Type 1 DiabetesNCT06098729

Digital Exercise for Middle-Aged Adults With Type 1 Diabetes and Other Absolute Insulin Deficiency Diabetes

A study testing Digital Exercise in people with Type 1 Diabetes and Latent Autoimmune Diabetes in Adults, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 65 years
Conditions the study is for: Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis
What is being tested?: Digital Exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 2 Nov 2023to 25 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
Low exercise levels
Smartphone ownership
English literacy
Under regular care by a healthcare provider
Home Broadband wireless Internet or cell phone network (≥25 mbps downloads, ≥3 mbps uploads)

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., Afib with RVR, new onset Afib, ventricular tachycardia, escape rhythms)

Show all 14Show fewer

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.

United States1 site

Yale School of Medicine
New Haven, Connecticut, 06510

Other trials in United States

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 Feasibility 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 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.

Conditions: Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis
Being tested: Digital Exercise
Medical subject headings: Diabetes Mellitus, Type 1, Latent Autoimmune Diabetes in Adults, Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digital ExerciseBehavioural
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

Study groups in NCT06098729
Study group	Role	What they receive
Digital Exercise	Experimental	Not described Receives: Behavioral: Digital Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility of Usage
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Measured: 4 weeks
Acceptability
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Measured: 4 weeks
Accuracy
Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy.
This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.
Measured: 4 weeks

Secondary outcomes (3)

Motivation States for Physical Activity
Scale name: Cravings for Rest and Volitional Energy Expenditure (CRAVE) Construct: Transient state motivation for physical activity Scale ranges: 0 (not at all) to 100 (more than ever). Higher values represent a better outcome.
Measured: 6 weeks
Moderate to Vigorous Physical Activity
Minutes of moderate to vigorous physical activity registered by hip accelerometer. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Measured: 6 weeks
Interview Themes
Qualitatively-identified determinants and sequalae of motivation states for physical activity
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Nov 202325 Oct 2024

First posted24 Oct 2023
Study start2 Nov 2023
Primary completion11 Oct 2024
Study completion25 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 1 DiabetesStudies 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: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06098729
Sponsor's protocol ID: 2000035846
Other IDs: K01DK129441
Status last verified: Aug 2025
First submitted: 19 Oct 2023
Last updated: 17 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2025. 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 Feasibility Study
ClinicalTrials.gov ID: NCT06098729
Acronym / sponsor ID: 2000035846
Conditions: Type 1 Diabetes, Latent Autoimmune Diabetes in Adults, Pancreatitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Exerscrip LLC
Study start: 2 Nov 2023 (actual)
Primary completion: 11 Oct 2024 (actual)
Study completion: 25 Oct 2024 (actual)
First posted: 24 Oct 2023 (actual)
Results: Posted 17 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Digital Exercise	Experimental	Behavioral: Digital Exercise

Who may qualify

Ages: 30 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Diagnosis with type 1 diabetes (T1D) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis)
Low exercise levels
Smartphone ownership
English literacy
Under regular care by a healthcare provider

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
Digital ExerciseA 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	Behavioural	Digital Exercise

Primary outcome

Feasibility of Usage
Time frame: 4 weeks
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Acceptability
Time frame: 4 weeks
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Accuracy
Time frame: 4 weeks
Accuracy to predict lapses in exercise behavior ahead of time. 50% accuracy is the lowest possible value (ie, equivalent to random guessing), 80% accuracy is the goal of the study, and 100% accuracy would be the highest possible accuracy. This is the single outcome of a regression analysis across the entire sample. Being a single outcome, there is no measure of dispersion.

3 secondary outcomes

Motivation States for Physical Activity
Time frame: 6 weeks
Moderate to Vigorous Physical Activity
Time frame: 6 weeks
Interview Themes
Time frame: 6 weeks

Results and safety

Results posted to the registry on 17 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Digital Exercise	24	23

Primary outcome: Feasibility of Usage

Time frame: 4 weeks. Mean (Standard Deviation). Unit: minutes/week

Measure	Digital Exercise n = 24
Value	168 (14)

Primary outcome: Acceptability

Time frame: 4 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Digital Exercise n = 24
Value	4.0 (0.9)

Primary outcome: Accuracy

Time frame: 4 weeks. Number. Unit: percentage of lapses

Measure	Digital Exercise n = 24
Value	70

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from consenting until end of follow-up, up to 9 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Digital Exercise	0 of 24 (0%)	12 of 24 (50%)	0 of 24

Limitations and caveats (from the sponsor): This was a pilot study focused on feasibility and acceptability, so efficacy cannot be determined.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Type 1 Diabetes

Recruiting
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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. This study is not recruiting at the moment.

Garrett Ash, PhD 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 Digital Exercise in people with Type 1 Diabetes and Latent Autoimmune Diabetes in Adults, 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 6 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: finished, as of the sponsor's last update on 17 Sep 2025. 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?

Yes. Results are posted in the registry (first posted 17 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of Usage (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06098729.

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 17 Sep 2025.