Phase 1 of the BETTER registry

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ID Parent

Welcome to the BETTER registry for people living with type 1 diabetes in Canada.

IMPORTANT: It takes approximately 15 minutes to answer this questionnaire. It is possible to start the questionnaire, save your answers and come back later to complete it.

WARNING: You want to know if you are already registered? Please contact us at better@ircm.qc.ca.

Do you live in the province of Quebec?

* must provide value

Yes

reset

At the moment, only people living in the province of Quebec can participate in the registry.

In which province or territories do you live?

* must provide value

Alberta

Quebec

Ontario

British Columbia

Prince Edward Island

Manitoba

New Brunswick

Nova Scotia

Saskatchewan

Newfoundland and Labrador

Nuvavut

Northwest Territories

Yukon

None of the above

reset

At the moment, only people living in Canada can participate in the registry.

Would you like to receive a newsletter to hear the latest news about the BETTER research program?

* must provide value

Yes

I prefer not to answer

I don't know

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What is you email address?

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Before answering the phase 1 questionnaire of the BETTER registry, please take the time to read the consent form.

The pdf of the information and consent form can be found below.

INFORMATION AND CONSENT FORM

REGISTRY OF INDIVIDUALS LIVING WITH TYPE 1 DIABETES IN CANADA : THE BETTER REGISTRY

PHASE 1

Principal investigator: Dr Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montréal

Co-investigator:
Dr Anne-Sophie Brazeau, McGill University
Dr André Carpentier, Centre Hospitalier Universitaire de Sherbrooke
Dr Kaberi Dasgupta, McGill University Health Centre
Dr Claudia Gagnon, Centre Hospitalier de l'Université Laval
Dr Melanie Henderson, Centre Hospitalier Universitaire Sainte-Justine
Dr Laurent Legault, McGill University Health Centre
Dr Meranda Nakhla, McGill University Health Centre
Dr Bruce Perkins, University of Toronto
Dr Peter Senior, Alberta Diabetes Institute
Dr Nadine Taleb, Centre Hospitalier de l'Université de Montréal
Dr Cynthia Turcotte, Centre de Psychologie de la Rive-sud

Funding agencies : Canadian Institutes of Health Research and Juvenile Diabetes Research Foundation

Registry coordinator : Virginie Messier, Institut de recherches cliniques de Montréal

Multicenter Identifier: MP-02-2019-7992
No of the project at the CHUM: 18.232

PREAMBLE

We request your participation in a data registry because you have type 1 diabetes. However, before agreeing to participate in this registry, please take the time to read, understand and consider carefully the information that follow.

This form may contain words that you do not understand. We invite you to ask any questions you may find useful to the researcher in charge of the registry or co-researchers and to ask them to explain the elements that are not clear (better@ircm.qc.ca; 514-987-5696 or 1-833-897-3172).

NATURE AND OBJECTIVES OF THE STUDY

Type 1 diabetes requires individuals to inject themselves with insulin to control their blood sugar levels because their pancreas no longer produces insulin. A consequence of this treatment is a risk of low blood sugar episodes called hypoglycemia. In some cases, hypoglycemic episodes can be severe (very low blood sugar) meaning that the individual needs the help of another person to raise his sugar level. Hypoglycemia, especially severe, is a very uncomfortable experience, which can make people confused, cause accidents (for example, driving) or injury (for example, a fall). If hypoglycemia is not treated and gets worse, it can lead to coma and sometimes death. Many people living with type 1 diabetes have expressed the need to identify better strategies to reduce these episodes of hypoglycemia.

We are creating a registry of individuals with type 1 diabetes. Any individual with type 1 diabetes living in Canada will be eligible to participate in the registry. The objective of the registry is to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc. The data collected through the registry questionnaires will enable research projects to be carried out.

Participation in the registry will be divided in 3 phases. The first phase is mandatory for all participants. Phases 2 and 3 are optional. This information and consent form is for phase 1 only. At the end of each questionnaire, you will be asked if you want to participate in the next phase of the registry. You can answer all questionnaires one after each other or start a questionnaire, save your answers and come back later to answer the remaining questions.

NUMBER OF STUDY PARTICIPANTS AND LENGTH OF THE PARTICIPATION

We hope to recruit 6,000 participants for phase 1 of the registry, 3,000 participants for phase 2 and 1,500 participants for phase 3.

The duration of the study is 6 years. The duration of your participation will depend on your degree of participation:
• Estimated time for Phase 1: 15 minutes
• Estimated time for Phase 2: 45 minutes
• Estimated time for phase 3: 25 minutes

NATURE OF THE REQUESTED PARTICIPATION

If you agree to participate in phase 1 of the registry, you will have to answer an online questionnaire whose objective is to draw an overall picture of the population with type 1 diabetes in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It will take you about 15 minutes to answer the questionnaire. When you answer the questionnaire, you can save your answers and come back later to answer the remaining questions. If you are using a continuous glucose monitor, you will be invited to send us the report of the last 14 days of your continuous glucose monitor.

Participation in phases 2 and 3 also consists of answering an online questionnaire. The objective of phase 2 and 3 is to obtain more details about the causes and consequences of hypoglycemia. At phase 2, if you accept, you will be invited to provide to the research team your latest list of medications as well as your latest blood and urine tests. Finally, at phase 3, if you accept, you will be invited to can also answer a food questionnaire, wear a step counter and measure your waist circumference.

Phase 1 will be done on an annual basis meaning that in one year from today, you will be invited to answer the same questionnaire once again, and if you accept, send us the report of the last 14 days of your continuous glucose monitor (if you are using one). In addition, you will be invited to answer additional questions coming from phase 2 and 3, and if you accept, to measure your waist circumference, wear a step counter, answer the food questionnaire and send us your latest blood and/or urine tests as well as your list of medications.

STORAGE OF DATA

All data will be stored in a secure database located on a server at the Institut de recherches cliniques de Montréal (Montreal, Quebec, Canada), under the responsibility of Dr. Rémi Rabasa-Lhoret, director of the BETTER registry. Security backup copies of the data are generated daily.

The data included in the registry will only be accessible by the director of the BETTER registry and its immediate collaborators in accordance with the BETTER Registry Management Framework.

RISKS

There is no known physical risk to participate in this registry. However, the time required to answer the questionnaire can be a disadvantage for some participants and cause questions or stress. You may stop responding to the questionnaire at any time or continue at another time if you wish.

Risk associated with a breach of confidentiality: There is a risk of a possible breach of confidentiality regarding your personal information that could result in a breach of your privacy. This risk however is minimal. Every effort will be made to protect your privacy and confidentiality as described in the "Confidentiality" section.

BENEFITS

You will not derive any personal benefit from participating in this registry or in the research projects in which your data will be used. However, the research done with your data included in the registry may enable the researchers to learn more about the occurrence of hypoglycemia and improve patient care in the future.

CONFIDENTIALITY

The principal investigator will protect your file so that your name, address and telephone number will remain confidential.

Your data entered into the database will be identified only by your identification number. It will be possible to identify you and link your data only by the identification number kept by the principal investigator and the coordinator responsible of the entry of your data in the registry.

Any researcher who is not part of the BETTER research team and who wants to have access to the registry data will have to submit his project to the Registry Management Committee, which will evaluate the research projects for which access to the registry data will be granted, in accordance with the registry management framework. In addition, a research ethics board will have approved any research based on your data included in the registry.

The reports concerning any research done using data included in the registry will not be sent to you because the research will be done based on data of a very large number of participants and will not be of any diagnostic or therapeutic consequence to you. Research data may be published or be the subject of scientific discussion, but it will not be possible to identify you.

COMPENSATION

You will receive no financial compensation for your participation in this registry. However, you have the chance to win a cash gift worth $500 (1 cash gift will be drawn for every 500 participation coupons). Your chances of winning will increase according to your degree of participation in the registry:
• Phase 1: one chance to win (1 coupon)
• Phase 2: two additional chances to win (3 coupons)
• Phase 3: two additional chances to win (5 coupons)
• Annual questionnaire: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 2: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 3: one additional chance to win (1 coupon per year)
• Report of the last 14 days of the continuous glucose monitor: one additional chance to win (1 coupon per year)
• Food questionnaire: one additional chance to win (1 coupon per year)
• Waist circumference measurement: one additional chance to win (1 coupon per year)
• Wear step counter for 14 consecutive days: one additional chance to win (1 coupon per year)
• Send latest blood and/or urine tests results: one additional chance to win (1 coupon per year)
• Send list of medications: one additional chance to win (1 coupon per year)

SHOULD YOU SUFFER ANY HARM

Should you suffer harm of any kind related to your participation in this registry, you are not waiving any of your legal rights nor discharging the principal investigator, the funding agencies or the institution, of their civil and professional responsibilities.

POSSIBILITY OF MARKETING

Your participation in this registry could lead to the creation of commercial products that could potentially be protected by patent or other intellectual property rights. However, in such a case, you will not be able to obtain any financial benefit.

FUNDING OF THE REGISTRY

This registry is funded by the funding agencies.

VOLUNTARY PARTICIPATION AND THE RIGHT TO WITHDRAW

Your participation in this registry is voluntary. You can decide not to participate or withdraw your consent at any time. If you choose not to participate or to withdraw from this registry, it will have no impact on the quality of care and services you receive or on your relationship with your doctor and the healthcare team.

If you decide to stop participating in the registry and no longer want your data to be used for research purposes, you must inform the research team. Your data will then be destroyed.

Any new information acquired during the course of the project likely to influence your decision to continue to participate in the registry will be communicated to you without delay verbally and in writing.

IDENTIFICATION OF CONTACT PEOPLE

Should you have any question regarding this registry, you may contact the principal investigator and director of the registry, Dr. Rémi Rabasa-Lhoret, at the following number: 514-987-5696 (between 8:00 and 16:00, Monday to Friday).

Shoud you have any questions about your rights as a participant in a registry or have any complaints or comments, you can contact:

• The associate commissioner for complaints and service quality of the CHUM at (514) 880-8484.
• The patient ombudsman of the Royal Victoria Hospital (MUHC) at (514) 934-1934, extension 35655.
• The CIUSSS de l'Estrie-CHUS' Office of Complaints and Quality of Services at plaintes.ciussse-chus@ssss.gouv.qc.ca or at the following number: 1-866-917-7903.
• The commissioner for complaints and service quality of the CHU de Québec-Université Laval at (418) 654-2211.
• The commissioner for complaints and service quality of the CHU Sainte-Justine at (514) 345-4749 or by email at commissaire.message.hsj@ssss.gouv.qc.ca.
• The commissioner for complaints and service quality of the CIUSSS du Saguenay-Lac-Saint-Jean at (418) 541-7026 or at 1-877 662-3963.
• The commissioner for complaints and service quality of the CISSS de Chaudière-Appalaches at 1-877 986-3587.
• Service Quality and Complaints Commissionner of the CIUSSS du Nord-de-l'Île-de-Montréal at (514) 384-2000, extension 3316 or by email at commissaire.plaintes.cnmtl@ssss.gouv.qc.ca.
• The commissioner for complaints and service quality of the CISSS des Laurentides at (450) 432-8708 or at 1-866 822-0549, or by email at info-plaintes@ssss.gouv.qc.ca.
• The Office of the Service Quality and Complaints Commissioner of the CISSS de Laval at (450) 668-1010, extension 23628 or by email at plaintes.csssl@ssss.gouv.qc.ca
• The commissioner for complaints and service quality of the CIUSSS de la Mauricie-et-du-Centre-du-Québec at 1-888 693-3606 or by email at commissaires.plaintes04@ssss.gouv.qc.ca.
• The Local Commissioner of Complaints and Quality of Service of the CIUSSS Centre-Ouest-de-l'Île-de-Montréal or the ombudsman of the institution at (514) 340-8222, extention 24222 or at the Jewish General Hospital Endocrinology clinic at (514) 340-8090.
• The Service Quality and Complaints Commissioner for the CIUSSS of the Est-de-l'Île-de-Montréal region at (514) 252-3400, extension 3510.
• The commissioner for complaints and service quality of the CISSS du Bas-Saint-Laurent at 1-844 255-7568 or by email at plaintes.cisssbsl@ssss.gouv.qc.ca.
• The commissioner for complaints and service quality of the CISSS de Lanaudière at (450) 759-5333, extension 2133 or by email at plaintes.cissslan@ssss.gouv.qc.ca.
• The Commissioner for Complaints and Quality Services of the CISSS de la Montérégie-Centre at (450) 466?5434.
• The commissioner for complaints and service quality of the CISSS de l'Outaouais at (819) 771-4179 (free call : 1 844 771-4179) or by email at commissairesauxplaintes@ssss.gouv.qc.ca.
• The commissioner for complaints and service quality of the CIUSSS Centre-Sud-de-l'Île-de-Montréal at 514-593-3600.

APPROVAL OF THE RESEARCH ETHICS BOARD

The CHUM's Research Ethics Board has approved the project to establish a registry and is responsible for monitoring it at all participating institutions in the health and social services network in Quebec.

COMMITMENT OF THE PRINCIPAL INVESTIGATOR

I undertake, together with the research team, to respect what was agreed upon in the information and consent form.

CONSENT TO PARTICIPATE IN PHASE 1 OF THE BETTER REGISTRY

I declare that I have read this consent form (or that it has been read to me), specifically as regards the nature of my participation in the registry and the extent of the associated risks. I acknowledge that all of my questions have been answered and that I have been given the necessary time to make a decision. I freely and voluntarily agree to participate in this registry.

By clicking on YES, I voluntarily agree to participate in phase 1 of the registry and will be redirected to the questionnaire.

By accepting to participate in phase 1 of the registry, I am not waiving any of my legal rights or and I do not release the researchers, funding agencies or the institution from their civil and professional responsibilities.

* must provide value

YES, I accept to participate in phase 1 of the BETTER registry. By the meantime, I accept that my coded data be used for various research projects approved by a Research Ethics Board.

NO, I do not accept to participate in phase 1 of the BETTER registry.

reset

PDF of the information and consent form

Attachment:18.232_FICadultesphase1_AN_v8.0_20220728_FinalCÉRCHUM_20221102.pdf

The PDF version of the participant consent form can be found below.

PARTICIPANT CONSENT FORM

Title of Study: Registry of individuals living with type 1 diabetes in Canada: The BETTER Registry

Local Principal Investigator: Dr. Peter Senior (Phone: 780-492-3077)
Local Study Coordinators: Caroline Lyster (Phone: 780-248-1770) and Jyoti Singh (Phone: 780-492-1098)

Study Principal Investigator: Dr. Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montréal

Registry Coordinator: Virginie Messier, Institut de recherches cliniques de Montréal

Why are you being asked to take part in this study?

You are being asked to participate in a data registry because you have type 1 diabetes. Before you decide to join this registry, it is important that you understand what is involved and what will be done with your information. Please take the time to read, understand, and consider carefully the information that follows.

This form may contain words that you do not understand. We invite you to ask any questions that you have to the local study coordinator or registry coordinator:
Caroline Lyster: clyster@ualberta.ca, 1-780-248-1770
Virginie Messier: better@ircm.qc.ca, 1-514-987-5696 or 1-833-897-3172

What is the reason for doing the study?

Individuals with type 1 diabetes need to inject themselves with insulin in order to control their blood sugar levels because their pancreas no longer produces insulin. A consequence of this treatment is a risk of low blood sugar, also called hypoglycemia. In some cases, hypoglycemic episodes can be severe, meaning that the individual needs the help of another person to raise their blood sugar level. Hypoglycemia, especially severe hypoglycemia, is a very uncomfortable experience, which can make people confused, cause accidents (for example, if it occurs while people are driving), or injury (for example, a fall). If hypoglycemia is not treated and gets worse it can lead to coma and sometimes death. Many people living with type 1 diabetes have expressed the need to identify better strategies to reduce these episodes of hypoglycemia.

We are creating a registry of individuals with type 1 diabetes. Any individual with type 1 diabetes living in Canada will be eligible to participate in the registry. The objective of the registry is to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, and the things that contribute to their hypoglycemia (for example, insulin therapy, food, or exercise). The data collected through the registry questionnaires will be used for future research projects.

What will I be asked to do?

Participation in the registry will be divided into 3 phases. This consent form and the following information is only for Phase 1 participation. When you have completed the phase 1 questionnaire you will be asked if you want to participate in the next phases of the registry (Phase 2 and Phase 3). We hope to recruit at least 6000 participants in phase 1.

Phase 1 is a longitudinal study, which means it tracks people over time. Phase 1 of the study will be ongoing for up to 6 years. Participation in this phase involves completing a questionnaire each year and allowing us to collect some data from your continuous glucose monitor (if you use one). The parts of the study are explained below:

Questionnaire: You will be asked to answer an online questionnaire with questions designed to allow researchers collect an overall picture of the population of people with type 1 diabetes in terms of demographics, diabetes treatment, hypoglycemia frequency, and diabetes complications.

Continuous glucose monitor: In addition to the online questionnaire, if you are using a continuous glucose monitor, you will be asked to send us the report of your continuous glucose monitor for the last 14 days. This part of the study is optional. A document explaining how to download the report of your continuous glucose monitor will be sent to you by email. The report will have to be uploaded in a form whose link will be sent to you by email.

How long will I be in this study?

If you agree to participate in BETTER Registry, you will be enrolled in the Registry and asked to complete questionnaires via a secure online platform called REDCAP. You will complete these questionnaires once a year for up to 6 years of the study. The online questionnaire takes about 15-20 minutes to answer and you can take breaks, save your answers, and come back later to answer the remaining questions.

Who will see the information collected about you

All data will be stored in a secure database located on a server at the Montreal Clinical Research Institute (Montreal, Quebec, Canada), under the responsibility of Dr. Rémi Rabasa-Lhoret, director of the BETTER registry. Security backup copies of the data are generated daily.

The data included in the registry will only be accessible by the director of the BETTER registry and its immediate collaborators in accordance with the BETTER Registry Management Framework.

Your name, address, email address, phone number, and date of birth will be visible to the principal investigator and coordinator responsible for the entry of your data into the registry. It will also be visible to the coordinators at the Montreal Clinical Research Institute: they may also to contact you in order to check that the data you entered is accurate.

Your data entered into the database will be identified only by your identification number. The principal investigator, coordinator responsible for the entry of your data into the registry, and coordinators in Montreal will be able to link your name to your identification number.

Any researcher who is not part of the BETTER research team and who wants to have access to the registry data will have to submit their project to the Registry Management Committee, which will evaluate the research projects for which access to the registry data will be granted, in accordance with the management framework. In addition, a research ethics board will have to approve any research based on your data included in the registry.

The reports concerning any research done using data included in the registry will not be sent to you because the research will be done based on data of a very large number of participants and will not be of any diagnostic or therapeutic consequence to you. Research data may be published or be the subject of scientific discussion, but it will not be possible to identify you.

Will my information be kept private?

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

How long will my information be stored?

Your information will be kept for a minimum of 10 years after the last survey has been completed. Beyond this period the data will be kept for an unlimited amount of time as long as the registry is of scientific interest to the community. This is described in the BETTER Registry Management Framework. You are free to withdraw your information at any time.

What are the risks and discomforts?

There is no known physical risk to participate in this registry. However, the time required to answer the questionnaire can be a disadvantage for some participants and may cause questions or stress. You may stop responding to the questionnaire at any time or continue at another time if you wish.

Risks associated with a breach of confidentiality

There is a risk of a possible breach of confidentiality regarding your personal information that could result in a breach of your privacy. This risk however is minimal. Every effort will be made to protect your privacy and confidentiality as described in the "Confidentiality" section

What are the benefits?

You will not derive any personal benefit from participating in this registry or in the research projects in which your data will be used. However, the research done with your data included in the registry may enable the researchers to learn more about the occurrence of hypoglycemia and improve patient care in the future.

Will I be paid to be in the research?

You will receive no financial compensation for your participation in this registry. However, you have the chance to win a cash gift worth $500: 1 cash gift will be drawn for every 500 participation coupons earned by all participants on the study. Your chances of winning will increase according to your degree of participation:

Phase 1 questionnaire: one chance to win (1 coupon)
Phase 1 annual questionnaire (Part-1): one chance to win (1 coupon per year)
Additional questions in the annual questionnaire in Part-2: one additional chance to win (1 coupon per year)
Additional questions in the annual questionnaire in Part-3: one additional chance to win (1 coupon per year)
Continuous glucose monitor report: one additional chance to win (1 coupon per year)

What happens if I am injured because of this research?

Should you suffer harm of any kind related to your participation in this registry, you are not waiving any of your legal rights nor discharging the principal investigator, the funding agencies, or the institution of their civil and professional responsibilities.

Possibility of marketing

Your participation in this registry could lead to the creation of commercial products that could potentially be protected by patent or other intellectual property rights. However, in such a case, you will not be able to obtain any financial benefit.

Funding of the registry

The registry is funded by the Canadian Institutes for Health Research and the Juvenile Diabetes Research Foundation.

Do I have to take part in the study?

Your participation in the registry is completely voluntary. You can decide not to participate or withdraw your consent at any time. If you choose not to participate or to withdraw from this registry, it will have no impact on the quality of care and services you receive or on your relationship with your doctor and the healthcare team.

If you decide to stop participating in the registry and no longer want your data to be used for research purposes, you must inform the research team. Your data will then be destroyed.

Any new information acquired during the course of the project likely to influence your decision to continue to participate in the registry will be communicated to you without delay verbally and in writing.

What if I have questions?

Should you have any questions regarding this registry you may contact any of the following people:
Dr. Peter Senior, local principal investigator: 780-492-3077
Caroline Lyster or Jyoti Singh, local study coordinators: 780-248-1770 or 780-492-1098
Virginie Messier and Catherine Leroux, registry coordinators: 514-987-5696 or 1-833-897-3172

The plan for this study has been reviewed by a Research Ethics Board at the University of Alberta. If you have any questions regarding your rights as a research participant, you may contact the Research Ethics Office at reoffice@ualberta.ca. This office is independent of affiliation with the study investigators.

How do I indicate my agreement to be in this study?

By agreeing below, you understand:

That you have read the above information and have had anything that you do not understand explained to you to your satisfaction.
That you will be taking part in a research study (Phase 1).
That you may freely leave the research study at any time.
That you do not waive your legal rights by being in the study
That the legal and professional obligations of the investigators and involved institutions are not changed by your taking part in this study.

Completion and submission of the survey means your consent to participate.

Please print the copy of this consent form for your records.

Consent to participate in the phase 1 of the BETTER registry

* must provide value

Yes

reset

PDF version of the participant consent form

Attachment:HREB Approved_BETTER Phase 1 ICF_UofA_V 2.0_30 Aug 2022.pdf

The pdf of the information and consent form can be found below.

INFORMATION AND CONSENT FORM

REGISTRY OF INDIVIDUALS LIVING WITH TYPE 1 DIABETES IN CANADA : THE BETTER REGISTRY

PHASE 1

Principal investigator: Dr Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montréal

Co-investigator:
Dr Anne-Sophie Brazeau, McGill University
Dr André Carpentier, Centre Hospitalier Universitaire de Sherbrooke
Dr Kaberi Dasgupta, McGill University Health Centre
Dr Claudia Gagnon, Centre Hospitalier de l'Université Laval
Dr Melanie Henderson, Centre Hospitalier Universitaire Sainte-Justine
Dr Laurent Legault, McGill University Health Centre
Dr Meranda Nakhla, McGill University Health Centre
Dr Bruce Perkins, University of Toronto
Dr Peter Senior, Alberta Diabetes Institute
Dr Nadine Taleb, Centre Hospitalier de l'Université de Montréal
Dr Cynthia Turcotte, Centre de Psychologie de la Rive-sud

Funding agencies : Canadian Institutes of Health Research and Juvenile Diabetes Research Foundation

Registry coordinator : Virginie Messier, Institut de recherches cliniques de Montréal

Multicenter Identifier: MP-02-2019-7992
No of the project at the CHUM: 18.232

PREAMBLE

We request your participation in a data registry because you have type 1 diabetes. However, before agreeing to participate in this registry, please take the time to read, understand and consider carefully the information that follow.

This form may contain words that you do not understand. We invite you to ask any questions you may find useful to the researcher in charge of the registry or co-researchers and to ask them to explain the elements that are not clear (better@ircm.qc.ca; 1-833-897-3172).

NATURE AND OBJECTIVES OF THE STUDY

Type 1 diabetes requires individuals to inject themselves with insulin to control their blood sugar levels because their pancreas no longer produces insulin. A consequence of this treatment is a risk of low blood sugar episodes called hypoglycemia. In some cases, hypoglycemic episodes can be severe (very low blood sugar) meaning that the individual needs the help of another person to raise his sugar level. Hypoglycemia, especially severe, is a very uncomfortable experience, which can make people confused, cause accidents (for example, driving) or injury (for example, a fall). If hypoglycemia is not treated and gets worse, it can lead to coma and sometimes death. Many people living with type 1 diabetes have expressed the need to identify better strategies to reduce these episodes of hypoglycemia.

We are creating a registry of individuals with type 1 diabetes. Any individual with type 1 diabetes living in Canada will be eligible to participate in the registry. The objective of the registry is to measure the frequency and the severity of episodes of hypoglycemia. Participants will be invited to answer questionnaires about the frequency of their hypoglycemic episodes, their fear about hypoglycemia, their symptoms of hypoglycemia, the factors in cause (insulin therapy, nutrition, exercise, etc.), etc. The data collected through the registry questionnaires will enable research projects to be carried out.

Participation in the registry will be divided in 3 phases. The first phase is mandatory for all participants. Phase 2 and 3 are optional. This information and consent form is for phase 1 only. At the end of this questionnaire, you will be asked if you want to participate in the next phase of the registry. You can answer all questionnaires one after each other or start a questionnaire, save your answers and come back later to answer the remaining questions.

NUMBER OF STUDY PARTICIPANTS AND LENGTH OF THE PARTICIPATION

We hope to recruit 6,000 participants for phase 1 of the registry, 3,000 participants for phase 2 and 1,500 participants for phase 3.

The duration of the study is 6 years. The duration of your participation will depend on your degree of participation:
• Estimated time for Phase 1: 15 minutes
• Estimated time for Phase 2: 45 minutes
• Estimated time for Phase 3: 25 minutes

NATURE OF THE REQUESTED PARTICIPATION

If you agree to participate in phase 1 of the registry, you will have to answer an online questionnaire whose objective is to draw an overall picture of the population with type 1 diabetes in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications. It will take you about 15 minutes to answer the questionnaire. When you answer the questionnaire, you can save your answers and come back later to answer the remaining questions. If you are using a continuous glucose monitor, you will be invited to send us the report of the last 14 days of your continuous glucose monitor.

Participation in phase 2 and 3 also consists of answering an online questionnaire. The objective of phase 2 is to obtain more details about the causes and consequences of hypoglycemia whereas the objective of phase 3 is to collect information on sleep habits, depression, social support, stigma and physical activity. You will be invited to answer a food questionnaire.

Phase 1 will be done on an annual basis meaning that in one year from today, you will be invited to answer the same questionnaire once again, and if you accept, send us the report of the last 14 days of your continuous glucose monitor (if you are using one). In addition, you will be invited to answer additional questions coming from phase 2 and 3, and if you accept, to answer the food questionnaire.

STORAGE OF DATA

All data will be stored in a secure database located on a server at the Institut de recherches cliniques de Montréal (Montreal, Quebec, Canada), under the responsibility of Dr. Rémi Rabasa-Lhoret, director of the BETTER registry. Security backup copies of the data are generated daily.

The data included in the registry will only be accessible by the director of the BETTER registry and its immediate collaborators in accordance with the BETTER Registry Management Framework.

RISKS

There is no known physical risk to participate in this registry. However, the time required to answer the questionnaire can be a disadvantage for some participants and cause questions or stress. You may stop responding to the questionnaire at any time or continue at another time if you wish.

Risk associated with a breach of confidentiality: There is a risk of a possible breach of confidentiality regarding your personal information that could result in a breach of your privacy. This risk however is minimal. Every effort will be made to protect your privacy and confidentiality as described in the "Confidentiality" section.

BENEFITS

You will not derive any personal benefit from participating in this registry or in the research projects in which your data will be used. However, the research done with your data included in the registry may enable the researchers to learn more about the occurrence of hypoglycemia and improve patient care in the future.

CONFIDENTIALITY

The principal investigator will protect your file so that your name, address and telephone number will remain confidential.

Your data entered into the database will be identified only by your identification number. It will be possible to identify you and link your data only by the identification number kept by the principal investigator and the coordinator responsible of the entry of your data in the registry.

Any researcher who is not part of the BETTER research team and who wants to have access to the registry data will have to submit his project to the Registry Management Committee, which will evaluate the research projects for which access to the registry data will be granted, in accordance with the registry management framework. In addition, a research ethics board will have approved any research based on your data included in the registry.

The reports concerning any research done using data included in the registry will not be sent to you because the research will be done based on data of a very large number of participants and will not be of any diagnostic or therapeutic consequence to you. Research data may be published or be the subject of scientific discussion, but it will not be possible to identify you.

COMPENSATION

You will receive no financial compensation for your participation in this registry. However, you have the chance to win a cash gift worth $500 (1 cash gift will be drawn for every 500 participation coupons). Your chances of winning will increase according to your degree of participation in the registry:
• Phase 1: one chance to win (1 coupon)
• Phase 2: two additional chances to win (3 coupons)
• Phase 3: two additional chances to win (5 coupons)
• Annual questionnaire: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 2: one additional chance to win (1 coupon per year)
• Annual questionnaire - Part 3: one additional chance to win (1 coupon per year)
• Report of the last 14 days of the continuous glucose monitor: one additional chance to win (1 coupon per year)
• Food questionnaire: one additional chance to win (1 coupon per year)

SHOULD YOU SUFFER ANY HARM

Should you suffer harm of any kind related to your participation in this registry, you are not waiving any of your legal rights nor discharging the principal investigator, the funding agencies or the institution, of their civil and professional responsibilities.

POSSIBILITY OF MARKETING

Your participation in this registry could lead to the creation of commercial products that could potentially be protected by patent or other intellectual property rights. However, in such a case, you will not be able to obtain any financial benefit.

FUNDING OF THE REGISTRY

This registry is funded by the funding agencies.

VOLUNTARY PARTICIPATION AND THE RIGHT TO WITHDRAW

Your participation in this registry is voluntary. You can decide not to participate or withdraw your consent at any time. If you choose not to participate or to withdraw from this registry, it will have no impact on the quality of care and services you receive or on your relationship with your doctor and the healthcare team.

If you decide to stop participating in the registry and no longer want your data to be used for research purposes, you must inform the research team. Your data will then be destroyed.

Any new information acquired during the course of the project likely to influence your decision to continue to participate in the registry will be communicated to you without delay verbally and in writing.

IDENTIFICATION OF CONTACT PEOPLE

Should you have any question regarding this registry, you may contact the principal investigator and director of the registry, Dr. Rémi Rabasa-Lhoret, at the following number: 1-833-897-3172 (between 8:00 and 16:00, Monday to Friday).

Shoud you have any questions about your rights as a participant in a registry or have any complaints or comments, you can contact:
• The associate commissioner for complaints and service quality of the CHUM at (514) 880-8484.

APPROVAL OF THE RESEARCH ETHICS BOARD

The CHUM's Research Ethics Board has approved the project to establish a registry and is responsible for monitoring it at all participating institutions in the health and social services network in Quebec.

COMMITMENT OF THE PRINCIPAL INVESTIGATOR

I undertake, together with the research team, to respect what was agreed upon in the information and consent form.

CONSENT

I declare that I have read this consent form (or that it has been read to me), specifically as regards the nature of my participation in the registry and the extent of the associated risks. I acknowledge that all of my questions have been answered and that I have been given the necessary time to make a decision. I freely and voluntarily agree to participate in this registry.

By clicking on YES, I voluntarily agree to participate in phase 1 of the registry and will be redirected to the questionnaire.

By accepting to participate in this registry, I am not waiving any of my legal rights or and I do not release the researchers, funding agencies or the institution from their civil and professional responsibilities.

* must provide value

YES, I accept to participate in phase 1 of the BETTER registry. By the meantime, I accept that my coded data be used for various research projects approved by a Research Ethics Board.

NO, I do not accept to participate in phase 1 of the BETTER registry.

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PDF version of the information and consent form

Attachment:18.232_FICadultesphase1_AN_autres_provinces_v1.0_20220728_FinalCÉRCHUM_20221102.pdf

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If you have any problems while answering the questionnaire, please consult our FAQ section on our website: https://type1better.com/en/frequently-asked-questions-faq/.

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