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

Garmin PACT (Physical Activity Tracking)

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

Study Overview

• Status: Recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Garmin physical activity tracker

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Priscilla Connell, MPH; Phone Number: 816-601-4543; Email: pcconnell@cmh.edu
• Study Contact Backup: Name: Emily DeWit; Phone Number: 913 5155173; Email: eldewit@cmh.edu

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Recruiting
      • Children's Mercy
      • Contact: Priscilla Connell, MPH; Phone Number: 816-601-4543; Email: pcconnell@cmh.edu
      • Contact: Mark Clements, MD PhD; Phone Number: 8169836982; Email: maclements@cmh.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)

Description

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

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City
• Investigators: Principal Investigator: Mark Clements, MD, Children's Mercy

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: August 7, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: STUDY00002582

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO