Follow-up:

- - -
Insulitis Islit (Insulinitis), near-total to total loss of
endogenous insulin caused by autoimmune attack
on pancreatic beta cells (Insulitis), the #1 specific
type of 15 disparate specific types of rapid onset
Insulinitis.
- - -

Note, confusing misleading parts of following
article translated to new superior clarifying
terminology & descriptions (with additional
clarification added in parentheses):

- - -
July 6 2021

Provention Bio slapped with FDA rejection
[for reducing risk of Insulitis Islit in high risk
individuals] by taking teplizumab https://www.fiercebiotech.com/biotech/provention-bio-slapped-fda-rejection-for-diabetes-hopeful-teplizumab
- - -

After scraping through a tough advisory com-
mittee in March, the FDA has returned a ver-
dict for Provention Bio’s Insulitis Islit reduced
risk for individuals at high risk of getting Insul-
itis Islit medicine: It’s a no.

Specifically, the FDA has slapped a complete
response letter on Provention for teplizumab,
which was gunning for an approval to help
delay clinical Insulitis Islit in at-high-risk of
getting Insulitis Islit individuals.

In the trial that underpinned the drug’s appli-
cation, Provention said teplizumab delayed
the onset of Islit by a median of two years.
That delay could (was claimed to) help high-
at-risk individuals avoid Islit ketoacidosis, a
life-threatening Disparate High Glucose ...

... Conditions (DHGCs) sequela (especially
in individuals with Islit).

Back in March, FDA experts assessing the
drug raised concerns about how small the
study was—it didn’t meet its enrollment
goal and wound up testing teplizumab in
just 44 patients—and about the fact that
the study did not follow patients after their
Islit diagnosis.

The company also submitted safety data
from other trials of the drug in another in-
dication, which the FDA reviewers noted
were not a perfect comparison.

...

On Wednesday, March 3, 2021 at 4:21:17 PM UTC-6, _ wrote:

- - -
March 3 2021

Teplizumab study in 76 antibody-positive
high-risk of Insulitis Islit individuals https://stm.sciencemag.org/content/13/583/eabc8980
- - -

o 76 participants classified as being at high risk
due to an unspecified family relationship to fam-
ily member(s) having Insulitis Islit. Unknown how
the study dealt with the disparate risks based on
the exact risk category the 76 participants were
in:

- The risks expressed in the following, if the par-
ent got Insulitis Islit at age < 11, the risk shown
doubles

- Father has Insulitis Islit, child has 5.88% chance
of getting it

- Mother has Insulitis Islit & child born before the
mother was age 25, child has 4% chance of getting
it

- Mother has Insulitis Islit & child born when mother
was age 25 or older, child has 1% chance of getting
it

- Father & Mother have Insulitis Islit, child has as
high as 25% chance of getting it

- Identical twin has Insulitis Islit, the twin that does
not have Insulitis Islit has a 50% chance of getting
it

- If the parent has Insulitis Islit -and- a condition
called type 2 polyglandular autoimmune syndrome,
child has 50% chance of getting Insulitis Islit

- Parents don't have it but a sibling has Insulitis Islit,
child has a 5% chance of getting it

These percents come from the following article: https://www.webmd.com/diabetes/diabetes-type-1-genetics

Notably, many (as high as 85%) who get Insulitis
Islit have no known relative with Insulitis Islit. My-
self, don't know if I was in the "high risk" category
as my only relative with Insulitis Islit was my half
uncle.

Note - the risk of Insulinitis (any type) in the general
population is less than one-half of 1%.

o 76 participants, unknown how they selected the
44 who got the experimental drug teplizumab and
the 32 who got the placebo.

o The median age was 13 (range, 8 to 49); sur-
prising that they included individuals > age 30,
as 50% of Insulitis Islit occurs at age 18 and
younger, and 20% at ages 19 to 29. Also sur-
prising that no individuals under age 8 were
included.

o Median time to diagnosis of Insulitis Islit was
59.6 months in the 22 of 44 teplizumab treated
individuals who got it -and- 27.1 months for the
25 of 32 placebo-treated individuals who got it.

Sidenote: The possibility of bias impacting the
result exists unless specific measures were tak-
en in the study to prevent bias. The article did
not indicate how "high risk" was determined, or
how selection was made for those receiving tep-
lizumab or placebo, or why it was decided that ...

... 44 would receive the drug and 32 would re-
ceive the placebo. The fact that 25 of 32 re-
ceiving the placebo got Insulitis Islit is highly
unusual (i.e., that's an extraordinarily high
diagnosis rate, far higher than it should be),

Also, the fact that 22 of 44 receiving teplizumab
got Insulitis Islit is unusually high, per the follow-
ing excerpt/article: https://www.endocrineweb.com/conditions/type-1-diabetes/type-1-diabetes-risk-factors

There are several risk factors that may make it
more likely that you’ll develop Insulitis Islit—if
you have the genetic marker that makes you
susceptible to Insulitis Islit.

That genetic marker is located on chromosome 6,
and it’s an HLA (human leukocyte antigen) complex.

Several HLA complexes have been connected to
Insulitis Islit, and if you have one or more of those,
you may develop Insulitis Islit.

(However, having the necessary HLA complex is
not a guarantee that you will develop Insulitis Islit;
in fact, less than 10% of people with the “right”
complex(es) actually develop Insulitis Islit.)

- - - end excerpt - - -

So that begs the question, did the study select an
unusually extremely very high risk for Insulitis Islit
group of individuals?

- - -

Per the following article, "The drug has been
awarded breakthrough status by the U.S. Food
and Drug Administration, which means it could
be approved for general use by summer." https://www.upi.com/Health_News/2021/03/03/type-1-diabetes-prevention-teplizumab-s.tudy/7511614791484/

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INSULINITIS (ISLIT)

New SUPERIOR clarifying name for near-
total to total loss of endogenous insulin https://prohuman.net/pix2/new_superior_clarifying_name_is_INSULINITIS.jpg

The overwhelming majority of Islit caused by
autoimmune attacks on pancreatic beta cells
(Insulitis Islit) but there are

o 15 specific types of rapid onset Islit, a
rare condition (only present in < one-half
of 1% of Americans & in a much lower rate
in most of the world), when present is typ-
ically diagnosed at age under 30
(50% at age < 18, 20% at age 19 to 29)

o 1 slow onset specific type, Latent Autoim-
mune Islit, frequency unknown but per a
recent report, misdiagnosed as Cellosis
(new clarifying name for type 2 diabetes)
almost 40% of the time due to its slow
onset and its occurrence typically at age
over 30

Old outdated anachronistic name for Islit is
type 1 diabetes, confusing in that diabetes
without clarifier is often used to describe
this condition which is 1 of the 7 Disparate
High Glucose Conditions (DHGCs).

That makes figuring out which DHGC is actu-
ally being referred to (and it can be any one,
or some, or all of them when the diabetes
or diabetic word is used without clarifier)
confusing / difficult: https://prohuman.net/pix2/diabetesdiabeticguessinggame.jpg https://prohuman.net/pix2/diabetesdiabeticconfusion.jpg https://prohuman.net/pix2/diabetesdiabeticendingthemisunderstanding.jpg

- - -

Insulin / Insulin Pump / CGM I use

Fiasp Ultra-Fast-Acting Insulin in a
tubeless Omnipod insulin pump catheter
placed into skin / pod with adhesive
stuck onto skin every 80 hours, control
via PDM (Personal Data Manager) https://prohuman.net/pix2/Fiaspinsulin_tubelessOmnipodDASHinsulinpump.jpg

Dexcom G6 CGM (continuous glucose monitor) https://prohuman.net/pix2/Dexcom_G6_CGM.jpg

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