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

Recruiting

• Conditions: Type 1 Diabetes

• Registration Number: NCT05992350
• Lead Sponsor: Children's Mercy Hospital Kansas City

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-08-07
• Study First Posted: 2023-08-15
• Study Start: 2024-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-27
• Last Update Posted: 2025-04-02
• Primary Completion: 2025-09
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minutes of Sleep per Day	Up to 365 days +- 30 days	Minutes of Sleep per Day
Diabetic Ketoacidosis (DKA) Admission	365 +-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	365 +- 30 days	machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Moderate to Vigorous Physical Activity (MVPA) Amount	Up to 365 days +- 30 days	Minutes per Day of MVPA

Secondary Outcome Measures

Name	Time	Method
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
Self Reported Physical Activity	12 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	12 months	Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, 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.

Trial Locations

Locations (1)

Children's Mercy; 🇺🇸 Kansas City, Missouri, United States