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

An observational study of Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 8 to 21 years
Conditions the study is for: Type 1 Diabetes
What is being tested?: Garmin physical activity tracker
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 16 Jan 2024to 18 Jun 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 8 to 21 years
All sexes
Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy
Kansas City, Missouri, 64111

Other trials in United States

About this study

Official title: 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

Conditions: Type 1 Diabetes
Being tested: Garmin physical activity tracker
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Garmin physical activity trackerOther
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Moderate to Vigorous Physical Activity (MVPA) Amount
Minutes per Day of MVPA
Measured: Up to 365 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Measured: 90 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Measured: 180 days +- 30 days
Diabetic Ketoacidosis (DKA) Admission
Rate of hospitalization for diabetic ketoacidosis
Measured: 365 +-30 days
Change in Time in Range
Time where blood glucose is in an appropriate range (and other glucose measurements)
Measured: 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
Measured: 90 +- 30 days
Predicted Change
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Measured: 180 +- 30 days
Predicted Change
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Measured: 365 +- 30 days
Minutes of Sleep Per Day
Minutes of Sleep per Day
Measured: Up to 365 days +- 30 days

Secondary outcomes (12)

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.
Measured: 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.
Measured: 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.
Measured: 12 months
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Measured: 0 months
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Measured: 6 months
Self Reported T1D Management
Hypoglycemic Fear Scale (HFS-II) min 0 max 132, higher scores are a worse outcome
Measured: 12 months
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Measured: 0 months
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Measured: 6 months
Self Reported T1D Management
Hypoglycemic Fear Scale II for Parents (HFS-P) min 0 max 143, higher scores are a worse outcome
Measured: 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.
Measured: 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
Measured: 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
Measured: Between 0, 6, and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 202418 Jun 2025

First posted15 Aug 2023
Study start16 Jan 2024
Primary completion18 Jun 2025
Study completion18 Jun 2025

Why it stopped: Staffing shortages

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05992350
Sponsor's protocol ID: STUDY00002582
Status last verified: Sep 2025
First submitted: 23 May 2023
Last updated: 20 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 34346318
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.
PubMed 35297778
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.
PubMed 34682355
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.
PubMed 32105515

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Type 1 Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Garmin PACT (Physical Activity Tracking)
ClinicalTrials.gov ID: NCT05992350
Acronym / sponsor ID: STUDY00002582
Conditions: Type 1 Diabetes
Study type: Observational
Recruitment status: TerminatedReason stopped: Staffing shortages
Enrolment: 45 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Study start: 16 Jan 2024 (actual)
Primary completion: 18 Jun 2025 (actual)
Study completion: 18 Jun 2025 (actual)
First posted: 15 Aug 2023 (actual)
Results: Posted 20 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Other
Time perspective: Prospective

Who may qualify

Ages: 8 to 21 years
Sex: All
Age groups: Child, Adult
Study population: Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 YO)

Key inclusion criteria (3 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Garmin physical activity trackerThe 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.	Other	–

Primary outcome

Moderate to Vigorous Physical Activity (MVPA) Amount
Time frame: Up to 365 days +- 30 days
Minutes per Day of MVPA
Diabetic Ketoacidosis (DKA) Admission
Time frame: 90 days +- 30 days
Rate of hospitalization for diabetic ketoacidosis
Diabetic Ketoacidosis (DKA) Admission
Time frame: 180 days +- 30 days
Rate of hospitalization for diabetic ketoacidosis
Diabetic Ketoacidosis (DKA) Admission
Time frame: 365 +-30 days
Rate of hospitalization for diabetic ketoacidosis
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)
Predicted Change
Time frame: 90 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Predicted Change
Time frame: 180 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Predicted Change
Time frame: 365 +- 30 days
machine learning models to predict change in HbA1c, DKA admissions, and change in Time in Range
Minutes of Sleep Per Day
Time frame: Up to 365 days +- 30 days
Minutes of Sleep per Day

12 secondary outcomes

Self Reported Physical Activity
Time frame: 0 months
Self Reported Physical Activity
Time frame: 6 months
Self Reported Physical Activity
Time frame: 12 months
Self Reported T1D Management
Time frame: 0 months
Self Reported T1D Management
Time frame: 6 months
Self Reported T1D Management
Time frame: 12 months
Self Reported T1D Management
Time frame: 0 months
Self Reported T1D Management
Time frame: 6 months
Self Reported T1D Management
Time frame: 12 months
Change in Self Reported Physical Activity Levels
Time frame: 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 Parents Feel About Episodes of Hypoglycemia in Their Children
Time frame: Between 0, 6, and 12 months

Results and safety

Results posted to the registry on 20 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Analysis Arm	24	3
Parent Arm	21	0

Primary outcome: Moderate to Vigorous Physical Activity (MVPA) Amount

Time frame: Up to 365 days +- 30 days

Population analysed: Study terminated before analysis took place, due to slow enrollment and unexpected termination the little data collected could not be analyzed. There is no future plan to analyze the data.

Primary outcome: Diabetic Ketoacidosis (DKA) Admission

Time frame: 90 days +- 30 days

Primary outcome: Diabetic Ketoacidosis (DKA) Admission

Time frame: 180 days +- 30 days

Primary outcome: Diabetic Ketoacidosis (DKA) Admission

Time frame: 365 +-30 days

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Primary Analysis Arm	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34346318Cescon 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.
Background: PubMed 35297778Grimes 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.
Background: PubMed 34682355Jaggers 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.
Background: PubMed 32105515Ozaslan 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Clements, MD principal investigator

Children's Mercy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 1 Diabetes, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Moderate to Vigorous Physical Activity (MVPA) Amount (time frame: Up to 365 days +- 30 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05992350, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2025.