Garmin PACT (Physical Activity Tracking)
Conditions: Type 1 Diabetes
Sponsor: Children's Mercy Hospital Kansas City

SHORT TITLE: Garmin PACT 
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Official Title: 
Garmin PACT (Physical Activity Tracking)   
NCT: 05992350 
Date:3/11/2025 

SHORT TITLE: Garmin PACT 
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PROTOCOL TITLE:  
Garmin PACT (Physical Activity Tracking) 
Study ID: STUDY00002582  
PRINCIPAL INVESTIGATOR: 
Mark Clements, MD, PhD  
Endocrinologist  
Pediatric Clinical Research Unit  
The Children's Mercy Hospital  
Email: maclements@cmh.edu  
Phone: 816-983-6982  
 
VERSION NUMBER/DATE: 
Version 1.0 4.12.22 
Version 1.1 12.22.22 
Version 1.2 1.16.2023 
Version 2.0 1.31.23 
Version 3.0 2.23.2023 
Version 4.0 3.10.2023 
Version 5.0 3.21.2023 
Version 5.1 4.5.23 
Version 5.2 4.10.23 
Version 5.3 4.11.23 
Version 5.4 4.14.23 
Version 5.5 6.7.23 
Version 5.6 7.27.23 
Version 6.0 8.23 
Version 7.0 11.23 
Version 7.1 03.24 
Version 7.2 4.24 
Version 8.0 5.24 
Version 9.0 12.24 
Version 10.0 1.25 
Version 11.0 2.25 

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REVISION HISTORY 
 
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
3 
1.2 
Correcting section 9.3 to specify that we will 
be looking at subjects with a predicted rise of 
0.3 points or are >8.5% HbA1C as candidates 
for the intervention 
no 
4 
2.0 
Updated protocol and consent letters per IRB 
suggestions. Updated section 9.3 to remove 
>8.5% HbA1c to streamline enrollment. 
Updated Section 8 to reflect accrual goals. 
Updated section 24 to clarify use of private 
information for study subjects. 
Yes 
5 
3 
Updated protocol per IRB comments, including 
the study summary, study calendar, 
enrollment goals, tangible property, and data 
collected, per IRB comments. 
The ICF letters included creating an entirely 
new adult information letter, and updates and 
editing in the information collected, data 
sharing, the study schedule, the study 
calendar to make the information shared clear 
and concise. 
Yes 
6 
4 
Updated section 23.3 chart per IRB comments. 
Updated information letters per IRB 
comments to record correct identifying 
information storage and data collection. 
Yes 
7 
5.1 
Updated section 5, 21.0, 21.2, and 22.3 to 
include a mid-study survey to provide the 
participants with the information letter and 
facilitate a discussion of any questions they 
have. 
The information letter study calendars have 
been updated with the new survey 
Created recruitment flyer and text and email 
messages for text, email, newsletters, clinic 
recruitment, event recruitment, etc.) 
Included device manuals, REDCap survey 
instructions, REDCap survey inviations 
Yes 
8 
5.2 
Moved the section 21 description of the mid-
point survey to section 10 but retained the 
 

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reminder that the mid-point survey was 
intended to facilitate a continuing consent 
discussion in section 21.0 and 22.3 per IRB 
comments (moved from 21.2 to 21.0). 
 
9 
5.3 
Clarifying section 9.3 to make the where how 
and why clear 
No 
10 
5.4 
 Updated sections 9, 21, & 22 to affirm that 
patient recruitment methods are approved by 
CM 
No 
11 
5.5 
Updated Garmin Health App title to Garmin 
Connect app for accuracy in sections 5, 6.3, 12, 
23.2, 26, and 32 
Updated sections 5, 12 and 26 to clarify that 
data from the Garmin Connect app will be 
uploaded by the Garmin Health API developed 
by Children’s Mercy Research Informatics. 
Updated sections  26 and 29.1 to specify that a 
copy of data will be kept in the diabetes data 
mart (D-dock), used for CGM uploads, and 
clarified that data collection would be 
completed by the diabetes data mart 
developed by CMH. 
Also updated ICF to better reflect data 
collected, privacy statements, account status 
after study completion, etc. Per IRB 
comments. Added in a clarification that the 
Glooko and Dexcom apps will only be used for 
data collection if the participant uses the apps. 
Yes 
12 
5.6 
Added language to section 9.3 to include the 
recruitment flyer in CM Find a Study 
 
13 
6.0 
Added in payment for completing surveys to 
section 18. Updated Garmin Connect wording 
in the information letter to current edition. 
And added insurance type as information 
collected to sections 23 and 26 and the 
information letter 
Yes 
14 
6.1 
Updated section 9.3 to include putting the 
study flyer in the clinic intake form 
Updated sections 26 & 29  to clarify that the 
Diabetes Data Mart (or RTDA Data 
Warehouse) is the Diabetes Data Dock 
Yes 

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And 29.1 & 23.3 to clarify data will be kept in 
the CMH Microsoft Azure Cloud which 
includes Sharepoint (originally stated as the 
drive), and will be stored per CM policy 
Corrected the payment schedule in the 
information letter 
Added in the CCPay handout for participant 
knowledge 
15 
 
Updated Section 5 Study Calendar to make 
study visits approximately the days stated in 
the protocol. Updated section 5.0 and 12 to 
make it clear any additional visits to 
troubleshoot Garmin issues will occur at Visit 
2, Visit 3 and Visit 4 (approximately at days 14, 
28, 56). 
Yes 
16 
 
Updated sections 23 to correctly document 
that the study database isn’t only in the 
Onedrive/ Microsoft Teams 
Updated information letters to clarify the 
study objectives 
Yes 
17 
 
Updated section 9.3, 24, and 26 to include the 
Health Device Portal texting system in 
communication. 
Updated section 21.4 to clarify how to handle 
data collection during and after the reconsent 
of a participant who turns 18. 
Updated section 23.3 to remove language 
about study coding study information with a 
study ID, as this is incorrect. Added in that the 
prescreening/ enrollment log and study data 
sheets are kept together in the study 
database. 
Updated section titles in section 26 to make it 
clear data is collected from both child and 
adult participants. Also removed language 
about coded data from section 26. Also 
updated language about parent demographics 
data including T1D information, as this is 
incorrect (includes data such as shipping 
information for sending Garmins which was 
added to the child/ adult participant section as 
well). 
 
18 
 
Clarified the sections 21, 21.2, 27.2on 
consent/ assent, because following the P/A/C 
 

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policy with a waiver of documentation of 
assent/ consent would not be a telephone 
consent as stated in the P/A/C policy we cited. 
However, we state we waive assent/ consent 
but perform telephone consents. 
Also updated section 22.4 and 27.2 to remove 
the titles/ numbers of policies to ensure 
outdated/ renamed policies are not being 
cited. 
Updated section 32 to include electronic 
(email, text) communication in the consent 
discussion. 
19 
 
Updated section 6.4 to allow participants to 
keep Garmins when they withdraw, and allow 
evaluating participants when they lose/ break 
a Garmin more than two times to see if they 
should be allowed more replacement Garmins.
No 
20 
 
Corrected protocol section 25 to note that 
participants may be lost to follow up if they 
are actively contacted three times, which does 
not include contacts like automatic text alerts. 
No 
 
Key Words: Type 1 diabetes (T1D), youth, physical activity monitors, HbA1c 
 

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Table of Contents 
STUDY INFORMATION 
1.0 Study Summary 
2.0 Objectives 
3.0 Background 
4.0 Study Endpoints 
5.0 Study Design 
6.0 Study Interventions 
PARTICIPANT MANAGEMENT 
7.0 Inclusion and Exclusion Criteria 
8.0 Local Number of Participants 
9.0 Screening and Recruitment Methods 
10.0 Surveys and Psychometric Testing 
11.0 Additional Study Activities 
12.0 Follow-Up 
13.0 Genetic Analysis Information 
14.0 Sharing of Results with Participants 
15.0 Risks to Participants 
16.0 Potential Benefits 
17.0 Investigator Assessment of Risk/Benefits Ratio 
18.0 Payment, Reimbursement and Tangible Property Provided to Participants 
19.0 Compensation for Research-Related Injury 
20.0 Economic Burden to Participants 
21.0 Parental Permission and Adult Consent Process 
22.0 Assent of Pediatric Participants 
23.0 HIPAA and Confidentiality 
24.0 Provisions to Protect the Privacy Interests of Participants 
25.0 Withdrawal of Participants 
DATA MANAGEMENT 
26.0 Data Collection 
27.0 Adverse Events and Unanticipated Problems 
28.0 Statistical Analysis 
29.0 Data and Specimen Management 

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30.0 Storage/Banking of Data and Specimens for Future Research 
31.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
DATA MANAGEMENT 
32.0 Settings and Locations 
33.0 Multi-Site Research 
34.0 International Research 
35.0 References 
ADDENDUMS 
Addendum A: Waiver of Documentation of Permission/Consent 
Addendum B: Waiver/Alteration of Permission/Assent/Consent 
Addendum C: Non-English Speaking Participants 
Addendum D: Surrogate Decision Maker Consent 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
 
 

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enSTUDY INFORMATION 
1. 
Study Summary* 
This is an observational study tracking physical activity for up to 200 youth wearing a 
Garmin physical activity tracker for up to 6 months, and tracking the attitudes on 
hypoglycemia of up to 100 parents of children with T1D. 
Study Title 
Garmin PACT (Physical Activity Tracking) 
Study Design 
Clinical observational study 
Primary Objectives 
Measure physical activity and sleep for up to 365 days using a 
Garmin physical activity tracker among youth and young adults 
with T1D.  
Evaluate the impact of physical activity and sleep related 
variables on rate of DKA admission over 90 and 180, and 365 ± 
30 days 
Evaluate the impact of physical activity and sleep related 
variables on change in Time in Range (TIR) and other 
continuous glucose monitor-derived metrics of glycemic 
control over 90, 180, and 365 ± 30 days 
Test the impact of physical activity and sleep related variables 
on machine learning models to predict change in HbA1c, DKA 
admissions, and change in Time in Range over 90, 180, and 365 
± 30 days 
 
Secondary Objectives 
Examine for correlations between self-reported physical 
activity (IPAQ), hypoglycemia fear (HFS-II), and parent 
hypoglycemia fear (HFS-P) at 0, 6, and 12 months after study 
enrollment. 
Evaluate any change in physical activity levels via self-report 
with the IPAQ survey (to allow comparisons to external 
cohorts). 
Evaluate any change in how participants feel about episodes of 
hypoglycemia while wearing the Garmin physical activity 
tracker via the Hypoglycemic Fear Scale II (HFS-II) 
Evaluate any 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)  
 
 
 
Research 
Intervention(s)/ 
Garmin physical activity tracker 

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Investigational 
Agent(s)  
IND/IDE #  
NA 
Study Population 
Youth (8-21 YO) diagnosed with T1D and parents of youth (8-17 
YO) 
Sample Size 
1000 pre-screened for total enrollment goal of 300 (200 youth 100 
parents) 
Study Duration for 
Individual Participants 
365 Days (± 30 days) 
Study Specific 
Abbreviations/ 
Definitions  
T1D = Type 1 diabetes  
DKA= Diabetic Ketoacidosis 
IPAQ=International Physical Activity Questionnaire 
HFS-II=Hypoglycemic Fear Scale II 
HFS-P= Hypoglycemic Fear Scale II for Parents 
HbA1c= Hemoglobin A1c 
 
 
 
 
2.0 Objectives* 
2.1 Primary Objectives: 
1. Measure physical activity and sleep for up to 365 (± 30 days) days using a Garmin 
physical activity tracker among youth and young adults with T1D.  
2. Evaluate the impact of physical activity and sleep related variables on rate of DKA 
admission over 90 and 180, and 365 ± 30 days 
3. Evaluate the impact of physical activity and sleep related variables on change in Time in 
Range and other continuous glucose monitor-derived metrics of glycemic control over 
90, 180, and 365 ± 30 days 
4. Test the impact of physical activity and sleep related variables on machine learning 
models to predict change in HbA1c, DKA admissions, and change in Time in Range over 
90, 180 and 365 ± 30 days 
2.2 Secondary Objectives: 
1. Examine for correlations between self-reported physical activity (IPAQ), hypoglycemia 
fear (HFS-II), and parent hypoglycemia fear (HFS-P) at 0, 6, and 12 months after study 
enrollment. 
2. Evaluate any change in physical activity levels via self-report with the IPAQ survey (to 
allow comparisons to external cohorts). 
3. Evaluate any change in how participants feel about episodes of hypoglycemia while 
wearing the Garmin physical activity tracker via the Hypoglycemic Fear Scale II (HFS-II) 
4. Evaluate any 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)  
 

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3.0 
Background*  
3.1 Physical activity is an important aspect of Type 1 Diabetes (T1D) management. 
However, very little investigation has specifically targeted the use of physical 
activity monitors in T1D management in youth. In a recent literature review of 
physical activity research using wearable devices in T1D, only three studies have 
been identified, all since 2019. It is important to establish the utility of physical 
activity trackers in T1D to identify patients who would benefit from interventions 
to increase physical activity. 
There is also interest in predicting clinical outcomes like future glycemic control, 
hospitalization, mental health, etc. No studies have examined the utility of physical 
activity data from wearable devices in making such predictions. 
 
3.2 Small studies have shown that it is feasible for people with T1D to wear physical 
activity trackers in non-clinical settings, and the devices show accuracy (Cescon 
et al., 2021). Additionally, T1D adolescents (7-19 Y.O.) can wear physical activity 
trackers while recording diet, although in this study the minimum device use 
time was three days (Jaggers et al., 2021). Physical activity trackers have also 
been used to study mealtime glucose control (Ozaslan, Patek, & Breton, 2020). 
Overall, there is support in the literature for the use of physical activity trackers 
in T1D management. 
3.3 There is a need for accurate and timely record of longitudinal physical activity 
which affects the overall health of youth (8-21 Y.O.) with T1D (variables include 
DKA admissions, time in range, HbA1c, etc.). It is necessary to confirm the 
feasibility and utility of physical activity trackers for predicting near-term T1d 
outcomes. This study builds on previous studies that establish the feasibility of 
tracking physical activity and T1D and the accuracy of such devices for doing so. 

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4.0 Study Endpoints 
1. Minutes/day of Moderate-to-vigorous physical activity (MVPA) – from Garmin device 
over 30, 90, 180, and 365 ± 30 days 
2. Sleep minutes/day– derived from Garmin device over 30, 90, 180, and 365 ± 30 days 
3. Other activity metrics derived from Garmin device over 30, 90, 180, and 365 ± 30 days 
4. HbA1c – collected from Electronic Medical Record, obtained via standard care (binned 
as 46-135 days, 136-225 days, 226-305 days, and 306-410 days 
5. Hospital admissions for DKA (0-180 days and 181-365 ± 30 days) 
6. 14-day Time in Range and other CGM-derived metrics of the quality of glycemic control 
over 30, 90, 180, and 365 ± 30 days  
7. Model performance characteristics (e.g. precision, recall, F1) of predictive models for 
the outcomes listed in 4.1-4.6 
 
5.0 
Study Design*Participants with T1D treated at the Children’s Mercy Endocrine clinic 
aged 8-21 years old will be asked to wear a Garmin VivoSmart 4 (or later) physical activity 
tracker for at least 6 months. This tracker will collect detailed physical activity and sleep data as 
measured by moderate to vigorous physical activity (MVPA) and sleep minutes/day. The tracker 
collects heart rate and accelerometry data, collected into the Garmin Connect application. The 
diabetes center will use the Garmin Health API connection developed by Children’s Mercy 
Research Informatics to extract the data into a data warehouse in Microsoft Azure (CMH 
account). As noted in previous studies, MVPA is automatically measured by the tracker when 
the wearer runs for >1 minute or walks for >10 consecutive minutes. The weekly MVPA and 
step count are both weighted by multiplying the mean of weekday activity by 5, adding it to the 
mean of weekend activity and dividing the sum by 7. 
Weighted MVPA= 
[(ெ௏௉஺)×ହ]ା (ெௐ௏௉஺)
଻
 
Weighted step count= 
[(ெௌ஼)×ହ]ା(ெௌ஼ ௪௘௘௞௘௡ௗ)
଻
 
If the subject wears the tracker for >8 hours between 9 AM and 9 PM, the day is 
used in the weighing calculation (Grimes et al., 2022).  Clinical data will be 
collected from the medical record and coded (labeled with the study ID to 
minimize use of personal data). Also, self-reported personal health will be 
collected from the CMH-approved vendor software to which they upload their 
self-management device data. Baseline and end of study surveys including 
International Physical Activity Questionnaire (IPAQ), the Hypoglycemic Fear Scale 
II (HFS-II) for participants, and Hypoglycemic Fear Scale for parents (HFS-P) will 
be collected from participants/ parents. Surveys will be given to participants 
based on their ages and the ages surveys are validated for. 
 
Table of Events:  

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a. 
Additional virtual or in person visits may be scheduled at Visit 2, Visit 3, and Visit 4 as needed for 
device troubleshooting and additional education, depending on the needs of the subjects 
b. 
A1c will be drawn SOC as a part of the clinical history, in the absence of A1c results, GMI will be 
deduced from CGM data 
c. 
The IPAQ (for>15 YO) and HFS-P/HFS-II (HFS-II child for 11-18 Y.O., HFS-II adult for >18 YO) 
 
 
6.0 
Study Interventions* 
6.1 Description: The Garmin VivoSmart 4 (or later) physical activity tracker is worn 
like a watch on the user. The tracker assesses several physical states (I.e., HRV, 
sleep, and activity) to provide the participants with a “Body Battery” measure. 
This measure indicates either when the body is at optimal time for activity, or if 
the individual needs to rest. The tracker also monitors stress levels using heart 
rate variability (HRV) and provides a reminder alert to “Take a moment to 
breathe.” The tracker utilizes behavioral principles to set goals with participants 
based on previously completed activity. To meet these goals the tracker alerts 
participants after a period of inactivity, encourages regular movement 
throughout the day, and decreases the amount of time spent sedentary. 
6.2 Behavioral Intervention: The Garmin VivoSmart 4 (or later) physical activity 
tracker will be part of a behavioral intervention with accepted standard of care 
that will help improve activity behaviors and decrease stress. This is done by 
prompting the participant to engage in activity when sedentary and/or stressed. 
6.3 Drugs, Biologics, or Devices:   
 
Pre-
screening 
(Pre-
consent) 
Visit 
1 
Day 
1 
app
x. 
Visit 2a 
Day 14 
appx. 
(PRN) 
Visit 3a 
 Day 28 appx. (PRN) 
Visit 4a 
Day 56 
appx. 
(PRN) 
 
Visit 5 
Day 180 
appx. 
Visit 6 
Day 365 
appx. 
Unscheduled 
Visit 
EMR Review 
Eligibility 
X 
 
 
 
 
Verbal Consent 
 
X 
 
 
 
 
Demographics 
 
X 
 
 
 
 
Clinical historyb 
 
X 
 
 
 
X 
Send Garmin 
tracker  
 
X 
 
 
 
 
Surveysc  
 
X 
 
 
 
X
X 
Mid-Study Check-
In Survey 
 
 
 
 
 
X 
 
Garmin 
Troubleshooting 
Visits 
 
 
X 
X 
X 
 
 

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Drug/Biologic/Device Name 
Describe how the article is being used under current FDA 
approved labeling 
 Garmin VivoSmart 4 (or later) 
This device will be continually used to monitor participants 
activity and sleep.  
 Garmin Connect App 
This app will be used by the diabetes team interventionists to 
monitor the data collected via the device.  
  
  
 
6.4 Device Handling: The trackers will be kept securely locked up in the office of the 
investigator. No one will have access to the trackers besides those involved in this 
study.  An inventory log will be kept of all tracker serial numbers and which tracker 
is sent to each participant. The tracker will be shipped to the participant after they 
verbally consent to the protocol and have their eligibility confirmed by the study 
team. Participants will activate the tracker and Garmin app upon receipt of the 
tracker. If the participant experiences any issues with tracker activation or use, 
additional study visits will be scheduled at Visit 2, Visit 3 and Visit 4 (approximately 
Day 14, 28, or 52). If the device is broken, the study team will schedule a virtual 
session to troubleshoot any issues per study calendar. If issues cannot be fixed, 
the participant will be offered a prepaid envelope to return the device. The study 
team will replace lost/ broken devices twice while the patient remains on study 
(during the 365 ± 30 days from enrollment). If the device is broken/lost a third 
time, we will evaluate if the patient should be taken off study, if the circumstances 
appeared to be out of the participant’s control we will offer to let them stay on 
the study and replace the Garmin again. 
 
 
PARTICIPANT MANAGEMENT 
7.0 
Inclusion and Exclusion Criteria* 
7.1 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 
7.2 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 
 

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7.3 Equitable Selection:   
Participants will be accrued to the study from the patient population at 
Children’s Mercy. No participant will be excluded based on sex, race, or 
ethnicity. However, if a non-English speaking participant speaks a language not 
supported by the Garmin device, they will not be able to participate. 
7.4 Vulnerable Populations: Check any vulnerable populations that are being 
targeted for enrollment into the study: (Members of the following populations 
may not be included as participants in the research unless selected here.) 
☐ Children/Minors (under 7 years of age) 
☒ Children/Minors (7-17 years of age) 
☐ Neonates (infants less than 30 days old) 
☐ Neonates of Uncertain Viability (infants 
less than 30 days old) 
☐ Non-Viable Neonates (infants less than 
30 days old) 
☐ Wards of the State 
☐ Fetuses 
☐ Pregnant Women  
☐ Adults with impaired decision-making 
capacity         
☐ CM Employees 
☐ CM Students/Residents/ Fellows 
☐ Economically or Educationally 
Disadvantaged Persons 
☐ Prisoners 
 
 
Children under age 18 are a vulnerable population. Because children recruited for 
this trial will be between 8 and 21 Y.O., adult parents will provide verbal consent for 
their child's participation who are <18 Y.O. 
If a child participant reaches the age of majority (18 years old) during the study, 
he/she will be asked to again provide verbal consent if they wish to remain on the 
study.  
 
 
8.0 
Local Number of Participants 
We will pre-screen up to 1000 participants, depending on the patients coming to the 
diabetes clinic. If patients meet the requirements for the study, they will be sent the 
information letter. 
 
Group 1: Pre-
screening/scr
een failures 
Group 2: 
participant 
Group 3: 
parent of 
participant 
Totals 

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Enrollment 
Goal: 
Number of 
participants to be 
enrolled = the 
number of 
participants to be 
consented 
1000 
200 
100 
1000 pre-screened for a tot
enrollment goal of 300 
 
9.0 
Screening and Recruitment Methods* 
9.1 Identification of Potential Participants:   
How will participants be identified? (Check all that apply) 
 
☒ Chart reviews  
 
☒ By their treating physician who will then provide the study team’s contact 
information to the potential participant/family 
☒ By their treating physician who will obtain patient/family permission to share 
contact information with the study team 
☒ Self-refer in response to IRB approved advertisements or websites  
☒ Through Cerner or other CM sources (e.g. databases, billing records, pathology 
reports, admission logs, etc.) May involve access of records by individuals not 
involved in the patient’s care. 
☐ List of candidates provided through the Data Report Request Form  
☐ Registry of individuals interested in research opportunities   
☐ Past participant list 
☐ Participants will roll-over from another research study: Study # 
☐ Other:  
 
9.2 Pre-Screening prior to HIPAA Authorization 
Will any of the identification methods checked above involve access to 
Protected Health Information (PHI) prior to obtaining HIPAA Authorization? 
☒ Yes 
 

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☐ No 
 If yes, a “Partial Waiver of HIPAA Authorization” is required.  Be sure to make 
this selection in the “HIPAA & Confidentiality” section below and complete 
Addendum E: Waiver/Alteration of HIPAA Authorization 
 
9.3 Recruitment of Potential Participants:   
Participants will be recruited from the CMH diabetes clinic, at diabetes events CM 
participates in (such as T1D walks or camps), by identifying youth 8-21 Y.O. with T1D 
who have a predicted rise in HbA1c of 0.3 points, by CM approved electronic 
communication (emails or texts- including the Health Device Portal Messaging) or by 
physician referral to the study. Flyers describing the study generally (discussing who 
researchers are looking for, what they would have to do, and receiving the Garmin 
devices) will be posted in the diabetes clinic, CM study lists (I.e. Find a Study, the 
clinic intake form), and at T1D events. Also, the flyer/ link to the flyer can be sent to 
T1D patients via email (via CM approved email servers)/ text (CM approved SMS 
servers including the Health Device portal messaging). The flyers will contain the 
study coordinator and PI contact information so the participant can reach out for 
information/ screening. After the initial screening to confirm eligibility, participants 
will be contacted via telephone and asked if they want to be emailed the consent 
letter to obtain verbal consent. Participants will be called up to three times, and all 
visits will be virtual unless a participant requests to be in person, if so the study visit 
will be coordinated with their standard of care clinical visit.  
 
 
10.0 Surveys and Psychometric Testing: 
Participants will be administered the International Physical Activity 
Questionnaire (IPAQ) to measure the amount and type of physical activity 
each participant reports per a usual week (or last week in the short form). 
The Hypoglycemic Fear Scale II (HFS-II) measures attitudes and fears of 
diabetics towards episodes of hypoglycemia. There will be two HFS surveys 
used for diabetics- the Child Hypoglycemic Fear Scale (C-HFS) for participants 
11-18 Y.O., and the Hypoglycemic Fear Scale for Adults >18 Y.O. The 
Hypoglycemic Fear Scale for Parents (HFS-P) measures the fears and actions 
taken by parents of children with T1D concerning hypoglycemic episodes. All 
surveys have been used in multiple T1D studies previously. 
At the mid-point of the study (day 180) participants will be asked to 
complete a REDCap survey.  The survey will provide the current information 
letter and ask if they have any follow-up questions about the study.   
 

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11.0 Additional Study Activities NABlood and Other Specimen Collection: NA 
 
12.0 Follow-up 
After the V1D1 visit, physical activity information will be collected from the 
participant trackers via the Garmin Connect app and uploaded into storage 
via the Garmin Health API connection developed by Children’s Mercy 
Research Informatics. If the participant experiences any issues with tracker 
activation or use, additional study visits will be scheduled at Visit 2, Visit 3 
and Visit 4 (approximately Day 14, 28, or 52). 
Participants will have information collected from the devices until 365 (+/- 30 
days) days following start of study, at which point they will have one more 
SOC clinic visit, complete surveys, and then will have completed the study 
requirements. There will not be any research follow up after this point, and if 
the participants elect to discontinue from the study, there will be no follow 
up. When participants complete the study requirements or elect to 
discontinue, they will be marked as such in the RedCap database of study 
participants. We will ask the patients if they are willing to complete the 
surveys prior to discontinuing the study. 
13.0 Genetic Analysis Information NA 
14.0 Sharing of Results with Participants NA 
15.0 Risks to Participants* 
The anticipated increase of activity places the participant at greater risk for 
hypoglycemia. As the participants increase their activity they should be 
aware of the guidelines to avoid/treat hypoglycemia and frequent 
adjustments to their insulin regimen may need to be made. The frequent 
adjustments may also lead to increased contact with the diabetes 
team. Participants will be surveyed about their level of stress, potentially 
leading to emotional discomfort. The participant must wear the watch every 
day throughout the study, must follow prompts provided by the watch, and 
charge it as frequent as every 2-3 days. These elements may cause 
inconvenience and/or discomfort. Per the device manual, there are 
additional risks if the device is not used appropriately, including rare risks of 
fire, chemical burn, electrolyte leak, and/ or injury, and health risks such as 
interfering with pacemakers, triggering seizures, and irritating skin. Because 
the research requires the collection of identifying data, there is a risk of 
breach in confidentiality.  

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16.0 Potential Benefits* 
There may not be direct benefits from taking part in the research. However, 
as the participants with T1D react to the watch interventions, they may 
become more active and more aware of stress throughout the day. As these 
elements improve, participants may see improvement in self-care, diabetes 
management, HbA1c, and decreased potential for long-term diabetes 
complications. There is no direct benefit for the parents of participants with 
T1D. The knowledge gained from this study may help other healthcare 
providers know how to better serve their patients by utilizing Garmin 
trackers or similar products to promote activity. 
 
17.0 Investigator Assessment of Risk/Benefits Ratio*  
17.1 
Please provide an assessment of risk and benefits in the table below.  Note, 
the IRB makes the final determination based upon responses in the two preceding 
sections. 
 
Select as applicable:
Pediatric Risk Category:
☒ 
Category 1 
Research not involving greater than minimal risk 
(45 CFR §46.404 and 21 CFR §50.51)   
☐ 
Category 2
Research involving greater than minimal risk but 
presenting the propect of direct benefit to the 
individual participants. (45 CFR §46.405 and 21 CFR 
§50.52) 
☐ 
Category 3
Research involving greater than minimal risk and no 
prospect of direct benefit to individual participants, 
but 
likely to yield generalizable knowledge about the 
participant's disorder or condition.  
(45 CFR §46.406 and 21 CFR §50.53) 
☐ 
Category 4
Research not otherwise approvable which presents 
an opportunity to understand, prevent, or alleviate a 
serious problem affecting the health or welfare of 
children. (45 CFR §46.407 and 21 CFR §50.54) 
Select if applicable:
Adult Risk Category:
☒ 
Not Greater than Minimal Risk
☐
Greater than Minimal Risk
 
 
18.0 Payment, Reimbursement and Tangible Property Provided to 
Participants*  
18.1 Is payment, reimbursement, or tangible property part of the study?  

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☒  Yes                 ☐  No (If No, delete the following subsections) 
18.2 Payment to Participants: 
 
☐X  CCPay 
☐  Gift Card: (Merchant:_____________) 
☐  Other: __________ 
 
Note: “Gift Card” and “Other” options require approval by Research Administration. Upon 
submission in myIRB, ORI staff will initiate the Research Administration approval process. 
 
18.3 Payment Schedule: 
Day 1 
Surveys 
Day 180 
Surveys 
Day 365 
Surveys 
Total 
Compensation 
Possible 
$15 
$15 
$15 
$45 
 
18.4  Reimbursement:  NA 
☐  CCPay 
☐  Check 
☐  Other: __________ 
          
18.5 Tangible Property: 
The participants will be given a Garmin tracking device (value 129.99$) when they 
begin the study, and we will let the participant keep the device after study 
completion.  
 
 
19.0 Compensation for Research-Related Injury NA 
20.0 Economic Burden to Participants NA 
21.0  Parental Permission and Adult Consent Process* 
Parents/ participants will be contacted and asked for verbal consent to participate in 
the study per CM policy. 
We will call the parent/participant and ask if they want to be emailed the study 
information letter to read over (via a CM approved email server). We will ask that if 
they are interested in participation, that they call us back to discuss the study in more 
detail. We will ensure the participant has plenty of time to consider the study and ask 
questions. They will be told they don’t have to participate. We will ask questions to 

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make sure they understand the study. We will follow the CM policy on obtaining 
p/a/c. 
To facilitate an ongoing consent discussion, the Information Letter will be included 
with the mid-point (day 180) REDCap survey. 
 
21.1 
Indicate below all methods of Permission/Consent that will be used in this 
study.   
 
 
Waiver of Documentation of Permission/Consent 
Permission/Consent form provided but signature will NOT be obtained (e.g. verbal consent) 
Must complete Addendum A: Waiver of Documentation of Permission/Consent 
 
☒ Waiver of written documentation of permission of parent/LAR for pediatric 
participants  
 
Study group(s) to which this method applies: Parent of Participants 8-17 years old 
☒ Waiver of written documentation of consent of adult participants  
 
Study group(s) to which this method applies: Participants 18 and above and Parent 
as a Participant   
☒ Waiver of written documentation of consent of participants turning 18  
 
Study group(s) to which this method applies: If a child participant reaches the age of 
majority (18 years old) during the study, he/she will be asked to again provide verbal 
consent if they wish to remain on the study.  
 
 
Additional Methods 
☐ Obtaining permission/assent/consent of non-English speaking parents or 
participants 
Must compete Addendum C: Non-English Speaking Participants 
 
Study group(s) to which this method applies: 
 
21.2  Permission/Consent/Consent at 18 Discussion:  
 
Permission/Consent Discussion:   

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Consent at 18 Discussion: Participants who turn 18 while active in the study will 
be contacted and asked for verbal consent to continue to participate in the study. 
We will contact the participant and email them the study information letter to read 
over (via a CM approved email server). We will ask that if they are interested in 
continuing participation, that they call us back to discuss the study in more detail. We 
will ensure the participant has plenty of time to consider the study and ask questions. 
They will be told they don’t have to participate. We will ask questions to make sure 
they understand the study. We will follow the CM policy on obtaining  p/a/c. 
 
 
21.3  Documentation of Permission/Consent/Consent at 18:  NA 
 
21.4 Identification of Participants turning 18: Participant age will be tracked on 
a master log. It will be assessed at enrollment if the participant will still be active in 
the study when they turn 18. A reminder will be put on the calendar for that day to 
contact and obtain verbal consent via the Adult consent. We will attempt to 
reconsent the participant as an adult up to three times. During the reconsent period 
we will mark the participant record as “reconsenting” and not collect any study data 
about the participant until they reconsent. If they have not consented after the third 
contact, we will remove the participant record from the study database. 
 
 
22.0 Assent of Pediatric Participants 
 
22.1 
Select the option(s) that apply to the study: 
 
☒ Assent of pediatric participants WILL BE SOUGHT following assessment of 
ability to assent. 
 
☐ Obtaining assent of pediatric participants is NOT POSSIBLE due to: 
☐  The capability of the participants (considering the ages, maturity, physical 
and/or psychological state) is so limited that they cannot reasonably be 
consulted. 
☐  The intervention or procedure involved in the research holds out a prospect of 
direct benefit that is important to the health or well-being of the participants 
and is available only in the context of the research. 
 
☐ Obtaining assent of pediatric participants is NOT PRACTICLE given the context of 
this study (e.g., minimal risk, no direct contact with participants). 
Must complete Addendum B: Waiver/Alteration of Permission/Assent/Consent 

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☐ 
 
22.2  Assessment of Ability to Assent:  
Ability to assent will be discussed with the parent/LAR and clinical care team to 
confirm the pediatric patient is able to understand the study and procedures. 
 
22.3  Assent Discussion: The parent of the child will be contacted via telephone and 
asked if they want to be emailed the study information letter to read over (via a CM 
approved email server). The parent will be instructed to call back with the child if 
they are interested in participating to discuss the study in more detail. If the parent 
and child feel more comfortable discussing the study in person, the discussion will 
be conducted in person. The parent and child will have plenty of time to consider 
the study and ask questions. They will be told they don’t have to participate. They 
will be asked questions to make sure they understand the study. The CM policy on 
obtaining p/a/c will be followed. 
To facilitate an ongoing consent discussion, the Information Letter will be included 
with the mid-point (day 180) REDCap survey. 
 
 
22.4  Documentation of Assent or Inability to Assent:  
We will follow CM Research Policy on obtaining permission/ assent/ consent and 
research documentation in the Electronic Health Record  
 
 
23.0 HIPAA and Confidentiality 
HIPAA regulations apply to this study if the data used or accessed relates to: 
 The past, present, or future physical or mental health or condition of an 
individual; 
 The provision of health care to an individual; OR 
 The payment for the provision of health care, AND 
 identifies the individual or for which there is a reasonable basis to believe it 
can be used to identify the individual. 
 
23.1 
HIPAA Authorization  
a. ☐  Full Written HIPAA Authorization will be obtained (within the p/a/c 
form or standalone form) 
 
☒ Partial Waiver of HIPAA Authorization (e.g. waiver for recruitment and pre-
screening purposes only) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 

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a) We will need to access their MRN, name, DOB, email and phone 
number for prescreening/recruitment purposes.  
 
☒ Alteration of HIPAA Authorization (some but not all required elements of an 
Authorization are present, e.g. signature will not be obtained) 
Must complete Addendum E: Waiver/Alteration of HIPAA Authorization 
 
a) We will obtain verbal consent as this is minimal risk study.  
 
☐ Waiver of HIPAA Authorization (authorization will NOT be obtained) 
 
☐ If Other, explain: 
 
23.2 Specify the PHI for which accessing (“viewing”) or recording (“writing 
down”) is necessary for the purpose of this research: 
 
1. Name/Initials 
☐ Accessed only 
☒ Recorded 
2. All elements of date (except year) directly 
related to an individual (e.g. date of birth, 
admission date, discharge date, date of 
death) 
☐ Accessed only 
☒ Recorded 
3. Medical record number 
☐ Accessed only 
☒ Recorded 
4. Account number 
☐ Accessed only 
☐ Recorded 
5. Health plan identification number 
☐ Accessed only 
☐ Recorded 
6. Social Security Number 
☐ Accessed only 
☐ Recorded 
7. Device identifiers and serial number 
☐ Accessed only 
☐ Recorded 
8. Certificate/License number 
☐ Accessed only 
☐ Recorded 
9. Telephone number 
☐ Accessed only 
☒ Recorded 
10. Fax number 
☐ Accessed only 
☐ Recorded 
11. Email addresses 
☐ Accessed only 
☒ Recorded 
12. Web addresses (URLs); Internet IP addresses 
☐  Accessed only 
☐ Recorded 
13. Street address, city, county, precinct, zip 
code or equivalent geographical codes 
☐ Accessed only 
☒ Recorded 
14. Full face photographic images and any 
comparable images 
☐ Accessed only 
☐ Recorded 
15. Biometric identifiers, including finger and 
voice print 
☐ Accessed only 
☐ Recorded 
16. Vehicle identifiers and serial numbers, 
including license plate number 
☐ Accessed only 
☐ Recorded 

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17. Any other unique identifying number, 
characteristic or code that may help identify 
individual participants including their initials 
(e.g. student or employee ID number) 
☐ Accessed only 
☐ Recorded 
18. Elements of date, including year, for persons 
90 years or older 
☐ Accessed only 
☐ Recorded 
19. Other: Garmin Connect account token 
number, CGM device (for data collection), 
insurance type (public vs private) 
☐ Accessed only 
☒ Recorded 
 
23.3 Information Security 
Only those working on the study will have access to the study data. The 
master list will be stored securely on the secure CMH Microsoft Azure Cloud 
(including Teams, Sharepoint, and OneDrive) with access restricted to 
research team members. Some additional data (such as correspondence) will 
be kept in the secure study file drive on the CMH network domain, and also 
in CM approved platforms (such as the SSN in the payment system for study 
payments). The minimum amount of PHI will be used for this study, and will 
be destroyed at the earliest possible time at completion of study after data 
analysis. The access to the REDCap study database will be protected by 
limiting access to the study team only. The prescreening log and subject log 
will be stored in the secure limited access study database with the study data 
sheets. The subject log may include the child’s name, date of birth, child’s 
medical record number, date consented, date of service, email address, 
phone number and study ID number. After the minimum length of time has 
lapsed (one to two years post study closure depending on the space needs of 
the team) physical records may be transferred to hospital approved offsite 
facility.  
 
 
23.4 Certificate of confidentiality: 
No Certificate of Confidentiality has been issued for this study.   
 
 
24.0 Provisions to Protect the Privacy Interests of Participants* 
24.1 
Participants will be contacted via phone to discuss enrollment into the study. 
If they prefer an in-person discussion, they can be approached and consented at the 
CM endocrine clinic. They will be given as much time needed to review the study 
information sheet and ask questions before deciding whether to participate. They 

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will be told this is voluntary, and enrolled subjects will be informed that they may 
withdraw at any time without penalty or loss of benefits. Any new information 
gathered during the study that may impact the subject desire to continue in the 
study, will be revealed as soon as it becomes available. Communication may include 
emails (per CM communication policy) or texting (via the Health Device Portal 
Messaging system). Follow up visits will be conducted remotely via phone, unless 
the patient requests in person visits, which will be held in the endocrinology offices. 
Follow-up may also occur via emails (per CM communication policy) or via texts (via 
the Health Device Portal messaging system). Recruitment may occur via the clinic 
intake form asking if the participant would like to join the observational study (see 
attached form).  
The subject study ID will be used to set up the Garmin account for all participants, 
with no personal information (PII or PHI) used. This will keep private information 
used in the study will remain secure in the study database. 
 
25.0 Withdrawal of Participants* 
Participants may withdraw from the study at any time at their own request, or they 
may be withdrawn at any time at the discretion of the investigator.  Reasons for 
withdrawal may include:  
 Participant no longer wants to participate in study 
visits/procedures/processes. 
 Participant’s clinical care deciding it is not in their best interest to 
continue participation 
 Participant stops providing information and cannot be reached by the 
research staff. For example, lost to follow up after three active 
attempts to contact participant (not including automated alerts, for 
example the automatic texts triggered when watches are inactive) 
If a participant is withdrawn or lost to follow up, this will be documented 
appropriately in the REDCap database developed for research 
documentation since this study may not be recorded in the medical record 
per CMH policy.  
All data collected prior to the participant withdrawal will be retained. 
DATA MANAGEMENT 
26.0 Data Collection* 
This study will be completely integrated into the Diabetes Data Dock  at CMKC. Data 
will be collected and paired with the other wearable devices, such as pump and 
continuous glucose monitor readings. 

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Surveys (IPAQ, HFS-II/P) will be collected at baseline and EOS. Data collected 
from EMR will include medical history, lab results, demographics, clinical 
data, insurance type (public vs private).  
Child/ adult participant data -  
Demographic data: We will use the REDCap demographics survey to collect 
demographic data. We may use the Diabetes Data Dock and/or the child’s electronic 
health record to verify or extend demographic data (e.g., T1D diagnosis, history of 
T1D-related complications, T1D regimen, shipping address to send the Garmin Device, 
shipping history).  
HbA1c data: We will use routine T1D care POC HbA1c levels to at baseline and at post-
treatment (~3 months post baseline). 
CGM or SMBG data: Families will use their personal, prescribed CGM or standard 
blood glucose monitor (SMBG) throughout the study.  Families will share CGM data 
with the study team using their personal, CM connected account. Data will be 
download automatically to the Diabetes Data Dock using API.  
Insulin delivery data: Participants will use their personal, prescribed insulin delivery 
device throughout the study. Participants and parents/LARs of adolescents will share 
participants’ insulin device data with the study team using their personal, CM 
connected account. 
Questionnaire data: We will use REDCap to electronically collect any survey data, 
including participants’ daily activity schedules. We will use a single REDCap database 
for all study participants. This REDCap data base will reside on a CM secured server.  
Garmin data and activity monitor: Data will be downloaded and stored on 
the Diabetes Data Dock using API connection. Primary physical data will be 
gathered from the Garmin Connect platform.  The anonymous participant 
Garmin data from the Garmin Connect platform will be loaded to a secure 
database through the Garmin Health API connection developed by Children’s 
Mercy Research Informatics. The Garmin tracker will not collect personal 
information. Also, the patient study record will be linked to the Garmin 
tracker. The Garmin Health Portal attached to the Garmin Health API will also 
contain the communication texted to the participants (if any). The 
interventionist team will be able to pull the data to Microsoft Azure database 
to evaluate. Clinical data will also be collected from EMR. 
 
 
Parent Data -  
Demographic data: We will use the REDCap demographics survey to collect 
demographic data. We may use the Diabetes Data Dock and/or the child’s 
electronic health record to verify or extend parent demographic data (e.g., 
shipping address to send the Garmin Device, shipping history, contact 
information, etc.).  

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Sensitive Data:  Adult participants with T1D will be asked in the HFS if they 
avoided sex to prevent a hypoglycemic event. All participants will be asked 
about physical activity and efforts to prevent hypoglycemic incidents, which 
can be sensitive topics. Participants will be assured in the consent letters that 
they do not need to answer any questions they want to, and answers will be 
kept in confidence. 
 
☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐☐
☐☐☐☐ 
 
27.0 Adverse Events and Unanticipated Problems* 
27.1 Monitoring:  
Participants/families will be instructed to contact the team if an adverse event or 
other unanticipated problem occurs. 
 
27.2 Reporting:  
We will follow the CM policy on reportable events to report adverse events and 
other unanticipated problems to the CM IRB. 
 
28.0 Statistical Analysis* 
28.1 Matched Cohort: 
Where possible, the intervention group will be compared to a matched cohort 
identified using propensity score matching. The propensity score for the groups will 
take into consideration age, baseline HBA1c, duration of diabetes, insurance, race, 
device usage, and time in range.