Latent Autoimmune Diabetes in Adult (LADA), Pancreatitis, Type 1 Diabetes (T1D)
Conditions
Keywords
exercise, physical activity, mobile phone, health coaching, fitness watch
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 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.
Interventions
BEHAVIORALExercise 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.
BEHAVIORALSelf-monitoring
Wear a fitness watch and keep daily health diary
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly exercise duration | 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
| Measure | Time frame | Description |
|---|---|---|
| Weekly exercise volume | 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. |
| Weekly exercise days | 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. |
| Glucose | 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. |
| Body mass index | 20 weeks | Calculated from body weight and height (kilograms per meters squared) |
| Waist circumference | 20 weeks | Measured in centimeters at umbilicus |
| Blood pressure | 20 weeks | Systolic and diastolic values in mmHg. Values above 130 / 85 are considered hypertensive range. Measured on home monitor in duplicate |
| Sleep disturbance | 20 weeks | NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep disturbance survey. Scores given in t-score reflecting value relative to population. |
| Sleep-related impairment | 20 weeks | NIH PROMIS (Patient-Reported Outcomes Measurement Information System) sleep-related impairment survey. Scores given in t-score reflecting value relative to population. |
| Affective motivation states | 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). |
| Fear of hypoglycemia | 20 weeks | Survey with subscales of fear-related behavior and worry respectively. Scores range from 0 (never) to 4 (almost always). |
| Fear of hyperglycemia | 20 weeks | Survey with subscales of glucose decisions, lifestyle decisions, and worry. Scores range from 1 (never) to 5 (always). |
| Exercise self-efficacy | 20 weeks | Asks about confidence to achieve exercise goals. Scores range from 0 (not confident) to 10 (very confident). |
| Exercise self-regulation | 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). |
Countries
United States
Contacts
CONTACTYashvi Verma, BS
CONTACTGarrett Ash, PhD, CSCS
PRINCIPAL_INVESTIGATORGarrett Ash, PhD, CSCS
Yale University
Outcome results
None listed