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FDA Approves Insulet Omnipod 5 (automatic basal adjustment every 5 minutes based on Dexcom 6 CGM readings)
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Jan 30, 2022, 11:07:31 AM1/30/22
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---
January 28 2022
FDA approves 1st automated, tubeless
insulin pump (Omnipod 5) for people with
Insulinitis (Islit, near-total to total loss of
endogenous insulin)
https://www.goodmorningamerica.com/wellness/story/fda-approves-1st-automated-tubeless-insulin-pump-people-82402529
---
Photo of Omnipod 5 control device along
with its pod & its Dexcom G6 CGM sensor:
https://s.abcnews.com/images/GMA/insulet-omnipod-main-ht-jt-220121_1642797775990_hpMain_16x9_1600.jpg
...
The Omnipod 5 will quickly begin rolling
out in a limited market release ... with a
full release coming later this year, accord-
ing to Shacey Petrovic, president & CEO of
Insulet, the Massachusetts-based maker
of Omnipod.
She said the device, which will be sold in
pharmacies, will be immediately available
for people ages 6 to 70, with clearance for
kids ages 2 and older expected later this
year.
---
Comment: I guess the only way I'll know
for sure if I can get it is to try to order it
when I next see my doctor (March 18 2022),
& see if my provider (Humana Pharmacy)
has it then or if they will get it later this
year.
Unstated anywhere, will this device be cov-
ered as DME (durable medical equipment)
or will it only be covered as a prescription?
DME avoids reduced coverage when one
goes over $4,000 (approximate) in a year
(the Medicare 'donut hole').
---
Information at the following Omnipod 5
website indicates it currently only works
with one cellphone, the
Samsung Galaxy S10 (4G) SM-G973U1
or SM-G973U (with Android 11).
However, one can still control the Omni-
pod 5 System with the wireless Omni-
pod 5 Controller, provided at no cost
with the 1st prescription.
https://www.omnipod.com/current-podders/resources/omnipod-5/device-compatibility
Based on prices displayed at a search via
amazon, I would use the 'no cost' device
available with the 1st prescription rather
than buying another cellphone:
https://smile.amazon.com/s?k=samsung+galaxy+s10+sm-g973u&crid=V6UV50KYFG6G&sprefix=Samsung+Galaxy+s10+SM-G973U%2Caps%2C131&ref=nb_sb_ss_ts-doa-p_1_27
~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~
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 Auto-
immune 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 slow onset
& 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
& the other 6 Disparate High Glucose Con-
ditions (DHGCs).
That makes figuring out which DHGC is actu-
ally being referred to (& it can be any 1, some,
or all of them when diabetes or diabetic word
used without clarifier) confusing / difficult:
https://prohuman.net/pix2/diabetesdiabeticguessinggame.jpg
https://prohuman.net/pix2/diabetesdiabeticconfusion.jpg
https://prohuman.net/pix2/diabetesdiabeticendingthemisunderstanding.jpg
Recent estimate that 20 million have Islit in the
world, 1 in 394 (2.583/10ths of 1%), less than
5% of the almost 470 million in the world who
have any of the 7 DHGCs, 95% having Cellosis
(see below for causalities):
https://groups.google.com/g/misc.health.diabetes/c/58ZoHZEZ51w/m/EBejqoJQAQAJ
Notably, one's relatives and one's birthplace
dramatically impact one's risk of getting the
Insulitis-caused Islit, as listed in details of all
15 specific types of rapid-onset Islit & the sole
specific type of slow onset Latent Autoimmune
Islit at
https://groups.google.com/g/misc.health.diabetes/c/aOsrugeqYqs/m/MlI8I6PzAAAJ
- - -
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
- - -
Stop Diabetes/Diabetic Confusion
with New Superior Clarifying Terms
https://www.change.org/stopdiabetesdiabeticconfusionwithNewSuperiorClarifyingTerms
- - -
o Preventable Cellosis is the only specific
type of Disparate High Glucose Condition
that is preventable & reversible (in many,
sometimes it's called type 2 diabetes, often
confusingly called diabetes with no clarifier)
Risk for Preventable Cellosis, Hypertension,
& Cardiovascular Disease increases as one's
weight increases but BMI risk increases at
lower BMI levels in non-white individuals:
https://prohuman.net/pix2/BMI-WaistCircumference-Cellosis&Hypertension&CardiovascularDisease-Risk.jpg
https://medicalxpress.com/news/2021-05-bmi-offs-obesity-diabetes-non-white.html
o PreCellosis (often confusingly called predia-
betes with no clarifier) is the oft-times preven-
table & reversible Cellosis precondition that all-
too-often the overwhelming majority having it
are unaware they have it (almost 3 times more
have PreCellosis than have Cellosis).
o 20 specific types of Cellosis, unpreventable
& nonreversible (thus far, sometimes called
type 2 diabetes, all-too-often confusingly called
diabetes with no clarifier)
Per the following article, 5.3% with Cellosis
used exogenous insulin in 2019.
https://www.bloomberg.com/press-releases/2019-12-13/tandem-diabetes-care-announces-fda-clearance-of-the-t-slim-x2-insulin-pump-with-control-iq-advanced-hybrid-closed-loop
- - -
o 4 other Disparate High Glucose Conditions
exist (Gestational Cellosis, Diminosis, Neonatal
Diminosis, Ohiglucons), all 7 DHGCs fully des-
cribed in the following article:
Logic and reasoning behind ceasing using
confusing / misleading / misinforming diabetes
& diabetic & reactive hypoglycemia words and
phrases, replacing all of that with vastly superior
clarifying names:
Diabetes Bubble / Diabetes Bubble Burst
https://prohuman.net/diabetesbubblediabetesbubbleburst.htm
~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~
January 28 2022
FDA approves 1st automated, tubeless
insulin pump (Omnipod 5) for people with
Insulinitis (Islit, near-total to total loss of
endogenous insulin)
https://www.goodmorningamerica.com/wellness/story/fda-approves-1st-automated-tubeless-insulin-pump-people-82402529
---
Photo of Omnipod 5 control device along
with its pod & its Dexcom G6 CGM sensor:
https://s.abcnews.com/images/GMA/insulet-omnipod-main-ht-jt-220121_1642797775990_hpMain_16x9_1600.jpg
...
The Omnipod 5 will quickly begin rolling
out in a limited market release ... with a
full release coming later this year, accord-
ing to Shacey Petrovic, president & CEO of
Insulet, the Massachusetts-based maker
of Omnipod.
She said the device, which will be sold in
pharmacies, will be immediately available
for people ages 6 to 70, with clearance for
kids ages 2 and older expected later this
year.
---
Comment: I guess the only way I'll know
for sure if I can get it is to try to order it
when I next see my doctor (March 18 2022),
& see if my provider (Humana Pharmacy)
has it then or if they will get it later this
year.
Unstated anywhere, will this device be cov-
ered as DME (durable medical equipment)
or will it only be covered as a prescription?
DME avoids reduced coverage when one
goes over $4,000 (approximate) in a year
(the Medicare 'donut hole').
---
Information at the following Omnipod 5
website indicates it currently only works
with one cellphone, the
Samsung Galaxy S10 (4G) SM-G973U1
or SM-G973U (with Android 11).
However, one can still control the Omni-
pod 5 System with the wireless Omni-
pod 5 Controller, provided at no cost
with the 1st prescription.
https://www.omnipod.com/current-podders/resources/omnipod-5/device-compatibility
Based on prices displayed at a search via
amazon, I would use the 'no cost' device
available with the 1st prescription rather
than buying another cellphone:
https://smile.amazon.com/s?k=samsung+galaxy+s10+sm-g973u&crid=V6UV50KYFG6G&sprefix=Samsung+Galaxy+s10+SM-G973U%2Caps%2C131&ref=nb_sb_ss_ts-doa-p_1_27
~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~
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 Auto-
immune 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 slow onset
& 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
& the other 6 Disparate High Glucose Con-
ditions (DHGCs).
That makes figuring out which DHGC is actu-
ally being referred to (& it can be any 1, some,
or all of them when diabetes or diabetic word
used without clarifier) confusing / difficult:
https://prohuman.net/pix2/diabetesdiabeticguessinggame.jpg
https://prohuman.net/pix2/diabetesdiabeticconfusion.jpg
https://prohuman.net/pix2/diabetesdiabeticendingthemisunderstanding.jpg
Recent estimate that 20 million have Islit in the
world, 1 in 394 (2.583/10ths of 1%), less than
5% of the almost 470 million in the world who
have any of the 7 DHGCs, 95% having Cellosis
(see below for causalities):
https://groups.google.com/g/misc.health.diabetes/c/58ZoHZEZ51w/m/EBejqoJQAQAJ
Notably, one's relatives and one's birthplace
dramatically impact one's risk of getting the
Insulitis-caused Islit, as listed in details of all
15 specific types of rapid-onset Islit & the sole
specific type of slow onset Latent Autoimmune
Islit at
https://groups.google.com/g/misc.health.diabetes/c/aOsrugeqYqs/m/MlI8I6PzAAAJ
- - -
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
- - -
Stop Diabetes/Diabetic Confusion
with New Superior Clarifying Terms
https://www.change.org/stopdiabetesdiabeticconfusionwithNewSuperiorClarifyingTerms
- - -
o Preventable Cellosis is the only specific
type of Disparate High Glucose Condition
that is preventable & reversible (in many,
sometimes it's called type 2 diabetes, often
confusingly called diabetes with no clarifier)
Risk for Preventable Cellosis, Hypertension,
& Cardiovascular Disease increases as one's
weight increases but BMI risk increases at
lower BMI levels in non-white individuals:
https://prohuman.net/pix2/BMI-WaistCircumference-Cellosis&Hypertension&CardiovascularDisease-Risk.jpg
https://medicalxpress.com/news/2021-05-bmi-offs-obesity-diabetes-non-white.html
o PreCellosis (often confusingly called predia-
betes with no clarifier) is the oft-times preven-
table & reversible Cellosis precondition that all-
too-often the overwhelming majority having it
are unaware they have it (almost 3 times more
have PreCellosis than have Cellosis).
o 20 specific types of Cellosis, unpreventable
& nonreversible (thus far, sometimes called
type 2 diabetes, all-too-often confusingly called
diabetes with no clarifier)
Per the following article, 5.3% with Cellosis
used exogenous insulin in 2019.
https://www.bloomberg.com/press-releases/2019-12-13/tandem-diabetes-care-announces-fda-clearance-of-the-t-slim-x2-insulin-pump-with-control-iq-advanced-hybrid-closed-loop
- - -
o 4 other Disparate High Glucose Conditions
exist (Gestational Cellosis, Diminosis, Neonatal
Diminosis, Ohiglucons), all 7 DHGCs fully des-
cribed in the following article:
Logic and reasoning behind ceasing using
confusing / misleading / misinforming diabetes
& diabetic & reactive hypoglycemia words and
phrases, replacing all of that with vastly superior
clarifying names:
Diabetes Bubble / Diabetes Bubble Burst
https://prohuman.net/diabetesbubblediabetesbubbleburst.htm
~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~
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