New Smart MDI system will be the first system
to deliver real-time, personalized insights on when and how much to
dose including for missed or inaccurate mealtime doses.
GALWAY, Ireland, Nov. 20,
2024 /PRNewswire/ -- Medtronic plc (NYSE: MDT),
a global leader in healthcare technology, today announced U.S. Food
and Drug Administration (FDA) clearance for its new InPen™ app
featuring missed meal dose detection, paving the way for the launch
of its Smart MDI system with the Simplera™ continuous glucose
monitor (CGM). The company's Smart MDI system combines its InPen™
smart insulin pen with its newest Simplera™ CGM — the company's
first disposable, all-in-one CGM that's half the size of previous
Medtronic CGMs.
With this clearance, the system will be the first in the market
to recommend corrections for missed or inaccurate insulin doses,
providing real-time, personalized insights for individuals on
multiple daily injection (MDI) therapy.
For people with diabetes who need daily insulin injections,
bolusing before a meal is essential as it helps regulate glucose
levels and prevent blood sugar spikes after eating. Minimizing the
frequency of these glucose highs reduces the risk of both short-
and long-term complications and supports better overall health.
However, it's estimated that individuals living with diabetes
regularly miss 1 out of 3 doses. The Missed Dose alert function
helps to minimize the frequency of these glucose highs.1
The Medtronic Smart MDI system reduces the guesswork out of
diabetes management, helping to address a significant unmet need
for MDI users who struggle with juggling numerous decisions related
to insulin dosing on a daily basis.
"I'm thrilled about the launch of the Medtronic Smart MDI system
with the InPen™ app and Simplera™ CGM. This is a significant
leap forward for those on multiple daily injections, offering
intelligent dosing insights and simplifying diabetes management,"
said Diana Isaacs, PharmD, BCPS,
BCACP, BC-ADM, CDCES, FADCES, FCCP. "By reducing the guesswork out
of insulin dosing, this tool helps maintain stable blood sugars,
optimize long-term health, and reduce complications from
hyperglycemia."2,3
Medtronic will initiate a limited market release beginning with
existing standalone CGM and InPen™ customers followed by a broad
commercial launch.
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1. MacLeod, J,
Heungyong Im, G, Smith, M, Vigersky, RA. Shining the Spotlight on
Multiple Daily Insulin Therapy: Real-World Evidence of the InPen
Smart Insulin Pen. Diabetes Technology & Therapeutics. 2024.
26:1, 33-39.
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2. Vigersky et al.,
Impact Of InPen Smart Insulin Pen Use on Real-World Glycemic and
Insulin Dosing Outcomes in Individuals with Poorly Controlled
Diabetes. Presented at: American Diabetes Association; 81st
Scientific Sessions; 2021 Jun 25-29.
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3. Chien A,
Thanasekaran S, Gaetano A, Im G, Wherry K, MacLeod J, Vigersky RA.
Potential cost savings in the United States from a reduction in
sensor-detected severe hypoglycemia among users of the InPen smart
insulin pen system. J Manag Care Spec Pharm. 2023
Mar;29(3):285-292.
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About the Diabetes Business
at Medtronic (www.medtronicdiabetes.com)
Medtronic Diabetes is on a mission to alleviate the burden of
diabetes by empowering individuals to live life on their terms,
with the most advanced diabetes technology and always-on support
when and how they need it. We've pioneered first-of-its-kind
innovations for over 40 years and are committed to designing the
future of diabetes management through next-generation sensors
(CGM), intelligent dosing systems, and the power of data science
and AI while always putting the customer experience at the
forefront.
About Medtronic
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare
technology company that boldly attacks the most challenging health
problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life —
unites a global team of 95,000+ passionate people across more than
150 countries. Our technologies and therapies treat 70 health
conditions and include cardiac devices, surgical robotics, insulin
pumps, surgical tools, patient monitoring systems, and more.
Powered by our diverse knowledge, insatiable curiosity, and desire
to help all those who need it, we deliver innovative technologies
that transform the lives of two people every second, every hour,
every day. Expect more from us as we empower insight-driven care,
experiences that put people first, and better outcomes for our
world. In everything we do, we are engineering the extraordinary.
For more information on Medtronic (NYSE: MDT), visit
www.Medtronic.com and follow Medtronic on LinkedIn.
Any forward-looking statements are subject to risks and
uncertainties such as those described in Medtronic's periodic
reports on file with the Securities and Exchange Commission. Actual
results may differ materially from anticipated results.
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Contacts:
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Ryan
Weispfenning
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Investor
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+1-818-403-7028
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+1-763-505-4626
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SOURCE Medtronic plc