Dr. Brandy Wicklow discusses diabetes research models, how individuals with diabetes can participate, and expectations as a research study participant.
Speaker: Dr. Brandy Wicklow, MD, MSC (epi), FRCPC
Speaker: Dr. Brandy Wicklow, MD, MSC (epi), FRCPC
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I'm so pleased that you are joining us0:10
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diabetes deep Dives is a series of0:14
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your Healthcare team if you have1:00
questions about your care please speak1:02
to your health care provider and team to1:05
make sure that you are getting the best1:06
advice1:09
have you ever wondered about what goes1:11
into the research that informs the1:13
development of a new diabetes treatment1:15
or how new technology is tested for1:18
diabetes management1:19
are you interested in getting involved1:21
in the research process1:24
in this video we will explore the1:26
different ways of conducting research1:28
that contributes to helping us prevent1:30
treat and find a cure for diabetes as1:33
well as how people affected by diabetes1:35
can participate1:37
our guest speaker Dr Brandy Wicklow will1:40
share her knowledge about commonly used1:42
research models for diabetes research1:44
and the ways in which people affected by1:47
diabetes can get involved1:49
she'll also tell us a little bit about1:51
what to expect as a participant in a1:53
research study1:55
after watching this video we hope that1:57
you will be able to1:59
identify the different types of research2:01
models and the differences between them2:04
find the resources to learn more about2:06
the diabetes research projects happening2:08
in Canada and internationally2:11
understand what to expect and what your2:13
rights are if you participate in a2:15
research project2:17
and make an informed decision if you are2:20
thinking about getting involved in a2:21
diabetes research project2:24
Dr Wicklow is an associate professor in2:27
the department of Pediatrics and child2:29
health at the University of Manitoba and2:31
a clinical investigator at the2:33
Children's Hospital Research Institute2:34
of Manitoba2:36
Dr micklow's research is focused on the2:39
determinants of type 2 diabetes and its2:41
renal complications in children with a2:43
particular interest in the Indigenous2:45
population of Northern Manitoba2:49
we hope that you will find this video2:50
informative and that it will spark your2:52
interest in learning more about diabetes2:55
research and about getting involved and2:57
now over to Dr Wicklow3:00
researching clinical trials is the basis3:03
of everything we know about diabetes3:05
that's how we learn how to diagnose3:07
diabetes how to screen for diabetes and3:09
its complications how to treat and3:12
manage blood sugars and how to prevent3:14
complications3:16
and support people living well with3:18
diabetes as a physician all of the3:20
clinical practice guidelines that I3:22
follow in my clinical practice3:24
are informed by this clinical research3:28
just like there are many different types3:31
of diabetes in many different3:32
populations of people affected by3:34
diabetes so the research is quite Broad3:37
in this area3:41
researchers cover anything from what are3:44
the most important and relevant3:46
questions to people living with diabetes3:49
how do we support people in terms of3:51
their mental health their nutrition and3:54
their physical activity when living with3:56
diabetes3:57
how to prevent diabetes4:00
and perhaps most importantly to those4:02
living with diabetes how to find a cure4:07
because all of these questions are very4:09
different and very important there are a4:12
multitude of different studies and4:14
different study types that someone4:16
living with diabetes can get involved4:18
with we're going to go through a few of4:20
those today on this deep dive looking at4:23
Clinical Research in diabetes4:25
when people think about research and4:28
specifically Research into diabetes they4:30
often think about two things4:32
the research that's looking into a cure4:34
and the research to prevent diabetes4:39
many of these research trials are4:41
clinical trials and often the randomized4:44
clinical trials4:46
a randomized clinical trial is a4:48
clinical trial that looks at a new4:51
medication4:52
a new preventative measure4:56
a new treatment for prevention of4:58
complications5:00
a new way to monitor or screen and it5:04
Compares these new Innovations to common5:07
practice5:09
or the current standard of clinical5:11
practice that you would experience when5:12
you go to see your doctor on a regular5:14
basis5:16
these new treatments or therapies have5:19
often been trialed in cellular models or5:22
animal models and at some point those5:24
same therapies need to be trod and5:26
humans with diabetes so that we can5:30
ensure that they're safe they're5:32
tolerable and they're efficacious or5:35
they work well5:37
oftentimes these types of Trials are5:39
what we call randomized randomization is5:43
really just like a flip of the coin5:45
if you're enrolled in a trial and you're5:48
going to be randomized what that means5:51
is you are going to be randomly selected5:54
to be either in the treatment group5:56
trying the brand new drug the brand new5:59
method of dosing the brand new way of6:03
screening6:04
and if you are randomized into the6:06
control group you'll be getting your6:09
usual Care by your usual clinician6:12
through usual means6:15
occasionally control groups will also6:17
experience additional testing screening6:20
or questionnaires that are given to the6:23
group that is receiving the intervention6:25
in order to compare things like6:28
vulnerability side effects quality of6:31
life6:33
these trials are incredibly important6:36
and they're a way to get a new6:38
medication such as empathoglobin6:42
closed-loop insulin pump system6:45
from Discovery and development6:49
to the market6:51
and only when these types of research6:53
Studies have shown that a medication or6:57
an innovation is safe is effective and7:01
oftentimes it's Superior to what we7:04
currently have and can recommend for7:05
people living with diabetes will it be7:08
made available through Health Canada for7:10
all people with living living with7:12
diabetes to be able to use7:15
prevention trials are often similar the7:18
randomized trials but they're performed7:21
in a population of people who have not7:23
yet developed diabetes or who have not7:27
yet developed complications of diabetes7:30
and these new Innovative treatments are7:33
used to prevent the develop or7:36
development or progression of diabetes7:38
in a population7:41
this is the discovery of insulin in7:43
Toronto over a hundred years ago7:45
Canadian researchers have been at the7:47
Forefront of many of these research7:49
projects7:50
often centers throughout Canada are7:53
recruiting people with diabetes to7:55
participate in these International7:56
research studies looking at new7:59
medications to prevent or treat Type 18:03
Diabetes Type 2 diabetes gestational8:06
diabetes or other types of diabetes8:09
in addition to randomized control trials8:12
there are several other types of8:13
research that you can get involved in8:16
some of these different types of8:17
research studies include focus groups8:19
observational trials and occasionally8:22
it's just a single sample of blood in8:25
order for fundamental scientists who do8:27
cell cellular modeling or stem cell8:29
therapy to look at potentials for8:32
prevention or a cure8:34
focus groups are often just that they're8:38
groups of individuals with lived8:39
experience8:41
with either Type 1 Diabetes Type 28:43
diabetes gestational diabetes or other8:47
they're asked a set of questions to8:49
inform what is the priority for research8:52
for people living with diabetes what are8:54
the important and relevant questions to8:57
you to your loved ones and to other8:59
families living and or affected by9:02
diabetes9:04
often these priority setting exercises9:06
are the basis of some of the largest9:09
networks of research there are in Canada9:11
including9:13
the patient-oriented research networks9:16
uh diabetes action Canada and cancel CKD9:21
for more about those two organizations9:23
in a minute9:25
personal interviews focus groups or9:29
questionnaires that look at how one9:32
lives with diabetes9:34
what's a barrier to living well with9:36
diabetes9:37
what has been found to be supportive of9:40
living well with diabetes and where9:42
people find there's not enough advice or9:45
information9:46
these are the places where researchers9:48
are going to focus their efforts in the9:51
future9:53
currently research at sites across9:55
Canada are looking at what's important9:58
to people living with diabetes in the10:01
research Realm10:03
how do we deliver care in the best10:05
possible way10:06
how do we screen for and prevent10:08
complications of diabetes10:11
how do we transfer transition patients10:14
from a pediatric diabetes Clinic to an10:16
adult diabetes clinic in the safe and10:19
most effective way10:21
researchers are looking to partner with10:24
persons affected or living with diabetes10:26
and their families or caregivers in10:29
order to do important and relevant10:31
research to those who are affected by10:34
diabetes10:36
as I mentioned previously there are10:38
several organizations which have10:40
information for patients and families10:42
which outlines some of the different10:45
projects that are happening in Canada10:47
and how you might be able to get10:48
involved one of those is diabetes action10:52
Canada10:54
if you Google diabetes action Canada10:56
you'll come to a face page which10:58
includes an area for patients or persons11:02
living with diabetes it also includes an11:05
outline of all of the researchers in11:07
Canada who belong to the organization11:09
and some of the work that they are doing11:12
through diabetes action in Canada there11:15
is a project called connect 1D11:19
connect 1D Canada is an interface on the11:23
computer which allows patients and11:25
people living with diabetes to register11:28
online to be contacted or considered for11:31
different clinical trials or research11:34
programs that come up11:37
other websites with useful information11:39
to look at research being done in11:41
diabetes across Canada include diabetes11:44
Canada11:45
the juvenile diabetes Research11:47
Foundation or JDRF and can solve CKD11:51
which looks specifically at kidney11:54
outcomes of people living with diabetes11:57
in addition to these websites they're12:00
also International websites that outline12:03
some of the projects where Canadians are12:05
included12:07
this includes trial net12:09
trial net is a type 1 diabetes screening12:12
and prevention platform12:15
is looking specifically at the genetic12:17
risks of diabetes and also the12:20
environmental risks of diabetes12:24
trial net is an international research12:26
organization that runs prevention trials12:29
and diabetes and also screening for12:31
diabetes12:33
specific research projects include12:35
looking at the genetic basis and risk of12:37
diabetes early detection of diabetes in12:40
order to use preventative novel12:43
therapies to delay the onset of diabetes12:47
or prevent it altogether12:49
other research programs can be found on12:52
the government website called12:54
clinicaltrials.gov This is where12:56
clinical trials register all of their12:59
inclusion criteria exclusion criteria13:02
what the study questions are and who13:05
they're looking for in terms of13:06
participation13:07
oftentimes if you type in the search13:11
type 1 diabetes type 2 diabetes13:14
gestational diabetes or whatever it is13:18
that is relevant to you into the search13:20
box up top you will also allow you to13:23
search by country13:25
if there's a Canadian site that is13:27
recruiting for one of those studies that13:30
you are interested in there's often13:32
times a contact information at the13:34
bottom of the page which allows you to13:36
connect with the researchers directly13:39
finally there's your local Health Care13:42
practitioners13:43
often although as a physician myself I13:46
don't always know about every new13:48
clinical trial or every research project13:51
that's happening in Canada if there are13:54
specific ones that are of interest to13:56
you with respect to exercise and13:58
hypoglycemia closed loop insulin pump14:03
systems14:04
or mental health supports for diabetes14:07
distress or diabetes burnout I can often14:11
find those projects for you by using my14:14
own Connections in the field14:17
and now I know you're asking how can I14:19
get involved14:20
you can start by talking to your health14:22
care provider about what speaks to you14:25
what are the most important research14:27
questions that you think there are in14:29
the field of diabetes what's relevant to14:32
you and to your family14:34
then often your physician Allied Health14:37
care provider diabetes educator can lead14:40
you to a website like one of the ones we14:43
spoke of above which will allow you to14:45
see what current projects are happening14:47
within Canada North America or14:50
internationally14:53
often times with the help of your14:55
physician your diabetes educator or14:57
another Allied Health professional you15:00
will be able to get connected to the15:01
primary researcher of those projects to15:04
look to see if you're eligible to15:06
participate15:07
if you're deemed eligible to participate15:10
then there you go you've started your15:12
research Journey15:14
oftentimes I'm asked what about my15:17
privacy my confidentiality15:20
who's going to know that I'm15:21
participating in this trial who gets to15:24
look at my a1cs over time15:26
how many people are going to see what my15:29
BMI is over time or how much physical15:33
activity I do on a regular basis or what15:36
I eat15:38
all research projects are reviewed and15:41
overseen by an Institutional ethics15:43
review board the purpose of that board15:46
is to make sure that you're safe in a15:49
trial and also that your data is15:51
protected and it protects your privacy15:53
and confidentiality15:56
every trial that you enroll in will give15:59
you a unique study identification number16:02
most trials will not have any16:05
information about you including name16:07
address birth date attached to either16:11
your questionnaire answers your food16:15
Diaries your blood samples or your urine16:18
samples16:20
these are all what we call anonymized or16:23
given a code so that even if someone16:26
were to see the results of your blood16:28
test they would have no idea that they16:30
belong to you16:34
your rights as a patient are to expect16:37
that the researchers follow their16:40
institutional ethics review board16:42
suggestions in terms of privacy and16:45
confidentiality16:46
that they keep all of your data safe in16:49
a secure network that is not hackable by16:52
outside sources and as password16:54
protected16:55
that your data does not leave16:57
institutional software17:00
and is not placed on personal equipment17:03
it's not shared with other individuals17:06
in the researchers family or friends17:09
circle17:10
and it is specific to This research17:12
project17:14
and the data is anonymized for analysis17:18
your data is often kept for several17:21
years within a locked facility on a17:25
secured17:27
computer hard drive within an17:30
institution just in case there are17:32
questions about data quality the data17:36
analysis or the outcomes of the data17:39
when the study or trial is ended17:42
after that mandatory period of time on17:46
which the files are capped they will be17:48
destroyed entirely17:50
or in some cases if the data is capped17:53
anonymized17:55
each individual who signs consent to17:58
belong to that study will be informed18:01
and consented again if that data is to18:04
be used for any other future analyzes18:06
that were not outlined in the original18:08
consent the risks of being involved in a18:11
clinical trial really depend on the type18:13
of trial that you get yourself involved18:15
with18:16
some clinical studies that are looking18:18
at priority setting what are the most18:21
relevant questions to people living with18:23
diabetes to inform what researchers18:25
actually research18:27
to how does mental health support or18:32
exercise advice or nutrition advice18:36
impact the lives of people with diabetes18:39
and finally there are clinical trials18:42
that are looking at novel medications or18:46
new ways to give insulin therapy18:50
in terms of management or prevention of18:53
diabetes18:56
in the former often those studies18:59
involve focus groups or interviews some19:02
questionnaires sometimes observational19:05
or longitudinal follow-up of blood work19:07
or19:09
complication screening19:12
there's often little risk associated19:14
with these types of studies as there's19:17
no novel intervention or drug being19:19
introduced19:22
when getting involved in a treatment19:24
trial then there is the possibility that19:27
you'll be randomized to a drug that19:30
currently either isn't licensed or isn't19:32
standard of care for people who are19:34
living with diabetes19:36
with that consumerous that the newer19:39
type of drug or medication either will19:42
have a side effect that you don't19:44
tolerate or perhaps won't work as well19:47
in you with respect to glycemic19:50
management19:51
complication management or prevention of19:54
complications19:56
oftentimes the risks that are associated19:59
with clinical trials that are trying new20:01
medications uh or new technology these20:07
risks are decreased because these have20:09
been either tried in a population20:11
without diabetes prior to being tried in20:15
a larger population of people with20:16
diabetes or they've been tried in other20:19
animal models in terms of safety and20:23
efficacy20:25
oftentimes the trial methodology20:28
includes very close follow-up more20:32
frequent blood work and more frequent20:34
contact with your physician or the study20:36
physician to ensure that you are safe20:39
that you are tolerating the intervention20:42
or the new treatment and that things are20:44
going well for you within the study20:46
trial as always if you're not doing well20:50
in the study the medication doesn't20:52
appear to be working or you're having20:54
significant side effects you might be20:56
withdrawn from The Trial by the study20:58
doctor who doesn't think it's in your21:00
best interest or you're always able to21:03
withdraw yourself from any clinical21:05
trial at any time21:07
if you decide to stop participation in21:10
any trial that's okay you'll still get21:14
clinical Care by your clinical team it21:16
won't impact how your doctors care for21:19
you it also doesn't impact whether or21:21
not you will be eligible to participate21:24
in a trial in the future21:26
as a physician at a clinical researcher21:28
I can tell you that we understand that21:31
participating in a clinical trial at any21:33
given time isn't the right thing for21:36
everybody and sometimes even though you21:38
start a clinical trial it doesn't21:41
benefit you to continue21:43
and perhaps in the future there will be21:45
a better clinical trial for you21:48
during a clinical trial it's difficult21:50
to give feedback on the trial design or21:56
the child protocol meaning what you have21:58
to do during the trial22:01
um in terms of changing the trial22:04
protocol22:06
oftentimes clinical trials have very22:09
standard and set protocols that every22:12
participating site follows across Canada22:15
North America or internationally22:18
depending on where the trial is being22:21
rolled out22:22
so often if you don't think that the22:25
visits are timed right or that you22:29
should be answering that many22:30
questionnaires there's often not an22:33
option at that point to make a change to22:36
that clinical trial however22:38
researchers are always looking for input22:42
of people who are participants in their22:44
trials on people with lived experience22:46
in order to make these trials uh more22:49
approachable for participation to make22:52
it easier and less burdensome on people22:55
who have agreed to participate in these22:57
trials and also23:00
to inform how to make future clinical23:02
trials better for people living with23:04
diabetes23:06
oftentimes researchers are looking for23:09
participants in their trial to help them23:11
decide whether or not what happens in a23:14
clinical trial is actually possible or23:16
it can be translated into real life and23:19
real day-to-day living and this is23:21
important because once a new treatment23:24
or a new motive therapy or a new23:27
screening protocol is put into place23:29
then it will become a standard of23:31
practice with the expectation that this23:34
will be useful and non-burdensome to23:37
people living with diabetes23:39
sometimes at the end of the trial or23:42
near the end of the trial the23:44
researchers will have an exit interview23:45
this is one of the formal ways to give23:47
feedback with respect to your experience23:49
in the trial what measures you thought23:52
were most important what measures you23:55
thought were more or less relevant to23:58
you and your lived experience all of24:00
these things are incredibly important to24:03
designing the next clinical trial24:06
if there isn't a formal exit interview24:09
or way to provide feedback you're always24:12
welcome to provide feedback by asking to24:14
speak to this study principal24:16
investigator or a member of the research24:19
team24:21
you won't always know of the feedback24:23
you get give gets incorporated into the24:25
next clinical trial or is incorporated24:29
into the next trial of that same24:31
medication with a different population24:33
you can always ask for feedback you can24:36
go on24:37
clinicaltrials.gov to look up the24:40
clinical trial that you were a part of24:41
oftentimes that will show you the24:43
preliminary results or the results of24:46
the study thus far that you participated24:48
in it often will also show you the edits24:51
or changes that are made to the protocol24:53
of research which oftentimes people24:57
living with diabetes have informed24:59
finally if you're interested in clinical25:02
trials and you want to get involved25:04
please reach out to any of the25:07
organizations that I discussed earlier25:09
to your local health care provider25:12
to the group of diabetes act in Canada25:14
or diabetes Canada25:17
there is so much incredible research25:19
that's going on right now with Canadian25:22
researchers here locally nationally and25:26
internationally that you could be a part25:28
of I hope you found this helpful25:31
thank you so much for joining us to dive25:33
deeper into diabetes research and how25:35
people affected by diabetes can25:37
participate and contribute to this very25:39
important work25:41
please take the opportunity to let us25:43
know what you learned what you liked and25:45
how we can do better25:47
you can do that by posting a comment in25:49
the comment section below or by clicking25:51
the link to the feedback survey in the25:53
description box25:54
if you have ideas for other topics you'd25:57
like to learn more about you can include25:58
that in the comments or feedback survey26:01
as well26:02
you will find the website links to the26:04
organizations that Dr Wicklow mentions26:07
in the video in the description box as26:09
well as some additional helpful26:11
resources on this topic from diabetes26:13
Canada26:14
if you are looking for more resources26:16
about diabetes management please visit26:18
our website at diabetes.ca you can also26:22
email us at info diabetes.ca or call our26:26
info line at 1-800-banting that's26:31
1-800-226-8464 and speak to one of our26:33
information and support Specialists who26:36
can address your needs thanks again for26:38
joining us and see you next time26:40
thank you26:43
[Music]
foreign0:08
I'm so pleased that you are joining us0:10
today0:11
diabetes deep Dives is a series of0:14
videos designed to dive deeper and0:16
Beyond the surface of different areas of0:18
diabetes management we are exploring0:20
those burning questions that you may0:22
have by featuring Dynamic and engaging0:24
guests with knowledge or lived0:26
experience on the topic our goal is to0:29
share information in ways that will0:31
spark continued interest and learning0:33
and leave you with practical tips and0:35
tools that you can easily use we'll be0:37
dropping a new video every month so0:39
subscribe to our YouTube channel and0:41
click on the notification Bell to be0:43
notified about new content you can also0:45
check us out on social media to find out0:47
when the next one will be posted on our0:49
YouTube channel0:52
just a reminder that the information0:54
shared in these videos in no way0:56
replaces the advice and direction from0:58
your Healthcare team if you have1:00
questions about your care please speak1:02
to your health care provider and team to1:05
make sure that you are getting the best1:06
advice1:09
have you ever wondered about what goes1:11
into the research that informs the1:13
development of a new diabetes treatment1:15
or how new technology is tested for1:18
diabetes management1:19
are you interested in getting involved1:21
in the research process1:24
in this video we will explore the1:26
different ways of conducting research1:28
that contributes to helping us prevent1:30
treat and find a cure for diabetes as1:33
well as how people affected by diabetes1:35
can participate1:37
our guest speaker Dr Brandy Wicklow will1:40
share her knowledge about commonly used1:42
research models for diabetes research1:44
and the ways in which people affected by1:47
diabetes can get involved1:49
she'll also tell us a little bit about1:51
what to expect as a participant in a1:53
research study1:55
after watching this video we hope that1:57
you will be able to1:59
identify the different types of research2:01
models and the differences between them2:04
find the resources to learn more about2:06
the diabetes research projects happening2:08
in Canada and internationally2:11
understand what to expect and what your2:13
rights are if you participate in a2:15
research project2:17
and make an informed decision if you are2:20
thinking about getting involved in a2:21
diabetes research project2:24
Dr Wicklow is an associate professor in2:27
the department of Pediatrics and child2:29
health at the University of Manitoba and2:31
a clinical investigator at the2:33
Children's Hospital Research Institute2:34
of Manitoba2:36
Dr micklow's research is focused on the2:39
determinants of type 2 diabetes and its2:41
renal complications in children with a2:43
particular interest in the Indigenous2:45
population of Northern Manitoba2:49
we hope that you will find this video2:50
informative and that it will spark your2:52
interest in learning more about diabetes2:55
research and about getting involved and2:57
now over to Dr Wicklow3:00
researching clinical trials is the basis3:03
of everything we know about diabetes3:05
that's how we learn how to diagnose3:07
diabetes how to screen for diabetes and3:09
its complications how to treat and3:12
manage blood sugars and how to prevent3:14
complications3:16
and support people living well with3:18
diabetes as a physician all of the3:20
clinical practice guidelines that I3:22
follow in my clinical practice3:24
are informed by this clinical research3:28
just like there are many different types3:31
of diabetes in many different3:32
populations of people affected by3:34
diabetes so the research is quite Broad3:37
in this area3:41
researchers cover anything from what are3:44
the most important and relevant3:46
questions to people living with diabetes3:49
how do we support people in terms of3:51
their mental health their nutrition and3:54
their physical activity when living with3:56
diabetes3:57
how to prevent diabetes4:00
and perhaps most importantly to those4:02
living with diabetes how to find a cure4:07
because all of these questions are very4:09
different and very important there are a4:12
multitude of different studies and4:14
different study types that someone4:16
living with diabetes can get involved4:18
with we're going to go through a few of4:20
those today on this deep dive looking at4:23
Clinical Research in diabetes4:25
when people think about research and4:28
specifically Research into diabetes they4:30
often think about two things4:32
the research that's looking into a cure4:34
and the research to prevent diabetes4:39
many of these research trials are4:41
clinical trials and often the randomized4:44
clinical trials4:46
a randomized clinical trial is a4:48
clinical trial that looks at a new4:51
medication4:52
a new preventative measure4:56
a new treatment for prevention of4:58
complications5:00
a new way to monitor or screen and it5:04
Compares these new Innovations to common5:07
practice5:09
or the current standard of clinical5:11
practice that you would experience when5:12
you go to see your doctor on a regular5:14
basis5:16
these new treatments or therapies have5:19
often been trialed in cellular models or5:22
animal models and at some point those5:24
same therapies need to be trod and5:26
humans with diabetes so that we can5:30
ensure that they're safe they're5:32
tolerable and they're efficacious or5:35
they work well5:37
oftentimes these types of Trials are5:39
what we call randomized randomization is5:43
really just like a flip of the coin5:45
if you're enrolled in a trial and you're5:48
going to be randomized what that means5:51
is you are going to be randomly selected5:54
to be either in the treatment group5:56
trying the brand new drug the brand new5:59
method of dosing the brand new way of6:03
screening6:04
and if you are randomized into the6:06
control group you'll be getting your6:09
usual Care by your usual clinician6:12
through usual means6:15
occasionally control groups will also6:17
experience additional testing screening6:20
or questionnaires that are given to the6:23
group that is receiving the intervention6:25
in order to compare things like6:28
vulnerability side effects quality of6:31
life6:33
these trials are incredibly important6:36
and they're a way to get a new6:38
medication such as empathoglobin6:42
closed-loop insulin pump system6:45
from Discovery and development6:49
to the market6:51
and only when these types of research6:53
Studies have shown that a medication or6:57
an innovation is safe is effective and7:01
oftentimes it's Superior to what we7:04
currently have and can recommend for7:05
people living with diabetes will it be7:08
made available through Health Canada for7:10
all people with living living with7:12
diabetes to be able to use7:15
prevention trials are often similar the7:18
randomized trials but they're performed7:21
in a population of people who have not7:23
yet developed diabetes or who have not7:27
yet developed complications of diabetes7:30
and these new Innovative treatments are7:33
used to prevent the develop or7:36
development or progression of diabetes7:38
in a population7:41
this is the discovery of insulin in7:43
Toronto over a hundred years ago7:45
Canadian researchers have been at the7:47
Forefront of many of these research7:49
projects7:50
often centers throughout Canada are7:53
recruiting people with diabetes to7:55
participate in these International7:56
research studies looking at new7:59
medications to prevent or treat Type 18:03
Diabetes Type 2 diabetes gestational8:06
diabetes or other types of diabetes8:09
in addition to randomized control trials8:12
there are several other types of8:13
research that you can get involved in8:16
some of these different types of8:17
research studies include focus groups8:19
observational trials and occasionally8:22
it's just a single sample of blood in8:25
order for fundamental scientists who do8:27
cell cellular modeling or stem cell8:29
therapy to look at potentials for8:32
prevention or a cure8:34
focus groups are often just that they're8:38
groups of individuals with lived8:39
experience8:41
with either Type 1 Diabetes Type 28:43
diabetes gestational diabetes or other8:47
they're asked a set of questions to8:49
inform what is the priority for research8:52
for people living with diabetes what are8:54
the important and relevant questions to8:57
you to your loved ones and to other8:59
families living and or affected by9:02
diabetes9:04
often these priority setting exercises9:06
are the basis of some of the largest9:09
networks of research there are in Canada9:11
including9:13
the patient-oriented research networks9:16
uh diabetes action Canada and cancel CKD9:21
for more about those two organizations9:23
in a minute9:25
personal interviews focus groups or9:29
questionnaires that look at how one9:32
lives with diabetes9:34
what's a barrier to living well with9:36
diabetes9:37
what has been found to be supportive of9:40
living well with diabetes and where9:42
people find there's not enough advice or9:45
information9:46
these are the places where researchers9:48
are going to focus their efforts in the9:51
future9:53
currently research at sites across9:55
Canada are looking at what's important9:58
to people living with diabetes in the10:01
research Realm10:03
how do we deliver care in the best10:05
possible way10:06
how do we screen for and prevent10:08
complications of diabetes10:11
how do we transfer transition patients10:14
from a pediatric diabetes Clinic to an10:16
adult diabetes clinic in the safe and10:19
most effective way10:21
researchers are looking to partner with10:24
persons affected or living with diabetes10:26
and their families or caregivers in10:29
order to do important and relevant10:31
research to those who are affected by10:34
diabetes10:36
as I mentioned previously there are10:38
several organizations which have10:40
information for patients and families10:42
which outlines some of the different10:45
projects that are happening in Canada10:47
and how you might be able to get10:48
involved one of those is diabetes action10:52
Canada10:54
if you Google diabetes action Canada10:56
you'll come to a face page which10:58
includes an area for patients or persons11:02
living with diabetes it also includes an11:05
outline of all of the researchers in11:07
Canada who belong to the organization11:09
and some of the work that they are doing11:12
through diabetes action in Canada there11:15
is a project called connect 1D11:19
connect 1D Canada is an interface on the11:23
computer which allows patients and11:25
people living with diabetes to register11:28
online to be contacted or considered for11:31
different clinical trials or research11:34
programs that come up11:37
other websites with useful information11:39
to look at research being done in11:41
diabetes across Canada include diabetes11:44
Canada11:45
the juvenile diabetes Research11:47
Foundation or JDRF and can solve CKD11:51
which looks specifically at kidney11:54
outcomes of people living with diabetes11:57
in addition to these websites they're12:00
also International websites that outline12:03
some of the projects where Canadians are12:05
included12:07
this includes trial net12:09
trial net is a type 1 diabetes screening12:12
and prevention platform12:15
is looking specifically at the genetic12:17
risks of diabetes and also the12:20
environmental risks of diabetes12:24
trial net is an international research12:26
organization that runs prevention trials12:29
and diabetes and also screening for12:31
diabetes12:33
specific research projects include12:35
looking at the genetic basis and risk of12:37
diabetes early detection of diabetes in12:40
order to use preventative novel12:43
therapies to delay the onset of diabetes12:47
or prevent it altogether12:49
other research programs can be found on12:52
the government website called12:54
clinicaltrials.gov This is where12:56
clinical trials register all of their12:59
inclusion criteria exclusion criteria13:02
what the study questions are and who13:05
they're looking for in terms of13:06
participation13:07
oftentimes if you type in the search13:11
type 1 diabetes type 2 diabetes13:14
gestational diabetes or whatever it is13:18
that is relevant to you into the search13:20
box up top you will also allow you to13:23
search by country13:25
if there's a Canadian site that is13:27
recruiting for one of those studies that13:30
you are interested in there's often13:32
times a contact information at the13:34
bottom of the page which allows you to13:36
connect with the researchers directly13:39
finally there's your local Health Care13:42
practitioners13:43
often although as a physician myself I13:46
don't always know about every new13:48
clinical trial or every research project13:51
that's happening in Canada if there are13:54
specific ones that are of interest to13:56
you with respect to exercise and13:58
hypoglycemia closed loop insulin pump14:03
systems14:04
or mental health supports for diabetes14:07
distress or diabetes burnout I can often14:11
find those projects for you by using my14:14
own Connections in the field14:17
and now I know you're asking how can I14:19
get involved14:20
you can start by talking to your health14:22
care provider about what speaks to you14:25
what are the most important research14:27
questions that you think there are in14:29
the field of diabetes what's relevant to14:32
you and to your family14:34
then often your physician Allied Health14:37
care provider diabetes educator can lead14:40
you to a website like one of the ones we14:43
spoke of above which will allow you to14:45
see what current projects are happening14:47
within Canada North America or14:50
internationally14:53
often times with the help of your14:55
physician your diabetes educator or14:57
another Allied Health professional you15:00
will be able to get connected to the15:01
primary researcher of those projects to15:04
look to see if you're eligible to15:06
participate15:07
if you're deemed eligible to participate15:10
then there you go you've started your15:12
research Journey15:14
oftentimes I'm asked what about my15:17
privacy my confidentiality15:20
who's going to know that I'm15:21
participating in this trial who gets to15:24
look at my a1cs over time15:26
how many people are going to see what my15:29
BMI is over time or how much physical15:33
activity I do on a regular basis or what15:36
I eat15:38
all research projects are reviewed and15:41
overseen by an Institutional ethics15:43
review board the purpose of that board15:46
is to make sure that you're safe in a15:49
trial and also that your data is15:51
protected and it protects your privacy15:53
and confidentiality15:56
every trial that you enroll in will give15:59
you a unique study identification number16:02
most trials will not have any16:05
information about you including name16:07
address birth date attached to either16:11
your questionnaire answers your food16:15
Diaries your blood samples or your urine16:18
samples16:20
these are all what we call anonymized or16:23
given a code so that even if someone16:26
were to see the results of your blood16:28
test they would have no idea that they16:30
belong to you16:34
your rights as a patient are to expect16:37
that the researchers follow their16:40
institutional ethics review board16:42
suggestions in terms of privacy and16:45
confidentiality16:46
that they keep all of your data safe in16:49
a secure network that is not hackable by16:52
outside sources and as password16:54
protected16:55
that your data does not leave16:57
institutional software17:00
and is not placed on personal equipment17:03
it's not shared with other individuals17:06
in the researchers family or friends17:09
circle17:10
and it is specific to This research17:12
project17:14
and the data is anonymized for analysis17:18
your data is often kept for several17:21
years within a locked facility on a17:25
secured17:27
computer hard drive within an17:30
institution just in case there are17:32
questions about data quality the data17:36
analysis or the outcomes of the data17:39
when the study or trial is ended17:42
after that mandatory period of time on17:46
which the files are capped they will be17:48
destroyed entirely17:50
or in some cases if the data is capped17:53
anonymized17:55
each individual who signs consent to17:58
belong to that study will be informed18:01
and consented again if that data is to18:04
be used for any other future analyzes18:06
that were not outlined in the original18:08
consent the risks of being involved in a18:11
clinical trial really depend on the type18:13
of trial that you get yourself involved18:15
with18:16
some clinical studies that are looking18:18
at priority setting what are the most18:21
relevant questions to people living with18:23
diabetes to inform what researchers18:25
actually research18:27
to how does mental health support or18:32
exercise advice or nutrition advice18:36
impact the lives of people with diabetes18:39
and finally there are clinical trials18:42
that are looking at novel medications or18:46
new ways to give insulin therapy18:50
in terms of management or prevention of18:53
diabetes18:56
in the former often those studies18:59
involve focus groups or interviews some19:02
questionnaires sometimes observational19:05
or longitudinal follow-up of blood work19:07
or19:09
complication screening19:12
there's often little risk associated19:14
with these types of studies as there's19:17
no novel intervention or drug being19:19
introduced19:22
when getting involved in a treatment19:24
trial then there is the possibility that19:27
you'll be randomized to a drug that19:30
currently either isn't licensed or isn't19:32
standard of care for people who are19:34
living with diabetes19:36
with that consumerous that the newer19:39
type of drug or medication either will19:42
have a side effect that you don't19:44
tolerate or perhaps won't work as well19:47
in you with respect to glycemic19:50
management19:51
complication management or prevention of19:54
complications19:56
oftentimes the risks that are associated19:59
with clinical trials that are trying new20:01
medications uh or new technology these20:07
risks are decreased because these have20:09
been either tried in a population20:11
without diabetes prior to being tried in20:15
a larger population of people with20:16
diabetes or they've been tried in other20:19
animal models in terms of safety and20:23
efficacy20:25
oftentimes the trial methodology20:28
includes very close follow-up more20:32
frequent blood work and more frequent20:34
contact with your physician or the study20:36
physician to ensure that you are safe20:39
that you are tolerating the intervention20:42
or the new treatment and that things are20:44
going well for you within the study20:46
trial as always if you're not doing well20:50
in the study the medication doesn't20:52
appear to be working or you're having20:54
significant side effects you might be20:56
withdrawn from The Trial by the study20:58
doctor who doesn't think it's in your21:00
best interest or you're always able to21:03
withdraw yourself from any clinical21:05
trial at any time21:07
if you decide to stop participation in21:10
any trial that's okay you'll still get21:14
clinical Care by your clinical team it21:16
won't impact how your doctors care for21:19
you it also doesn't impact whether or21:21
not you will be eligible to participate21:24
in a trial in the future21:26
as a physician at a clinical researcher21:28
I can tell you that we understand that21:31
participating in a clinical trial at any21:33
given time isn't the right thing for21:36
everybody and sometimes even though you21:38
start a clinical trial it doesn't21:41
benefit you to continue21:43
and perhaps in the future there will be21:45
a better clinical trial for you21:48
during a clinical trial it's difficult21:50
to give feedback on the trial design or21:56
the child protocol meaning what you have21:58
to do during the trial22:01
um in terms of changing the trial22:04
protocol22:06
oftentimes clinical trials have very22:09
standard and set protocols that every22:12
participating site follows across Canada22:15
North America or internationally22:18
depending on where the trial is being22:21
rolled out22:22
so often if you don't think that the22:25
visits are timed right or that you22:29
should be answering that many22:30
questionnaires there's often not an22:33
option at that point to make a change to22:36
that clinical trial however22:38
researchers are always looking for input22:42
of people who are participants in their22:44
trials on people with lived experience22:46
in order to make these trials uh more22:49
approachable for participation to make22:52
it easier and less burdensome on people22:55
who have agreed to participate in these22:57
trials and also23:00
to inform how to make future clinical23:02
trials better for people living with23:04
diabetes23:06
oftentimes researchers are looking for23:09
participants in their trial to help them23:11
decide whether or not what happens in a23:14
clinical trial is actually possible or23:16
it can be translated into real life and23:19
real day-to-day living and this is23:21
important because once a new treatment23:24
or a new motive therapy or a new23:27
screening protocol is put into place23:29
then it will become a standard of23:31
practice with the expectation that this23:34
will be useful and non-burdensome to23:37
people living with diabetes23:39
sometimes at the end of the trial or23:42
near the end of the trial the23:44
researchers will have an exit interview23:45
this is one of the formal ways to give23:47
feedback with respect to your experience23:49
in the trial what measures you thought23:52
were most important what measures you23:55
thought were more or less relevant to23:58
you and your lived experience all of24:00
these things are incredibly important to24:03
designing the next clinical trial24:06
if there isn't a formal exit interview24:09
or way to provide feedback you're always24:12
welcome to provide feedback by asking to24:14
speak to this study principal24:16
investigator or a member of the research24:19
team24:21
you won't always know of the feedback24:23
you get give gets incorporated into the24:25
next clinical trial or is incorporated24:29
into the next trial of that same24:31
medication with a different population24:33
you can always ask for feedback you can24:36
go on24:37
clinicaltrials.gov to look up the24:40
clinical trial that you were a part of24:41
oftentimes that will show you the24:43
preliminary results or the results of24:46
the study thus far that you participated24:48
in it often will also show you the edits24:51
or changes that are made to the protocol24:53
of research which oftentimes people24:57
living with diabetes have informed24:59
finally if you're interested in clinical25:02
trials and you want to get involved25:04
please reach out to any of the25:07
organizations that I discussed earlier25:09
to your local health care provider25:12
to the group of diabetes act in Canada25:14
or diabetes Canada25:17
there is so much incredible research25:19
that's going on right now with Canadian25:22
researchers here locally nationally and25:26
internationally that you could be a part25:28
of I hope you found this helpful25:31
thank you so much for joining us to dive25:33
deeper into diabetes research and how25:35
people affected by diabetes can25:37
participate and contribute to this very25:39
important work25:41
please take the opportunity to let us25:43
know what you learned what you liked and25:45
how we can do better25:47
you can do that by posting a comment in25:49
the comment section below or by clicking25:51
the link to the feedback survey in the25:53
description box25:54
if you have ideas for other topics you'd25:57
like to learn more about you can include25:58
that in the comments or feedback survey26:01
as well26:02
you will find the website links to the26:04
organizations that Dr Wicklow mentions26:07
in the video in the description box as26:09
well as some additional helpful26:11
resources on this topic from diabetes26:13
Canada26:14
if you are looking for more resources26:16
about diabetes management please visit26:18
our website at diabetes.ca you can also26:22
email us at info diabetes.ca or call our26:26
info line at 1-800-banting that's26:31
1-800-226-8464 and speak to one of our26:33
information and support Specialists who26:36
can address your needs thanks again for26:38
joining us and see you next time26:40
thank you26:43
[Music]
Category Tags: Research;