Follow-up:
Per a recent study of the Omnipod 5, as I
documented in the following post ...
https://groups.google.com/g/misc.health.diabetes/c/nd6zyPma6Ak/m/6cglmld6BwAJ
... the study included individuals with HbA1c
levels < 5.7, < 6, < 6.5, < 7, & > 7.
I previously made a mistake when the average
HbA1c levels being > 7, I misinterpreted that
thinking they didn't include anyone with lower
HbA1c levels. I apologize for that mistake.
Actually, they did include Islit folks that are in
the HbA1c good & great gang, HbA1c < 7,
< 6.5, < 6, & < 5.7. Until details are provided,
don't know the breakdown as to how many
had HbA1c levels that low & how many were
> 7.
My last 90 days CGM readings, average glu-
cose level 125 mg/dl, latest HbA1c = 5.4, my
time in range = 91.4%. The following chart/
article indicates why my HbA1c is lower than
what my CGM average glucose level would
indicate (note the time in range graphic ...
... which indicates the higher one's time in
range, the lower one's HbA1c level):
Clinical Targets for CGM Data Interpretation
https://www.novomedlink.com/content/dam/novonordisk/novomedlink/patient-support/product-education/insulin/docs/Clinical_Targets_For_CGM_Data-Interpretation.pdf
Also note my coefficient of variation = 32.6%,
another factor involved in HbA1c. I won't know
'til the Omnipod 5 is available, but I anticipate
that I'll be able to have HbA1c level < 5.7 with
less hypoglycemia, more time in range, less
hyperglycemia, and better sleep than I'm cur-
rently having.
On Sunday, June 27, 2021 at 12:58:26 PM UTC-5, _ wrote:
.> The following article, optimistic views on
.> Omnipod 5 FDA approval and some angles
.> on what the Omnipod 5 consists of that I
.> previously had given little (if any) attention
.> to (article dated June 25 2021):
.>
https://www.healthline.com/diabetesmine/omnipod-5-excitement-diabetes
.>
.> [clarifying insert included in brackets,
.> not part of original article]
.>
.> [Individuals with Islit (Insulinitis, near-total to
.> total loss of endogenous insulin) + individuals
.> with non-Islit DHGCs who use exogenous in-
.> sulin (estimated in 2019 to include 5.3% of
.> individuals with Cellosis - continued but prob-
.> lematic endogenous insulin no longer able ...
.>
.> ... to lower glucose levels < HbA1c 6.5)] can’t
.> wait until the first tubeless insulin pump be-
.> comes a “closed loop” automated system, with
.> the introduction of the Omnipod 5 expected by
.> the end of 2021.
.>
.> This new system will combine the Omnipod
.> patch pump [tubeless insulin pump] with the
.> Dexcom G6 continuous glucose monitor (CGM)
.> and a controller algorithm to help automate in-
.> sulin delivery.
.>
.> Notably, Omnipod 5 is set to bring mobile app
.> control and insulin dosing directly from your
.> smartphone, eliminating the need to carry a
.> separate Personal Diabetes Manager (PDM)
.> around to control the system.
.>
.> Omnipod maker Insulet in Massachusetts had
.> experienced some delays with this product due
.> to the COVID-19 pandemic, but now pivotal trials
.> are complete and they submitted it to the Food
.> and Drug Administration (FDA) right around the
.> start of the year.
.>
.> Many expect the federal agency will give it their
.> green light by mid-2021. As in, it could be ready
.> for purchase by patients by the end of the year!
.>
.> What exactly is Omnipod 5?
.>
.> Omnipod 5 is the latest Automated Insulin Delivery
.> (AID) system that combines an insulin pump and a
.> CGM with a controller algorithm to automatically
.> adjust insulin in response to predicted glucose lev-
.> els.
.>
.> Specifically, these are referred to as hybrid closed
.> loop systems because they partially mimic what a
.> healthy pancreas does automatically — but some
.> user intervention is still required around food intake
.> and exercise.
.>
.> Omnipod 5 will be the third commercially available
.> AID system, after Medtronic’s original 670G and the
.> newer Tandem Control-IQ system.
.>
.> But Omnipod brings the first AID system with a no-
.> tubing pump.
.>
.> It is a major upgrade from Insulet’s latest Omnipod
.> DASH platform launched in 2019 and uses the same
.> pods and mobile app. It will first connect with the
.> Dexcom CGM and later with Abbott’s FreeStyle
.> Libre, Insulet says.
.>
.> Here are some of the key features to know about:
.>
.> o It’s the same size and shape as existing Pods, worn
.> for up to 3 days and holding anywhere between 85
.> and 200 units of insulin.
.>
.> o Unlike previous Omnipod versions, this new system
.> will eliminate the need to carry a separate PDM con-
.> troller device, as users can control it directly from a
.> smartphone app.
.>
.> o At first, the mobile app will be compatible only with
.> certain Android smartphones, but eventually it will
.> work with iPhones.
.>
.> o Insulet has said during investor earnings calls that
.> it will provide a basic phone to those who don’t have
.> a compatible smartphone, for use exclusively with the
.> Omnipod 5 app.
.>
.> o The algorithm will make auto-adjustments to basal
.> (background) insulin rates every 5 minutes, based on
.> current and projected glucose values from the con-
.> nected CGM. It also takes into consideration insulin
.> on board (IOB) that’s already been dosed, and the
.> users recorded insulin sensitivity factors.
.>
.> o It allows for varying glucose targets for different
.> times of day.
.>
.> o Glucose targets are customizable in 10 mg/dL incre-
.> ments between 110 to 150 mg/dL — different than other
.> first-generation AID systems that have fixed targets you
.> can’t change.
.>
.> o It includes a “HypoProtect” feature to ward off low
.> blood sugar that temporarily sets the target to 150
.> mg/dL and minimizes basal insulin delivery for exer-
.> cise.
.>
.> o The system learns a user’s needs after the first two or
.> three Pods with the smart algorithm making more aggres-
.> sive self-adjustments based on results during the past
.> several days.
.>
.> o It takes about 9 days for a new foundational basal pro-
.> gram to be set.
.>
.> o You still need to bolus for food and can manually deliver
.> insulin corrections for higher blood sugars, but the smart
.> algorithm will automatically increase or decrease those
.> boluses based on CGM trends if glucose levels are rising
.> or falling.
.>
.> What’s unique compared to competing commercial sys-
.> tems is that Omnipod 5 will be the only tubeless patch
.> pump system offering automation, plus the first to offer
.> full smartphone control including dosing capabilities from
.> the phone.
.>
.> * * * * * * * * * * * * * * * * * * * * * * * * * * * * *
.>
.> Pro-Humanist FREELOVER, I got Insulinitis
.> (Islit) which was caused by Insulitis at age 5
.> in March 1961, requiring multiple exogenous
.> insulin doses to try to stay alive. There are
.> 15 specific types of rapid-onset Islit.
.>
.> There is 1 specific type of slow-onset Islit,
.> Latent Autoimmune Islit, also unpreventable
.> & nonreversible (thus far).
.>
.> - - -
.>
.> 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
.>
.> - - -
.>
.> C.ure I.nsulinitis A.ssociation
.>
https://prohuman.net/cureinsulinitisassociation.htm
.>
.> Glucose Anomalies Research regarding
.> Potential Cures / Improvements in Treatments
.>
https://prohuman.net/glucoseanomaliesresearch.htm
.>
.> - - -
.>
.> 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
.>
.> 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
.>
.> * * * * * * * * * * * * * * * * * * * * * * * * * * * * *