Time frame: 20 weeks
Waist circumference
Time frame: 20 weeks
Blood pressure
Time frame: 20 weeks
Sleep disturbance
Time frame: 20 weeks
Sleep-related impairment
Time frame: 20 weeks
Affective motivation states
Time frame: 20 weeks
Fear of hypoglycemia
Time frame: 20 weeks
Fear of hyperglycemia
Time frame: 20 weeks
Exercise self-efficacy
Time frame: 20 weeks
Exercise self-regulation
Time frame: 20 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 22 Jul 2026.
- Individual participant dataSharing planned: Yes
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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.
Garrett Ash, PhD, CSCS 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 Exercise program and Self-monitoring in people with Type 1 Diabetes (T1D) and Latent Autoimmune Diabetes in Adult (LADA), 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 9 inclusion and 14 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 22 Jul 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 Yashvi Verma, BS (203-444-0678, activity@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly exercise duration (time frame: 20 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 22 Jul 2026.