Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)

Study Overview
=================
Brief Summary
-----------------
The goal of this observational study is to test the Garmin Vivosmart in children and youth (8-21) with Type 1 Diabetes (T1D) and their parents. The main questions it aims to answer are: Does the Garmin Vivosmart increase physical activity (PA)? Does the Garmin Vivosmart improve T1D status Participants will: Wear the Garmin Vivosmart (4 or higher) for a year Complete surveys at the beginning, middle and end of participation asking about your T1D, T1D management, and PA Parents of children will also complete similar surveys about T1D

Official Title
-----------------
Garmin PACT (Physical Activity Tracking)

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Other: Garmin physical activity tracker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged 8-21 years of age and/or parent of participant aged 8-17 years of age Participants diagnosed with T1D greater than 6 months ago Participants must be patients at the Children's Mercy Kansas City network Exclusion Criteria: Participants who do not meet age criteria above Participants who do not have T1D Participants who are unwilling to wear the device for at least 6 months

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Garmin physical activity tracker|The Garmin physical activity tracker is worn like a watch on the user. The tracker assesses several physical states, indicates when the body is at optimal time for activity or when the body needs to rest. The tracker also monitors stress levels and prompts relaxation when appropriate. The tracker sets goals with participants based on previously completed activity. The tracker alerts participants after a period of inactivity, encourages regular movement throughout the day, and decreases the amount of time spent sedentary.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Moderate to Vigorous Physical Activity (MVPA) Amount | Minutes per Day of MVPA | Up to 365 days +- 30 days | 
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 90 days +- 30 days | 
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 180 days +- 30 days | 
| Diabetic Ketoacidosis (DKA) Admission | Rate of hospitalization for diabetic ketoacidosis | 365 +-30 days | 
| Change in Time in Range | Time where blood glucose is in an appropriate range (and other glucose measurements) | Over 90, 180, and 365 +- 30 days | 
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | 90 +- 30 days | 
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | 180 +- 30 days | 
| Predicted Change | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range | 365 +- 30 days | 
| Minutes of Sleep per Day | Minutes of Sleep per Day | Up to 365 days +- 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | 0 months | 
| Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ- SF), no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | 6 months | 
| Self Reported Physical Activity | Self-reported physical activity via the International Physical Activity Questionnaire Short Form (IPAQ-SF), no min or max, recording the amount of time spent in MVPA in the past week higher amounts are better. | 12 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 0 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 6 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome | 12 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 0 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 6 months | 
| Self Reported T1D Management | Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | 12 months | 
| Change in self reported physical activity levels | Change in self reported physical activity levels via self-report with the IPAQ survey no min or max, recording the amount of time spent in MVPA in the past week, higher amounts are better. | Between 0, 6, and 12 months | 
| Change in how participants feel about episodes of hypoglycemia | Change in how participants feel about episodes of hypoglycemia measured via the Hypoglycemic Fear Scale II (HFS-II) min 0 max 132, higher scores are a worse outcome | Between 0, 6, and 12 months | 
| Change in how parents feel about episodes of hypoglycemia in their children | Change in how parents feel about episodes of hypoglycemia in their children wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome | Between 0, 6, and 12 months |