April 22, 2025 • 38 mins
Episode Summary
In Episode 31 of Think Like a Pancreas-The Podcast, host Gary Scheiner and guest Ginger Vieira discuss the innovative approaches being taken by Diamyd Medical in the quest for a cure for type 1 diabetes.
They explore the significance of using precision medicine, and the role of GAD65 therapy to modulate the immune response in the early stages of type one diabetes.
Gary and Ginger share the potential of benefits of Diamyd Medical’s Diagnode-3’s clinical trial, the screening process for participants, and the hope it brings to newly diagnosed individuals.
Key Topics Discussed- Recent Vertex results
- The autoimmune process
- The importance of precision medicine in treating type 1 diabetes.
- How GAD65 therapy targets specific antibodies without widespread immune suppression.
- The process and benefits of participating in clinical trials
- What is different about Diamyd's Diagnode-3 trial.
- Who qualifies for the Diagnode-3 trial?
- What is involved in being a part of Diamyd's clinical trial?
-
How are outcomes measured?
-
What is in it for participants?
- 00:14 – Welcome and Disclaimer
- 01:00 - Introducing Ginger Vieira
- 03:09 – Why Ginger is talking about Diamyd
- 04:00 – Lessons to be learned from Veretex
- 06:11 - How do you define a cure for type 1 diabetes?
- 07:33- What is unique about Diamyd's therapy?
- 08:45 - What is unique about Diamyd's therapy?
- 11:27 – The importance of pre-diabetes screening
- 17:19 - The problem of widespread immunosuppression
- 20:45 - Why should you participate in the Diagnode-3 Clinical Trial?
- 25:36 - How does Diamyd's clinical trial differ from other trials?
- 26:56 - Final Thoughts and Future Directions
- 31:41 - Gary's thoughts on Diamyd Medical's clinical trial
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Transcript
Episode Transcript
Available transcripts are automatically generated. Complete accuracy is not guaranteed.
Gary (00:13):
Welcome to Think Like a Pancreas, the podcast where our goal is to keep
you informed, inspired, and a littleentertained on all things diabetes.
The information contained in thisprogram is based on the experience
and opinions of the IntegratedDiabetes Services clinical team.
Please discuss any changes to yourtreatment plan with your personal
(00:33):
healthcare provider before implementing.
Today's program is sponsored by DiamydMedical, sponsors of the Dianode-3 study.
Welcome to Think Like aPancreas, the podcast.
I'm your host, Gary Scheiner.
Today's topic is the Quest for a Cure.
Have we found a Diamyd in the rough?
Ginger Vieira (00:53):
Very clever!
Gary (00:54):
I'm pleased to be joined by Ginger Vieira.
Ginger's joined us at other times.
Ginger, tell the folks at homea little bit about yourself.
Ginger Vieira (01:03):
Oh, I have lived with Type one diabetes for quite a while,
since 1999, and I've been writingbooks and articles and creating videos
about diabetes, uh, for many years.
But today I'm actually hereon behalf of Diamyd Medical.
Gary (01:19):
Okay.
I like the 1999, so you, we could redothat prince song, had diabetes since 1999.
Ginger Vieira (01:28):
You know, sometimes I say 25 years, but that's not true next year.
Right?
So I'm, I try to always say 1999.
So it's gives,
Gary (01:36):
it... so practically writes itself.
Ginger Vieira (01:37):
It's perfect.
Gary (01:40):
Well, you do more than just, uh, your work with Diamyd.
Uh, you have your own podcast.
Ginger Vieira (01:45):
Yeah.
Gary (01:45):
The diabetes nerd.
Ginger Vieira (01:47):
Diabetes Nerd YouTube channel.
I'm actually launchingthe Diabetes Nerd Podcast.
Next week is gonna be, uh, I callit high quality conversations
with very low production.
I'm going for the zero editing approach.
It's gonna be really laidback conversations with
people I adore or admire.
Gary (02:05):
Guaranteed.
You're gonna sneeze right in the middle.
It's gonna happen.
Ginger Vieira (02:08):
I did one before this that I. I tell my guests, if you say
something that you don't mean that's onyou, you're gonna have to deal with it.
Gary (02:16):
You're gonna try your best to hold that sneeze in and it's
just gonna explode all over.
Ginger Vieira (02:21):
Just be real.
You sneeze on the podcast andthat's just how it's gonna go.
Gary (02:25):
That's fair.
When I first met you decadesago, I mean, I was impressed
that you were a powerlifter.
You could squat a Buickback then, couldn't you?
Ginger Vieira (02:35):
Squat a Buick?
I could squat 265, Icould deadlift 300 pounds.
That was my best deadlift,and I could bench 190.
That was, that was a different lifetime.
I forget about it.
Honestly, I was about 30 pounds larger,as you recall, and was definitely
at the beginning of my own diabetesself-education, experimenting journey.
Gary (02:59):
For sure.
Yeah.
You've done a lot with socialmedia over the years and done
consulting for a lot of companies.
How did you latch on with Diamyd?
Ginger Vieira (03:09):
Diamyd was trying to do study recruitment and they're, they're
trying to find the right candidatesfor their precision medicine, medicine
therapy, which we can get into later.
But Diamyd is doing something prettyinnovative that no one else has done
quite, you know, there's a lot ofcompanies out there trying to develop.
(03:30):
Functional cures for type one or waysto prevent the full onset of Type one
Diamyd is doing is unlike anythingany of these other biotechs have done.
Gary (03:40):
You know, between us, we've been living with type one for 65 years.
Ginger Vieira (03:45):
All right.
Wow.
Gary (03:46):
And we've, we've seen our share of Miracle Cures come and go.
The most recent one, which hasa lot of us, A bit distressed.
Ginger Vieira (03:57):
Yeah.
Gary (03:58):
Had to do with, with Vertex, you know, they have a, a, a stem
cell line that's cultivated.
It's helped to develop beta, uh,insulin producing beta cells.
And, um, their most recent research reportshowed that the cells just aren't working.
Doing what?
They're...
Ginger Vieira (04:16):
Well, no, wait, I wanna correct that.
It's not that the cells aren't working.
Because VX eight 80 Vertex's clinicaltrial that uses immunosuppression, the
cells are working there, but they're usingimmunosuppression drugs, which are not
an ideal trade off for you and me in VX 264, the one that they snuck into a recent
(04:36):
press release to say, um, wasn't working.
That one.
What's not working is the devicethat was surgically implanted
along with the cells to protect thecells without immunosuppression.
So they've gotta now go back tothe drawing board, and I'm sure
they've already got some ideasthat, you know, I'm sure they,
they've been working on this threat.
Right.
(04:56):
I'm curious to see whatthey come up with next.
But they're trying, you know, like it's.
Gary (05:01):
Tomato, tomato, you know?
Ginger Vieira (05:04):
No, no, it's not the cells.
We have hope.
I feel like.
Gary (05:06):
We've had the ability to transplant beta cells for a long time,
but you have to suppress the immunesystem, which leads to a lot of other
health problems and complications.
So we're no further along than we were.
So the encapsulationpart needs to improve.
Ginger Vieira (05:23):
Absolutely the true protection part, and I mean their VX eight
80 trial has like 11 out of 12 patientsthat are no longer taking insulin.
I'm really hoping that they would partnerwith another company that has a therapy.
There's one company in particular,SAB Bio that I've learned a lot about.
(05:44):
I would love it if SAB and Vertex wouldpartner so that sabs therapy can work
to protect vertex's cells 'cause we knowthe cells produce insulin successfully.
Sabs therapy tells the immune systemthe specific part of the immune system
that targets beta cells to chill out.
(06:05):
But that really...
Gary (06:06):
I've got my own way of viewing a cure for type one diabetes when I
don't have to think about it anymore.
Or minimally have to think about it.
Then we're look, andmy glucose is managed.
I consider that a cure.
How do you define a cure for type one?
Ginger Vieira (06:23):
I would say the same.
It's that it takes care of itself.
I would be okay with having somethingsurgically implanted or showing up once
a year to get an injection or even threetimes a year to get an injection right, of
something that when I leave that clinic, Iam not checking my blood sugar every day.
I'm not taking micro doses of insulin.
Gary (06:44):
Yeah, I think about two areas.
We have mechanical cures, artificialdevices that can regulate glucose.
Yeah, we're making progress with thecurrent A ID technologies, but we
still got a ways to go with those.
We still have to do a lot ofthe thinking for those systems.
Ginger Vieira (07:01):
Yeah.
Gary (07:01):
And then we have the biological type cures, which involves.
ilet cell transplantation, uh,selective immunosuppression.
Even these concepts of smart insulinthat activate only as they're needed.
Ginger Vieira (07:14):
Which it still seem like a fantasy smart insulin.
Nobody's really done that.
They've been talkingabout that for 20 years.
Gary (07:21):
Conceptual.
Ginger Vieira (07:22):
Yeah.
Yeah.
Gary (07:23):
So where does Diamyd fit in that spectrum of, of cures?
Ginger Vieira (07:28):
Okay, so Diamyd's therapy is about precision medicine,
which might sound like, oh, thatjust means it's a specific type of
medicine for a specific disease.
Well, that's nearly everything, right?
This is actually boils all the waydown to a certain gene that they have
pinpointed that they know their therapyis most effective in people with type
(07:51):
one who carry this specific gene.
And we're getting a little, you know,I'll explain this more, but one, 40% of
people with type one carry this gene.
Gary (08:02):
That was my next question.
Ginger Vieira (08:03):
Yeah.
Yeah.
So it's clearly a, a relativelycommon gene and they have already been
conducting clinical trials in Europe.
They're now at phase three ofthis current clinical trial.
Diagnode-3 is the name of the clinicaltrial, so phase three for anybody
who doesn't know, that means thatthey know their therapy is, uh,
(08:25):
highly effective and safe, right?
They've passed the phase one andphase two of a clinical trial.
Phase three is where you'resaying, okay, is this better
than what's currently available?
So that's where they're at.
But in terms of that whole range, who it'sfor, it's not for people like you and me.
(08:46):
We've lived with type one for too long.
We don't have beta cells left to protect.
This is for people who are newlydiagnosed or in stage one, two, or three.
Currently the Diagnode-3 trialis looking for people in stage
three of type one diabetes.
Gary (09:02):
So right now it's, it applies to recently diagnosed
type ones, or at least diag.
People who are at the point wherethey, their glucose is elevated,
they require insulin to manage it.
Ginger Vieira (09:13):
There's a specific timeframe they
want, they're for the trial.
They're looking for people who arediagnosed within the last six months.
Gary (09:20):
Right.
So it's been, and they, so peoplediagnosed recently and have to start
insulin treatment, but also have to havethis specific gene sequence that would
make the medication applicable to them.
That's when I've learned about otherresearch like this with other companies.
Is that if they figure out a way forthis to work in this population, it can
(09:41):
often be adapted to other populationsand it can be applied earlier in the
course of development of type one.
Ginger Vieira (09:51):
Yes.
So,
Gary (09:52):
And most, most people don't realize that type one diabetes doesn't
start when glucose levels go up.
Ginger Vieira (09:58):
Yeah.
Let's explain that, Gary, becausea lot of people don't know there's
different stages of diabetes.
Yeah.
Let's, let's dig into that.
Gary (10:04):
Yeah.
I mean, stage one is thepresence of antibodies.
And there are four, maybe fivedifferent antibodies that are
precursors to, you know, the developmentof, of, of insulin requirement.
But these antibodies, oncethey're present, then the
chance of the progressing tothe next steps is very high.
I. And you know, stage two is you'vegot the antibodies and now your
(10:28):
glucose levels are a bit abnormal.
It's not so high that symptoms areappearing, but the glucose levels aren't
perfectly managed the way they should be.
Then stage three is when they do getexcessively high and we have to start
treatment with insulin to manage it.
So we don't diagnose type one anymore.
At the point where treatment'sneeded, we diagnose it with the
(10:51):
antibodies are first detected.
Ginger Vieira (10:54):
Ideally if, I mean, and, but another thing a lot of people still
don't know is that these antibodiescan develop years before you ever have
symptoms and are officially diagnosed.
And they know through Trialnet researchthat many people have antibodies present
before they're even five years old.
Even if you weren't diagnosed at,you know, I was diagnosed at 13,
(11:17):
that's when my symptoms developed.
But had someone tested me back then Imost likely would've tested positive
before I was even five, which is whyI've actually screened my kids multiple
times before they were even five.
Gary (11:30):
Okay, I screened mine as well.
Now, for those who are not biochemmajors, explain what antibodies are.
Ginger Vieira (11:37):
Yeah, so antibodies are basically the result of
your immune system attacking anddestroying some part of your body.
So in type one diabetes, they know thespecific, like you mentioned, specific
antibodies, and they can actually testfor them, and it's a simple blood test.
Getting it isn't always as simple.
You can't really just go toyour doctor and ask for it.
(11:58):
They haven't, I know Breakthrough T1D is working, um, developing just
a panel that a doctor could look upand order, order for T 1D screening.
But kind of the best place right nowto go get screened would be through
TrialNet, Anodea if you live in Europe,trial that is working in Europe and
then there's, there's a bunch ofothers, uh, through Barbara Davis
(12:19):
Center and Ask health.org is anotherone, but there's so much reluctance.
You know, I've seen so many peoplethat you and I have known for years
who don't wanna screen their kidsbecause, oh, I'll know the symptoms.
I don't need to worry about it.
Right?
Like, oh, what, what good is that?
We don't wanna have tojust worry about that.
(12:40):
They're gonna develop type one.
Well, there's somethingyou can do about it, right?
And you could potentially enroll yourchild in a clinical trial like Diagnode-3
with Diamyd, and there are others like it.
If you don't carry the gene, sogetting screened is so important.
And if we can't even convince adultswith type one to screen their children,
(13:02):
how are you gonna convince, youknow, non, you know, families that
aren't affected by type one at all?
Gary (13:07):
Yeah.
So antibodies can form in responseto different aspects of the insulin
production and secretion process.
So I said there's four, possiblyfive different antibodies that we
look at, but one of them stands out.
Ginger Vieira (13:23):
Yes.
Gary (13:23):
It seems to be an antibody that is most closely linked to
progression to the next steps.
Which antibody is that?
Ginger Vieira (13:32):
GAD.
Gary (13:33):
Yep.
GAD 65, that's the one that seemsto be, uh, the most evil of the
autoantibodies, if you will.
So what, what does Diamyd have tooffer to counteract this gads beast?
Ginger Vieira (13:47):
So let's go back in time a little bit.
So, the, the creator, the founder ofDiamyd is Anders Mueller, and his
daughter was diagnosed, they live inSweden, diagnosed at 10 years old.
So this is a, a Swedish born company.
And whenever I hear the conspiracytheories that, oh, they've
already got a cure for type one,they're just hiding it right.
(14:10):
So many of these companies and thesetherapies that are in clinical trials
are developed by people who are veryclosely related to type one diabetes,
and that is very true of Diamyd.
He set out basically immediately andsaid, I wanna try to do something about
this, and that's when he discovered theGAD enzyme and that it wasn't really
(14:30):
being boost in any other researcharound type one diabetes and developing
a functional cure or a prevention So.
GAD is an enzyme in the body that playsa major role in producing insulin.
And the immune system, like you said, isattacking and destroying that GAD enzyme.
(14:50):
So GAD autoantibodies aresomething that can be measured.
GAD 65 dias the therapy.
Sorry, Barbara, it's a bumpy sentence.
So GAD 65.
Actually talks to your immune system andsays, Hey, stop attacking the GAD enzyme.
(15:14):
Stop attacking the beta cells.
And it's not animmunosuppression drug, right?
It's not like putting you at riskof catching a cold and getting,
you know, it's not changing howyour immune system protects you.
It's an immune modulator.
So it's just changing specificallyhow your immune system is reacting.
(15:34):
To your beta cells.
Gary (15:38):
It's, it's targeting a specific antibody.
It's not causing widespread suppressionof the body's immune system.
Ginger Vieira (15:46):
Right.
Gary (15:47):
It's just really focusing on the one specific one that most likely
leads to progression and developmentor progression of type one diabetes.
I guess that's what youmeant by precision medicine.
Ginger Vieira (16:00):
Well, the precision part is also the genetic, the gene factor.
So in Diamyd's case, the precisiontherapy is speaking directly to
people with this certain type of gene.
They know this medicine works preciselyin, right, and there's a lot of cancer
treatments that are the same way.
They've figured out that peoplewith breast cancer who have a
(16:24):
certain gene respond better tosome treatments than others.
Gary (16:29):
I think of it kinda like laser treatment for retinopathy now.
You know, it used to be if you hadhemorrhages in the back of the eye,
there wasn't much they could do.
Anything they tried to do would destroyareas of the retina that it shouldn't.
But now with lasers we can pinpoint thoseblood vessels that are damaged, seal them
up without damaging the tissues around it.
(16:51):
In this case, you're able to takea specific, this Diamyd drug.
And target the, the, the specificauto antibody that is damaging beta
cells and just keep that one fromcausing the damage without affecting
other aspects of the immune system.
Widespread immune suppressioncauses a lot of issues.
(17:15):
Can you detail some of the problems thatwe see with widespread immune suppression?
Ginger Vieira (17:20):
I would rather you detail that.
Gary, I can't, I can'tspeak to those specifically.
I know it doesn't sound good.
Gary (17:27):
It's not, I mean, it, it opens us up to all kinds of infections.
It's hard for the body to fight viraland bacterial infections when the immune
system is impaired on a large scale.
There is a lot of side effects involvinglike oral health and a lot of other
parts, you know, body functions that,yeah, we tend to have issues with, with
(17:48):
immune sup, widespread immune suppression.
So this targeted therapy, yeah,seems to make a lot more sense
Ginger Vieira (17:56):
It's critical
Gary (17:56):
Then we've had in the past.
Ginger Vieira (17:58):
I hear from people whenever I post anything about diabetes
cure research, I always hear from peoplesaying, well, why can't we have X, Y, Z?
Like VX eight 80, for example, requiresimmunosuppression, which makes it very
undesirable for a significant percentageof the population with type one, right?
(18:18):
It's really intended only forpeople who are struggling to get
through their day and function.
They to explain like, Hey, you reallydon't wanna be on immunosuppression
drugs for the rest of your life,even though type one is so hard,
the trade off is not worth it.
Gary (18:37):
That's it.
It's a trade off.
And for most, the vast majority ofpeople with type one widespread immune
suppression is not worth the trade off.
Yeah.
Ginger Vieira (18:45):
Okay.
Thank you for explaining that.
Gary (18:48):
And now a word from our sponsor.
If you were diagnosed with T 1D inthe past six months and are between
ages 12 and 29, here's a clinicaltrial you might want to consider.
GAD 65 from Diamyd Medicalteaches your immune system to stop
attacking your pancreas beta cells.
Diamyd is currently recruiting studyparticipants in the US and Europe.
(19:10):
Visit diagnode-3.com or emailclinicaltrials@diamyd.com to
learn and see if you qualify.
And now back to our program.
So what, what exactly isthe screening process?
So if somebody either has recentlydiagnosed, type one, knows
(19:30):
somebody recently diagnosed mm-hmm.
What's, what's the screening processto see if they qualify for this drug?
Ginger Vieira (19:36):
So the first thing is age range.
So they're looking for people betweenthe ages of 12 up to 29 years old.
And then you've been diagnosedwithin the last six months.
And then the first step afteryou've reached out through the
di, it's di node-three.com.
After you've reached out, the next thingthey're gonna ask you to do is a blood
(19:58):
test to see if you carry this gene.
And if you don't carry the gene,you don't qualify to participate.
And that makes it a little harder forDiomede to find participants, right?
Because they're looking for people who arejust diagnosed and who carry this gene.
And many people who are diagnosed withinthe last six months, they're just still
(20:19):
overwhelmed by this new diagnosis.
You know, it's like they're notthinking about clinical trials.
That's a really big step, especially ifyou're someone who's never really had
to be involved in the medical system.
Now you're gonna go participatein a clinical trial.
That can be daunting.
So it, it is a hard recruitment effort'cause it's such a specific population.
Gary (20:41):
What's in it for someone who receives the treatment?
Let's say it works, it's beautiful.
And how does somebody benefitfrom receiving the Diamyd...
Ginger Vieira (20:52):
So what Diamyd's therapy aims to do is prevent
or delay or significantly reduceyour need for exogenous insulin.
Insulin from a vial, from a pen, rightversus endogenous inside your body.
So if someone is diagnosed in the lastsix months, like you said earlier,
they're already taking insulin.
(21:13):
But Diamyd's therapyhopes to significantly.
Change how much insulin they actuallyare going to need every day and
potentially even delay the progressionbecause we don't realize it.
If you think back, you're, you're notgonna remember how much insulin were
you on in the first six months whenyou were diagnosed, and many people
(21:36):
are still in the honeymoon phase.
So Diamyd's therapy hopes to prolong thathoneymoon phase where your pancreas is
still producing enough insulin to keepyour need for injections relatively low.
And it makes it a lot harder to have superhighs when you're in that honeymoon phase.
I remember when I was in the honeymoonphase, there was two of us in my school.
(21:59):
We had to go to the nurse's officeand prick our fingers there and then
determine what we were gonna take forinsulin with the nurse's approval.
And I was only a few months in.
And there was a girl there who livedwith type one for years and years, and
I remember seeing on her meter, like a225 blood sugar level and being like,
because I hadn't seen that yet, becausemy pancreas was still helping me so much.
Gary (22:22):
Right.
You were a honeymoon girl.
Ginger Vieira (22:23):
Yeah.
Yeah.
I was living my best T1D lifewith a pancreas still helping out.
So GADs therapy, sorry.
Diamyd's therapy really aims toprolong that honeymoon phase.
Um.
That's a big one.
Gary (22:36):
That is such an important thing, and any family with type one knows
how wonderful the honeymoon phase is.
I, I have enough patients I've seen whereif the, if someone's producing just even
the tiniest bit of their own insulin,it provides this beautiful buffer.
Glucoses don't get to extreme highsor lows because the pancreas can
(22:58):
make adjustments to keep thingsfrom getting too far outta range.
So you can almost do no wrong.
Even if you take the wrong dose,eat a lot, whatever, it doesn't
really cause extreme highs or lows.
Ginger Vieira (23:10):
Do those families, they don't.
So you were saying how much theyappreciate the honeymoon phase, but
can they appreciate it when they're init or is it only after looking back?
Gary (23:19):
It's usually afterwards.
Ginger Vieira (23:21):
Yeah.
They don't even know what's coming.
Gary (23:23):
Yeah.
Yeah.
I try to show them graphs of mineor someone else's glucose bouncing
around and they, oh my goodness,this is what I'm headed for.
Yeah.
I didn't get a honeymoon becausewhen I, when I was diagnosed, I had
already gone about three or fourmonths of peeing my brains out,
losing weight, all the symptoms.
So by the time I was diagnosed.
(23:44):
My beta cells were dead on arrival.
I had no insulin production left atall, and I see this now with patients.
Once they lose all their insulinproduction, blood sugar control is,
is a thousand times more difficult.
So preserving the honeymoonhas so much value.
It makes living with diabetes much easier.
(24:06):
It also helps improve long-term outcomes.
'cause if you manage your glucosewell for many years, your risk for
complications goes down and your dailyquality of life is that much better.
Ginger Vieira (24:18):
Yeah.
And so another thing to think about,uh, when you're considering a clinical
trial is in many clinical trialsit's 50/50 of who gets the placebo
and who gets the actual therapy.
And in Diamyd's trial,there's a 30/70 split.
So 30% are getting a placebo,which is basically like, you know,
(24:41):
they're giving you a pretend.
It's like, might as well inject youwith saline instead of the therapy.
Right?
And then 70% are actually gettingGAD 65, the investigational therapy.
So that's a big deal.
It means that you've gota really good chance.
Getting the treatment.
It's, you know, can't help.
(25:02):
But
Gary (25:03):
Yeah.
But even if you don't, you'recontributing to some very important
research, the groundbreaking research.
Ginger Vieira (25:09):
Absolutely.
Gary (25:11):
You're familiar with, uh, tzealed?
Ginger Vieira (25:13):
Yes.
Gary (25:14):
Sanofi's Drug Tocilizumab is a generic name.
What are some of the differencesbetween Diamyd treatment and something
like Tezealed, because they'reTezealed Sanofi's already studying it.
In phase three, you know, whensomebody's recently diagnosed, so yes.
What are some of the differences?
Ginger Vieira (25:32):
So, well, one of the first biggest differences
is how it's administered.
Tezealed, I think, is a10 day infusion process.
So you have to,
Gary (25:40):
yeah, two week.
Two week,
Ginger Vieira (25:42):
14 days full.
14. You have to show up every day.
For 14 days, which means mom and dadare taking off from work, you're missing
school, potentially traveling somewhere.
Right.
You're, you're paying for all that.
And I wanna remind me to mention thatwith Diamyd's in Diamyd's clinical trial,
it's three injections, not some big to-do.
(26:04):
It's you're not sitting there for threedays and there are three injections
over the course of three months,and the injection is in a vein in
your groin, which sounds a littlescary, but it feels no different
than getting your blood drawn.
It's not
Gary (26:20):
squirming in my chair here.
Ginger Vieira (26:21):
No, no, no.
Squirming Gary.
No squirming.
It is really no different thangetting a, a blood draw from a vein
in your arm, and they just knowthat is the, the most effective
spot to introduce their therapies.
Gary (26:33):
So three monthly injections.
Ginger Vieira (26:35):
Yeah.
So one, you know, three monthprocess with one injection per month.
And here's the cool thing, ifyou don't live near one of the
clinical trial sites, they will payfor your travel to get you there.
And their, their trial is there's awhole bunch of cities across the US
you can find all those cities listedat diagnode-3.com and then multiple
(26:57):
countries in Europe are also recruiting.
So they're really trying to makeit as easy for the participant
to get involved as possible.
Yeah.
Gary (27:06):
So once the injections begin, is there additional care that's
provided or treatment that's applied?
Ginger Vieira (27:13):
Yeah.
Then there's, um, monitoring andbasically looking at blood glucose
levels and C-peptide levels to measure.
Gary (27:20):
For anyone listening, C-peptide is an indication of how
much insulin you're producing.
Ginger Vieira (27:25):
I recently had funny story for you.
I have a, a new endocrinologist.
I don't really.
I don't really go to an endocrinologistfor like ongoing support.
Right.
I have Gary Scheiner in my back pocket.
If I have a real insulinquestion, I can call Gary, right?
Um, or Jenny, who's on your team?
I'm good friends with.
My endocrinologist writes prescriptionsfor me and she, she was like, oh, you
(27:49):
only taking this much long-acting insulin.
You must still be producing insulin.
I was like, well, I'velived type one for 25 years.
I highly doubt I'mstill producing insulin.
She insisted, she made me payfor a C-peptide test and it said
I was producing less than 0.01.
My C-peptide level.
Sorry.
Yeah, so I basically,I'm producing no insulin.
(28:11):
So Diamyd's clinical trial willmeasure your C-peptide level, which
indicates how much insulin you're stillproducing and if, if their therapy
is effective, your insulin productionshould sustain your C-peptide level.
Should...
Gary (28:24):
Yeah.
So when somebody makes their owninsulin, when the pancreas puts out
insulin, we also get this littlemolecule called a C-peptide, and
they only call it that 'cause it'sshaped like a c. It's very scientific.
Uh, and when we inject or,or pump insulin, it doesn't
have that C-peptide part.
So that's how we know how muchinsulin your body's making as
(28:46):
opposed to how much you're taking.
Yeah.
So the C-peptide is sort of asurrogate measure of how much insulin
the body is making on its own.
So, yeah, that, that's an importantpart of the follow up as well.
What kind of outcome measurementsare the study personnel?
Are they looking at how muchinsulin someone requires?
(29:06):
They looking at C-peptideglucose management.
Ginger Vieira (29:09):
It's primarily C-peptide and blood, blood sugar levels, and A1C.
So there is that follow up period andyou're contributing to an incredible,
hopeful breakthrough in research thatcould, I mean, I just imagine like
if another really cool thing about.
(29:30):
GAD 65.
This therapy is that it really hasno significant adverse effects.
You can't say no side effects of anymedication, but its safety profile
is considered remarkable by the wholescientific, that's the language I use.
A remarkable safety profile, right?
(29:52):
Which is a good thing.
And if my children were to develop typeone, and I missed the opportunity to
enroll them in a trial like this, Iwould be so bummed because it is a hu,
like you described, the honeymoon phase.
I mean, imagine my 7-year-old,she's a wild maniac.
I don't not wanna manage insulin dosesand intake in a child that knows how
(30:17):
to sneak over to the chocolate bowl.
And my other kid's favorite newsnack lately is pretzels and Nutella.
If I can have their pancreas helpthem through pretzels and Nutella, I
would not wanna miss that opportunity.
So it really starts with screening,getting your kids screened.
Gary (30:36):
Absolutely.
And it applies to adults too,you know, it's not just kids.
Ginger Vieira (30:40):
Absolutely.
No.
Gary (30:40):
Adults who they enjoy the honeymoon and they benefit from that
honeymoon equally, as much as kids do.
Okay, so you mentioned that if somebodydoesn't live near one of the test
sites, you said there's 13 acrossthe US and several in Europe as well.
Mm-hmm.
That Diamyd as a company, will pay fortheir travel to receive their treatments.
Ginger Vieira (31:04):
They will.
Yeah.
Gary (31:05):
So that would be like once every three, once a month for three months.
Ginger Vieira (31:09):
So you're committing to traveling to that clinic site
three times and then at some pointdown the road, six months to a year.
A follow up appointment.
Gary (31:19):
Okay.
Yeah.
A lot of the other data, the sensordata, insulin data that can be collected
on a virtual remote basis, I imagine.
Ginger Vieira (31:27):
I believe so.
Gary (31:30):
Okay.
All right.
Um, well, I mean, that was mainlywhat I wanted to learn about this.
I mean, this is exciting.
Uh, it's just a matter of, of getting theword out, I guess, and letting clinicians
know if you got newly diagnosed patients.
'cause we've got a lot of clinicianswho listen to this podcast and I want
(31:51):
them to know you got newly diagnosedpatients, age 12 to 20, 12 to 29.
Consider them for this.
Yes, this is a greatopportunity to do well by them.
Uh, if you can prolong theirhoneymoon indefinitely, you
know they're gonna appreci, theyshould appreciate that to no end.
Ginger Vieira (32:11):
Yeah.
I mean, can you imagine,I just can't even imagine.
I've had a couple families, parentsreach out to me on like private
messages on Instagram saying,Hey, my child was just diagnosed.
Last month, and I see that youdo a lot of stuff on research.
Is there anything they can enroll in?
And I've introduced those familiesto the DRI, the Diabetes Research
(32:34):
Institute, which works closely withDiamyd and many other companies
trying to develop cures and treatmentsfor Type 1 DRI can support them.
That family, they, they are activelyright now supporting that family.
They find a clinical trial and see, youknow, if you don't qualify for Diamyd's
clinical trial, there are others.
(32:54):
I mean, clinicians listening, oh my gosh.
Please encourage your patients to pursuethis because it's just crazy not to.
Gary (33:03):
Yeah.
That applies to bothpediatric and adult patients.
Yeah.
'cause this goes up to age 29.
I'm guessing that, you know, oncethis study is completed, they're
gonna start looking at similaroutcomes in younger kids and in
older adults, and maybe start lookingbeyond the six month time interval.
So it, it'll end up, uh, like I said,they'll be able to extrapolate this to
(33:25):
a lot more people eventually, but thisis a very important starting point.
Ginger Vieira (33:29):
Yeah, and they're a very small company.
Um, they're really only 30 people.
This is not big pharma.
This is a really small company thatstarted, um, the heart of it is Anders
and his daughter, who's an adultnow, but they're determined to find
a therapy that that's life changing.
Gary (33:48):
It's how things happen.
Necessity is the motherof invention, right?
Uh, this is how, you know, islet asa, or the Beta Bionics got started,
said Dana's child had diabetes.
This is how all the open source,you know, the loop systems and all.
Ginger Vieira (34:05):
Yeah.
Gary (34:05):
Got started.
Parents got tired of waitingfor good tech for their kids.
So they,
Ginger Vieira (34:09):
and Vertex, I mean, vertex bought sema.
Doug Melton's son was diagnosedat like six months old.
So yeah, it, it all startsreally at the heart of having
known this disease up close.
Gary (34:23):
So, Diamyd, this is exciting stuff.
Uh, right now it's, it's a. They'relooking for research participants
between ages of 12 and 29 who arerecently diagnosed and started
treatment for type one diabetes.
Uh, it involves a, uh, oh, and they alsohave to have that specific gene, and
(34:46):
almost half of the diagnoses have thisspecific gene that helps ensure that
the medication, the Diamyd medicationis gonna be effective for them.
Ginger Vieira (34:55):
And Diamyd will test you for that gene.
I've had people say, well, how do I know?
And I'm like, well,that's, you call 'em up.
Clinical trials@Diamyd.com is their email.
You get involved and they will,that's the very first thing they'll
do is see if you carry that gene.
Gary (35:09):
Yeah.
Our show notes will have allof the contact information
people can look for, but.
The basic info diagnode-3.com now theycan go and learn pretty much everything
we covered today, um, at that site,and I strongly encourage people to do
so, and healthcare providers encourageyour patients to do so as well.
(35:32):
So Ginger, thank you so much.
Someday I gotta get you to my gym.
You gotta teach me how to work.
My, my deadlift is lagging.
I've gotta build up, I thinkwomen have some extra back
muscles that men don't have.
Ginger Vieira (35:46):
Oh, that must be it.
Uh, yeah.
Gary (35:48):
Yeah, because I, I've known, 'cause even there's a couple people
on my team, like Anna, our uh, oursocial worker, she, she can deadlift
more than I can also, and I'm like.
What am I missing?
Ginger Vieira (35:59):
Deadlifting was my favourite favorite, that was my favorite.
And the little details and the techniqueof how you're standing and how you're
grabbing the bar and where you put yourweight in your feet and what you do with
your arms and your shoulders and yourlats before you lift that bar a little.
Those little details.
Gary (36:16):
Yeah, I got some things to learn from you.
That's for sure.
Ginger Vieira (36:20):
It's about time, Gary.
Gary (36:21):
Yeah.
And, uh, I, you just, uh, publishedsecond edition of your book on
type one Diabetes and Pregnancy.
Ginger Vieira (36:30):
Yes.
We're super excited about that.
It's got all new sections,all about AID pumping during
pregnancy and yeah was overdue.
Jenny and I were both about to givebirth to our second children before
we published the first edition.
We were like, oh my gosh, get thisout because we'll never get this
book done if we don't get it outbefore these children are born.
Gary (36:51):
That's right.
Yeah.
Your kids are about the same age.
Ginger Vieira (36:53):
Yeah.
Yeah, they are.
Gary (36:56):
Alright, well again, thank you Ginger.
I encourage people to look forthe information about Diagnode-3.
Thank you so much.
I'm Gary Scheiner.
Thank you for listening, andI wanna remind everyone to
keep thinking like a pancreas.
Thanks for tuning in to ThinkLike a Pancreas, the podcast.
(37:17):
If you enjoyed today's episode, don'tforget to like, follow or subscribe
on your favorite podcast app.
Think like a pancreas.
The podcast is brought to you byIntegrated Diabetes Services, where
experience meets expertise, passionmeets compassion, and diabetes care
is personal because we live it too.
(37:37):
Our team of clinicians all livingwith type one diabetes understands
the challenges firsthand.
We're here to help no matterwhere you are in the world.
From glucose management to self-carestrategies, the latest tech,
sports, and exercise, weight losstype one, pregnancy and emotional
wellbeing, we've got you covered.
(37:57):
We offer consultations inEnglish and Spanish via phone,
video, chat, email and text.
Wanna learn more?
Visit integrated diabetes.com oremail info@integrateddiabetes.com
to schedule a consultation.
On behalf of Think Likea Pancreas, the podcast.
I'm Gary s Scheiner, wishing youa fantastic week ahead, and don't
(38:19):
forget to think like a pancreas.
Welcome to Think Like a Pancreas, the podcast where our goal is to keep
you informed, inspired, and a littleentertained on all things diabetes.
The information contained in thisprogram is based on the experience
and opinions of the IntegratedDiabetes Services clinical team.
Please discuss any changes to yourtreatment plan with your personal
(00:33):
healthcare provider before implementing.
Today's program is sponsored by DiamydMedical, sponsors of the Dianode-3 study.
Welcome to Think Like aPancreas, the podcast.
I'm your host, Gary Scheiner.
Today's topic is the Quest for a Cure.
Have we found a Diamyd in the rough?
Ginger Vieira (00:53):
Very clever!
Gary (00:54):
I'm pleased to be joined by Ginger Vieira.
Ginger's joined us at other times.
Ginger, tell the folks at homea little bit about yourself.
Ginger Vieira (01:03):
Oh, I have lived with Type one diabetes for quite a while,
since 1999, and I've been writingbooks and articles and creating videos
about diabetes, uh, for many years.
But today I'm actually hereon behalf of Diamyd Medical.
Gary (01:19):
Okay.
I like the 1999, so you, we could redothat prince song, had diabetes since 1999.
Ginger Vieira (01:28):
You know, sometimes I say 25 years, but that's not true next year.
Right?
So I'm, I try to always say 1999.
So it's gives,
Gary (01:36):
it... so practically writes itself.
Ginger Vieira (01:37):
It's perfect.
Gary (01:40):
Well, you do more than just, uh, your work with Diamyd.
Uh, you have your own podcast.
Ginger Vieira (01:45):
Yeah.
Gary (01:45):
The diabetes nerd.
Ginger Vieira (01:47):
Diabetes Nerd YouTube channel.
I'm actually launchingthe Diabetes Nerd Podcast.
Next week is gonna be, uh, I callit high quality conversations
with very low production.
I'm going for the zero editing approach.
It's gonna be really laidback conversations with
people I adore or admire.
Gary (02:05):
Guaranteed.
You're gonna sneeze right in the middle.
It's gonna happen.
Ginger Vieira (02:08):
I did one before this that I. I tell my guests, if you say
something that you don't mean that's onyou, you're gonna have to deal with it.
Gary (02:16):
You're gonna try your best to hold that sneeze in and it's
just gonna explode all over.
Ginger Vieira (02:21):
Just be real.
You sneeze on the podcast andthat's just how it's gonna go.
Gary (02:25):
That's fair.
When I first met you decadesago, I mean, I was impressed
that you were a powerlifter.
You could squat a Buickback then, couldn't you?
Ginger Vieira (02:35):
Squat a Buick?
I could squat 265, Icould deadlift 300 pounds.
That was my best deadlift,and I could bench 190.
That was, that was a different lifetime.
I forget about it.
Honestly, I was about 30 pounds larger,as you recall, and was definitely
at the beginning of my own diabetesself-education, experimenting journey.
Gary (02:59):
For sure.
Yeah.
You've done a lot with socialmedia over the years and done
consulting for a lot of companies.
How did you latch on with Diamyd?
Ginger Vieira (03:09):
Diamyd was trying to do study recruitment and they're, they're
trying to find the right candidatesfor their precision medicine, medicine
therapy, which we can get into later.
But Diamyd is doing something prettyinnovative that no one else has done
quite, you know, there's a lot ofcompanies out there trying to develop.
(03:30):
Functional cures for type one or waysto prevent the full onset of Type one
Diamyd is doing is unlike anythingany of these other biotechs have done.
Gary (03:40):
You know, between us, we've been living with type one for 65 years.
Ginger Vieira (03:45):
All right.
Wow.
Gary (03:46):
And we've, we've seen our share of Miracle Cures come and go.
The most recent one, which hasa lot of us, A bit distressed.
Ginger Vieira (03:57):
Yeah.
Gary (03:58):
Had to do with, with Vertex, you know, they have a, a, a stem
cell line that's cultivated.
It's helped to develop beta, uh,insulin producing beta cells.
And, um, their most recent research reportshowed that the cells just aren't working.
Doing what?
They're...
Ginger Vieira (04:16):
Well, no, wait, I wanna correct that.
It's not that the cells aren't working.
Because VX eight 80 Vertex's clinicaltrial that uses immunosuppression, the
cells are working there, but they're usingimmunosuppression drugs, which are not
an ideal trade off for you and me in VX 264, the one that they snuck into a recent
(04:36):
press release to say, um, wasn't working.
That one.
What's not working is the devicethat was surgically implanted
along with the cells to protect thecells without immunosuppression.
So they've gotta now go back tothe drawing board, and I'm sure
they've already got some ideasthat, you know, I'm sure they,
they've been working on this threat.
Right.
(04:56):
I'm curious to see whatthey come up with next.
But they're trying, you know, like it's.
Gary (05:01):
Tomato, tomato, you know?
Ginger Vieira (05:04):
No, no, it's not the cells.
We have hope.
I feel like.
Gary (05:06):
We've had the ability to transplant beta cells for a long time,
but you have to suppress the immunesystem, which leads to a lot of other
health problems and complications.
So we're no further along than we were.
So the encapsulationpart needs to improve.
Ginger Vieira (05:23):
Absolutely the true protection part, and I mean their VX eight
80 trial has like 11 out of 12 patientsthat are no longer taking insulin.
I'm really hoping that they would partnerwith another company that has a therapy.
There's one company in particular,SAB Bio that I've learned a lot about.
(05:44):
I would love it if SAB and Vertex wouldpartner so that sabs therapy can work
to protect vertex's cells 'cause we knowthe cells produce insulin successfully.
Sabs therapy tells the immune systemthe specific part of the immune system
that targets beta cells to chill out.
(06:05):
But that really...
Gary (06:06):
I've got my own way of viewing a cure for type one diabetes when I
don't have to think about it anymore.
Or minimally have to think about it.
Then we're look, andmy glucose is managed.
I consider that a cure.
How do you define a cure for type one?
Ginger Vieira (06:23):
I would say the same.
It's that it takes care of itself.
I would be okay with having somethingsurgically implanted or showing up once
a year to get an injection or even threetimes a year to get an injection right, of
something that when I leave that clinic, Iam not checking my blood sugar every day.
I'm not taking micro doses of insulin.
Gary (06:44):
Yeah, I think about two areas.
We have mechanical cures, artificialdevices that can regulate glucose.
Yeah, we're making progress with thecurrent A ID technologies, but we
still got a ways to go with those.
We still have to do a lot ofthe thinking for those systems.
Ginger Vieira (07:01):
Yeah.
Gary (07:01):
And then we have the biological type cures, which involves.
ilet cell transplantation, uh,selective immunosuppression.
Even these concepts of smart insulinthat activate only as they're needed.
Ginger Vieira (07:14):
Which it still seem like a fantasy smart insulin.
Nobody's really done that.
They've been talkingabout that for 20 years.
Gary (07:21):
Conceptual.
Ginger Vieira (07:22):
Yeah.
Yeah.
Gary (07:23):
So where does Diamyd fit in that spectrum of, of cures?
Ginger Vieira (07:28):
Okay, so Diamyd's therapy is about precision medicine,
which might sound like, oh, thatjust means it's a specific type of
medicine for a specific disease.
Well, that's nearly everything, right?
This is actually boils all the waydown to a certain gene that they have
pinpointed that they know their therapyis most effective in people with type
(07:51):
one who carry this specific gene.
And we're getting a little, you know,I'll explain this more, but one, 40% of
people with type one carry this gene.
Gary (08:02):
That was my next question.
Ginger Vieira (08:03):
Yeah.
Yeah.
So it's clearly a, a relativelycommon gene and they have already been
conducting clinical trials in Europe.
They're now at phase three ofthis current clinical trial.
Diagnode-3 is the name of the clinicaltrial, so phase three for anybody
who doesn't know, that means thatthey know their therapy is, uh,
(08:25):
highly effective and safe, right?
They've passed the phase one andphase two of a clinical trial.
Phase three is where you'resaying, okay, is this better
than what's currently available?
So that's where they're at.
But in terms of that whole range, who it'sfor, it's not for people like you and me.
(08:46):
We've lived with type one for too long.
We don't have beta cells left to protect.
This is for people who are newlydiagnosed or in stage one, two, or three.
Currently the Diagnode-3 trialis looking for people in stage
three of type one diabetes.
Gary (09:02):
So right now it's, it applies to recently diagnosed
type ones, or at least diag.
People who are at the point wherethey, their glucose is elevated,
they require insulin to manage it.
Ginger Vieira (09:13):
There's a specific timeframe they
want, they're for the trial.
They're looking for people who arediagnosed within the last six months.
Gary (09:20):
Right.
So it's been, and they, so peoplediagnosed recently and have to start
insulin treatment, but also have to havethis specific gene sequence that would
make the medication applicable to them.
That's when I've learned about otherresearch like this with other companies.
Is that if they figure out a way forthis to work in this population, it can
(09:41):
often be adapted to other populationsand it can be applied earlier in the
course of development of type one.
Ginger Vieira (09:51):
Yes.
So,
Gary (09:52):
And most, most people don't realize that type one diabetes doesn't
start when glucose levels go up.
Ginger Vieira (09:58):
Yeah.
Let's explain that, Gary, becausea lot of people don't know there's
different stages of diabetes.
Yeah.
Let's, let's dig into that.
Gary (10:04):
Yeah.
I mean, stage one is thepresence of antibodies.
And there are four, maybe fivedifferent antibodies that are
precursors to, you know, the developmentof, of, of insulin requirement.
But these antibodies, oncethey're present, then the
chance of the progressing tothe next steps is very high.
I. And you know, stage two is you'vegot the antibodies and now your
(10:28):
glucose levels are a bit abnormal.
It's not so high that symptoms areappearing, but the glucose levels aren't
perfectly managed the way they should be.
Then stage three is when they do getexcessively high and we have to start
treatment with insulin to manage it.
So we don't diagnose type one anymore.
At the point where treatment'sneeded, we diagnose it with the
(10:51):
antibodies are first detected.
Ginger Vieira (10:54):
Ideally if, I mean, and, but another thing a lot of people still
don't know is that these antibodiescan develop years before you ever have
symptoms and are officially diagnosed.
And they know through Trialnet researchthat many people have antibodies present
before they're even five years old.
Even if you weren't diagnosed at,you know, I was diagnosed at 13,
(11:17):
that's when my symptoms developed.
But had someone tested me back then Imost likely would've tested positive
before I was even five, which is whyI've actually screened my kids multiple
times before they were even five.
Gary (11:30):
Okay, I screened mine as well.
Now, for those who are not biochemmajors, explain what antibodies are.
Ginger Vieira (11:37):
Yeah, so antibodies are basically the result of
your immune system attacking anddestroying some part of your body.
So in type one diabetes, they know thespecific, like you mentioned, specific
antibodies, and they can actually testfor them, and it's a simple blood test.
Getting it isn't always as simple.
You can't really just go toyour doctor and ask for it.
(11:58):
They haven't, I know Breakthrough T1D is working, um, developing just
a panel that a doctor could look upand order, order for T 1D screening.
But kind of the best place right nowto go get screened would be through
TrialNet, Anodea if you live in Europe,trial that is working in Europe and
then there's, there's a bunch ofothers, uh, through Barbara Davis
(12:19):
Center and Ask health.org is anotherone, but there's so much reluctance.
You know, I've seen so many peoplethat you and I have known for years
who don't wanna screen their kidsbecause, oh, I'll know the symptoms.
I don't need to worry about it.
Right?
Like, oh, what, what good is that?
We don't wanna have tojust worry about that.
(12:40):
They're gonna develop type one.
Well, there's somethingyou can do about it, right?
And you could potentially enroll yourchild in a clinical trial like Diagnode-3
with Diamyd, and there are others like it.
If you don't carry the gene, sogetting screened is so important.
And if we can't even convince adultswith type one to screen their children,
(13:02):
how are you gonna convince, youknow, non, you know, families that
aren't affected by type one at all?
Gary (13:07):
Yeah.
So antibodies can form in responseto different aspects of the insulin
production and secretion process.
So I said there's four, possiblyfive different antibodies that we
look at, but one of them stands out.
Ginger Vieira (13:23):
Yes.
Gary (13:23):
It seems to be an antibody that is most closely linked to
progression to the next steps.
Which antibody is that?
Ginger Vieira (13:32):
GAD.
Gary (13:33):
Yep.
GAD 65, that's the one that seemsto be, uh, the most evil of the
autoantibodies, if you will.
So what, what does Diamyd have tooffer to counteract this gads beast?
Ginger Vieira (13:47):
So let's go back in time a little bit.
So, the, the creator, the founder ofDiamyd is Anders Mueller, and his
daughter was diagnosed, they live inSweden, diagnosed at 10 years old.
So this is a, a Swedish born company.
And whenever I hear the conspiracytheories that, oh, they've
already got a cure for type one,they're just hiding it right.
(14:10):
So many of these companies and thesetherapies that are in clinical trials
are developed by people who are veryclosely related to type one diabetes,
and that is very true of Diamyd.
He set out basically immediately andsaid, I wanna try to do something about
this, and that's when he discovered theGAD enzyme and that it wasn't really
(14:30):
being boost in any other researcharound type one diabetes and developing
a functional cure or a prevention So.
GAD is an enzyme in the body that playsa major role in producing insulin.
And the immune system, like you said, isattacking and destroying that GAD enzyme.
(14:50):
So GAD autoantibodies aresomething that can be measured.
GAD 65 dias the therapy.
Sorry, Barbara, it's a bumpy sentence.
So GAD 65.
Actually talks to your immune system andsays, Hey, stop attacking the GAD enzyme.
(15:14):
Stop attacking the beta cells.
And it's not animmunosuppression drug, right?
It's not like putting you at riskof catching a cold and getting,
you know, it's not changing howyour immune system protects you.
It's an immune modulator.
So it's just changing specificallyhow your immune system is reacting.
(15:34):
To your beta cells.
Gary (15:38):
It's, it's targeting a specific antibody.
It's not causing widespread suppressionof the body's immune system.
Ginger Vieira (15:46):
Right.
Gary (15:47):
It's just really focusing on the one specific one that most likely
leads to progression and developmentor progression of type one diabetes.
I guess that's what youmeant by precision medicine.
Ginger Vieira (16:00):
Well, the precision part is also the genetic, the gene factor.
So in Diamyd's case, the precisiontherapy is speaking directly to
people with this certain type of gene.
They know this medicine works preciselyin, right, and there's a lot of cancer
treatments that are the same way.
They've figured out that peoplewith breast cancer who have a
(16:24):
certain gene respond better tosome treatments than others.
Gary (16:29):
I think of it kinda like laser treatment for retinopathy now.
You know, it used to be if you hadhemorrhages in the back of the eye,
there wasn't much they could do.
Anything they tried to do would destroyareas of the retina that it shouldn't.
But now with lasers we can pinpoint thoseblood vessels that are damaged, seal them
up without damaging the tissues around it.
(16:51):
In this case, you're able to takea specific, this Diamyd drug.
And target the, the, the specificauto antibody that is damaging beta
cells and just keep that one fromcausing the damage without affecting
other aspects of the immune system.
Widespread immune suppressioncauses a lot of issues.
(17:15):
Can you detail some of the problems thatwe see with widespread immune suppression?
Ginger Vieira (17:20):
I would rather you detail that.
Gary, I can't, I can'tspeak to those specifically.
I know it doesn't sound good.
Gary (17:27):
It's not, I mean, it, it opens us up to all kinds of infections.
It's hard for the body to fight viraland bacterial infections when the immune
system is impaired on a large scale.
There is a lot of side effects involvinglike oral health and a lot of other
parts, you know, body functions that,yeah, we tend to have issues with, with
(17:48):
immune sup, widespread immune suppression.
So this targeted therapy, yeah,seems to make a lot more sense
Ginger Vieira (17:56):
It's critical
Gary (17:56):
Then we've had in the past.
Ginger Vieira (17:58):
I hear from people whenever I post anything about diabetes
cure research, I always hear from peoplesaying, well, why can't we have X, Y, Z?
Like VX eight 80, for example, requiresimmunosuppression, which makes it very
undesirable for a significant percentageof the population with type one, right?
(18:18):
It's really intended only forpeople who are struggling to get
through their day and function.
They to explain like, Hey, you reallydon't wanna be on immunosuppression
drugs for the rest of your life,even though type one is so hard,
the trade off is not worth it.
Gary (18:37):
That's it.
It's a trade off.
And for most, the vast majority ofpeople with type one widespread immune
suppression is not worth the trade off.
Yeah.
Ginger Vieira (18:45):
Okay.
Thank you for explaining that.
Gary (18:48):
And now a word from our sponsor.
If you were diagnosed with T 1D inthe past six months and are between
ages 12 and 29, here's a clinicaltrial you might want to consider.
GAD 65 from Diamyd Medicalteaches your immune system to stop
attacking your pancreas beta cells.
Diamyd is currently recruiting studyparticipants in the US and Europe.
(19:10):
Visit diagnode-3.com or emailclinicaltrials@diamyd.com to
learn and see if you qualify.
And now back to our program.
So what, what exactly isthe screening process?
So if somebody either has recentlydiagnosed, type one, knows
(19:30):
somebody recently diagnosed mm-hmm.
What's, what's the screening processto see if they qualify for this drug?
Ginger Vieira (19:36):
So the first thing is age range.
So they're looking for people betweenthe ages of 12 up to 29 years old.
And then you've been diagnosedwithin the last six months.
And then the first step afteryou've reached out through the
di, it's di node-three.com.
After you've reached out, the next thingthey're gonna ask you to do is a blood
(19:58):
test to see if you carry this gene.
And if you don't carry the gene,you don't qualify to participate.
And that makes it a little harder forDiomede to find participants, right?
Because they're looking for people who arejust diagnosed and who carry this gene.
And many people who are diagnosed withinthe last six months, they're just still
(20:19):
overwhelmed by this new diagnosis.
You know, it's like they're notthinking about clinical trials.
That's a really big step, especially ifyou're someone who's never really had
to be involved in the medical system.
Now you're gonna go participatein a clinical trial.
That can be daunting.
So it, it is a hard recruitment effort'cause it's such a specific population.
Gary (20:41):
What's in it for someone who receives the treatment?
Let's say it works, it's beautiful.
And how does somebody benefitfrom receiving the Diamyd...
Ginger Vieira (20:52):
So what Diamyd's therapy aims to do is prevent
or delay or significantly reduceyour need for exogenous insulin.
Insulin from a vial, from a pen, rightversus endogenous inside your body.
So if someone is diagnosed in the lastsix months, like you said earlier,
they're already taking insulin.
(21:13):
But Diamyd's therapyhopes to significantly.
Change how much insulin they actuallyare going to need every day and
potentially even delay the progressionbecause we don't realize it.
If you think back, you're, you're notgonna remember how much insulin were
you on in the first six months whenyou were diagnosed, and many people
(21:36):
are still in the honeymoon phase.
So Diamyd's therapy hopes to prolong thathoneymoon phase where your pancreas is
still producing enough insulin to keepyour need for injections relatively low.
And it makes it a lot harder to have superhighs when you're in that honeymoon phase.
I remember when I was in the honeymoonphase, there was two of us in my school.
(21:59):
We had to go to the nurse's officeand prick our fingers there and then
determine what we were gonna take forinsulin with the nurse's approval.
And I was only a few months in.
And there was a girl there who livedwith type one for years and years, and
I remember seeing on her meter, like a225 blood sugar level and being like,
because I hadn't seen that yet, becausemy pancreas was still helping me so much.
Gary (22:22):
Right.
You were a honeymoon girl.
Ginger Vieira (22:23):
Yeah.
Yeah.
I was living my best T1D lifewith a pancreas still helping out.
So GADs therapy, sorry.
Diamyd's therapy really aims toprolong that honeymoon phase.
Um.
That's a big one.
Gary (22:36):
That is such an important thing, and any family with type one knows
how wonderful the honeymoon phase is.
I, I have enough patients I've seen whereif the, if someone's producing just even
the tiniest bit of their own insulin,it provides this beautiful buffer.
Glucoses don't get to extreme highsor lows because the pancreas can
(22:58):
make adjustments to keep thingsfrom getting too far outta range.
So you can almost do no wrong.
Even if you take the wrong dose,eat a lot, whatever, it doesn't
really cause extreme highs or lows.
Ginger Vieira (23:10):
Do those families, they don't.
So you were saying how much theyappreciate the honeymoon phase, but
can they appreciate it when they're init or is it only after looking back?
Gary (23:19):
It's usually afterwards.
Ginger Vieira (23:21):
Yeah.
They don't even know what's coming.
Gary (23:23):
Yeah.
Yeah.
I try to show them graphs of mineor someone else's glucose bouncing
around and they, oh my goodness,this is what I'm headed for.
Yeah.
I didn't get a honeymoon becausewhen I, when I was diagnosed, I had
already gone about three or fourmonths of peeing my brains out,
losing weight, all the symptoms.
So by the time I was diagnosed.
(23:44):
My beta cells were dead on arrival.
I had no insulin production left atall, and I see this now with patients.
Once they lose all their insulinproduction, blood sugar control is,
is a thousand times more difficult.
So preserving the honeymoonhas so much value.
It makes living with diabetes much easier.
(24:06):
It also helps improve long-term outcomes.
'cause if you manage your glucosewell for many years, your risk for
complications goes down and your dailyquality of life is that much better.
Ginger Vieira (24:18):
Yeah.
And so another thing to think about,uh, when you're considering a clinical
trial is in many clinical trialsit's 50/50 of who gets the placebo
and who gets the actual therapy.
And in Diamyd's trial,there's a 30/70 split.
So 30% are getting a placebo,which is basically like, you know,
(24:41):
they're giving you a pretend.
It's like, might as well inject youwith saline instead of the therapy.
Right?
And then 70% are actually gettingGAD 65, the investigational therapy.
So that's a big deal.
It means that you've gota really good chance.
Getting the treatment.
It's, you know, can't help.
(25:02):
But
Gary (25:03):
Yeah.
But even if you don't, you'recontributing to some very important
research, the groundbreaking research.
Ginger Vieira (25:09):
Absolutely.
Gary (25:11):
You're familiar with, uh, tzealed?
Ginger Vieira (25:13):
Yes.
Gary (25:14):
Sanofi's Drug Tocilizumab is a generic name.
What are some of the differencesbetween Diamyd treatment and something
like Tezealed, because they'reTezealed Sanofi's already studying it.
In phase three, you know, whensomebody's recently diagnosed, so yes.
What are some of the differences?
Ginger Vieira (25:32):
So, well, one of the first biggest differences
is how it's administered.
Tezealed, I think, is a10 day infusion process.
So you have to,
Gary (25:40):
yeah, two week.
Two week,
Ginger Vieira (25:42):
14 days full.
14. You have to show up every day.
For 14 days, which means mom and dadare taking off from work, you're missing
school, potentially traveling somewhere.
Right.
You're, you're paying for all that.
And I wanna remind me to mention thatwith Diamyd's in Diamyd's clinical trial,
it's three injections, not some big to-do.
(26:04):
It's you're not sitting there for threedays and there are three injections
over the course of three months,and the injection is in a vein in
your groin, which sounds a littlescary, but it feels no different
than getting your blood drawn.
It's not
Gary (26:20):
squirming in my chair here.
Ginger Vieira (26:21):
No, no, no.
Squirming Gary.
No squirming.
It is really no different thangetting a, a blood draw from a vein
in your arm, and they just knowthat is the, the most effective
spot to introduce their therapies.
Gary (26:33):
So three monthly injections.
Ginger Vieira (26:35):
Yeah.
So one, you know, three monthprocess with one injection per month.
And here's the cool thing, ifyou don't live near one of the
clinical trial sites, they will payfor your travel to get you there.
And their, their trial is there's awhole bunch of cities across the US
you can find all those cities listedat diagnode-3.com and then multiple
(26:57):
countries in Europe are also recruiting.
So they're really trying to makeit as easy for the participant
to get involved as possible.
Yeah.
Gary (27:06):
So once the injections begin, is there additional care that's
provided or treatment that's applied?
Ginger Vieira (27:13):
Yeah.
Then there's, um, monitoring andbasically looking at blood glucose
levels and C-peptide levels to measure.
Gary (27:20):
For anyone listening, C-peptide is an indication of how
much insulin you're producing.
Ginger Vieira (27:25):
I recently had funny story for you.
I have a, a new endocrinologist.
I don't really.
I don't really go to an endocrinologistfor like ongoing support.
Right.
I have Gary Scheiner in my back pocket.
If I have a real insulinquestion, I can call Gary, right?
Um, or Jenny, who's on your team?
I'm good friends with.
My endocrinologist writes prescriptionsfor me and she, she was like, oh, you
(27:49):
only taking this much long-acting insulin.
You must still be producing insulin.
I was like, well, I'velived type one for 25 years.
I highly doubt I'mstill producing insulin.
She insisted, she made me payfor a C-peptide test and it said
I was producing less than 0.01.
My C-peptide level.
Sorry.
Yeah, so I basically,I'm producing no insulin.
(28:11):
So Diamyd's clinical trial willmeasure your C-peptide level, which
indicates how much insulin you're stillproducing and if, if their therapy
is effective, your insulin productionshould sustain your C-peptide level.
Should...
Gary (28:24):
Yeah.
So when somebody makes their owninsulin, when the pancreas puts out
insulin, we also get this littlemolecule called a C-peptide, and
they only call it that 'cause it'sshaped like a c. It's very scientific.
Uh, and when we inject or,or pump insulin, it doesn't
have that C-peptide part.
So that's how we know how muchinsulin your body's making as
(28:46):
opposed to how much you're taking.
Yeah.
So the C-peptide is sort of asurrogate measure of how much insulin
the body is making on its own.
So, yeah, that, that's an importantpart of the follow up as well.
What kind of outcome measurementsare the study personnel?
Are they looking at how muchinsulin someone requires?
(29:06):
They looking at C-peptideglucose management.
Ginger Vieira (29:09):
It's primarily C-peptide and blood, blood sugar levels, and A1C.
So there is that follow up period andyou're contributing to an incredible,
hopeful breakthrough in research thatcould, I mean, I just imagine like
if another really cool thing about.
(29:30):
GAD 65.
This therapy is that it really hasno significant adverse effects.
You can't say no side effects of anymedication, but its safety profile
is considered remarkable by the wholescientific, that's the language I use.
A remarkable safety profile, right?
(29:52):
Which is a good thing.
And if my children were to develop typeone, and I missed the opportunity to
enroll them in a trial like this, Iwould be so bummed because it is a hu,
like you described, the honeymoon phase.
I mean, imagine my 7-year-old,she's a wild maniac.
I don't not wanna manage insulin dosesand intake in a child that knows how
(30:17):
to sneak over to the chocolate bowl.
And my other kid's favorite newsnack lately is pretzels and Nutella.
If I can have their pancreas helpthem through pretzels and Nutella, I
would not wanna miss that opportunity.
So it really starts with screening,getting your kids screened.
Gary (30:36):
Absolutely.
And it applies to adults too,you know, it's not just kids.
Ginger Vieira (30:40):
Absolutely.
No.
Gary (30:40):
Adults who they enjoy the honeymoon and they benefit from that
honeymoon equally, as much as kids do.
Okay, so you mentioned that if somebodydoesn't live near one of the test
sites, you said there's 13 acrossthe US and several in Europe as well.
Mm-hmm.
That Diamyd as a company, will pay fortheir travel to receive their treatments.
Ginger Vieira (31:04):
They will.
Yeah.
Gary (31:05):
So that would be like once every three, once a month for three months.
Ginger Vieira (31:09):
So you're committing to traveling to that clinic site
three times and then at some pointdown the road, six months to a year.
A follow up appointment.
Gary (31:19):
Okay.
Yeah.
A lot of the other data, the sensordata, insulin data that can be collected
on a virtual remote basis, I imagine.
Ginger Vieira (31:27):
I believe so.
Gary (31:30):
Okay.
All right.
Um, well, I mean, that was mainlywhat I wanted to learn about this.
I mean, this is exciting.
Uh, it's just a matter of, of getting theword out, I guess, and letting clinicians
know if you got newly diagnosed patients.
'cause we've got a lot of clinicianswho listen to this podcast and I want
(31:51):
them to know you got newly diagnosedpatients, age 12 to 20, 12 to 29.
Consider them for this.
Yes, this is a greatopportunity to do well by them.
Uh, if you can prolong theirhoneymoon indefinitely, you
know they're gonna appreci, theyshould appreciate that to no end.
Ginger Vieira (32:11):
Yeah.
I mean, can you imagine,I just can't even imagine.
I've had a couple families, parentsreach out to me on like private
messages on Instagram saying,Hey, my child was just diagnosed.
Last month, and I see that youdo a lot of stuff on research.
Is there anything they can enroll in?
And I've introduced those familiesto the DRI, the Diabetes Research
(32:34):
Institute, which works closely withDiamyd and many other companies
trying to develop cures and treatmentsfor Type 1 DRI can support them.
That family, they, they are activelyright now supporting that family.
They find a clinical trial and see, youknow, if you don't qualify for Diamyd's
clinical trial, there are others.
(32:54):
I mean, clinicians listening, oh my gosh.
Please encourage your patients to pursuethis because it's just crazy not to.
Gary (33:03):
Yeah.
That applies to bothpediatric and adult patients.
Yeah.
'cause this goes up to age 29.
I'm guessing that, you know, oncethis study is completed, they're
gonna start looking at similaroutcomes in younger kids and in
older adults, and maybe start lookingbeyond the six month time interval.
So it, it'll end up, uh, like I said,they'll be able to extrapolate this to
(33:25):
a lot more people eventually, but thisis a very important starting point.
Ginger Vieira (33:29):
Yeah, and they're a very small company.
Um, they're really only 30 people.
This is not big pharma.
This is a really small company thatstarted, um, the heart of it is Anders
and his daughter, who's an adultnow, but they're determined to find
a therapy that that's life changing.
Gary (33:48):
It's how things happen.
Necessity is the motherof invention, right?
Uh, this is how, you know, islet asa, or the Beta Bionics got started,
said Dana's child had diabetes.
This is how all the open source,you know, the loop systems and all.
Ginger Vieira (34:05):
Yeah.
Gary (34:05):
Got started.
Parents got tired of waitingfor good tech for their kids.
So they,
Ginger Vieira (34:09):
and Vertex, I mean, vertex bought sema.
Doug Melton's son was diagnosedat like six months old.
So yeah, it, it all startsreally at the heart of having
known this disease up close.
Gary (34:23):
So, Diamyd, this is exciting stuff.
Uh, right now it's, it's a. They'relooking for research participants
between ages of 12 and 29 who arerecently diagnosed and started
treatment for type one diabetes.
Uh, it involves a, uh, oh, and they alsohave to have that specific gene, and
(34:46):
almost half of the diagnoses have thisspecific gene that helps ensure that
the medication, the Diamyd medicationis gonna be effective for them.
Ginger Vieira (34:55):
And Diamyd will test you for that gene.
I've had people say, well, how do I know?
And I'm like, well,that's, you call 'em up.
Clinical trials@Diamyd.com is their email.
You get involved and they will,that's the very first thing they'll
do is see if you carry that gene.
Gary (35:09):
Yeah.
Our show notes will have allof the contact information
people can look for, but.
The basic info diagnode-3.com now theycan go and learn pretty much everything
we covered today, um, at that site,and I strongly encourage people to do
so, and healthcare providers encourageyour patients to do so as well.
(35:32):
So Ginger, thank you so much.
Someday I gotta get you to my gym.
You gotta teach me how to work.
My, my deadlift is lagging.
I've gotta build up, I thinkwomen have some extra back
muscles that men don't have.
Ginger Vieira (35:46):
Oh, that must be it.
Uh, yeah.
Gary (35:48):
Yeah, because I, I've known, 'cause even there's a couple people
on my team, like Anna, our uh, oursocial worker, she, she can deadlift
more than I can also, and I'm like.
What am I missing?
Ginger Vieira (35:59):
Deadlifting was my favourite favorite, that was my favorite.
And the little details and the techniqueof how you're standing and how you're
grabbing the bar and where you put yourweight in your feet and what you do with
your arms and your shoulders and yourlats before you lift that bar a little.
Those little details.
Gary (36:16):
Yeah, I got some things to learn from you.
That's for sure.
Ginger Vieira (36:20):
It's about time, Gary.
Gary (36:21):
Yeah.
And, uh, I, you just, uh, publishedsecond edition of your book on
type one Diabetes and Pregnancy.
Ginger Vieira (36:30):
Yes.
We're super excited about that.
It's got all new sections,all about AID pumping during
pregnancy and yeah was overdue.
Jenny and I were both about to givebirth to our second children before
we published the first edition.
We were like, oh my gosh, get thisout because we'll never get this
book done if we don't get it outbefore these children are born.
Gary (36:51):
That's right.
Yeah.
Your kids are about the same age.
Ginger Vieira (36:53):
Yeah.
Yeah, they are.
Gary (36:56):
Alright, well again, thank you Ginger.
I encourage people to look forthe information about Diagnode-3.
Thank you so much.
I'm Gary Scheiner.
Thank you for listening, andI wanna remind everyone to
keep thinking like a pancreas.
Thanks for tuning in to ThinkLike a Pancreas, the podcast.
(37:17):
If you enjoyed today's episode, don'tforget to like, follow or subscribe
on your favorite podcast app.
Think like a pancreas.
The podcast is brought to you byIntegrated Diabetes Services, where
experience meets expertise, passionmeets compassion, and diabetes care
is personal because we live it too.
(37:37):
Our team of clinicians all livingwith type one diabetes understands
the challenges firsthand.
We're here to help no matterwhere you are in the world.
From glucose management to self-carestrategies, the latest tech,
sports, and exercise, weight losstype one, pregnancy and emotional
wellbeing, we've got you covered.
(37:57):
We offer consultations inEnglish and Spanish via phone,
video, chat, email and text.
Wanna learn more?
Visit integrated diabetes.com oremail info@integrateddiabetes.com
to schedule a consultation.
On behalf of Think Likea Pancreas, the podcast.
I'm Gary s Scheiner, wishing youa fantastic week ahead, and don't
(38:19):
forget to think like a pancreas.
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