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

September 30, 2025 updated by: Children's Mercy Hospital Kansas City

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Children's Mercy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Moderate to Vigorous Physical Activity (MVPA) Amount
Time Frame: Up to 365 days +- 30 days
Minutes per Day of MVPA
Up to 365 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Time Frame: 90 days +- 30 days
Rate of hospitalization for diabetic ketoacidosis
90 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Time Frame: 180 days +- 30 days
Rate of hospitalization for diabetic ketoacidosis
180 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Time Frame: 365 +-30 days
Rate of hospitalization for diabetic ketoacidosis
365 +-30 days
Change in Time in Range
Time Frame: Over 90, 180, and 365 +- 30 days
Time where blood glucose is in an appropriate range (and other glucose measurements)
Over 90, 180, and 365 +- 30 days
Predicted Change
Time Frame: 90 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
90 +- 30 days
Predicted Change
Time Frame: 180 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
180 +- 30 days
Predicted Change
Time Frame: 365 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
365 +- 30 days
Minutes of Sleep Per Day
Time Frame: Up to 365 days +- 30 days
Minutes of Sleep per Day
Up to 365 days +- 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self Reported Physical Activity
Time Frame: 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.
0 months
Self Reported Physical Activity
Time Frame: 6 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.
6 months
Self Reported Physical Activity
Time Frame: 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.
12 months
Self Reported T1D Management
Time Frame: 0 months
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
0 months
Self Reported T1D Management
Time Frame: 6 months
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
6 months
Self Reported T1D Management
Time Frame: 12 months
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
12 months
Self Reported T1D Management
Time Frame: 0 months
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
0 months
Self Reported T1D Management
Time Frame: 6 months
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
6 months
Self Reported T1D Management
Time Frame: 12 months
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
Time Frame: 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.
Between 0, 6, and 12 months
Change in How Participants Feel About Episodes of Hypoglycemia
Time Frame: 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
Between 0, 6, and 12 months
Change in How Parents Feel About Episodes of Hypoglycemia in Their Children
Time Frame: 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
Between 0, 6, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Mercy Hospital Kansas City

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mark Clements, MD, Children's Mercy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00002582

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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