DOCTO Feasibility Study

Participant Information and Consent Form

Principal Investigators: Dina Panagiotopoulos

Clinical Professor
Department of Paediatrics, Division of Endocrinology
University of British Columbia
Endocrinologist, BC Children's Hospital
Telephone: 604 875 2624

Who do I contact if I have questions about the study during my participation?

If you have any questions or desire further information about this study before or during
participation, or if you experience any adverse effects, you can contact Dr Dina Panagiotopoulos
at 604-875-2624.

Who do I contact if I have any questions or concerns about my rights as a participant?

If you have any concerns or complaints about your rights as a research participant and/or your
experiences while participating in this study, contact the Research Participant Complaint Line in
the University of British Columbia Office of Research Ethics by e-mail at RSIL@ors.ubc.ca or by
phone at 604-822-8598 (Toll Free: 1-877-822-8598).

If you are a parent or legal guardian of a child who may take part in this study, permission from
you and the assent (agreement) of your child may be required. When we say you or your in
this consent form, we mean you and/or your child; we means the doctors and other staff.

1. Invitation
You are being invited to take part in this research study because you have been diagnosed with
Type 1 Diabetes (T1D).

2. Your participation is voluntary

Your participation is voluntary. You have the right to refuse to participate in this study. If you
decide to participate, you may still choose to withdraw from the study at any time without any
negative consequences to the medical care, education, or other services to which you are entitled
or are presently receiving.

If you wish to participate in this study, you will be asked to sign this form.
Please take time to read the following information carefully and to discuss it with your family,
friends, and doctor before you decide.

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3. Who is conducting this study?
Drs. Panagiotopoulos, of the Department of Pediatrics, University of British Columbia, are
conducting the study. The study will be carried out at British Columbias Childrens Hospital
(BCCH).

4. What is the purpose of the study?

This is small study called a pilot study to test whether a continuous glucose monitoring system
(CGM) and a new App called DOCTO that is loaded on to your iPhone can be used to predict a
persons blood sugar (glycemic) variability better than the current glucose monitoring system. The
study is being carried out only at BC Childrens Hospital and will have 10 participants. You will be
asked to come for a study visit twice and the complete study will take about 60 days or two
months to complete.

5. Who can participate in this study?

You can take part in this study if:
You are between the ages 6- 25 years
Diagnosed with Type I Diabetes by primary care provider at least one year prior to the start
date
You currently using a Decom G4 or similar CGM system
You own an iPhone 5 or higher, with a continuous connectivity data plan

6. What does the study involve?

If you agree to take part in this study, we will ask you to come to BCCH in Vancouver for a study
visit. At this time, you will be asked to sign this consent form.
At your scheduled visit, you will be asked to do the following:

Day 1 (2 hours):
You will be asked to sign this consent form if you would like to participate in this study
You will receive the equipment needed to help run this study: Fitbit to monitor your
activity and your heart rate.
You will receive instructions on how to use the Fitbit, and what needs to be done for the
study.
The study App DOCTO will be loaded onto your cell phone

Day 2, Day 7, Day 14, and Day 56 (telephone call 15 minutes)

You will be contacted by phone and asked if all the equipment is working as intended, and
if you are having any problems or concerns data obtained will not be discussed with you
and will thus not lead to clinical decisions being made.

Day 30 (telephone call - 15minutes)

Equipment will be discussed but the data obtained will not be discussed with you and will
thus not lead to clinical decisions being made.

Day 61 (study visit at BCCH-2 hours)

You will be asked to come to BCCH to return the equipment that has been leant to you for
use Fitbit. The study App DOCTO will be removed from your phone.

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Total time in the study will be 60 days, and it will take 5.25 hours to complete the study visits and
phone calls. During the study you will need to wear the Fitbit 24 hours a day.

Day 1 Day 2 Day7 Day 14 Day 30 Day 56 Day 61

Sign consent X
Receive equipment X
Instructions for equipment X
Telephone call to review X X X X X
Study visit X X
Return loaned equipment X

7. What are my responsibilities?

You are responsible for wearing the wearing Fitbit and Dexcom 24 hours a day, keeping phone
within a 5m range from yourself at all times. You will be responsible for returning all equipment at
the end of the study. If at any point during the study you are unable to or unwilling to wear the
CGM transmitter for more than 5 days, you are asked to notify the study team immediately; you
will be discontinued from the study and asked to return the equipment (Fitbit bracelet).

Please Make Sure: To use your CGM values to make any medical decisions.
Information gathered, collected and displayed by the DOCTO app is for research
use only and should not form the basis for any clinical decisions to be made
regarding the users care.

8. What are the possible harms and discomforts?

The study is only assessing the App DOCTO, there is no possible harm or discomfort.

9. Who will know that I am in this study?

Your confidentiality will be respected. However, research records and health or other source
records identifying you may be inspected in the presence of the Investigator or his or her
designate by representatives of the UBC Clinical Research Ethics Board for the purpose of
monitoring the research. No information or records that disclose your identity will be published
without your consent, nor will any information or records that disclose your identity be removed
or released without your consent unless required by law.

You will be assigned a unique study number as a participant in this study. This number will not
include any personal information that could identify you (e.g., it will not include your Personal
Health Number, SIN, or your initials, etc.). Only this number will be used on any research-related
information collected about you during the course of this study, so that your identity will be kept
confidential. Information that contains your identity will remain only with the Principal
Investigator and/or designate. The list that matches your name to the unique study number that is
used on your research-related information will not be removed or released without your consent
unless required by law.

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Federal and provincial laws that require safeguards to insure that your privacy is respected legally
protect your rights to privacy. You also have the legal right of access to the information about you
that has been provided to the sponsor and, if need be, an opportunity to correct any errors in this
information. Further details about these laws are available on request to your study doctor.

Disclosure of Race/Ethnicity
Studies involving humans now routinely collect information on race and ethnic origin as well as
other characteristics of individuals because these characteristics may influence how people
respond to different medications. Providing information on your race or ethnic origin is voluntary.

10. What are the potential benefits of participating?

There may not be a direct benefit to you from taking part in this study. However, we hope that the
information learned from this study can be used in the future to benefit other youth with T1D.

11. What are the alternatives to the study treatment?

The only alternative is to choose not to participate in the study. You can consult with your health
care provider before deciding whether or not to take part in this research project.

12. What if new information becomes available that may affect my decision to participate?
You will be advised of any new information that becomes available that may affect your
willingness to remain in this study.

13. What happens if I decide to withdraw my consent to participate?

Your participation in this research is entirely voluntary. You may withdraw from this study at any
time without giving reasons. If you decide to take part in this study and to withdraw at any time in
the future, there will be no penalty or loss of benefits to which you are otherwise entitled. If you
choose to take part in the study and withdraw or are withdrawn at a later date, all data collected
about you in the study will be remain in the study for analysis.

14. Can I be asked to leave the study?

If you are not able to follow the requirements of the study or for any other reason, the study
doctor may withdraw you from the study and will arrange for your care to continue. If you are
asked to leave the study, the reasons for this will be explained to you and you will have the
opportunity to ask questions about this decision.

15. What happens if something goes wrong?

By signing this form, you do not give up any of your legal rights and you do not release the study
doctor, participating institutions, or anyone else from their legal and professional duties. If you
become ill or physically injured as a result of participation in this study, medical treatment will be
provided at no additional cost to you. The costs of your medical treatment will be paid by your
provincial medical plan.

In case of a serious medical event, please report to an emergency room and inform them that you
are participating in a clinical study and that the following person can then be contacted for further
information: Dr. Panagiotopoulos at telephone number: 604-875-2624.

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16. What will the study cost me?
The study will not cost you anything. All equipment will be supplied, but must be returned at the
end of the study.

17. After the study is finished

After your participation in the study is completed, information about your results will be provided
to you, and with your permission, to your primary care physician/specialist, such that you can
discuss these results. We will publish the results of the study in a scientific journal and may
present the results at conferences. No information that would identify you will be published or
presented.

Future Contact

I give permission for the investigator/research assistant to contact me about future studies.

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DOCTO Feasibility Study
Participant Information and Consent Form
My signature on this consent form means:
I have read and understood the information in this consent form.
I have had enough time to think about the information provided and to ask for advice if
needed.
I have been able to ask questions and have had satisfactory responses to my questions.
I understand that all of the information collected will be kept confidential and that the
results will only be used for scientific purposes.
I understand that my participation in this study is voluntary.
I understand that I am completely free at any time to refuse to participate or to withdraw
from this study at any time, and that this will not change the quality of care that I receive.
I understand that I am not waiving any of my legal rights as a result of signing this consent
form.
I understand that there is no guarantee that this study will provide any benefits to me.
I will receive a signed and dated copy of this consent from for my own records.

The parent(s)/guardian(s)/substitute decision-maker (legally authorized representative) and the

investigator are satisfied that the information contained in this consent form was explained to the
child/participant to the extent that he/she is able to understand it, that all questions have been
answered, and that the child/participant assents to participating in the research

I consent to participate in this study.

________________________ __________________________ _______________

Participants or Substitute Printed name Date
Decision-Makers Signature

Signature of Person Printed name Study Role Date

Obtaining Consent

Investigator Signature

Investigator Signature Printed name Date

My signature above signifies that the study has been reviewed with the study participant by me
and/or by my delegated staff. My signature may have been added at a later date, as I may not
have been present at the time the participants signature was obtained.

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