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

NCT05992350 | Terminated Results

• 1 other identifier: STUDY00002582
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (12)

• Self Reported Physical Activity

  0 months

• Self Reported Physical Activity

  6 months

• Self Reported Physical Activity

  12 months

• Self Reported T1D Management

  0 months

• Self Reported T1D Management

  6 months

Interventions

Garmin physical activity tracker OTHER

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.

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy

Kansas City, Missouri, 64111, United States

Location

Related Publications (4)

• 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.

  PMID: 34346318 BACKGROUND

• 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.

  PMID: 35297778 BACKGROUND

• 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.

  PMID: 34682355 BACKGROUND

• 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.

  PMID: 32105515 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Priscilla Connell
• Organization: Children's Mercy Research Institute

Endocrine-RisingT1deAlliance@cmh.edu

8166014543

Study Officials

• Mark Clements, MD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: August 15, 2023
• Study Start: January 16, 2024
• Primary Completion: June 18, 2025
• Study Completion: June 18, 2025
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)