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| ID | Type | Description | Link |
|---|---|---|---|
| K01DK129441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Self-Monitoring | Active Comparator | Wear a fitness watch and keep daily health diary |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 20 weeks |
| Weekly exercise days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yashvi Verma, BS | Contact | 203-444-0678 | activity@yale.edu | |
| Garrett Ash, PhD, CSCS | Contact | 203-444-3079 | garrett.ash@yale.edu |
| Name | Affiliation | Role |
|---|---|---|
| Garrett Ash, PhD, CSCS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale School of Medicine | Recruiting | New Haven | Connecticut | 06510 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D010195 | Pancreatitis |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D055070 | Resistance Training |
| D015190 | Blood Glucose Self-Monitoring |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| Self-monitoring | Behavioral | Wear a fitness watch and keep daily health diary |
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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. |
| 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. | 20 weeks |
| Body mass index | Calculated from body weight and height (kilograms per meters squared) | 20 weeks |
| Waist circumference | Measured in centimeters at umbilicus | 20 weeks |
| Blood pressure | Systolic and diastolic values in mmHg. Values above 130 / 85 are considered hypertensive range. Measured on home monitor in duplicate | 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. | 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. | 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). | 20 weeks |
| Fear of hypoglycemia | Survey with subscales of fear-related behavior and worry respectively. Scores range from 0 (never) to 4 (almost always). | 20 weeks |
| Fear of hyperglycemia | Survey with subscales of glucose decisions, lifestyle decisions, and worry. Scores range from 1 (never) to 5 (always). | 20 weeks |
| Exercise self-efficacy | Asks about confidence to achieve exercise goals. Scores range from 0 (not confident) to 10 (very confident). | 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). | 20 weeks |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D001519 | Behavior |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D000085263 | Self-Testing |
| D012648 | Self Care |
| D008919 | Investigative Techniques |