Follow-up 2:
Unlike the plethora of details in the original
post in this thread, the following report has
a few sparse details. I expect a plethora of
details will appear in the future.
Odd, they don't mention the critical continu-
ous glucose monitor tie-in to the Omnipod 5,
using a term I haven't seen before, Automated
Insulin Delivery (AID) System, not mentioning
that to auto-adjust basal insulin dosaging, the
glucose levels from a tied-in CGM are critical.
Another glaring shortcoming, they focus on
Islit individuals with high glucose levels in
their tests, ignoring Islit individuals whose
current glucose levels are < 7, < 6.5, < 6,
& < 5.7 (the good-to-great HbA1c gang).
I'm disappointed that they are so focused
on Islit individuals with HbA1c > 7 they ig-
nore Islit individuals with HbA1c levels men-
tioned. One would hope that those individuals
would also have significant benefits (less ...
... hypoglycemia, more time in range, less
hyperglycemia, as good or better HbA1c)
via Omnipod 5, but unfortunately, their test-
ing ignores the good-to-great-HbA1c gang.
- - -
June 26 2021
Insulet’s Omnipod® 5 Automated Insulin
Delivery (AID) System Pivotal Studies
Demonstrate Improved Outcomes Across
the Lifespan from Ages 2 to 70 years
https://www.businesswire.com/news/home/20210626005002/en/Insulet%E2%80%99s-Omnipod%C2%AE-5-Automated-Insulin-Delivery-System-Pivotal-Studies-Demonstrate-Improved-Outcomes-Across-the-Lifespan-from-Ages-2-to-70-years
- - -
... 80 preschool aged children across 10 U.S.
sites for this study. The participants, who were
between 2 and 5.9 years of age with an HbA1c
of under 10.0%, used Omnipod 5 at home for a
period of 3 months after a 14-day period using ...
... their standard therapy, which included either
pump therapy or multiple daily injections (MDI).
The children were unrestricted in eating and
exercise throughout the study.
The study showed an overall reduction in HbA1c
from an average of 7.4% to 6.9%, and a signifi-
cant increase in time in range (70-180 mg/dL),
from an average of 57.2% to 68.1%, or an addi-
tional 2.6 hours per day. Median time in hypo-
glycemia (<70 mg/dL) was reduced, from 2.2%
to 1.9% overall.
... subjective sleep quality. Parents and care-
givers reporting “very good” or “fairly good”
sleep increased from 65% at baseline to 90%
at the end of the study.
... 33 participants in the pivotal trial transitioning
from MDI to Omnipod 5 achieved significant im-
provement in HbA1c (children: 7.73% to 6.74%,
adolescents and adults: 7.57% to 6.97%) & time
in range (children: 52.2% to 68.9%; adolescents
& adults: 60.4% to 72.3%) after 3 months of use.
... 224 pivotal study participants continuing use
of Omnipod 5 in an extension study demonstrated
sustained improvements in HbA1c over a total of
6 months of system use.
Pediatric results decreased from an average of
7.7% at baseline to 6.9% at 6 months, and the
adolescent and adult cohort decreased from an
average of 7.2% to 6.7%. The extension study
also revealed sustained improvements in time in
range with minimal time below range.
,,, users perceived Omnipod 5 to be a more usable
product compared to their prior therapy.
Adults and caregivers of teens and children also
reported increased satisfaction with their treatment
... suggesting that Omnipod 5 may alleviate some
of the burdens associated with existing treatment
options for Islit both for adults and caregivers of
younger users.
Furthermore, Omnipod 5 led to significant improve-
ments in quality-of-life measures, including reduc-
tions in Islit-related distress across all groups, and
improved hypoglycemic confidence among adults
and caregivers of children.
As indicated by these outcomes, reduced Islit dis-
tress and improved quality of life are key benefits
of using the Omnipod 5 AID system that are com-
plementary to the glycemic benefits achieved. ...
On Thursday, June 24, 2021 at 1:38:47 PM UTC-5, _ wrote:
.> Follow-up:
.>
.> Per the following, Insulet (maker of Omnipod)
.> plans to release a new study on June 26 2021
.> of Preschool Children and Adults using the
.> Omnipod® 5 System:
.>
https://www.biospace.com/article/releases/insulet-to-present-new-clinical-data-for-preschool-children-and-adults-using-the-omnipod-5-system/
.>
.> I expect the results will be disappointing for the
.> tiny minority of Islit individuals who currently have
.> HbA1c levels < 5.7, but hey, we'll soon see if the
.> study shows any indication anyone using the new
.> Omnipod 5 has glucose levels anywhere near to
.> what I have on manual pilot using the Omnipod 4
.> + Dexcom G6.
.>
.> The previous study referenced below didn't show
.> any sign of anyone having HbA1c levels < 5.7 when
.> using the Omnipod 5, displaying disappointing aver-
.> age glucose levels, hyperglycemia%s, & time 'tween
.> 70 to 180 mg/dl. The only thing they excelled at was
.> lowering the hypoglycemia%.
.>
.> The article above, disappointing in that it says that
.> Insulet "... expects to launch Omnipod 5 in limited
.> release during the second half of 2021. ..."
.>
.> So, it's patience-required time for Islit individuals
.> in the U.S. who are interested in the Omnipod 5,
.> Dexcom G7, & Abbott Freestyle Libre 3, their avail-
.> ability in the U.S. probably not transpiring 'til 2022
.> (hopefully they'll surprise me by appearing late in
.> 2021, but unlikely to be here 'til sometime in 2022).
/> On Saturday, March 20, 2021 at 8:31:31 PM UTC-5, _ wrote:
/> .> This device, scheduled to be released in
/> .> the last half of 2021.
/> .>
/> .> The Omnipod 5 System underwent three
/> .> months of at-home testing in
/> .>
/> .> o 128 adults and adolescents ages 14 to
/> .> 70 years (actual ages 20.5 to 65.5)
/> .>
/> .> and
/> .>
/> .> o 112 children ages 6 to less than 14 years.
/> .> (actual ages, 6.6 to 13.4)
/> .>
/> .> Why age 14-17 was included with adults
/> .> rather than children, don't know, but as it
/> .> turns out, the youngest Adult was 20.5
/> .> years young. No one age 14 to 19 was
/> .> included in the study.
/> .>
/> .> I found the following study after reading
/> .> a brief report about the study which had
/> .> far less detail.
/> .>
/> .> As typically happens in studies, individuals
/> .> who have HbA1c levels < 5.7 are ignored.
/> .> Here are the HbA1c levels of participants
/> .> before the Omnipod 5 (Horizon) was used:
/> .>
/> .> Children mean: 7.8 (6.7–9.6)
/> .> Adults mean: 7.1 (5.9–8.9)
/> .>
/> .> - - -
/> .> January 18 2021
/> .>
/> .> First Outpatient Evaluation of a Tubeless
/> .> Closed Loop Omnipod 5 (Horizon), Basal
/> .> Insulin Auto-Managed with Dexcom 6 CGM,
/> .> Automated Insulin Delivery System with
/> .> Customizable Glucose Targets in Children
/> .> and Adults with Insulinitis
/> .>
https://www.liebertpub.com/doi/10.1089/dia.2020.0546
/> .> - - -
/> .>
/> .> Insulinitis (Islit, near-total to total loss of
/> .> endogenous insulin).
/> .>
/> .> Using my Omnipod 4 and a separate
/> .> Dexcom G6 CGM, here are my results
/> .> for the last 90 days for comparison to
/> .> the results displayed for Standard Ther-
/> .> apy & Omnipod 5 Horizon Therapy below.
/> .>
/> .> Mean Sensor Glucose: 129 mg/dl
/> .>
/> .> < 70 mg/dl: 1.3%
/> .>
/> .> 70-180 mg/dl: 90.7%
/> .>
/> .> > 180 mg/dl: 8%
/> .>
/> .> Latest HbA1c: 5.4
/> .>
/> .> ~~~
/> .>
/> .> Detailed results: ST = Standard Therapy
/> .> HCL = Hybrid Closed Loop Therapy, i.e.
/> .> Omnipod 5 (Horizon) Therapy
/> .>
https://www.liebertpub.com/na101/home/literatum/publisher/mal/journals/content/dia/0/dia.ahead-of-print/dia.2020.0546/20210117/images/medium/dia.2020.0546_inline2.jpg
/> .>
/> .> Mean Sensor Glucose: Children 173 mg/dl to 183 mg/dl,
/> .> Adults 154 mg/dl to 170 mg/dl, much higher than my levels
/> .> of 129 mg/dl
/> .>
/> .> < 70 mg/dl: Children were .5% to .8%, lower than my 1.3%,
/> .> Adults were .6% to 1.4%, higher than my 1.3% only when
/> .> their target glucose was 130 mg/dl
/> .>
/> .> 70-180 mg/dl: 53.5% to 75.1%, much lower than my 90.7%
/> .>
/> .> > 180 mg/dl: Alarmingly high 23.4% to 46.7%, much higher
/> .> than my 8%
/> .>
/> .> So, unless the Omnipod 5 (Horizon) can
/> .> mate to the glucose levels I have now,
/> .> I'd be hard pressed to use it, albeit I'd
/> .> enjoy being able to sleep without waking
/> .> up 4 times each night, but I'd fear its ap-
/> .> parent propensity for much higher glucose
/> .> levels than I'm able to achieve now.
/> .>
/> .> I'd probably have to override whatever set-
/> .> tings they used in their test, because their
/> .> time in range is far lower than what I have
/> .> now and their time > 180 mg/dl is much
/> .> higher than what I have now, unacceptably
/> .> higher.
/> .>
/> .> I have to add, see the following post for
/> .> details on what the glucose levels are of
/> .> individuals with a fully functional pancreas,
/> .> and note that my glucose levels, while
/> .> considerably better than the Omnipod 5
/> .> (Horizon) glucose levels, mine are ...
/> .>
/> .> ... disappointingly short of the perfectly
/> .> controlled glucose levels that those with
/> .> a fully functional pancreas achieve with-
/> .> out one iota of effort on their part.
/> .>
https://groups.google.com/g/misc.health.diabetes/c/4E_1OM3ZzSk/m/LIj0zVsWAwAJ
/> .>
/> .> Put another way, I'm disappointed in what I
/> .> see for the closed-loop Omnipod 5 (Horizon),
/> .> and Islit individuals need something far better
/> .> to have glucose levels like what we had prior
/> .> to Insulitis destroying our beta cells (the pri-
/> .> mary cause of Islit, but other infrequent ...
/> .>
/> .> ... causes can result in the near-total to total
/> .> loss of endogenous insulin).
/> .>
/> .> ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~
/> .>
/> .> 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
/> .>
/> .> ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~ ~~~