A Prospective Study of the Role and Accuracy of Consumer-Facing Wearable Technology in Gastrointestinal Endoscopy
Phase: NA
Conditions: Healthy
Sponsor: Mayo Clinic

 
 
A Prospective Study of the Role and Accuracy of 
Consumer-Facing Wearable Technology in 
Gastrointestinal Endoscopy 
 
NCT05044104 
 
January 4, 2022 

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CONFIDENTIAL 
 
Study Title: A Prospective Study of the Role and Accuracy of Consumer-Facing 
Wearable Technology for Patient Monitoring in Gastrointestinal Endoscopy 
 
Principal Investigator 
 
 
 
 
 
Vinay Chandrasekhara, MD 
Division of Gastroenterology and Hepatology 
Department of Medicine 
Mayo Clinic 
200 First St SW, Rochester, MN 55905 
 
Funding Sponsor: 
Investigator-Funded 
 
 
Protocol Number: (IRBe) 
PLM MSR:    
 
21-007738 
2021-305261-H01 
 
 
 
 
 
 
Initial version: 7/9/2021 Version (1.0)  
Revised: 1/04/2022 
 
 
 
 

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Protocol Investigator Signature Page   
   
STUDY TITLE:  
  
A Prospective Study of the Role and Accuracy of Consumer-
Facing Wearable Technology for Patient Monitoring in 
Gastrointestinal Endoscopy 
PROTOCOL VERSION:  
  
 15/JUL/2021 Version (1.0)  
  
STUDY CENTER:    
Mayo Clinic Rochester 
   
I, the undersigned, have read and understand the protocol specified above and agree on its content. I agree to 
perform and conduct the trial as described in the protocol and in accordance with applicable laws and regulations. 
In addition, when applicable, I agree to enlist sub- investigators who also agree to perform and conduct the trial 
as described in the protocol.  
   
   
   
   
   ________________________________________________________________________                                                   
 
Principal/Coordinating Investigator (Print Name)  
Date  
 
 
 
 
 
_________________________________________________________________ 
  
  
                                   
Principal/Coordinating Investigator (Signature)    
Date  
   
 
 
 

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Table of Contents 
STUDY SUMMARY ............................................................................................................................................ 5 
1 
INTRODUCTION ...................................................................................................................................... 6 
1.1 
BACKGROUND ...................................................................................................................................... 6 
1.2 
INVESTIGATIONAL DEVICE ................................................................................................................... 6 
1.3 
CLINICAL DATA TO DATE .................................................................................................................... 6 
1.4 
STUDY RATIONALE AND RISK ANALYSIS (RISKS TO BENEFITS RATIO) ................................................ 7 
1.4.1 
Study Rationale ............................................................................................................................... 7 
1.4.2 
Anticipated Risks ............................................................................................................................ 7 
1.4.3 
Potential Benefits............................................................................................................................ 7 
1.5 
ANTICIPATED DURATION OF THE CLINICAL INVESTIGATION ................................................................ 8 
2 
STUDY OBJECTIVES ............................................................................................................................... 8 
3 
STUDY DESIGN ........................................................................................................................................ 8 
3.1 
GENERAL DESIGN ................................................................................................................................ 8 
3.2 
9 
FIGURE 1: STUDY DESIGN .................................................................................................................................. 9 
3.3 
VISIT DESCRIPTIONS .......................................................................................................................... 10 
3.3.1 
Visit 1 ............................................................................................................................................ 10 
3.3.2 
Visit 2 ............................................................................................................................................ 10 
3.3.3 
Follow-Up Analysis ........................................................................ Error! Bookmark not defined. 
3.4 
PRIMARY SAFETY ENDPOINTS ............................................................................................................ 11 
4 
SUBJECT SELECTION, ENROLLMENT AND WITHDRAWAL.................................................... 11 
4.1 
INCLUSION CRITERIA ......................................................................................................................... 11 
4.2 
EXCLUSION CRITERIA ........................................................................................................................ 11 
4.3 
SUBJECT RECRUITMENT, ENROLLMENT AND SCREENING .................................................................. 11 
4.4 
EARLY WITHDRAWAL OF SUBJECTS................................................................................................... 11 
4.4.1 
When and how to Withdraw Subjects ........................................................................................... 11 
4.4.2 
Data Collection and Follow-up for Withdrawn Subjects ............................................................. 11 
5 
STATISTICAL PLAN .............................................................................................................................. 12 
5.1 
SAMPLE SIZE DETERMINATION .......................................................................................................... 12 
5.2 
STATISTICAL METHODS ..................................................................................................................... 12 
5.3 
SUBJECT POPULATION(S) FOR ANALYSIS ........................................................................................... 12 
6 
SAFETY AND ADVERSE EVENTS ...................................................................................................... 12 
7 
DATA HANDLING AND RECORD KEEPING ................................................................................... 13 
7.1 
CONFIDENTIALITY.............................................................................................................................. 13 
7.2 
SOURCE DOCUMENTS......................................................................................................................... 13 
7.3 
RECORDS RETENTION ........................................................................................................................ 14 
8 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................ 14 
8.1 
STUDY MONITORING PLAN ................................................................................................................ 14 
8.2 
AUDITING AND INSPECTING ............................................................................................................... 15 
9 
ETHICAL CONSIDERATIONS ............................................................................................................. 15 
10 
STUDY FINANCES ................................................................................................................................. 15 
10.1 
FUNDING SOURCE .............................................................................................................................. 15 
11 
PUBLICATION PLAN ............................................................................................................................ 15 

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REFERENCES ......................................................................................................................................... 15 
13 
ATTACHMENTS ...................................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 
LIST OF ABBREVIATIONS 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOE 
Schedule of Events 
SOP 
Standard Operating Procedure 
  IQR/M 
 
 
 Interquartile Range/Median  
 
 
 
 

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Study Summary 
Title 
A Prospective Study of the Role and Accuracy of Consumer-
Facing Wearable Technology for Patient Monitoring in 
Gastrointestinal Endoscopy 
Running Title 
Wearable Technology Endoscopy 
Title Acronym 
Wearable Tech 
IRB Protocol 
Number 
21-007738 
Phase 
Prospective study  
Methodology 
Subjects who are eligible will have two consumer-facing wearable 
smart devices placed before scheduled endoscopy. Data from the 
devices will be downloaded after the procedure and analyzed, 
Patients and providers will complete a survey regarding their 
experience.  
Overall Study 
Duration 
6 months Recruitment and Active study execution, 3 months 
analysis and 3 months publication. Total: 12 months  
Subject 
Participation 
Duration 
Up to 60 days screening prior to study procedure, duration of the 
procedure itself, and completion of a survey within 14 days of 
procedure date 
Objectives 
Measure the accuracy and safety of wearable technology in patients 
undergoing endoscopic gastrointestinal procedures with sedation.  
Assess patient and provider preferences regarding wearable 
technology. 
Number of Subjects 
Five hundred (500)   
Diagnosis and Main 
Inclusion Criteria 
Subjects over 18 years of age who are scheduled to undergo an 
endoscopic procedure with sedation  
Study Device 
Consumer-facing wearable smart devices(examples include Apple 
Watch Series 6, FitBit Versa, The QardioCore ECG ambulatory 
monitoring device)  
Reference Modality 
Sedation/Anesthesia record 
Statistical 
Methodology 
All continuous variables will be expressed as mean and standard 
deviation. Categorical variables will be expressed as percentages.  
 
 

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1 Introduction 
 
This document is a clinical research protocol relating to a prospective study of the role and 
accuracy of consumer-facing wearable technology in gastrointestinal endoscopy. The 
described study will be conducted in compliance with this protocol, applicable United States 
government regulations and Mayo Clinic policies and procedures.  
1.1 
Background 
 
The term wearable technology encompasses a wide spectrum of devices worn on or near a 
person. (1) Market research suggests that one in five Americans are users of wearable 
technology with the market currently valued at over 30 billion dollars annually. (2,3) These 
devices have the ability to record physical information, ranging from heart rate to pulse 
oximetry, as well as audio and video. These devices are often marketed to improve health 
and well-being, and there has been significant interest in their use to diagnose, monitor and 
treat disease. (4) However there remain significant issues regarding the use of wearable 
technology (5). Rigorous studies of consumer-facing products have shown significant issues 
with accuracy and reliability. (6,7) Beyond simply inaccurate data, there have also been 
reports of unintended interference from consumer wearables, resulting in disabled clinical 
devices. (8) This is in addition to questions regarding the medicolegal, ethical and practical 
implications of recording data, audio, and video during a clinical encounter. 
 
1.2 
Investigational Device 
 
Consumer-facing wearable smart watches are the latest is wearable watch technology and 
have the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and 
blood oxygen saturation. The devices are widely available in retail stores and often 
advertised as the future of health. The devices have been cleared by the FDA and are already 
permitted inside procedure procedural areas at Mayo Clinic. 
 
Consumer-facing wearable smart watches are the latest is wearable watch technology and 
have the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and 
blood oxygen saturation. The devices are widely available in retail stores and often 
advertised as the future of health. The devices have been cleared by the FDA and are already 
permitted inside procedure procedural areas at Mayo Clinic. Additional FDA-approved 
accessories are available to increase the monitoring capabilities of smart devices. The 
QardioCore is one such accessory that allows for more detailed ambulatory 
electrocardiography monitoring in addition to other vital signs like skin temperature and 
respiratory rate.  
1.3 
Clinical Data to Date 
 

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Currently there is no available literature that systemically evaluates the performance of these 
smart devices within a controlled healthcare environment. Our study would provide the first 
prospective evaluation of its use in this setting. 
1.4 
Study Rationale and Risk Analysis (Risks to Benefits Ratio) 
1.4.1 Study Rationale 
 
We hope to further characterize and define the role of consumer-facing technology in the 
clinical environment by focusing on device accuracy when compared to standard clinical 
monitoring in patients undergoing an endoscopic procedure. We will generate and answer 
questions related to these devices that have not yet been explored in the gastroenterology 
literature. We will provide a timely and much-needed framework that addresses both 
practical and theoretical considerations around a technology that has become increasingly 
relevant to patients.  
 
This study will specifically address whether consumer facing wearable devices can serve as 
patient monitoring devices in a comparable manner to the current gold standard in the 
procedural suite. In addition to accuracy, we will assess whether certain procedural 
maneuvers interfere with device data collection. This information will be relevant to patients, 
providers and healthcare institutions and can help inform policy regarding these devices.   
1.4.2 Anticipated Risks 
 
Patients would be undergoing endoscopic procedure that was clinically indicated with inherent 
risk of the procedure but minimal additional risk with placement of a watch in the pre-operative 
area. Wearable technologies (e.g. smartphones, smart watches) are already permitted in the 
endoscopy suite, so this protocol would not significantly alter standard of care. 
 
There is a minimal risk of allergic reaction to a component of the watch or band. The devices 
may be re-used for multiple procedures or handled by study personnel and therefore carries the 
risk of transmitting infection. Precautions will be taken to ensure that all devices are cleaned 
similarly to reusable devices in the procedural suite. As with all research, there is a chance that 
confidentiality could be compromised; however, we take precautions to minimize this risk.  
As with all research, there is a chance that confidentiality could be compromised; however, we 
take precautions to minimize this risk.  
 
1.4.3 Potential Benefits 
 
If successful and reliable, the use of mass-produced consumer devices could be used in 
locations where traditional cardiopulmonary monitoring devices are unavailable. 
Alternatively, inaccurate device readings would have medicolegal implications of which 
patients, providers and healthcare systems should be aware. This information can help inform 
institutional policy.  
 

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1.5 
Anticipated Duration of the Clinical Investigation 
 
The overall duration of the study is estimated to be twelve months. 6 months recruitment and 
active study execution, 3 months analysis and 3 months for publication. 
 
 
2 Study Objectives 
 
2.1 Primary Objective 
 
Measure the accuracy of wearable technology for patient monitoring compared to currently 
used equipment in patients undergoing gastrointestinal endoscopic procedures with sedation  
 
2.2 Secondary Objective 
 
1. Assess patient and provider preferences regarding wearable technology 
2. Outline current practices and policies regarding wearable devices at Mayo Clinic 
 
3 Study Design 
3.1 
General Design 
 
We will perform a prospective, non-blinded, exploratory study to assess the accuracy and 
safety of smart technology in the endoscopy suite for patients undergoing gastrointestinal 
endoscopic procedures with sedation. We will also simultaneously perform an assessment of 
patient and provider preferences using narrative-driven, qualitative evaluation. 
 
Patients will be identified by reviewing daily procedure listings on endoscopy units on Alfred 
6, Gonda 2 and Gonda 9. Recruitment will occur over the phone the day prior to a procedure, 
or the pre-procedure areas on the day of the procedure. Patients who meet inclusion criteria 
and consent to participation in the study will be provided the smart devices. The devices will 
be secured to the wrist and torso by study personnel prior to administration of sedatives. The 
smart watch will be programmed to record respiratory rate, heart rate,  and oximetry using 
native, first party device applications. These applications include Blood Oxygen (measures 
oxygen saturation), ECG (records single lead ECG), Heart Rate (heart rate), and Health (which 
logs respiratory rate while sleeping). The QardioCore ECG device will measure a single-lead 
ECG, heart rate, skin temperature, and respiratory rate. 
 
The patient will undergo his or her scheduled procedure. Patients, proceduralists and 
anesthetists will not be blinded to their enrollment as the devices will be visible. On completion 
of the procedure, the devices will be removed by the study coordinator and data downloaded 
onto a central device for analysis. Procedural information will be extracted from the operative 
note, sedation record, and anesthesia encounter in EPIC. The day after the patient’s procedure, 
a survey will be submitted to them electronically which will remain open until 14 days after 

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the procedure. A en electronic reminder will be sent if uncompleted at 7 days, followed by a 
telephone reminder if not completed at 13 days. There will be no additional patient follow up 
after completion of the survey. At study completion, a survey will be sent to involved 
proceduralists and anesthetists.  
3.2 
 
Figure 1: Study Design 
 
 
 
 
Table 1. Schedule of Events 
 

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3.3 
Visit Descriptions 
3.3.1 Baseline Screening & Enrollment (Visit 1) 
Eligible study participants will be screened, approached, and consented for the study. The 
screening and enrollment process may be performed remotely via telephone prior to the 
procedure date, or performed in the pre-procedure area on the day of procedure. Relevant study 
material will be provided to the patient at this time.  
 
3.3.2 Clinical Procedure/Accrual (Visit 2) 
The devices will be secured to the wrist and torso by study staff prior to administration of 
sedatives. The devices will be programmed to record respiratory rate, heart rate, oximetry, skin 
temperature as well as single-lead ECG. The patient will undergo his or her scheduled 
procedure. On completion of the procedure, the devices will be removed by the study staff will 
download data onto a central device for analysis.  
3.3.3 
Survey (Visit 3) 
The day after the patient’s procedure, a survey will be submitted to them electronically which 
will remain open until 14 days after the procedure. An electronic reminder will be sent if 
uncompleted at 7 days, followed by a telephone reminder if not completed at 13 days. There 
will be no additional patient follow up after completion of the survey. At study completion, a 
survey will be sent to involved proceduralists and anesthetists. will be provided electronically 
to patients to assess their satisfaction and opinions regarding their experience.  
 
Baseline 
Screening & 
Enrollment 
Visit 1 
Days -60 to 0 
Accrual: Study 
Intervention 
Visit 2 
Day 0 
Patient 
Survey 
Visit 3 
Day +1 to 
+14 
Provider 
survey 
Days 0 to 180 
Inclusion/ 
Exclusion 
X 
X 
(if not performed 
earlier) 
 
 
Device(s) 
Placement/ 
Recording 
 
X 
 
 
Patient Survey 
 
 
X 
 
Provider Survey 
 
 
 
X 

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3.4 
Primary Safety Endpoints 
There are no specific primary safety endpoints pertaining to the study given the non-invasive 
intervention. Wearable technology like smart watches and smart phones are already permitted 
within the procedural area.  
4 Subject Selection, Enrollment and Withdrawal 
 
All patients who are undergoing gastrointestinal endoscopic procedures with sedation may be 
eligible for the study. It is anticipated that we will screen up to 1000 subjects and enroll 500 
subjects to the study.  
 
4.1 
Inclusion Criteria 
 
1. Adults over 18 years of age  
2. Undergoing gastrointestinal endoscopic procedures with sedation 
3. Able to give appropriate consent to the study or have an appropriate representative to 
do so.  
 
4.2 
Exclusion Criteria 
1. Pregnancy 
2. Physical deformity, wound, or dressing preventing placement of a wearable device on 
the wrist or torso 
3. Allergy to aluminum, nickel or acrylate 
 
4.3 
Subject Recruitment, Enrollment and Screening 
 
Potential study subjects will be screened, recruited and enrolled by the principal and co-
investigators, along with trained research personnel who are able to gain consent. Relevant 
material regarding the study will be handed to the subject for review.  
 
4.4 
Early Withdrawal of Subjects 
4.4.1 When and how to Withdraw Subjects 
The subjects will undergo the clinically indicated procedure with the wearable devices. Early 
withdrawal would include removal of the devices prior to procedure completion, which can 
be performed at the discretion of the patient or clinical providers at any point. 
 
4.4.2 Data Collection and Follow-up for Withdrawn Subjects 
Withdrawn subjects will be recorded in the study record in order to calculate the withdrawal 
rate. There will be not further utilization of any subject related data.  

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5 Statistical Plan 
5.1 
Sample Size Determination 
Power analysis not performed as this study is descriptive and we do not plan to perform any 
statistical testing. 
 
5.2 
Statistical Methods  
 
Descriptive Statistics 
Baseline values for demographic, clinical, and outcome will be tabulated for the study 
subjects.  Continuous variables will be expresses as mean and standard deviation. Categorical 
variables will be expressed as percentages.  
 
We will measure the rate of concordance between device detection and documentation in 
anesthesia record (# of events recorded on wearable device / events noted on anesthesia 
record). Events to be recorded include tachycardia (HR > 100), bradycardia (HR < 60), 
desaturation (peripheral O2 saturation < 88%), any arrythmia, and tachypnea (RR > 18).   
 
We will also calculate the difference in maximum and minimum heart rate, respiratory rate, 
and oxygen saturation recorded by the watch compared to the sedation record. 
 
Handling of Missing Data 
Subjects with missing or incomplete data will be noted but will not include in the final 
analysis. Available information regarding these patients will be reported separately to allow 
for evaluation of external validity 
 
5.3 
Subject Population(s) for Analysis 
All subjects who wore the device for the duration of procedure will be included in the analysis.  
 
6 Safety and Adverse Events 
 
Patients will be undergoing endoscopic procedures that are clinically indicated with inherent 
risk of the procedure itself. There will be minimal additional risk with placement of a smart 
device in the pre-operative area. Wearable technologies (eg. smartphones, smart watches) are 
already permitted in the endoscopy suite, so this protocol would not significantly alter standard 
of care. Therefore, this study will not track any adverse events.  
 
Definitions 
 
Adverse Effect (Event) 

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Any untoward medical occurrence in a subject involved in clinical study of an investigational 
device; regardless of the causal relationship of the problem with the device or, if applicable, 
other study related treatment(s). 
 
Life-threatening adverse effect: Any adverse effect that places the subject, in the view of 
either the investigator or the sponsor, at immediate risk of death from the effect as it 
occurred.  It does not include a reaction that, had it occurred in a more severe form, might 
have caused death. 
 
Serious adverse effect: An adverse effect is considered “serious” if, in the view of either the 
investigator or the sponsor, it results in any of the following outcomes:  
• death  
• a life-threatening AE 
• inpatient hospitalization or prolongation of existing hospitalization 
• a persistent or significant disability/incapacity 
• a congenital anomaly/birth defect. 
 
Unanticipated adverse effect: Any adverse effect, the nature, specificity, severity, or 
frequency of which is not consistent with the risk information in the clinical study protocol or 
elsewhere in the current IDE application. 
 
All inclusion and exclusion criteria are set out and there will be no protocol deviation.  
7 Data Handling and Record Keeping 
7.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the 
following: 
• What protected health information (PHI) will be collected from subjects in this study? 
• Who will have access to that information and why? 
• Who will use or disclose that information? 
• The rights of a research subject to revoke their authorization for use of their PHI. 
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (long term 
survival status that the subject is alive) at the end of their scheduled study period. 
7.2 
Source Documents 
 
Source data comprise all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  

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Source data are contained in source documents.  Examples of these original documents, and 
data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after verification 
as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. When applicable, information 
recorded on the CRF shall match the Source Data recorded on the Source Documents. 
 
Data Management 
All data points gathered for the study will remain confidential and only available to 
designated research personnel. The data will be managed using Excel Subject Tracking. 
 
Data Security and Confidentiality 
 
All collected data points and information will be securely stored in Mayo Clinic issued 
laptops, desktops or tablets with password encryption. Only study personnel will have access 
to the study data and information.  
 
 
7.3 
Records Retention 
 
The study team will maintain records and essential documents related to the conduct of the 
study.  These will include subject case histories and regulatory documents. 
 
The study team will retain the specified records and reports during the study and for the longer 
of the following. 
1. As outlined in the Mayo Clinic Research Policy Manual –“Retention of and Access to 
Research Data Policy” http://mayocontent.mayo.edu/research-policy/MSS_669717,  
 
OR 
 
2. A period of 2 years after the latter of the following two dates: The date on which the 
investigation is terminated or completed, or the date that the records are no longer 
required for purposes of supporting a premarket approval application or a notice of 
completion of a product development protocol. 
 
 
8 Study Monitoring, Auditing, and Inspecting 
8.1 
Study Monitoring Plan 
 
The investigator will allocate adequate time for such monitoring activities. Data safety 
monitoring plan (DSMP) will be completed after the first subject, then at 3 months and then 

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annually if required. Delegated study staff will conduct the review. The review will be 
written up as reports and submitted to IRB for further review if required. The Investigator 
will also ensure that the monitor or other compliance or quality assurance reviewer is given 
access to all the study-related documents and study related facilities (e.g., pharmacy, 
diagnostic laboratory, etc.), and has adequate space to conduct the monitoring visit. 
 
8.2 
Auditing and Inspecting 
The sponsor-investigator will permit study-related monitoring, audits, and inspections by the 
IRB, the monitor, and government regulatory agencies, of all study related documents (e.g., 
source documents, regulatory documents, data collection instruments, study data etc.).  The 
sponsor-investigator will ensure the capability for inspections of applicable study-related 
facilities (e.g., pharmacy, diagnostic laboratory, etc.). 
 
9 Ethical Considerations 
This study is to be conducted according to United States government regulations and 
Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted local 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study.  The decision of the IRB concerning the conduct of the study will be 
made in writing to the sponsor-investigator before commencement of this study. 
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for review 
and approval by the IRB for the study.  The formal consent of a subject, using the Approved 
IRB consent form, must be obtained before that subject undergoes any study procedure.  The 
consent form must be signed and dated by the subject or the subject’s legally authorized 
representative, and the individual obtaining the informed consent. 
10 Study Finances 
10.1 Funding Source 
This is an investigator-initiated and investigator-funded study.  
11 Publication Plan 
The results of the study will be written up and submitted to gastroenterology/endoscopy 
journals for publication.  
12 References 
 
1. Godfrey A, Hetherington V, Shum H, Bonato P, Lovell NH, Stuart S. From A to Z: Wearable technology 
explained. Maturitas 2018;113:40–7.  

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2. Lamkin P. Wearable Tech Market To Be Worth $34 Billion By 2020. Forbes. [cited 2021 Feb 
23];Available from: https://www.forbes.com/sites/paullamkin/2016/02/17/wearable-tech-market-to-be-
worth-34-billion-by-2020/ 
3. US Consumer IoT Market: Key Penetration Rates Creeping Toward 30% in 2023. [cited 2021 Feb 
23];Available from: https://www.spglobal.com/marketintelligence/en/news-insights/blog/us-consumer-
iot-market-key-penetration-rates-creeping-toward-30-in-2023 
4. Pevnick JM, Birkeland K, Zimmer R, Elad Y, Kedan I. Wearable Technology for Cardiology: An Update 
and Framework for the Future. Trends Cardiovasc Med 2018;28(2):144–50.  
5. Chandrasekhara V, Kane SV, Buttar NS. Wearable technology during GI endoscopic procedures with 
sedation. Gastrointestinal Endoscopy 2020;92(1):173–5. 
6. Case MA, Burwick HA, Volpp KG, Patel MS. Accuracy of Smartphone Applications and Wearable 
Devices for Tracking Physical Activity Data. JAMA 2015;313(6):625–6.  
7. Piwek L, Ellis DA, Andrews S, Joinson A. The Rise of Consumer Health Wearables: Promises and 
Barriers. PLOS Med 2016;13(2):e1001953.  
8. Greenberg JC, Altawil MR, Singh G. Letter to the Editor—Lifesaving Therapy Inhibition by Phones 
Containing Magnets. Heart Rhythm [Internet] 2021 [cited 2021 Feb 23];0(0). Available from: 
https://www.heartrhythmjournal.com/article/S1547-5271(20)31227-3/abstract