Clinical trial NCT05992350: Garmin PACT (Physical Activity Tracking in Type 1 Diabetes Using Garmin Vivosmart)
Official title: Garmin PACT (Physical Activity Tracking)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type 1 Diabetes
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)

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


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

Primary outcomes:
measure: Moderate to Vigorous Physical Activity (MVPA) Amount
timeFrame: Up to 365 days +- 30 days
measure: Diabetic Ketoacidosis (DKA) Admission
timeFrame: 90 days +- 30 days
measure: Diabetic Ketoacidosis (DKA) Admission
timeFrame: 180 days +- 30 days
measure: Diabetic Ketoacidosis (DKA) Admission
timeFrame: 365 +-30 days
measure: Change in Time in Range
timeFrame: Over 90, 180, and 365 +- 30 days
measure: Predicted Change
timeFrame: 90 +- 30 days
measure: Predicted Change
timeFrame: 180 +- 30 days
measure: Predicted Change
timeFrame: 365 +- 30 days
measure: Minutes of Sleep per Day
timeFrame: Up to 365 days +- 30 days
Secondary outcomes:
measure: Self Reported Physical Activity
timeFrame: 0 months
measure: Self Reported Physical Activity
timeFrame: 6 months
measure: Self Reported Physical Activity
timeFrame: 12 months
measure: Self Reported T1D Management
timeFrame: 0 months
measure: Self Reported T1D Management
timeFrame: 6 months
measure: Self Reported T1D Management
timeFrame: 12 months
measure: Self Reported T1D Management
timeFrame: 0 months
measure: Self Reported T1D Management
timeFrame: 6 months
measure: Self Reported T1D Management
timeFrame: 12 months
measure: Change in self reported physical activity levels
timeFrame: Between 0, 6, and 12 months
measure: Change in how participants feel about episodes of hypoglycemia
timeFrame: Between 0, 6, and 12 months
measure: Change in how parents feel about episodes of hypoglycemia in their children
timeFrame: Between 0, 6, and 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy
state: Missouri
Study officials:
affiliation: Children's Mercy
name: Mark Clements, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cescon M, Choudhary D, Pinsker JE, Dadlani V, Church MM, Kudva YC, Doyle Iii FJ, Dassau E. Activity detection and classification from wristband accelerometer data collected on people with type 1 diabetes in free-living conditions. Comput Biol Med. 2021 Aug;135:104633. doi: 10.1016/j.compbiomed.2021.104633. Epub 2021 Jul 12.
citation: Grimes A, Lightner JS, Eighmy K, Steel C, Shook RP, Carlson J. Decreased Physical Activity Among Youth Resulting From COVID-19 Pandemic-Related School Closures: Natural Experimental Study. JMIR Form Res. 2022 Apr 15;6(4):e35854. doi: 10.2196/35854.
citation: Jaggers JR, McKay T, King KM, Thrasher BJ, Wintergerst KA. Integration of Consumer-Based Activity Monitors into Clinical Practice for Children with Type 1 Diabetes: A Feasibility Study. Int J Environ Res Public Health. 2021 Oct 10;18(20):10611. doi: 10.3390/ijerph182010611.
citation: Ozaslan B, Patek SD, Breton MD. Impact of Daily Physical Activity as Measured by Commonly Available Wearables on Mealtime Glucose Control in Type 1 Diabetes. Diabetes Technol Ther. 2020 Oct;22(10):742-748. doi: 10.1089/dia.2019.0517.