Latent Autoimmune Diabetes in Adults, Pancreatitis, Type 1 Diabetes
Conditions
Brief 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. 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.
Interventions
BEHAVIORALDigital Exercise
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
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Exerscrip LLC
Yale University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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)
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., Afib with RVR, new onset Afib, 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Usage | 4 weeks | Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts. |
| Acceptability | 4 weeks | Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied) |
| Accuracy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation States for Physical Activity | 6 weeks | 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. |
| Moderate to Vigorous Physical Activity | 6 weeks | 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. |
| Interview Themes | 6 weeks | Qualitatively-identified determinants and sequalae of motivation states for physical activity |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digital Exercise Digital exercise intervention | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Digital Exercise |
|---|---|
| Age, Continuous | 48 years STANDARD_DEVIATION 11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 24 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 12 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Acceptability
Likert-style survey of participant satisfaction. Responses are on a scale from 1 (very dissatisfied) to 5 (very satisfied)
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Exercise | Acceptability | 4.0 score on a scale | Standard Deviation 0.9 |
Primary
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Digital Exercise | Accuracy | 70 percentage of lapses |
Primary
Feasibility of Usage
Minutes of using application to exercise. 0 minutes/week is the lowest value, 150 minutes/week meets clinically recommended amounts.
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Exercise | Feasibility of Usage | 168 minutes/week | Standard Deviation 14 |
Secondary
Interview Themes
Qualitatively-identified determinants and sequalae of motivation states for physical activity
Time frame: 6 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Digital Exercise | Interview Themes | 4 themes |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Exercise | Moderate to Vigorous Physical Activity | 168 minutes/week | Standard Deviation 14 |
Secondary
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digital Exercise | Motivation States for Physical Activity | 60.1 units on a scale | Standard Deviation 4.1 |