Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppresive Therapies for Acute Leukemia and Other Childhood Cancers
Phase: NA
Conditions: Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin Lymphoma
Sponsor: Massachusetts General Hospital

 
 
Status Page 
 
 
 
 
PROTOCOL 14-485 
 
 
 
 
 
 
 
 
 
 
Closed to New Accrual 
 
 
 
 
 
 
 
 
 
 
 
 
Closure Date: May 8, 2017 
 
 
 
 
No new subjects may be enrolled in the study as described above. 
Any questions regarding this closure should be directed to the 
study’s Principal Investigator 

Total Study-Wide Enrollment Goal: 25 dyads 
Greater than 25% of the overall study accrual will be at DF/HCC: 
Yes 
No 
Total DF/HCC Estimated Enrollment Goal: 25 dyads 
Adult Age Range: 18+ 
Pediatric Age Range: 2-17 
Will all subjects be recruited from pediatric clinics? 
Yes 
No 
Office for Human Research Studies 
 
DANA-FARBER / HARVARD CANCER CENTER 
 
Protocol Front Sheet 
DFCI Protocol No.: 14-485 
1. PROTOCOL INFORMATION 
 
Title: Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppressive Therapies for Acute Leukemia and other Childhood Cancers 
Phase: Feasibility/Pilot 
Sponsor Study Number: 
2. DF/HCC STUDY CONTACT INFORMATION 
Primary Study Contact: Amanda Centi 
Email:  acenti@partners.org 
Phone: 617 724 2158 
INVESTIGATORS: (List only those under DFCI IRB, i.e., from institutions listed in Section 6 below) 
Overall PI: 
Stephen Agboola MD, MPH 
Phone: 617-643-0291 
Institution(s): 
MGH 
Site Responsible PI: 
Phone: 
Institution(s): 
3. DRUG / DEVICE INFORMATION 
N/A: 
Drug(s), Biologic(s): 
Device(s) Name: iThermonitor 
Provided by: 
IND Exempt: 
‐or‐ 
IND#: 
Holder Type: [pull down] 
IND Holder Name: 
Provided by: Raiing Medical Company 
IDE Exempt: 
‐or‐ 
IDE #: 
Holder Type: [pull down] 
IDE Holder Name: 
 
4. PROTOCOL COORDINATION, FUNDING, MODE 
Regulatory Sponsor: 
Funding/Support (check all that apply): 
DF/HCC Investigator 
Industry: Raiing Medical Company 
Federal Organization: 
CTEP Study: No 
Grant #: 
Internal Funding: 
Non-Federal: 
Other: 
 
Protocol Involves (check all that apply as listed in the protocol document, even if not part of the research but is mandated by the protocol document): 
Chemotherapy 
Immunotherapy 
Hormone Therapy 
Vaccine 
Medical Record Review 
Questionnaires/Surveys/Interviews 
Surgery 
Bone Marrow/Stem Cell Transplant 
Data Repository 
Exercise/Physical Therapy 
Radiological Exams 
Required Biopsy Study 
Cell Based Therapy 
Gene Transfer (use of recombinant DNA) 
Radiation Therapy 
Genetic Studies 
Human Material Banking 
Human Material Collection 
Human Embryonic Stem Cell 
Quality of Life 
Other: use of study device 
5. SUBJECT POPULATION (also applies to medical record review and specimen collection studies) 
 
 
 
 
If enrolling both adults and pediatric subjects, anticipated percent of pediatric subjects: 50% (1/2 of each dyads) 
Retrospective Medical Record Reviews only (Please provide date range): from 
to 
 
6. DF/HCC PARTICIPANTS UNDER DFCI IRB (check all that apply) 
Beth Israel Deaconess Medical Center (BIDMC) 
Beth Israel Deaconess Medical Center – Needham (BIDMC-Needham) 
Boston Children’s Hospital (BCH) 
Dana-Farber/New Hampshire Oncology-Hematology (DFCI @ NHOH) 
Brigham and Women’s Hospital (BWH) 
 Dana-Farber at Steward St. Elizabeth’s Medical Center (DFCI @ SEMC) 
Dana-Farber Cancer Institute (DFCI) 
 Dana-Farber at Milford Regional Cancer Center (DFCI @ MRCC) 
Massachusetts General Hospital (MGH) 
Mass General/North Shore Cancer Center (MGH @ NSCC) 
Mass General at Emerson Hospital – Bethke (MGH @ EH) 
New England Cancer Specialists (NECS) 
DF/BWCC in Clinical Affiliation with South Shore Hospital (DFCI @ SSH) 
 
7. NON-DF/HCC PARTICIPANTS UNDER DFCI IRB (check all that apply) 
 
Cape Cod Healthcare (CCH) 
Lowell General Hospital (LGH) 
New Hampshire Oncology-Hematology-P.A. (NHOH) 
Newton-Wellesley Hospital (NWH) 
Broad Institute 
Lawrence & Memorial Cancer Center in affiliation with Dana-Farber 
Community Cancer Care (LMCCC) 
 
8. DF/HCC INITIATED STUDIES ONLY - INSTITUTIONAL PARTICIPANTS UNDER OTHER IRB (N/A: 
) 
 
DF/HCC Multi-Center Protocols: (list institution/location) 
DF/PCC Network Affiliates: (list institution/location) 
 
 
Version: 01.08.16 

Log Sheet 
 
 
Protocol Number: 14-485 
 
Approval Date:   
03/09/2015  
(IRB meeting date when protocol/consent 
approved or conditionally approved) 
 
Activation Date:   
04/16/2015    (Date when protocol open to patient entry) 
 
Approval signatures are on file in the Office for Human Research Studies, tel. 617-632-3029. 
 
Date 
Posted 
Revised Sections 
IRB 
Approval 
Date 
OHRS 
Version 
Date 
07/06/15 
Consent Form, Protocol, Front Sheet, Appendix table of 
contents, Appendix 1.4, Appendix 3.1, Appendix 3.3, 
Appendix 4.1, Appendix 5.2, Appendix 6.0 replaced due 
to Amendment #2 
05/01/15 
06/30/15 
01/08/16 
Consent Form replaced due to Amendment #5 
01/06/16 
01/07/16 
Date 
Posted 
Revised Sections 
IRB Approval 
Date 
Oncore 
Version Date 
03/07/16 
Study renewal/Consent Form footer replaced due to 
Continuing Review #1 (Note: 6 month approval only 
from date of IRB Review) 
02/08/16 
03/07/16 
03/16/16 
Protocol, Consent Form and Front Sheet replaced due 
to Amendment #7 
02/18/16 
03/15/16 
05/31/16 
Permanent Site Closure to New Accrual: DFCI site 
closing to accrual; Site PI no longer wishes to 
participate in the study (effective date:04/18/16; 
Amendment #9) 
04/19/16 
N/A 
05/31/16 
Protocol, Local Appendices, Consent Form and Front 
Sheet replaced due to Amendment #10 
05/06/16 
05/31/16 
07/06/16 
Study renewal/Consent Form footer replaced due to 
Continuing Review #2 
07/06/16 
07/06/16 
05/08/17 
Permanent Closure to New Accrual: Objective(s)/ 
Accrual Met (effective date: 5/8/2017; Amendment #11) 
5/8/2017 
N/A 
06/21/17 
Study renewal due to Continuing Review # 3 
(Note: Consent form removed due to Data Analysis 
only phase) 
06/15/17 
N/a 
 
 
 
 
Page 1 of 1 

 
Recruitment 
 Solicit participation of pediatric oncology team at the MGH Cancer Centers 
 Potential subjects identified from the MGH Cancer Centers 
Enrollment 
 Study staff meets with subject/caregiver for consent 
 Enrollment procedures, baseline data collection and initial set-up 
During 
the 
study 
 Subjects continue care as usual 
 Use the iThermonitor 
Close- 
out 
 Complete final questionnaires and other closeout procedures 

Protocol Version 1.8 15 April , 2016 
Page 2 
 
Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppressive Therapies for 
Acute  Leukemia and other  Childhood Cancers 
 
Stephen Agboola, M.D., M.P.H. 
 
Detailed IRB protocol 

Protocol Version 1.8 15 April , 2016 
Page 3 
 
Table of Contents 
 
 
1.0 
Introduction 
1.1 Overview 
1.2 Background and Rationale 
 
 
2.0 
Objectives 
2.1 Hypothesis 
2.2 Primary & Secondary Aims 
2.21 Primary aim 
2.22 Secondary aims 
 
 
3.0 
Research Subject Selection 
3.1 Inclusion/Exclusion Criteria 
 
 
4.0 
Research Subject Entry 
4.1 Recruitment and Enrollment 
 
 
5.0 
Study Design and Methods 
5.1 Design/Study Type 
5.2 Selection of Instruments 
5.3 Description of Intervention 
5.4 Data Collection 
5.5 Risks and Privacy Concerns 
5.6 Description of Study Process 
5.61 Enrollment visit 
5.62 Registration Procedures 
5.63 During the Study 
5.64 Closeout Visit 
5.65 Instrument Administration 
5.66Intervention Administration 
5.67 Special Concerns 
5.68 Remuneration 
5.7 Adverse Reactions and Their Management 
5.71 Reporting Adverse or Unanticipated Events 
5.72 Anticipated Reactions 
5.73 Reaction Management 
 
 
6.0 
Statistical Analysis 

Protocol Version 1.8 15 April , 2016 
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6.1 Primary and Secondary Endpoints 
6.2 Sample Size and Statistical Power 
6.3 Stratification Factors 
6.4 Stratification Factors and their Impact on Design 
6.5 Early stopping rules 
6.6 Unevaluable/ineligible participants 
6.7 Analysis Plan 
6.8 Handling of missing data 
 
 
7.0 
References 
 
 
8.0 
Appendices 
1.1  Premarket notification 501(k) summary 
 
1.2  Biocompatibility statement 
 
1.3  Tech specs 
 
1.4  Quick user guide 
 
 
 
 
2.1  Letter for participation to provider 
 
2.2  Enrollment notification to provider 
 
 
 
 
3.1  Phone script 
 
3.2 Appointment reminder 
 
3.3 Parent recruitment letter 
 
 
 
 
4.1 Close-out questionnaire 
 
4.2  GAD-7 
 
4.3 Enrollment questionnaire 
 
 
 
 
5.1 Eligibility checklist 
 
5.2 Daily event monitoring log 

Protocol Version 1.8 15 April , 2016 
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6.0 iThermonitor Informational Material 
 
6.1 Partners Broadcast Ad 

Protocol Version 1.8 15 April , 2016 
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1.0 Introduction 
 
 
1.1 Overview 
 
 
This is a pilot study to evaluate the use feasibility of the iThermonitor, a continuous 
temperature monitoring device, as a clinical support and patient self-management tool in the 
management of pediatrics patients on myelosuppressive therapies for acute leukemia and 
other childhood cancers. 
 
 
1.2 Background and Rationale 
 
 
Since 1975, the incidence rate of childhood cancers has been steadily increasing by an 
average of 0.6% every year.1 Based on 2014 data, it is estimated that 1 in 285 children will be 
diagnosed with cancer before age 20 years.1 Cancer is also expected to be the cause of death 
in about 1,960 children in 2014 making it the second leading cause of death in children. 1 This 
rise in cancer rates corresponds with increased rates of four childhood cancers:  acute 
lymphocytic leukemia, acute myeloid leukemia, non-Hodgkin lymphoma, and testicular germ 
cell tumors.1 
Specifically, acute lymphocytic leukemia is the most common childhood cancer, 
accounting for 26% and 80% of all cancers and leukemia respectively in children aged 0- 
14years.1 Due to improvement in treatment strategies, the 5-year survival rate has increased 
from 57% in 1975 to about 90% in 2009.1 In general, the treatment of ALL is in three phases 
over 2-3years: remission induction, consolidation and maintenance. Patients who relapse may 
be eligible for stem cell transplantation. Patients undergoing treatment for acute leukemia are 
particularly prone to profound neutropenia due to intensive chemotherapy during the induction 
phase.2This neutropenic state is expected to last about 10 days during intensive phase of 
treatment.2 Similarly, patients undergoing allogeneic stem cell transplantation and other 
myelosuppressive therapies are also at high risk for neutropenia. 
Neutropenia predisposes patients to significant risk for infectious complications which 
increases morbidity and mortality.2 Usually, fever is the first clinical sign of the inflammatory 
response to the infective process; and early detection is an indication for empiric antimicrobial 
therapy and further evaluation to determine risk for sepsis. Today, broad-spectrum 
antimicrobial therapy at the first detection of fever has helped significantly decreased the 
mortality associated with neutropenia in the intensive phase of chemotherapy.2 
Therefore, early detection of fever, through regular temperature monitoring, in a neutropenic 
patient is critical to improved clinical outcome. Vigilance on the part of care providers and care 
givers is crucial to early detection. Traditionally, this is simply done through episodic oral or 
axillary monitoring of temperature. In this study, we propose to test the use feasibility of an 
innovative device that continuously monitors body temperature as a clinical decision support 
tool in pediatric patients undergoing myelosuppressive therapies for acute leukemias and other 
childhood cancers. 
 
 
The iThermonitor, a FDA class II device, is a high accuracy device that continuously 
captures body temperature and automatically delivers the data wirelessly (via blue tooth or wi- 

Protocol Version 1.8 15 April , 2016 
Page 7 
 
fi) to mobile devices or for cloud storage. It has the capacity to store 10 days worth of recorded 
temperature data.  The device can be used to effortlessly monitor patients on a continuous 
basis during the intensive phase of chemotherapy as opposed to the usual episodic oral or 
axillary measurements. It is also able to generate and deliver out-of-range temperature alerts 
on a mobile application for care givers or providers. It also provides care providers an 
opportunity to remotely monitor their patients’ temperature in the immediate period after 
discharge from the hospital. Therefore, we hypothesize that the iThermonitor can serve as a 
feasible clinical decision support in the management of pediatric patients undergoing intensive 
treatments for acute leukemia and other childhood cancers. The device hasn’t been previously 
tested for use in pediatric patients and finding from this study could generate useful data for 
future studies. 
 
 
Proposed Study 
This study will be implemented as a pilot study to test the use feasibility of the iThermonitor as a 
clinical decision support for continuous temperature monitoring in a dyad of 25 pediatrics patients, 
(aged 2yrs – 17yrs) on myelosuppressive therapies for acute leukemia and other childhood 
cancers at the MGH Pediatric Hematology and Oncology group and their caregivers. The 
iThermonitor will be used by patients and their caregivers for 14 days of data collection. There will 
be up to be two study visits: study enrollment and study closeout. Participants will be given the 
option to complete study closeout online via RedCap. REDCap is a secure, web-based application 
for building and managing on line surveys. The REDCap version offers a more convenient means 
for survey administration and eliminates the need for an in-person closeout visit. Should the 
participant choose this option, a member of the study staff will email a link to the RedCap survey 
via RedCap’s secure email system. 
We have chosen to implement this study as a feasibility study because our goal is to determine if 
continuous temperature monitoring by the iThermonitor can work in home settings. This is in 
keeping with the definition for feasibility studies proposed by the National Institute for Health 
Research Evaluation, Trials and Studies Coordinating Centre (NETSCC), which states that 
“feasibility studies are pieces of research done before a main study in order to answer the 
question ‘can it work?’”3 Bowen et al further suggests that they could be used to answer the 
questions – “does it work and will it work?” and that they are used to determine whether an 
intervention is appropriate for further testing.4 Based on the paper by Bowen et al describing the 
diverse types of feasibility studies funded by the National Cancer Institute, this study meets the 
criteria for conducting feasibility studies. According to them, one of the indications for a feasibility 
study is when “there are few previously published studies or existing data using a specific 
intervention technique”.4 To our knowledge, we are not aware of any previous research exploring 
continuous temperature monitoring in pediatric oncology patients on myelosuppressive therapies. 
Therefore, findings from this study have the potential to advance knowledge about the 
management of fever in pediatric patients on myelosuppressive therapies. 
 
2.0 Objectives 
 
2.1 Hypothesis 

Protocol Version 1.8 15 April , 2016 
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We hypothesize that at least 80% of study subjects will be able to successfully use the 
iThermonitor to continuously monitor their body temperature. A subject must be able to view 
temperature data on the provided iPad mini at least 80% of the time in the study to be 
considered successful. “Time in the study” here is defined as the number of days the subject 
spends in the study which is expected to be 14 days. 
 
 
 
 
2.2 Primary and Secondary aims: 
 
2.21 The primary aim of this trial is to assess the use feasibility of the iThermonitor as a clinical 
decision support tool in the management of patients on myelosuppressive therapies for acute 
leukemia and other childhood cancers. We will consider the iThermonitor as a feasible clinical 
decision support tool if it successfully captures body temperature data, transmit and displays 
the data on the iPad mini in at least 80% of the study subjects. We will also assess the ability 
of the device to alert the caregiver if the temperature falls outside of pre-set range which is 
defined for all patients as temperature less than or equal to 96 and greater than or equal to 
100. 
 
2.22 Secondary outcomes: 
 
 Usability, acceptability and satisfaction with the iThermonitor. 
 
 Caregiver engagement with the iThermonitor. 
 
 Effect of the study on caregiver anxiety. 
 
3.0 Research Subject Selection 
 
Pediatric patients undergoing myelosuppressive therapies for acute leukemias and other 
childhood cancers at the Massachusetts General Hospital Cancer Center and their caregivers will 
be eligible to participate in this study. Eligible patients and their caregivers will be enrolled to 
participate in this study as a dyad. 
 
3.1 Inclusion/Exclusion 
 
All male and female patients, regardless of ethnicity, are candidates for enrollment in this study if 
they meet all of the inclusion and exclusion criteria listed below. 
 
3.1a Inclusion criteria - Child: 
 
  Pediatrics patients aged 2-17 years undergoing myelosuppressive therapies for acute 
leukemias and other childhood cancers. 
 
  If applicable, willingness of the patient to shave axillary (armpit) hair. 
 
 Ability of patient (if old enough) to read and speak English 
 
  Has a caregiver, ≥ 18 years of age that is willing to participate in the study 

Protocol Version 1.8 15 April , 2016 
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3.1b Inclusion criteria – Caregiver/Parent: 
 
  Caregivers (parents or legal guardians) must give informed consent 
 
  Ability of caregiver to read and speak English 
 
3.1b Justification of inclusion criteria: 
 
 The iThermonitor is recommended for use only in children aged 2 years and above. 
 
 Shaving is recommended for older children who have attained puberty because the 
device works best when in contact with flat and smooth skin. 
 
 Participation of caregivers is needed because they will be required to monitor 
temperature data on the provided iPad mini and also to help answer questions 
pertaining to the usability of the iThermonitor. 
 
 Fluency in English is required because the study materials will be administered only 
in English. 
 
 No study procedure will be performed without informed consent from the parents or 
legal guardians of patients. 
 
3.1c Exclusion criteria 
 
 Patients with history of allergy to hydrogel dressing or ongoing skin diseases. 
 
 Patients with ongoing febrile illness or documented infectious disease. 
 
3.1d Justification for exclusion criteria 
 
 We are excluding patients with history of allergy to hydrogel dressing or skin diseases to 
limit the possibilities of adverse skin reactions. 
 
 We are excluding patients with ongoing febrile illness or documented infectious disease 
to decrease the chances of study-related adverse effects. 
 
4.0 Research Subject Entry 
 
4.1 Recruitment and Enrollment 
All pediatric patients undergoing myelosuppressive therapies for acute leukemias and other childhood 
cancers at Massachusetts General Hospital Cancer Center and their caregivers will be considered 
potential candidates for this pilot study. Recruitment information will be posted through the following 
online channels: Partner’s Healthcare and MGH research broadcast email services (Appendix6.1). 
These broadcasts are sent out to members enrolled in the broadcast at either Partners Healthcare or 
MGH. Additionally, the investigators will work directly with pediatric oncologists at the MGH Cancer 
Center to recruit their patients for this study. The hematology-oncology team, led by Dr. Howard 
Weinstein at Massachusetts General Hospital Cancer Center will help identify potential subjects for 

Protocol Version 1.8 15 April , 2016 
Page 10 
 
the study. Identified candidates could either be on hospital admission for chemotherapy or  have an 
upcoming clinic visit for chemotherapy. 
For identified candidates  with upcoming hospitalization or clinic visit for chemotherapy, the 
research team will send out letters and study consent forms prior to the hospital visit. The letters will 
briefly describe the study and the study commitments. The letter will explain that a research assistant 
(RA) will be approaching the candidate and caregiver during their upcoming hospital visit for 
chemotherapy. The letter will clearly explain to the patient that if s/he does not wish to be approached 
by study staff, s/he should call the study line and inform the research team. If we do not hear from 
patients after one week of sending the recruitment letter, study staff will contact them by phone to tell 
them more about the study and answer any questions they may have about their participation. 
Additionally, study staff will leave the study informational flyers (appendix 6.0) in the pediatric 
oncology clinics so that oncologists will be able to introduce the study to their patients and their 
families. This group of patients who are directly informed about the study by their oncologists will not 
be sent recruitment letters. 
During the clinic visit, the research assistant will provide the patient with further detail 
regarding the study. If the patient is interested, the RA will aim to enroll the patient during the clinic 
visit or a day before hospital discharge for those on hospitalization. For those patients that are 
already on hospital admission, the oncologist will introduce the study staff to the patient and 
caregiver. Before commencing study related activity, the study staff will inform patients and their 
caregivers about the study and give them a consent form for them to review and consider 
participating in the study. Study staff will return after about 30 mins – one hour to confirm their 
willingness or unwillingness to participate in the study. 
For the interested patient-caregiver dyad, the research assistant will aim to enroll them in the 
study at the clinic visit or one day prior to hospital discharge by going through the consent form with 
the subject and caregivers to ensure adequate comprehension of study protocol. After, explaining 
study details and procedures, subjects and their caregivers will be given sufficient time to review the 
consent form and will be encouraged to ask questions. Patients who fulfill the eligibility criteria and 
their caregivers will be enrolled together as a dyad after the parents/legal guardians’ consents to their 
participation. The parents/legal guardians will sign two copies of the consent form – one for the 
subject and the other for the study team. However, patients aged to 10 -17 years will also be required 
to confirm their willingness to participate in the study by signing the assent box.  All enrollment 
procedures, including the informed consent process, will be done by research assistants. While 
enrollment procedures will occur during the clinic visit for chemotherapy or prior to hospital discharge, 
patients will  not begin to use the iThermonitor until they get back home. We will also make it clear 
that participation in this study does not preclude participation in other research studies. 
 
 
If for any reasons some patients or their caregivers needs more time to consider participating 
in the study, we will leave them a copy of the consent form so that they can further review the study 
details. No patient-caregiver dyad will be coerced into participating. We will emphasize that 
participation is voluntary and their non-participation will not affect their treatment. They will be asked 
to contact the study staff by phone if they do decide to participate. After the informed consent 
process, the RA will then perform all other enrollment procedures. 
 
 
5.0 Study Design and Materials 

Protocol Version 1.8 15 April , 2016 
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5.1 Study Design: This study will be implemented as a pilot study to evaluate the use feasibility 
 
 
of the iThermonitor as a clinical decision support tool for the continuous temperature 
monitoring in pediatrics patients (on myelosuppressive therapies for acute leukemia and 
other childhood cancers at the MGH Cancer Center) and their caregivers over a 2-week 
study period upon the start of device use. This will ensure that 14 days of data is collected. 
Apart from the enrollment and closeout procedures that will be occur in the hospital 
settings, all other procedures will be performed at home. The iThermonitor will only be used 
by the patient-caregiver dyad at home for 14 days of data collection (starting from the next 
day post-chemotherapy) to monitor the patient’s temperature. For hospitalized patients, 
their 14 days will start from the first day after hospital discharge. 
 
5.2 Selection of instruments: 
 
 An enrollment survey that will gather information regarding the dyad’s demographic 
info and their technology use (Appendix 4.3) 
 
 This study will use usability and satisfaction questionnaires specifically designed for 
this study. (Appendix 4.1) 
 
 We will also assess caregiver anxiety with the Generalized Anxiety Disorder 
Questionnaire (GAD-7) (Appendix 4.2). 
 
5.3 Description of intervention: 
 
The iThermonitor is an electronic device that continuously monitors body temperature and 
connects to a receiver (iPad mini) via Bluetooth to display body temperature data in real 
time. The iThermonitor is attached to the skin by a hydrogel dressing which can be 
changed as needed.  It captures data even without connection to a receiver and it can 
establish connection to a paired receiver device (the iPad mini) within a range of three 
meters. The provided iPad mini will be pre-loaded with the iThermonitor app which will be 
used to pair the receiver with the iThermonitor device. If a caregiver prefers to use their 
own smart device such as an iPad, iPad mini or iPhone, study staff will install the 
iThermonitor app to the caregiver’s device for the duration of the study. The iThermonitor 
monitors body temperature every four seconds and is able to store 10 days’ worth of data 
that can be offloaded as soon as it establishes connection with a receiver. It is able to 
measure temperature in the range of 25-45 degrees Celsius. Users are able to set 
temperature limits at which alerts for which out-of-range temperature can go off. However, 
for this study, the range will be fixed at less than or equal to 96°F and greater than or equal 
to 100°F as recommended by the pediatric oncology team at MGH. This alert can be audio 
or visual and will be displayed on the receiver. In the event of an out-of-range temperature 
alert, we will encourage subjects/caregivers to confirm the alert with their usual methods of 
temperature monitoring or personal thermometers before notifying their care providers. In 
the case of a true fever, we will emphasize during the enrollment visit that 
subjects/caregivers should continue to monitor patients’ temperature through usual care 
methods and also to follow usual care protocols in managing fever as recommended by 
their care providers. If the out-of-range temperature alert is not confirmed by their usual 

Protocol Version 1.8 15 April , 2016 
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temperature monitoring methods, we would encourage them to disregard the alert and log it 
 
 
as a false alarm. 
 
Caregivers who have smartphones can also view their children’s temperature data on their 
personal smartphones (in addition to the iPad mini provided) if they wish. To be able to 
view temperature data on their smartphones, caregivers will have to download the 
iThermonitor from the Apple App and Google Play  stores. The iThermonitor app is 
available for iPhone and Android users and there is no cost to downloading it on their 
phones. User manuals to guide use will be given to all subjects. (Appendices 1.4,) 
 
5.4 Data Collection 
 
 The use feasibility data will be collected by a daily event monitoring log designed 
specifically for this study which will be recorded manually by subjects everyday 
throughout the study period. 
 
  Data collected by the iThermonitor is automatically uploaded to a paired receiver 
within a range of five meters for cloud storage. These data will be downloaded on a 
weekly basis and stored in the Partners Healthcare network of computer files 
available to only the IRB approved study staff at the Partners Connected Health 
Innovation. Partners Connected Health Innovation is an established leader in the 
creation and implementation of effective healthcare delivery strategies supported by 
patient-centric technology.  At PCHI, we leverage information technology – mobile 
phones and apps, remote monitoring tools, personal health trackers, sensors, 
computers and networked devices – to help providers and patients manage chronic 
conditions, maintain health and wellness, and improve adherence, engagement and 
clinical outcomes. 
 
 We will collect information about the participant’s type of cancer, stage of disease 
and treatment regimens from a review of the electronic medical records. 
 
 Enrollment, usability and satisfaction data will be collected by questionnaires 
designed specifically for this study. 
 
Outcome data will be stored in computer network files that are accessible only to IRB 
approved study staff. Outcome data will be linked to each subject by a unique number, 
which will not have any identifying information. All data collected will be analyzed at the end 
of the study period. 
 
A summary of data points to be assessed in this study is summarized in the table below: 
 
Assessments 
At entry 
During 
the study 
Close out (+/- 
5days) 
Enrollment  questionnaires 
X 
Temperature measurements via device 
X 
X 
Daily event monitoring log 
X 
X 

Protocol Version 1.8 15 April , 2016 
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Number of out-of-range temperature episodes 
detected 
X 
Usability and satisfaction questionnaires and other 
closeout surveys 
X 
GAD-7 
X 
X 
 
5.5 Risks and Privacy Concerns: 
We do not foresee any significant risks for subjects/caregivers: 
 
 
 Participants will continue to receive usual treatments including having their temperature 
monitored by their clinical team and caregivers according to standard care protocols. 
 Participants are free to leave the study at any point without restriction. 
 While we do not expect the iThermonitor to fail, the risk involved revolves around failure to 
appropriately notify subject/caregiver of a true fever episode or the generation of a false out- 
of-range temperature alert. Therefore, we will emphasize that subjects/caregivers should 
continue to monitor their temperature as recommended by their care providers. In the event of 
an out-of-range temperature alert, we will encourage subjects/caregivers to confirm the out-of- 
range temperature with their personal thermometers before notifying their care providers. 
 Although subjects/caregivers are asked to complete questionnaires at the start and at the end 
of the study they will be instructed that they can choose not to answer any question(s) they do 
not wish to answer. 
 The study team members responsible for completing chart reviews to gather the required 
information will be CITI certified and well-versed in HIPAA requirements. These team 
members will be trained and familiarized with the process of obtaining the required data points 
and will minimize viewing of any non-essential information. 
 
 
 
Data security and privacy will be maintained through: 
 
 Separation of participant names from all study data will be done through the use of unique 
identifiers. Only Study ID numbers will be used on the iThermonitor Application. 
 
 The record review will be done by IRB approved study staff and will be focused only at 
collecting pre-specified information namely, temperature data while on hospitalization, type 
and stage of cancer and treatment regimens. 
 
 Any information transferred via the internet will be done using 128 bit SSL encryption. 
 
 Virus and password protected facilities within the Partners Healthcare network of computers 
will be provided for the research team. 
 
 To safeguard confidentiality, access to all collected data will be limited to only the IRB 
approved study staff. Study subjects will be referred to by a unique study number and not 
by name. 
 
 All communications via telephone or other media with subjects/caregivers will be stored in 
their study file. 

Protocol Version 1.8 15 April , 2016 
Page 14 
 
 
 At the end of the study, all identifiable information will be destroyed and the study data will 
be maintained for at least two years after the completion of the study. 
 
 Only de-identified outcomes data will be shared with study sponsors at the end of the study. 
 
 Identifiable information will not be used or disclosed except as required by law, for 
authorized oversight of research, or for other research for which the use and disclosure 
would be permitted. 
 
 
5.6 Description of Study Process: 
 
Each subject/ caregiver dyad will participate in this pilot study for 2 weeks starting from the 
next day after the onset of chemotherapy. There are two study visits involved: 
 
5.61 Enrollment visit: 
 
This will take place during the clinic visit for chemotherapy or on the day before 
discharge for hospitalized patients. 
 
 Enrollment into the study by signing the informed consent form. This will be done 
before performing any study procedures. 
 
 Rescreening to confirm eligibility as described above. A screening checklist will be 
provided to guide the RA. 
 
 Complete all enrollment surveys. Caregivers will be required to complete the GAD-7 
 
 The research assistant will explain and demonstrate how to use the iThermonitor 
and also leave subjects with user manuals. (Appendices 1.4,) 
 
 Subjects who wish to use their own smartphones, in addition to the provided study 
iPad minis, will be instructed to download the iThermonitor’s app on the app store. 
 
 Finally, study staff will emphasize that the iThermonitor is not a replacement for 
usual temperature monitoring protocols and will instruct participants to continue to 
receive medical care from their physicians as usual. 
 
5.62 Registration Procedures 
General Guidelines for DF/HCC and DF/PCC Institutions 
 
Institutions will register eligible participants with the DF/HCC Quality Assurance Office for Clinical 
Trials (QACT) central registration system. 
 
 
An investigator will confirm eligibility criteria and a member of the study team will complete the QACT 
protocol-specific eligibility checklist. 
 
Registration Process for DF/HCC and DF/PCC Institutions 

Protocol Version 1.8 15 April , 2016 
Page 15 
 
 
The QACT registration staff is accessible on Monday through Friday, from 8:00 AM to 5:00 PM 
Eastern Standard Time. 
 
 
 
 
The registration procedures are as follows: 
 
 Obtain written informed consent from the participant prior to the performance of any protocol 
specific procedures or assessments. 
 
 
 
 Complete the QACT protocol-specific eligibility checklist using the eligibility assessment 
documented in the participant’s medical record and/or research chart. To be eligible for 
registration to the protocol, the participant must meet all inclusion and exclusion 
criterion as described in the protocol and reflected on the eligibility checklist. 
 
 
 
 Fax the eligibility checklist(s) and all pages of the consent form(s) to the QACT at 617-632- 
2295. For Phase I protocols, attach participant dose level assignment confirmation from the 
sponsor. 
 
 
 
 The QACT Registrar will (a) review the eligibility checklist, (b) register the participant on the 
protocol, and (c) randomize the participant when applicable. 
 
 
 
 An email confirmation of the registration and/or randomization will be sent to the Overall PI, 
study coordinator(s) from the Lead Site, treating investigator and registering person 
immediately following the registration and/or randomization. 
 
 
5.63 During the study: 
 
 
If the study team does not receive data from the iThermonitor by the second day 
after study enrollment, study staff will follow-up (telephone call) with subjects to 
ensure that they are able to correctly set-up the device. We will encourage 
participants to continue to receive medical treatment and adhere to other 
management protocols as recommended by their physicians as usual. We will 
emphasize that the iThermonitor does not replace usual temperature monitoring 
protocols. 
 
 
Use the iThermonitor everyday to monitor the patient’s temperature continuously 
until final study closeout. 
 
 
Complete the event monitoring log every day. 
 
 
In the event of a hospital admission during the study period, the hospitalized subject 
will stop using the device. If the subject has contributed less than 50% of data (i.e. 
used the device for less than 7 days) prior to hospitalization, they will be dropped 
from the study and another subject will be recruited to make up the enrollment 

Protocol Version 1.8 15 April , 2016 
Page 16 
 
 
target. However, subjects who have contributed at least 50% of data prior to 
hospitalization will stop using the device but will be included in final analyses. 
 
5.64 Close out visit: 
 
  This visit will occur 2 weeks post-chemotherapy. If possible, subjects will schedule 
their final study visit at the enrollment visit. Study staff will also send an appointment 
reminder letter in the mail 3 days prior to the scheduled visit. They will also receive a 
reminder phone call to confirm the appointment a day before the final study visit. If 
participants would like, they can complete close-out surveys online via RedCap and 
return study devices during their next doctor visit or via a provided pre-paid FedEx 
envelope. 
 
Participants will: 
 
 
Complete all close-out surveys 
 
 
Return the provided iPad mini devices. 
 
 
Be instructed to continue their medical care as usual. 
 
5.65 Instrument administration 
 
All study questionnaires will be administered by research assistants. 
 
5.66 Intervention administration 
 
At enrollment, study staff will demonstrate how the device works to subjects. They 
will also be available to answer questions or help subjects troubleshoot their 
devices.  Subjects will receive user manuals to guide them for subsequent set-up 
and use.  (Appendices 1.4,) They will be encouraged to use the iThermonitor to 
monitor the patient’s body temperature continuously for the 2-weeks study period. 
 
5.67 Special Concerns 
 
One special concern in this study is that the intervention may increase the sensitivity 
of detection of fever which may prompt caregivers to alerts care providers and hence 
increase the reporting of fever. We will instruct caregivers to confirm out-of-range 
temperature alerts with standard thermometers before notifying their care providers. 
We will emphasize that this intervention does not replace their usual care protocols. 
 
5.68 Remuneration 
 
Each patient-caregiver dyad will receive a Partners-issued check of $100 after 
completing the final study visit and returning the study iPad mini. The check will be 
mailed at the end of the study. No additional remuneration or reimbursement will be 
provided. 
 
5.7 Adverse Reactions and their Management: 

Protocol Version 1.8 15 April , 2016 
Page 17 
 
 
There is minimal chance for adverse effects directly from this study. However, because the 
iThermonitor is attached to the skin a hydrogel dressing patch, we cannot rule out the 
possibility of a skin reaction to the adhesive surface of the device. After discharge from the 
hospital, we will instruct caregivers to continue monitoring patients as recommended by 
their care providers. While we do not expect the iThermonitor to fail, we will emphasize that 
caregivers are to continue all standard protocols care for each patient. 
 
5.71 Reporting Adverse or Unanticipated Events 
 
The Investigator will ensure that all adverse events AEs that occur during the study 
period are well documented and reported timely to the IRB. 
 
Documentation of AEs includes: date and time of onset and resolution of AE, 
intensity, frequency, seriousness, related interventions, and outcome. The 
Investigator will also evaluate the probability of a causal relationship of the AE to the 
study intervention as being: “definite, probable, possible, unlikely, or unrelated.” 
Intensity of adverse events will be graded as mild, moderate, or severe according to 
the following criteria: 
 
Mild: symptoms that are easily tolerated and transient in nature with minimal or no 
impairment of normal activity 
 
Moderate: symptoms that are poorly tolerated, are sustained, and interfere with 
normal activity 
 
Severe: symptoms that are incapacitating and render the subject unable to work or 
participate in many or all usual activities 
 
All AEs will be reported to the IRB according to the IRB’s requirements, regardless of 
causality. 
 
5.72 Anticipated Reactions 
 
We do not anticipate any adverse reaction consequent to participating in this study. This 
study is not invasive and does not prescribe medications nor recommend new treatment 
protocols. The iThermonitor only helps to timely detect the onset of out-of-range 
temperature.  Participants will be advised to contact their physicians if they experience 
any problems with their medications or medical illness 
 
5.73 Reaction Management 
 
Should an AE be encountered, the first step in the process, after any actions required 
for patient stabilization, will be to record the event on the adverse event reporting log 
and also notify the principal investigator.  The event will be classified base on the 
relatedness, severity and whether it is an anticipated or not. The AE will be reported 
and managed based on relatedness to the use of the iThermonitor, seriousness and 
whether it was anticipated or unanticipated.  The principal investigator will in turn 
notify the IRB and the subject’s physician.  All AEs will be monitored until resolution 

Protocol Version 1.8 15 April , 2016 
Page 18 
 
 
or until, in the investigator’s judgment, they are stable. If an emergency situation 
should occur, appropriate medical emergency measures should be taken to stabilize 
the subject. 
 
 
 
 
6.0 Statistical Analysis 
 
This study will be implemented as a  pilot study to evaluate the use feasibility of the iThermonitor 
as a clinical decision support tool for continuous temperature monitoring in a dyad of 25 pediatrics 
patients (aged 2-17yrs) on myelosuppressive therapies for acute leukemia and other childhood 
cancers at the MGH Cancer Center and their caregivers over a 2-week study period. 
 
6.1 Primary and secondary endpoints 
 
6.1a Primary outcome measurement: use feasibility of the iThermonitor will be assessed by 
ability of the device to successfully capture, transmit and display the patient’s body 
temperature data on the study iPad mini. To limit recall bias, subjects will be required to log 
(Appendix 5) the ability to view the temperature data on the iPad mini once a day for the entire 
duration of the study. The device will be deemed a feasible continuous temperature monitoring 
tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor 
their body temperature. A subject must be able to view temperature data on the provided iPad 
mini at least 80% of the time in the study to be considered successful. “Time in the study” here 
is defined as the number of days the subject spends in the study which is expected to be two 
weeks. 
 
6.1b Secondary outcomes: secondary outcomes which will be assessed at the end of the study 
include: 
 
i. 
Usability, acceptability and satisfaction with the iThermonitor.  This will be 
assessed by questionnaires specifically designed for this study. We will be 
assessing ease of use, acceptability, connection and use problems like the 
device falling off the skin, usefulness of out-of-range temperature alerts and 
adverse reactions. We will also assess to see if the device helps to build 
caregiver self-efficacy skills in caring for the patient. 
 
ii. 
Caregiver engagement with the iThermonitor. This will be assessed by time to 
first measurement and upload from the time of discharge and also by the 
frequency of logins to the iThermonitor app. 
 
iii. 
Caregiver anxiety will be assessed using the GAD-7 questionnaire. 
 
6.2 Sample size and statistical power or precision associated with the sample size: The 
length of time required to accrue an adequate number of subjects to the study should be 
indicated. 
 
We will be able to estimate a feasibility success rate of 80% to within a 95% confidence 
interval of +/- 16% with a sample size of 25 evaluable patients. This is in keeping with a 

Protocol Version 1.8 15 April , 2016 
Page 19 
 
 
recommendation of sample size of at least 24 subjects for feasibility studies.5 Therefore, 
a dyad of 25 pediatric patients and their caregivers will be enrolled in the study. Based on 
estimates from the Partners Healthcare Research Patient Data Registry, about 101 
pediatrics patients with hematologic malignancies alone were seen in 2013 at the MGH 
Cancer Center. We envisage that we would be able to accrue enough subjects over 12 
months after the enrollment of the first subject. 
 
6.3 Stratification factors and intervention allocation plan for randomized studies 
 
This is not a randomized trial and we will not be stratifying on any variable. 
 
6.4 Stratification factors and their impact on design 
 
None. 
 
6.5 Early stopping rules, if appropriate 
 
None. 
 
6.6 Unevaluable/ineligible participants 
 
Our aim is to evaluate how the device is used in home settings. Therefore, subjects who 
become hospitalized will stop using the device. If the hospitalized subject has contributed 
less than 50% of data (i.e. used the device for less than 7 days) prior to hospitalization, 
they will be dropped from the study and another subject will be recruited to make up the 
enrollment target. However, subjects who have contributed at least 50% of data prior to 
hospitalization will stop using the device but will be included in final analyses. We estimate 
that less than 20% of subjects enrolled in the study might be inevaluable. 
 
6.7 Analysis plan 
 
Data collected will be verified before analysis, which will be done with Data Analysis and 
Statistical Software: STATA, version 13 with an alpha of 0.05 set a priori. All participants will 
be followed up for two weeks and we will summarize their baseline demographic and 
technology use characteristics. 
 
To address the primary aim, the feasibility success rate will be calculated as the number of 
evaluable patients who meet the criteria for ‘success’ (per section 6.1)  divided by the total 
number of evaluable patients.  A 95% confidence interval will be calculated on this proportion. 
If the upper limit of the 95% confidence interval is less than 80%, then we will consider the 
iThermonitor not to be a feasible clinical decision support tool. 
 
Descriptive analyses will be performed on all baseline data. Endpoints for all study outcomes 
are defined in section 6.1 above. All continuous variables will be computed as means with 
standard deviations, median and ranges while categorical variables will be computed as 
frequency distributions and percentages. The binomial test of proportion will be used to our 
dichotomous outcome of successfully using the iThermonitor. Paired t-test will be used to 

Protocol Version 1.8 15 April , 2016 
Page 20 
 
 
analyze pre- and post- GAD-7 scores measured as a continuous variable.  All other outcome 
variables will be summarized with descriptive statistics. 
 
6.8 Handling of missing data in the analysis 
 
We have adopted simple data collection techniques to limit missing data for this trial.  Since 
this is largely exploratory work with descriptive statistics, a complete case analysis approach 
will be adopted for this study. . 
 
7.0 References 
 
1.  American Cancer Society. Cancer facts & figures 2014. Atlanta: American Cancer Society; 
2014. 
 
2.  Neuburger S, Maschmeyer G. Update on management of infections in cancer and stem cell 
transplant patients. Ann Hematol. 2006 Jun;85(6):345-56. 
 
3.  National Institute for Health Research. Feasibility studies, in NIHR NETSCC glossary. 
http://www.nets.nihr.ac.uk/glossary/feasibility-studies 
4.  Bowen, Deborah J., et al. "How we design feasibility studies." American journal of preventive 
medicine 36.5 (2009): 452-457. 
 
5.  Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat 
2005;4:287-291 

Protocol Version 1.8 15 April , 2016 
Page 21 
 
 
 
 
 
 
 
 
 
 
8.0 Appendices 
 
Appendix 1: Device 
 
1.1 
Premarket notification 501(k) summary 
 
1.2 
Biocompatibility statement 
 
1.3 
Device Technical specifications 
 
1.4 
Quick Manual for Parents 
 
 
 
 
Appendix 2: Provider contact 
 
2.1 
iTherm letter to oncologists 
 
2.2 
Enrollment notification 
 
 
 
 
Appendix 3: Parent contact 
 
3.1 
Parent Telephone Script 
 
3.2 
iThermonitor_appt_reminder 
 
3.3 
Parent Recruitment Letter 
 
 
 
 
Appendix 4: Study instruments 
 
4.1 
iThermonitor Closeout Survey 
 
4.2 
GAD-7 
 
4.3 
Enrollment survey 
 
 
 
 
Appendix 5: Inclusion Criteria 
 
5.1 
iTherm Eligibility Checklist 

Protocol Version 1.8 15 April, 2016 
Page 22 
 
 
5.2 
Daily Event Monitoring Log 
 
 
 
 
Appendix 6: Promotional Material 
 
6.0 
iThermonitor Informational Material 
 
6.1 
Partners Broadcast Ad 

 
 
Appendix Table of Contents 
 
Use Feasibility of the iThermonitor in Pediatric Patients on Myelosuppressive Therapies for 
Acute Leukemia and other Childhood Cancers 
 
 
 
Appendix 1: Device 
 
1.1 
Premarket notification 501(k) summary 
 
1.2 
Biocompatibility statement 
 
1.3 
Device Technical specifications 
 
1.4 
Quick Manual for Parents 
 
 
 
Appendix 2: Provider contact 
 
2.1 
iTherm letter to oncologists 
 
2.2 
Enrollment notification 
 
 
 
Appendix 3: Parent contact 
 
3.1 
Parent Phone Script 
 
3.2 
iThermonitor appt reminder 
 
3.3 
Parent Recruitment Letter 
 
 
 
Appendix 4: Study instruments 
 
4.1 
iThermonitor Closeout Survey 
 
4.2 
GAD‐7 
 
4.3 
Enrollment survey 
 
 
 
Appendix 5: Inclusion Criteria 
 
5.1 
iTherm Eligibility Checklist 
 
5.2 
Daily Event Monitoring 
 
 
 
Appendix 6: Informational Material 
 
6.0 
iThermonitor Informational Material 

   Premarket Notification 51 O(k) Submission  
Section  3 5 10 Summary  
 
3-1 
 
 
 
 
JUL   0 8  2014 
 
 
 
Section 3  510(k) Summary 
 
 
 
This 5 IO(k) Summary of SIO(k) safety and effectiveness  information  is being submitted  in accordance  with 
requirements ofSMDA 1990 and Title 21, CFR-Section 807.92. 
 
The assigned 510(k) Number:  K132761 
 
 
I.  Prepared Date: Aug. 26, 2013 
 
 
2. 
Sponsor Identification 
 
 
Raiing Medical Company 
21 Huoju St, Beijing, China 
 
 
Establishment Registration  Number: 30 I 0052175 
 
 
Mr. WuWei 
Title: General Engineer 
Email: tjww@raiing.com 
Tel: 86-10-64118658 
' 
Fax: 86-10-80115555  ext. 776445 
Raiing Medical Company 
21 Huoju St, Beijing, China 
 
 
3. 
Submission Correspondent 
 
 
Mr. Wu Wei 
Title: General Engineer 
Email: tjww@raiing.com 
Tel: 86-10-64118658 
Fax: 86-10-80115555  ext. 776445 
Raiing Medical Company 
21 Huoju St, Beijing, China 

3-2 
   Premarket ·Notification 51 O(k) Submission  
Section  3 510 Summary  
 
 
 
 
 
 
 
 
4. 
Proposed Device Identification 
 
 
PrOposed Device Name: Wireless Thermometer 
Proposed Device Common Name: Thermometer 
 
 
Regulatory Information: 
Classification Name: Clinical Electronic Thermometer; 
Classification:  II; 
Product Code: FLL; 
Regulation Number: 21 CFR 880.2910; 
Review Panel: General Hospital; 
 
Intended Use Statement: 
The Wireless Theimometer is/a  battery-operated  electronic  device  with intended  use of measuring  and 
· monitoring  human  armpit  temperaturcontinuously  via wireless  signal  transmission  of the measuring 
result.·This system is reusable and intended for armpit temperature  monitoring for persons over two years 
old. 
 
5. Predicate Device Identification 
 
 
510(k) Number: Kl21696 
Predicate Device Name: Wireless Thermometer WTM-BT30-l 
Manufacturer: Raling Medical Company 
 
 
 
6. 
Device Description 
 
 
The wireless thermometer,  WT701, which is the combination  device of thermometer and Bluetooth 
communication  unit intended to be worn at axilla.to m nitor  the annpit  temperature continuously. 
 
For the monitoring  operation,  switch  the thermometer  on and stick the thermometer  in the user's 
. 
1 
axilla. The thermometer  will  make a Bluetooth  connection  between  the thermometer  and the receiver 
 
·automatically  (User  should  setup  Bluetooth  properly  on  receiver).  Then  the  thermometer   starts  to 
measures the body temperature  by means of testing the NTC resistor's  resistance value and calculates the 
body temperature  every  4 seconds continuously  and sends the temperature  data to the receiver through 

3-3 
   Premarket Notification 51 O(k) Submission  
Section  3 510 Summary  
 
 
 
 
 
 
 
Bluetooth connection. 
 
 
The wireless thermometer  uses a CR2032  battery for operation.  When the battery is low, internal circuit 
will detect the low battery condition automatically and send "low battery" signal through Bluetooth 
communication  unit to receiver. 
 
 
 
7.    Non-Clinical Test Conclusion 
 
 
Non-clinical tests were conducted to verifY that the proposed device met all design specifications as was 
Substantially  Equivalent  (SE)  to the predicate  device.  The test· results demonstrated  that the proposed 
device complies with the following standards: 
 
IEC60601-1:2005   Medical  electrical  equipment   Part  1:  General   requirements   for  basic  safety  and 
essential performance 
IEC 60601-1-2:2007  Medical  electrical equipment-  Part 1-2: General  requirements  for basic safety and 
essential performance- Collateral standard: Electromagnetic compatibility-  Requirements and tests 
FCC Part 15 Subpart C test FCC Part 15.247 
ASTM   Elll2-00:  2006    Standard    Specification    for   Electronic    Thermometer    for   Intermittent 
Determination of Patient Temperature. 
EN 12470-4: 2000+AI:2009 Clinical  thermometers  Part-4: performance  of electrical thermomet-'rs  for 
 
continuous measurement. 
And the proposed device  also conducted  the performance  test, which  include  Dimension Test, Weight 
Test, and accuracy transmission test under a complex electromagnetic environment. 
 
 
 
8.    Substantially Equivalent (SE) Conclusion 
 
 
The  following  table compares the  DEVICE to  the  predicate device  with  respect to  intended use, 
technological  characteristics and principles of operation, etc. 
 
 
Table 3-1 Comparison of Technology Characteristics 
 
ITEM 
Proposed Device 
WT701 
Predicate Device 
K121696 
Product Code 
FLL 
FLL 
Regulation No. 
880.2910 
880.2910 
Class 
Class II 
Class II 

3-4 
   Premarket  Notification 510(k) Submission  
Section  3 510 Summary  
 
 
 
c 
 
 
- 
The    Wireless  Thermometer is    a 
The   Wireless 
 
 
Thennometer, model 
battery-operated  
electronic device  
WTM-B530-J,   is  a  battery-operated 
with  intended  use  of  measuring  and 
elected 
electronic device 
with 
monitoring human an"Il.pit  temperature intended 
use 
of 
measuring and 
continuously via 
wireless 
signal 
monitoring  human armpit temperature 
Intended Use 
transmission  of the measuring  result. continuously via wireless signal 
' 
This  system  is reusable  and  intended 
transmission  of the measuring result. 
for armpit temperature monitoring  f?r This    system     is 
reusable    and    is 
persons over two years old. 
intended for 
armpit 
temperature 
monitoring for persons over two years 
old. 
Display Unit Specification  
iOS device Display 
. LED and iOS device Display 
Working voltage  
DC3V 
DC3.7V 
Battery 
The button battery 3.0 V, 2 IOmAh 
Internal 3.7V, IOOmAh Li Battery 
Measurement range 
25 ·c-45 ·c 
,2s ·c-45 ·c 
Accuracy 
±o.o5 ·c(35 ·c-38.5 'CJ 
±O.I'C 
±O.I'C(25'C-34.99'C  and 
38.5I'C-45'C) 
Temperature unit 
·c or 'F  
·c or 'F 
Signal transmission 
 
Wireless 2.4G Bluetooth BLE 
Wireless 2.4G Bluetooth 3:0 
Receiver 
 iPhone 4S, iPhone 5, iPad(3rd 
iPod  touch  4,  iPhone  4,  iPhone  4S, 
generation), iPad(4th 
iPad, iPad 2, The new iPad 
generation), iPad mini, iPod 
touch(5th generation) 
Valid transmission distance 
Up to 5 meters 
Upto 5 meters 
. 
Operating Temperature! 
5'C-40 'C 
5'C-40. 'C 
Operating Humidity 
 15-85%  
 15-85% 
 
Based on the compafison and analysis abov,  the proposed device is determined  to be Substantially 
Equivalent (SE) to the predicate device. 

 
 
 
 
DEPARTMENT OF  IlEALTil & IIUMAN  SERVICES 
Public lleahh Scr\'iCc 
 
 
Food and Dntg Administration 
10903 New Hampshire Avenue 
Document Control Center- W066·G609 
Silver Spring. MD 20993-0002 
 
 
 
July 8. 2014 
 
 
Raiing Medical Company 
Mr. Wei Wu 
General Engineer 
No.I I   Huatong Rd 
Beijing 
CHINA 
 
 
 
Re: Kl32761 
Trade/Device Name:  Wireless Thermometer, Model WT70 I 
Regulation Number: 21 CFR 880.2910 
Regulation Name: Clinical electronic thermometer 
Regulatory Class: Class II 
Product Code: FLL 
Dated: June 3, 2014 
Received: June 6, 2014 
 
 
 
Dear Mr. Wu: 
 
We have reviewed your Section 51 O(k) premarket notification  of intent to market the device 
referenced above and have determined the device is substantially equivalent (for the indications 
for usc stated in the enclosure) to legally marketed predicate devices marketed in interstate 
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to 
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, 
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 
You may, therefore, market the device, subject to the geneml controls provisions of the Act. 
The general controls provisions of the Act include requirements for annual registration, listing of 
devices, good manufacturing practice, labeling, and prohibitions against misbranding and 
adulteration. Please note: CDRH does not evaluate information related to contract liability 
warranties. We remind you. however, that device labeling must be truthful and not misleading. 
 
If your device is classified (sec above) into either class II (Special Controls) or class Ill (PMA), it 
may be subject to additional controls.  Existing major regulations affecting your device can be 
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, fDA may 
publish lt1rthcr announcements concerning your device in the federal Register. 

 
 
Page 2- Mr. Wu 
 
 
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 
that FDA has made a determination that your device complies with other requirements of the Act 
or any Federal statutes and regulations administered by other Federal agencies. You must 
comply with all the Act's requirements, including, but not limited to: registration and listing (21 
CFR Part 807); labeling (21 CFR Part 80 I); medical device reporting (reporting of medical 
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 
product radiation control provisions (Sections 531-542 of the Act); 21 CFR I 000-1050. 
 
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801}, please 
contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 
or (30 I) 796-7100 or at its Internet address 
http://www.fda.gov/MedicaiDevices/ResourcesforYoullndustry/default.htm. Also, please note 
the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 
CFR Part 803), please go to 
http://www.fda.gov/MedicaiDevices/Safetv!ReportaProblem/default.htm for the CDRH's Office 
of Surveillance and Biometrics/Division ofPostmarket Surveillance. 
 
You may obtain other general information on your responsibilities under the Act from the 
Division oflndustry and Consumer Education at its toll-free number (800) 638-2041 or (301) 
796-7100 or at its Internet address 
http://www.fda.gov/MedicalDevices/ResourcesforYou!Jndustry/default.htm. 
 
Sincerely yours, 
 
MaryS. Runner -5 
 
Erin I. Keith, M.S. 
Director 
Division of Anesthesiology, General Hospital, 
Respiratory, Infection Control and Dental Devices 
Office of Device Evaluation 
Center for Devices and Radiological Health 
 
 
 
Enclosure 

 
 
DEPARTMENT OF HEALTH AND HUMAN SERVICES 
Food and Drug Administration 
Indications for Use 
Form Approved: OMB No. 0910.0120 
Expiration Date: January 31, 2017 
See PRA Statement below. 
 
510(k) Number (if known) 
KJ32761 
 
Device Name 
Wireless Thermometer, Model WT701 
 
 
 
Indications for Use (Describo) 
The Wireless Thermometer  is a battery-operated electronic device with intended use of measuring 
and monitoring human annpit temperature continuously via wireless signal transmission of the measuring 
result. This system is reusable and intended for armpit temperature monitoring for persons over two years 
old. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Type of Use (Select one or both, as applicable) 
D Prescliption Use (Part 21 CFR 801 Subpart D) 
l:8l  Over-The-Counter Use (21 CFR 801 Subpart C) 
PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON A SEPARATE PAGE IF NEEDED. 
FOR FDA USE ONLY 
Concurrence of Center tor Devices and RadiologicalHealth (CDRH) (Signatural 
 
Digitally signed by Richard C. Chapman -S 
Date: 2014.07.08 11:26:01 -04'00' 
 
 
This section appnes only to requirements of the Paperworl< Reduction  Act of 1995. 
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* 
The burden time for this collection of information is estimated to average 79 hours per response, including the 
time to review instructions. search existing data sources, gather and maintain the data needed and complete 
and review the collection of information. Send comments regarding this burden estimate or any other aspect 
of this information collection, including suggestions for reducing this burden, to: 
Department of Health and Human Services 
Food and Drug Administration 
Office of Chief Information Officer 
Paperworl< Reduction Act (PRA) Staff 
PRAStaff@fda.hhs.gov 
"An agency may not conduct or sponsor, and a person is not requirad to raspond to. a collection of 
information unless It displays a currently valid OMB number.• 
 
 
FORM FDA 3881(1114)                                                  Page 1 of 1 

 
 
Premarket Notification 510(k) Submission 
Exhibit #8 Biocompatibility 
  
Statement  
 
 
 
 
 
 
 
 
 
 
 
Exhibit #8 Biocompatibility Statement 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
E8- 1 

 
 
Premarket Notification 51 O(k) Submission     C\hibit #8 Biocompaubilit) 
                                                                            Statement                                                                               
 
 
 
Biocompatibility Statement 
 
 
 
The  material of Double coated medical tape and  Shell, is identical to that 
of  the  wireless thermometer as  it was  approved in  k 121696 in Oct.   II, 
2012,  in formulation, and  processing, and  no other  chemicals have  been 
added   (e.g.,   plasticizers,  filers,   color   additives,  cleaning  agents,  mold 
release  agents, etc.). 
 
 
 
 
 
 
 
 
 
Authorized Signature 
 
Wu Wei 
 
General  Engineer 
 
Raiing  Medical  Company 
 
Aug. 26, 20 13 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 .8-1 

 
 
 
 Premarket Notification 510(k) Submission    Section 9 Biocompatibility  
 
 
 
 
 
Section 9 
Biocompatibility 
 
 
 
1.    Patient--Contact Material Identification 
 
 
The patient--contact components and materials are presented as follows: 
 
 
Table 9--1 Patient Contact Material Identification 
 
Components 
Material 
Contact Level 
Contact Duration 
Double coated 
medical tape 
Medical Tape 
Surface 
Short--term (<24h) 
Shell 
ABS 
Surface 
Short--term (<24h) 
 
NOTE:  The  contact  level  and  contact  duration  are  determined  according  to  Annex  A  of  ISO 
10993--1:2009 Biological evaluation of medical devices — Part 1 Evaluation and testing within a risk 
management process. 
 
2.    Biocompatibility 
 
The patient contact material(s) of the proposed device as identified is(are) identical device to that(those) 
of the legally marketed device, wireless thermometer , as cleared in K121696 at date Oct. 11, 2012. 
Biocompatibility Statement is provided in Exhibit #8 Biocompatibility Statement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
9--1 

 
 
3M Health Care 
3M Center 
Skin and Wound Care Division 
St. Paul, Minnesota  55144-1000 
651-733-1110 
 
 
 
 1 
 
 
 
May 23, 2012 
 
 
Dear Valued 3M Customer: 
 
This letter is in response to your request for composition information on the products listed below. 
You requested information regarding the following 3M products: 
3M™ Spunlace Nonwoven Tape 2476 and 2476P 
 
3M Skin and Wound Care Division does not add animal derived materials or tissues to these products 
during manufacture. We are not aware that the suppliers for the ingredients used to make these products 
add or use animal derived materials or tissues during their operations. Since the products do not contain 
any animal derived material they are compliant with US and EU regulations for Bovine Spongiform 
Encephalopathy (BSE) or Transmissible Spongiform Encephalopathy (TSE) control. 
 
This information was prepared based on the best knowledge and understanding of the Skin and Wound 
Care Division and, in part, on other information provided by 3M suppliers. 
 
In the event any product listed above is proven not to conform with 3M's certification, then to the extent 
permitted by law, 3M's entire liability and Buyer's exclusive remedy, will be at 3M's option either: (i) 
replacement of Product with a conforming product, or (ii) refund of the purchase price paid by Buyer for 
each non-conforming Product, within a reasonable time after written notification of said non-conformance 
and return of said Product to 3M.   3M shall not under any circumstances be liable for direct, incidental, 
special, or consequential damages (including but not limited to loss of profits, revenue, or business) related 
to or arising out of this certification, including, the use, misuse or inability to use the Product. Unless stated 
otherwise in writing, the foregoing language cannot be waived, modified, or supplemented in any manner 
whatsoever. 
 
If you have other related questions or need further information you may contact me at 651-733-0257. 
Sincerely, 
 
 
Tammy Johnson 
3M Skin and Wound Care Division 
Product Responsibility 
3M Company 
3M Center, Bldg. 275-5W-06 
St. Paul, MN., 55144-1000 
e-mail: tljohnson1@mmm.com 

 
 
 
 
 
 
Preliminary Technical Information Sheet 
Product Number #2476P [formerly MSX-6935B] 
3MTM  Single Coated Nonwoven Medical Silicone Adhesive Tape on Premium Liner 
Effective:   March 2013 
Supersedes all previous versions 
 
Proposed Features and Benefits: 
- 
Hypoallergenic Silicone Pressure Sensitive Adhesive   - 
No Natural Rubber Latex 
- 
Flexible, Conformable  
- 
EtO Sterilization Compatible Only 
- 
Excellent Initial Skin Adhesion 
- 
Premium Clear Polypropylene Liner 
 
Current Composition: 
Tape Caliper 
14.6 mil [0.37 mm] single-coated Film Tape on Clear Polyester Liner 
Backing 
10.6 mil [0.27 mm] White Polyester Spunlace Nonwoven/Film Laminate 
Adhesive 
4 mil [0.10 mm] Medical Grade Gentle 3M Silicone Adhesive 
Release Liner 
3.5 mil [0.09mm] Clear Polypropylene Film, one side Fluoropolymer Release 
 
Preliminary Properties+: 
Adhesion to Stainless Steel, 180q Peel 
4.5 oz/inch [128 gms/25.4 mm] [1.25 N/25.4 mm] 
Typical Liner Release, 180q Peel 
10 gm/inch width [10 gms/25.4 mm width] 
Moisture Vapor Transmission Rate, MVTR 800 gms/sq m/24hrs 
+ 3M test methods are available upon request. 
1 Preliminary results based on limited run data.  Subject to change. 
 
Proposed Roll Description: Tape supplied on 3 inch (76 mm) diameter cores. 
Length, Maximum 
100 yds [91.4 meters] 
Width, Maximum 
12 inches (30.5 cm) 
 
 
Packaging and Recommended Storage: 
Product as supplied in original packaging will maintain stated properties for a period of two years 
from date stamped on shipping container when stored at temperatures of 50-80qF (10-27qC) and 
relative humidity between 40-60 percent. 
 
 
Note: Product should be stored in the original packaging out of direct sunlight or high-intensity 
indoor lighting. 
 
 
 
 
 
 
Please see reverse side for important product, safety and warranty information. 
 
 
 
 
© 3M 2013 All Rights Reserved 

 
 
Product and Safety Information: User is solely responsible for determining the suitability of 3M samples and products for the intended use including any 
necessary safety or toxicity assessment. 3M will provide Material Safety Data Sheets and results of toxicity testing upon request. In every case before using any 
product in full scale production users should conduct their own tests to determine to their own satisfaction whether the product is of acceptable quality and is 
suitable for their particular purposes under their own operating conditions. 
Notice: Nothing contained herein shall be construed to imply the nonexistence of any relevant patents or to constitute a permission, inducement or 
recommendations to practice any invention covered by any patent, without authority from the owners of this patent. 
 
Warranty Information 
All statements, technical information and recommendations herein are based on tests 3M believes to be reliable, but the accuracy or completeness thereof is not 
guaranteed. 3M warrants only that products will meet 3M’s specifications at the time of shipment to the customer. 3M does not offer any other warranty and does 
not warrant the performance, safety or such other characteristics of Products in combination with other materials. 3M specifically DOES NOT warrant Products 
for any intended or unintended uses (whether or not foreseeable); for compatibility or suitability with other components or compatibility with any methods of 
manufacture or conversion. The foregoing warranty is made in lieu of all other warranties, expressed or implied, including the implied warranties of 
merchantability, fitness for a particular purpose and freedom from non-infringement. 
 
Limitation of Remedies: If products are proven not to meet 3M’s specifications, the sole and exclusive remedy available and 3M’s only obligation shall be, at 
3M’s option, to replace such quantity of Products which are proven out of specification or to refund the purchase price paid for Products. 
 
Limitations of Liabilities: The remedies provided herein are exclusive remedies against 3M for any alleged or actual nonconformance to specifications or defect 
or other failure in products or for 3M’s performance of its supply obligations. Under no circumstances is 3M liable for any direct, indirect, incidental, special or 
consequential damages (including lost profits) in any way related to the product under any theory of law including, but not limited to, negligence and strict 
liability. 
Ordering Information 
Call us at Customer Service to place an order: 800-742-1994 (U.S.). Visit our website: www.3M.com/medicalspecialties for product and 
services information, news about conferences we will be attending, new product highlights or to make a direct inquiry. 
To have a sales representative contact you, to request samples or clinical and safety summaries, please contact us at 3M HELPLINE 800-228- 
3957 (U.S.) or for international inquiries, please contact your local country representative.  Our 3M Medical Specialties subsidiary contacts are 
listed below. 
International Locations 
 
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Tel: +41 44 724 92 44 
Fax: +41 44 724 94 80 
 
 
 
  
3M Medical Specialties 
 
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Tel: 886-2-2704-9011 
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Tel: 9 (0212) 3507777 
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Tel: +380 44 490 57 77 
Fax: +380 44 490 57 75 
 
United Kingdom & Ireland 
3M Health Care Ltd. 
Tel: 44-1509-611-611 
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Venezuela 
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Tel: 58-241-8391911 
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Viet Nam 
3M Viet Nam Ltd. 
Tel:  84 8 640986 
Fax: 84 8 641024 
Tel:  45-43-48-0100 
Fax: 45-43-96-8596 
Tel: +39 2 7035-2406 
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Tel: (632) 8133781 to 95 
Fax: (632) 8145873 to 74 
3M Center, Building 275-5W-05 
St. Paul, MN 55144-1000 USA 
Tel.: 800 228-3957 

 
 
 
 
 
 
 
 
TECHNICAL SPECIFICATIONS 
 
 
Product name 
Wireless Thermometer 
Valid transmission distance 
Up to 5 meters 
 
Model 
WT701 
Temperature unit 
·c or 'F 
 
Size 
51.9mmx31.6mmx6.5mm 
Measurement range 
25'(-45'( 
 
Weight 
6g (without battery) 
 
Battery 
CR2025 
Accuracy 
±O.OS'C (35'C-38SC) 
±O.l"C (25'C-34.99' C and 38.51' C-45'C) 
 
Receiver 
iPhone 4s+,iPad 3+, 
iPad mini+,iPad Air,iPod touch 5+ 
Android Devices 
(with 4.3+ system and Bluetooth 4.0;for more details 
about Android support,please see our website} 
 
Battery life 
120 days a t 8 hours per day 
Note: frequent synchronization of data 
may deplete power more quickly 
 
Operating conditions 
Temperature: s·c - 40'C 
Humidity:15% - 85% 
Barometric pressure: 86kPa - 106kPa 

Appendix 1.4 User Manual – to be sent home with subjects 
 
 
 
 
 

Appendix 1.4 User Manual – to be sent home with subjects 
 
 
 
 
 iThermonitor Instruction Guide  
 
Preparation of the iThermonitor  
 
 Remove the cover of the patch. The patch is the sticky adhesive. 
  Face the temperature sensor up and stick the other side with the button to 
the patch. Make sure the device is in the center of the sticker. 
 The iThermonitor should be aligned vertically with the patch 
 
 
 
 
 
Sensor facing up 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Wearing the iThermonitor  
 
 Lift the child’s arm naturally. 
 Paste the device facing vertically into the armpit. Try to get the device as 
close to the most inner part of the armpit. 
 Make sure that the device is laying flat and smooth against the skin 

Appendix 1.4 User Manual – to be sent home with subjects 
 
 
 
 
 
 
 
 
within 10 feet 
 
 
 
 
 
 
 
 
 
 If the connection is lost, the sensor will continue recording and storing 
temperature data for maximum 10 days. The data will be automatically 
synced with iPad once the connection is back. 
 
Changing the battery 
 
Your device will come with a battery installed. This battery should last throughout 
the two‐week study. If you believe the battery has died, please follow the 
instructions below to install the replacement battery, which was given to you at 
enrollment. 
 
 Use the battery tool and rotate clockwise to open. 
 Remove the old battery. 
 Insert the new battery (+) side up. 
 Replace battery cover and rotate counterclockwise to close. 
 
 

Appendix 1.4 User Manual – to be sent home with subjects 
 
 
 
 
 
 
 
 
+ side up 
 
 
 
 
 
 
 
 
 
If you want to download on your own iOS device, please use the following link: 
 
http://doc.raiing.com/enterprise/mgh.html 
 
 
 
 
Using and maintaining the iThermonitor 
 
 Charge the iPad regularly and keep the iThermonitor app open. Do not log 
out of the app. 
 
 Make sure the Bluetooth is in the on position. 
 
• If you have a Wi‐Fi connection in your home, connect the iPad to the 
Wi‐Fi to allow the iThermonitor to sync for data collection. 
 
 DO NOT change settings of the iPad or the iThermonitor app. 
 
 DO NOT get the iThermonitor wet (shower, bath swimming, etc). 
 
 DO NOT wear the iThermonitor at one side for more than 24 consecutive 
hours. Change sides everyday to wear it for continuous monitoring. 
 
 If your child feels unwell (uncomfortable or allergic) when using the patch, 
replace it with another type of adhesive dressing based on your doctor’s 
advice. A fully‐covered patch larger than 76mm×62mm should be used. 
 
 Do not reuse the patches. If a patch is already folded over, a new patch is 
required. 

Appendix 1.4 User Manual – to be sent home with subjects 
 
 
 
 
 Shave armpits in advance. Make sure the area of skin in contact with the 
patch is flat and smooth. 
 
 For the most accurate results, make sure the iThermonitor has been at 
room temperature for at least 5 minutes before using it. 

Appendix 1.4 User Manual- to be sent home with subjects 
 
 
 

Appendix 1.4 User Manual- to be sent home with subjects 
 
 
 

Appendix 2.1: Letter to oncologists requesting patient referrals 
 
 
 
 
Dear Dr.  
, 
I am writing to share details about an upcoming study being conducted by Partners Healthcare Connected 
Health Innovation, a research division of Massachusetts General Hospital, in collaboration with the MGH 
Cancer Center and the Dana Farber Cancer Institute’s Pediatric Oncology department. Stephen Agboola, MD, 
MPH is the PI on this project. The primary aim of this study (DFCI Protocol 14‐485) is to assess the feasibility 
of the iThermonitor device as a clinical support tool in the management of pediatric patients undergoing 
myelosuppressive therapies. The iThermonitor is an electronic device that continuously measures the 
wearer’s body temperature. It is secured to the skin via hydrogel dressing. Full technical details of the device 
and its functionality are included below. 
 
A total of 25 dyads will be enrolled in this study. Dyads will include one pediatric cancer patient and his/her 
caregiver. The caregiver will be asked to use the iThermonitor device for a period of 2 weeks to monitor the 
child’s body temperature. Upon registering and creating an account on the iThermonitor mobile application, 
the device will be paired with a wirelessly enabled iPad Mini or Smartphone receiver which should be within 
3 meters of each other. Upper and lower temperature limits can be set on the device to alert users when 
temperatures are outside of pre‐set range. However, for this study, the range will be fixed at less than or 
equal to 96 and greater than or equal to 100 as recommended by the pediatric oncology team at MGH. If you 
would like to review a more detailed description of the protocol, please let me know and I’ll be happy to 
share that with you. 
 
There will be 2 study visits (enrollment and closeout) and patient/caregiver dyads will receive a total of $100 
for their participation. The eligibility criteria are as follows: 
‐ 
Pediatric patient Aged 2‐ 17 years 
‐ 
English speaking patient/caregiver (18 yrs or older) 
‐ 
Undergoing myelosuppressive therapies for acute leukemia or other childhood cancers. 
‐ 
If applicable, willingness of the patient to shave axillary (armpit) hair. 
We are excluding patients who may have: 
a history of allergy to hydrogel dressing or ongoing skin diseases, patients with ongoing febrile illness or 
documented infectious disease. We are contacting you to request your help identifying and referring eligible 
patients for this study. Upon physician approval, study staff will approach parents or legal guardians of 
eligible patients about recruiting them and their children for this study. Participation in this study will not 
interfere with their treatments nor does it preclude participation in other research studies. 
Please let me know if you have any questions. 
Thank you for your consideration. 
 
Stephen Agboola, MD, MPH 
Principal Investigator 
Center for Connected Health, 
25 New Chardon St., Suite 300 
Boston, MA 02114 
Phone: 617.643.0291 
SAgboola@partners.org 
 
Lisa Diller, MD 
Principal Investigator 
Dana Building, Dana Farber Cancer Institute 
44 Binney St. 
Boston, MA 02115 
617.632.5642 
LDiller@partners.org 

Appendix 2.2: Enrollment notification letter to provider 
 
 
 
 
 
 
 
 
 
Dear Colleague, 
 
I am writing to inform you that your patient  name, DOB, is now participating in the 
iThermonitor device study. Your patient’s caregiver consented on behalf of patient name 
to enroll in a research study being conducted by the Partners Center for Connected 
Health, a research division of Massachusetts General Hospital. 
 
The 2-week study is a use feasibility pilot of the iThermonitor device, which 
continuously measures body temperature. During your patient’s enrollment in this study, 
s/he will wear this device and his/her consenting caregiver will be able to use the device 
to detect fever in the child. 
 
This study does not interfere with your patient’s medical care, and s/he should continue 
to receive usual medical care throughout the study. 
 
If you have any new information that may jeopardize your patient’s clinical condition due 
to his/her continued participation in this trial, please do not hesitate to share your 
concerns with me. 
 
If you would like additional information about this study, please call or email me at 617- 
643-0291 or SAgboola@mgh.harvard.edu 
 
Thank you. 
 
Stephen Agboola, MD, MPH 
Principal Investigator 
Center for Connected Health, 
25 New Chardon St., Suite 300 
Boston, MA 02114 
 
Phone: 617.643.0291 
SAgboola@partners.org 

Appendix 3.1: Parent phone script 
 
 
 
 
Screener’s Name_  
 
Date:  
 
 
Section 1: Introduction 
 
Hello, my name is  
, and I am calling from Partners Connected Health Innovation/Massachusetts 
General Hospital. May I speak with Mr./Mrs./Miss  
_? 
 
[If the person is unavailable, ask for a good time to call back and or leave a name and number for them 
to call you.] 
 
[If the person is available to speak] 
 
We are conducting a study to assess the use of a monitoring device, the iThermonitor, as a tool for 
parents caring for kids undergoing myelosuppressive therapies. We believe your child may be an eligible 
candidate for this study and I would like to tell you about the study. 
 
The iThermonitor device is a thermometer that, when worn on the skin, can measure body temperature 
continuously. The device takes the wearer’s temperature every 4 seconds and uploads this data to a 
mobile application on a smart device – like a smartphone. The device can then alert parents when a 
child’s temperature goes above a certain limit or below a certain limit. The visit involves 2 study visits at 
the MGH or DFCI. The study lasts for 2‐weeks and during this time, we’ll ask your child to wear the 
iThermonitor device every day. You could receive up to $100 for your participation in the study. 
 
Would you like to hear more about this study? 
 
[If No]: Okay, thank you for speaking with me today. Have a nice day. 
[If Yes]: Great, l’d be happy to tell you a little more about the study. 
Section 2: Study Description 
So during our first visit, we’ll first review the consent form together. The consent form is a really 
important document that will explain all of the study details to you. If, after reviewing this consent form, 
you want to participate in this study, we’ll sign the consent form together and that will officially begin 
your participation in this study. 
 
Once the consent form has been signed, we’ll have you fill out a couple surveys; then, the research 
assistant will give you the iThermonitor device and show you how it works. If you have a smartphone, 
we’ll show you how to download the iThermonitor app so you can receive alerts from the device. If you 
do not have a smartphone, you can use a study‐issued iPad mini during your child’s enrollment in this 
study. 
 
During the study, we’ll ask you to have your child wear the iThermonitor device daily. You should change 
the location of the device every day. So you can take it off to give your child a bath and then put the 
device back on. Anytime your child is wearing the device, the device will be checking your child’s 

Appendix 3.1: Parent phone script 
 
 
 
 
temperature. The app will alert you when your child has a fever and when his/her temperature is too 
low. 
 
We’ll ask you to have your child wear the device for 2‐weeks. At the end of this time, we’ll have you 
come back into MGH or DFCI for a close‐out visit. During this visit, we’ll ask you to fill out some surveys 
about how you liked using the device. At the end of the study you’ll receive a $100 check for your 
participation in the study. If you’ve been using a study‐issued iPad mini, you’ll be asked to return this 
device and the iThermonitor before your check can be issued. 
 
Please note we will have to ask for your social security number or tax ID number in order to issue the 
$100 check. 
 
Before we continue do you have any questions? [Answer any questions] 
 
Are you interested in participating in the study? 
 
[If No]: Okay, thank you for your time. 
 
[If Yes]: Great, when would you be available to meet? 
Do you have any final questions? [Answer questions] 
Thank you for taking the time to speak with me and for your interest in this study. I look forward to 
meeting with you on [Date, time, location]. Have a nice day. 

Appendix 3.2: Appointment reminder letter to parents 
 
 
 
 
 
 
 
[Date] 
 
 
 
 
Dear   
, 
 
Thank you for your participation in the iThermonitor study. This is a friendly reminder that your final 
study visit is scheduled for the following time: 
 
Date:   
 
Time:   
 
 
Location:   
 
   
 
Take along: smartphone/provided iPad Mini 
 
At this study visit, we’ll ask you to complete some surveys about your experience using the iThermonitor 
device. You will receive a $100 check for completing the study. If you have been using a study‐provided 
iPod Touch, you will only receive this check upon returning the iPod Touch. 
 
Please feel free to contact us with any questions or concerns at [###‐###‐####]. We look forward to 
seeing you! 
 
Best Regards 
 
 
 
 
Study Staff 
iThermonitor Study 

 
 
Appendix 3a: Recruitment Letter to Patient 
 
Date 
 
 
Dear [Parent Name], 
 
 
We are contacting you because your child, [CHILD NAME], is currently undergoing chemotherapy. This 
letter is to tell you about a research study being conducted by Partners Connected Health Innovation, a 
research division of Partners HealthCare and Massachusetts General Hospital. This research study is being 
conducted at the MGH Pediatric Oncology department as well as the Dana Farber Cancer Institute’s 
Pediatric Oncology department. The Principle Investigator on this study is Stephen Agboola, MD, MPH. I 
think this study may be of interest to you. 
 
 
The goal of the study is to assess the use of a monitoring device, the iThermonitor, as a tool for parents 
caring for kids undergoing myelosuppressive therapies. The iThermonitor device is a thermometer that, 
when worn on the skin, can measure body temperature continuously. The device can then alert parents when 
a child’s temperature goes outside of a set temperature range. We hope to show that the iThermonitor device 
is successful in a home setting at continuously monitoring your child’s temperature. 
 
 
The study involves 2 study visits at your child’s pediatric oncology clinic at the Massachusetts General 
Hospital or Dana Farber Cancer Institute. The visits will last no longer than 1-hour. The study lasts for 2- 
weeks and during this time, we’ll ask your child to wear the iThermonitor device every day. You could 
receive up to $100 (Partners-issued check) for your participation in the study. 
 
 
Taking part in this research study completely is voluntary and you can end your participation when you so 
desire. 
 
 
The study phone number is ###-###-####. Please call this number if you have any questions about the 
study. The line is open Monday-Friday 9am-5pm. You can also call this number to tell us if you are not 
interested in participating in this study. If we do not hear from you after one week of sending this letter, a 
member of our research team will attempt to contact you by phone to tell you more about the study and 
answer any questions you may have. We look forward to speaking with you soon. 
Thank you for your consideration. 
Sincerely, 
 
Your MGH/DFCI provider 

Appendix 4.1 
iThermonitor Closeout Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Closeout Survey April 2 
, 2015. 
Page 1 of 5 
 
 
 
 
 
Thank you participating in the iThermonitor study. Please answer the following 
questions about your experience using the device to monitor your child’s 
temperature. 
 
 
 
1.  The following are statements about your experience using the iThermonitor. 
Please rate how much the following statements concerning the iThermonitor 
are true for you. (Please circle the number of your answer): 
 
 
 
Definitely 
NOT true 
A little 
bit 
true 
 
Mostly 
true 
 
Definitely 
true 
 
1) 
Overall, I am satisfied with how easy it 
was to use the device 
1 
2 
3 
4 
 
2) 
It was easy learning to use the device 
1 
2 
3 
4 
 
3) 
I felt comfortable using the device 
1 
2 
3 
4 
 
4) 
I was able to easily monitor my child’s 
temperature by using this device 
1 
2 
3 
4 
 
5) 
I feel more confident monitoring my 
child’s temperature by using the device 
1 
2 
3 
4 
 
6) 
The device was helpful in starting 
discussions about my child’s health 
with my doctor 
 
7) 
Using the device makes me feel more 
connected to my care team 
 
8) 
I found the mobile application very 
useful in monitoring my child’s 
temperature 
 
9) 
I found the out-of-range temperature 
alert function very useful when my 
child’s temperature was out of range 
1 
2 
3 
4 
 
 
 
1 
2 
3 
4 
 
 
 
1 
2 
3 
4 
 
 
 
 
1 
2 
3 
4 
 
10) I would recommend iThermonitor to a 
friend or family member 
1 
2 
3 
4 
 
11) The iThermonitor stayed on my child’s 
body for most days during the study. 
Yes 
No 

Appendix 4.1 
iThermonitor Closeout Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Closeout Survey April 2 
, 2015. 
Page 2 of 5 
 
 
 
 
 
12) I was able to view my child’s 
temperature data on the provided iPad 
mini for most days during the study. 
 
 
Yes 
No 
 
 
 
2.  Did you view your child’s temperature on the iThermonitor app? 
(Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
 
3.  Did you use another device other than the provided iPad mini to monitor 
your child’s temperature? (Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
 
 
4.  How often did you view the measurements? (Please circle one of these 
options) 
a.  Hourly 
b. 2-hourly 
c. 4-hourly 
d.  Daily 
e.  2-3 times per week 
f. Once a week 
g.  never 
h.  other:                                    
 
5. Was viewing measurements on the app useful in being able to better manage 
your child’s health? (Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
6. Did viewing measurements on the app help you become more  interested in 
your child’s health? (Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 

Appendix 4.1 
iThermonitor Closeout Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Closeout Survey April 2 
, 2015. 
Page 3 of 5 
 
 
 
 
 
 
7. Did you discuss the iThermonitor device with others? 
(Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
 
 
 
 
 
8. Did you discuss the iThermonitor device with your doctor? 
(Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
 
9. If you were given the choice would you like to continue using the iThermonitor 
device to monitor your child’s health? 
(Please circle one of these options) 
a. Yes 
b. No 
c. Prefer not to answer 
 
 
10. If the iThermonitor were for sale in a store, would you buy it? 
(Please circle all that apply) 
a. Yes, for my child. 
b. No 
c. Prefer not to answer 
d. Yes, for someone else (please tell us who):   
 

Appendix 4.1 
iThermonitor Closeout Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Closeout Survey April 2 
, 2015. 
Page 4 of 5 
 
 
 
 
 
11. How much do you like the components of the iThermonitor system below? 
(Please circle the number of your answer) 
 
Not at 
all 
A little 
bit 
I like it 
Very 
much 
 
 
a)  Continuous temperature monitoring 
0 
1 
2 
3 
 
 
b)  Viewing measurements on the app 
0 
1 
2 
3 
 
 
c)  Alerts when measurements are out of 
range 
0 
1 
2 
3 
 
 
 
d)  Other (please specify): 
 
0 
1 
2 
3 
 
 
 
 
12. Did you experience problems using the iThermonitor? 
(Please circle one of these options) 
a. Yes 
b. No* 
c. Prefer not to answer * 
*[If No or “Prefer not to answer”, skip to question 14] 
 
 
 
13. What problems did you experience? 
(Please circle all that apply) 
a. Problems keeping the device on my child’s body 
b. Problems linking the device with my smartphones 
c. Problems with the iThermonitor battery 
d. Problems setting out-of-range temperature alerts 
e. Other problems:   
 

Appendix 4.1 
iThermonitor Closeout Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Closeout Survey April 2 
, 2015. 
Page 5 of 5 
 
 
 
 
 
14. Please explain in detail the nature of the problem(s) you experienced as 
marked above: 
 
 
 
 
 
 
 
 
 
 
15. What else would you want added to the iThermonitor system to help to you 
better monitor your child’s health? 
 
 
 
 
 
 
 
 
 
 
16. Did the iThermonitor alert you when your child’s temperature was of out-of- 
range during the study period? 
a)  Yes 
b) No 
c)  Prefer not to answer 
 
*[If No or “Prefer not to answer”, skip to question 17] 
 
17. How many times did the iThermonitor detect out-of-range temperatures? (If 
multiple times, please indicate number) 
a)  Once 
b)  Twice 
c)  3  times 
d)  Other:   
times 
 
18. We understand that this questionnaire may not fully capture your 
experiences participating in this study.  Would you be interested in speaking with 
a research staff about your experiences in this research study? 
a)  Yes 
b)  No 
 
Your answers are important to us. Please take a moment to check that you have 
answered all of the questions. Thank you for taking the time to complete this 
questionnaire! 

 
 
Appendix 4.2 GAD-7 
 
 
Subject  ID: 
  
 
Visit: 
  
 
Date: 
  
 
 
 
GAD-7 
 
 
Over the last 2 weeks,how often have you  
Not 
Several 
More than 
Nearly 
been bothered by the following problems? 
at all  
days 
 
(Use "I/' to indicate your answer) 
hal f the 
days 
every day 
 
 
1. Feeling nervous,anxious or on edge  
0  
2 
3 
 
 
2.  Not being able to stop or control worrying 
0  
2 
3 
 
 
3. Worrying too much about different things 
0  
2 
3 
 
 
4. Trouble relaxing 
0 
2 
3 
 
 
5. Being so restless that it is hard to sit still 
0  
2 
3 
 
 
6. Becoming easily annoyed or irritable 
0  
2 
3 
 
 
7. Feeling afraid as if something awful  
0 
2 
3 
might happen 
 
 
(For office coding: Total Score T  
= 
+ 
+ _) 
 
 
 
 
 
 
 
 
 
Developed by Drs.Robert L. Spitzer. Janet B.W. Williams, Kurt Kroenke and colleagues,with an 
educationalgrant from Pfizer Inc. No permission required to reproduce,translate, display or 
distribute. 

iThermonitor Enrollment Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Enrollment survey V1 November 6, 2014 
 
 
 
There are three sections in this form – A, B and C. Section A contains questions 
about your child. Sections B and C contains questions for the caregiver. 
 
 
 
 
Section A: Child-specific information 
 
Please answer the following questions about your child. 
 
 
1. 
What is your child’s age?    
(Years) or   
(Months) 
 
2. 
What is your child’s gender? 
(Circle the number of your answer.) 
 
1 
Male 
 
2 
Female 
 
 
3. 
Is your child Hispanic or Latino? 
(Circle the number of your answer.) 
 
1 
Yes 
 
2 
No 
 
 
4. 
Which one or more of the following would you say is your child’s race? 
(Circle the number of your answers, more than one may apply.) 
 
1 
American Indian or Alaska Native 
 
2 
Asian 
 
3 
Black or African American 
 
4 
Native Hawaiian or other Pacific Islander 
 
5 
White 
 
6 
Other, please specify:    
 
 
 
Section B: Caregiver-specific information 
 
Please answer the following questions about yourself. 
 
 
1. 
What is your age?    
 (Write in number of years.) 
 
2. 
What is your gender? 
(Circle the number of your answer.) 
 
1 
Male 
 
2 
Female 
 
 
3. 
What is your marital status? 
(Circle the number of your answer.) 

iThermonitor Enrollment Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Enrollment survey V1 November 6, 2014 
 
 
 
1 
Married 
 
2 
Living with partner 
 
3 
Divorced or separated 
 
4 
Widowed 
 
5 
Single, never been married 
 
 
5. 
What is the highest grade at school or years in college that you have completed? 
(Circle the number of your answer.) 
 
1 
1st – 8th grade 
 
2 
9th – 11th grade 
 
3 
12th grade, completed high school, or GED 
 
4 
1 to 3 years of college 
 
5 
4 or more years of college 
 
 
6. 
Are you Hispanic or Latino? 
(Circle the number of your answer.) 
 
1 
Yes 
 
2 
No 
 
 
7. 
Which one or more of the following would you say is your race? 
(Circle the number of your answers, more than one may apply.) 
 
1 
American Indian or Alaska Native 
 
2 
Asian 
 
3 
Black or African American 
 
4 
Native Hawaiian or other Pacific Islander 
 
5 
White 
 
6 
Other, please specify:    
 
 
 
8. 
What is your current employment status? 
(Circle the number of your answer.) 
 
1 
Employed full-time (includes self-employment) 
 
2 
Employed part-time (includes self-employment) 
 
3 
Unemployed 
 
4 
Homemaker 
 
5 
Student 
 
6 
Retired 
 
7 
Disabled 
 
8 
Other, please specify:    
 

iThermonitor Enrollment Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Enrollment survey V1 November 6, 2014 
 
 
 
 
 
Section C: Technology Ownership and Use 
 
 
1. 
Do you ever go online to access the Internet or World Wide Web, 
or to send and receive email?  (Circle the number of your answer.) 
 
1 
Yes 
 
2 
No  [skip to question 4] 
 
 
 
2. 
When you use the Internet, do you access it through… 
(For each item, please circle the number for your answer. 
You may answer “YES” to more than one question.) 
Yes 
No 
a. A regular dial-up telephone line. 
1 
2 
b. Broadband such as DSL, cable or FiOS. 
1 
2 
c.  A cellular network (e.g., smartphone, 3G/4G) 
1 
2 
d. A wireless network (Wi-Fi) 
1 
2 
 
 
3. 
Have you ever used the Internet to do any of the following things? 
(For each item, please circle the number for your answer.) 
Yes 
No 
a. Send or receive email. 
1 
2 
b. Send or receive instant messages or chat 
online. 
1 
2 
c.  Upload pictures to share with others. 
1 
2 
e. Look for health or medical information online. 
1 
2 
f.  Track weight, diet or exercise routine. 
1 
2 
g. Track any other health indicators like blood 
pressure, sleep patterns, headaches, etc. 
1 
2 
h. Check your bank account balance or do any 
online banking. 
1 
2 
i.   Use a social networking service like 
Facebook or MySpace. 
1 
2 

iThermonitor Enrollment Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Enrollment survey V1 November 6, 2014 
 
 
 
4. 
Do you have any of the following devices? 
(For each item, please circle the number for your answer.) 
Yes 
No 
a. A landline telephone. 
1 
2 
b. A desktop computer. 
1 
2 
c.  A laptop computer or netbook. 
1 
2 
d. A tablet computer like an iPad. 
1 
2 
 
 
5. 
Have you ever used your cell phone or smartphone to do any of the following things? 
(For each item, please circle the number for your answer.) 
Yes 
No 
a. Send or receive email. 
1 
2 
b. Send or receive text messages. 
1 
2 
c.  Take a picture to share with others. 
1 
2 
d. Access the Internet. 
1 
2 
e. Look for health or medical information online. 
1 
2 
f.  Track weight, diet or exercise routine. 
1 
2 
g. Track any other health indicators like blood 
pressure, sleep patterns, headaches, etc. 
1 
2 
h. Check your bank account balance or do any 
online banking. 
1 
2 
i.   Use a social networking service like 
Facebook or MySpace. 
1 
2 

iThermonitor Enrollment Questionnaire 
Study ID:     
 
Date:     
 
iThermonitor Enrollment survey V1 November 6, 2014 
 
 
 
 
 
6. 
How much do you agree or disagree with each of the following statements? 
(For each item, please circle the number for your answer.) 
Strongly 
agree 
Somewhat 
agree 
Somewhat 
disagree 
Strongly 
disagree 
a. I am willing to try new technology. 
1 
2 
3 
4 
b. I plan to make greater use of technology in 
the future to manage my health. 
1 
2 
3 
4 
c.  I generally feel confident using new 
technology. 
1 
2 
3 
4 
d. I generally feel confident that I can use new 
technology to manage my medical condition. 
1 
2 
3 
4 
e. I worry about security issues of sending 
health information by the Internet. 
1 
2 
3 
4 
f.  It is easy for me to follow instructions and set 
up new technology. 
1 
2 
3 
4 
g. I have no difficulty setting up computers or 
Internet modems. 
1 
2 
3 
4 
h. Learning how to use new technology is easy 
for me. 
1 
2 
3 
4 
i.   New technology can be useful in keeping me 
healthy. 
1 
2 
3 
4 
j.   I find using new technology to be a waste of 
time. 
1 
2 
3 
4 

 
 
Subject Eligibility Criteria Checklist 
 
All subjects enrolled must meet eligibility criteria based on the inclusion/exclusion criteria detailed in the 
application and approved by the IRB. 
 
I. Study Information 
 
Protocol Title: 
iThermonitor study 
Protocol Number: 
14-485 
Principal Investigator: 
Stephen Agboola, MD, MPH 
II. Subject Information: 
 
Subject Name/ID: 
Gender: 
Male 
Female 
 
III. Inclusion/Exclusion Criteria 
 
Inclusion Criteria 
(From IRB approved protocol) 
Yes 
No 
Supporting 
Documentation* 
1. 
Dyad consists of a pediatric patient aged 2-17 
years undergoing myelosuppressive therapies for 
acute leukemia and other childhood cancers. 
2.   Dyad also includes a caregiver, ≥ 18 years of age 
that is willing to participate in the study. 
3.   Ability of caregiver and or patient (if old 
enough) to read and speak English. 
4.   If applicable, willingness of the patient to shave 
axillary (armpit) hair. 
5.   Caregiver (parent or legal guardian) must give 
informed consent for dyad participation. 
Exclusion Criteria 
(From IRB approved protocol) 
1.   Patient has a history of allergy to hydrogel dressing or 
ongoing skin diseases 
2.   Patients with ongoing febrile illness or documented 
infectious disease. 
 
*All subject files must include supporting documentation to confirm subject eligibility.  The method of confirmation 
can include, but is not limited to, laboratory test results, radiology test results, subject self-report, and medical record 
review. 
IV. Statement of Eligibility 
 
This subject is [ 
eligible / 
ineligible ] for participation in the study. 
Signature: 
Date: 
Printed Name: 
 
 
 
v. March 2006 
Partners Human Research Quality Improvement Program 

 
 
Subject ID:   
 
Date of Enrollment:   
 
 
iThermonitor Daily Event Monitoring Log 
 
Please indicate Yes or No for each column everyday during the study. 
 
Day 
The iThermonitor 
stayed on the body for 
most of the day 
I was  able  to  view  the 
temperature data on the 
iPad mini 
Yes 
No 
Yes 
No 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
 
Caregiver Signature  
 Date  
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Is your 
child (age 2 - 17 yrs) Study 
undergoing chemotherapy? 
Do you need to monitor your child’s 
temperature as part of your follow up care? 
 
If you are over the age of 18, you 
and your child may be eligible to 
 
participate in a study to test a new, small 
continuous temperature-monitoring 
device. 
 
• You will be asked to use the new 
device in your home along with your 
standard treatment for 2 weeks in an 
effort to see how it works in a home 
setting. 

 
 
• Compensation is provided in recognition of your time and 
willingness to participate. 
 
Ask your doctor for more information and to see if 
you qualify! 
 
Contact - Amanda Centi at acenti@partners.org for more 
details 
 
This study is being conducted by Partners HealthCare, Connected Health 
Innovation in conjunction with the MGH and DFCI Pediatric Oncology 
Groups. 

 
 
A Pilot study to evaluate the use feasibility of a continuous temperature monitoring device 
for pediatric patients on myelosuppressive therapies for childhood cancers. 
 
 
Is your child (age 2 - 17 yrs) undergoing chemotherapy? Do you need to monitor your child’s 
temperature as part of your follow up care? 
 
We are enrolling pediatric patients (ages 2-17) undergoing myelosuppressive therapies for 
childhood cancers. You and your child may be eligible to participant in a study to test a new, 
small continuous temperature-monitoring device. You will be asked to use the new device in 
your home along with your standard treatment for 2 weeks in an effort to see how it works in a 
home setting. There will be up to be two study visits: study enrollment and study closeout. 
 
Compensation of $100 will be provided upon completion of the study. 
 
Please contact 617-726-6831 or email iThermoStudy@partners.org and ask about the 
iThermonitor study!