Type 1 Diabetes
Conditions
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
Interventions
OTHERGarmin 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.
Sponsors
Children's Mercy Hospital Kansas City
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minutes of Sleep Per Day | Up to 365 days +- 30 days | Minutes of Sleep per Day |
| Moderate to Vigorous Physical Activity (MVPA) Amount | Up to 365 days +- 30 days | Minutes per Day of MVPA |
| Diabetic Ketoacidosis (DKA) Admission | 90 days +- 30 days | Rate of hospitalization for diabetic ketoacidosis |
| Change in Time in Range | Over 90, 180, and 365 +- 30 days | Time where blood glucose is in an appropriate range (and other glucose measurements) |
| Predicted Change | 90 +- 30 days | machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Physical Activity | 0 months | 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. |
| Self Reported T1D Management | 0 months | Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome |
| Change in Self Reported Physical Activity Levels | Between 0, 6, and 12 months | 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. |
| Change in How Participants Feel About Episodes of Hypoglycemia | Between 0, 6, and 12 months | 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 |
| Change in How Parents Feel About Episodes of Hypoglycemia in Their Children | Between 0, 6, and 12 months | 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 |
Countries
United States
Participant flow
Pre-assignment details
Only parent data was collected for Secondary Outcomes 16, 18, and 21. Parents only completed the Hypoglycemic Fear Scale II for Parents (HFS-P).
Participants by arm
| Arm | Count |
|---|---|
| Primary Analysis Arm Youth (8-21 YO) diagnosed with T1D | 24 |
| Parent Arm Parents of youth (8-18 YO) diagnosed with T1D | 21 |
| Total | 45 |
Baseline characteristics
| Characteristic | Primary Analysis Arm | Total |
|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 3 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 21 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 3 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
Change in Time in Range
Time where blood glucose is in an appropriate range (and other glucose measurements)
Time frame: Over 90, 180, and 365 +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Time frame: 180 days +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Time frame: 365 +-30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Time frame: 90 days +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Minutes of Sleep Per Day
Minutes of Sleep per Day
Time frame: Up to 365 days +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Moderate to Vigorous Physical Activity (MVPA) Amount
Minutes per Day of MVPA
Time frame: Up to 365 days +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Predicted Change
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Time frame: 90 +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Predicted Change
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Time frame: 180 +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Primary
Predicted Change
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Time frame: 365 +- 30 days
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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
Time frame: Between 0, 6, and 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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
Time frame: Between 0, 6, and 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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.
Time frame: Between 0, 6, and 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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.
Time frame: 6 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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.
Time frame: 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
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.
Time frame: 0 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Time frame: 0 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Time frame: 6 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Time frame: 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Time frame: 6 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Time frame: 0 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.
Secondary
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Time frame: 12 months
Population: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.