Results Demonstrate 76% Time in Range and 94% Time in
Advanced Hybrid Closed Loop Mode
DUBLIN, June 2, 2021 /CNW/ -- Medtronic
plc (NYSE:MDT), the global leader in medical technology, today
announced real-world clinical outcomes for 4,120 individuals on the
MiniMed™ 780G system, a small subset of those on the latest system
today across nine countries in Europe. Data showed an average overall Time in
Range of 76.2% and an overnight Time in Range of 83%, mirroring
results from the pivotal trial. From an experience perspective,
users remained in Advanced Hybrid Closed Loop (AHCL) mode, also
referred to as the SmartGuard™ algorithm, for an average of 94% of
the time, and an overall reduction in interactions required with
the system demonstrated a more seamless experience than previous
insulin pump systems.*
"It is extremely encouraging to see Medtronic advancing both
clinical outcomes as well as the user experience through their
latest MiniMed 780G system. It is clear that learnings from the
launch of the world's first hybrid closed loop informed the design
of this next-generation system," said Prof. Chantal Mathieu, endocrinologist at University
Hospitals Leuven-KULeuven, Belgium. "We know that no two individuals with
type 1 diabetes are the same, and that life gets in the way of
managing diabetes perfectly. I am confident in this system's
ability to do what a person with diabetes may not be able to do on
their own by helping them minimize highs and lows, and ultimately
live their lives less burdened by their diabetes."
The advanced SmartGuard algorithm in the MiniMed 780G system
automates and personalizes the delivery of basal insulin by
adjusting every five minutes, 24 hours a day. The latest system
also includes an advanced algorithm that automatically corrects
highs every five minutes through autocorrection dosing, in addition
to protecting against lows.1,2. Autocorrection dosing is
designed to correct highs that may result from not logging a meal
(also known as bolusing), logging a meal late, or underestimating
the carbohydrate content of the meal.
The MiniMed 780G system is the most advanced insulin pump system
from Medtronic, currently approved for the treatment of type 1
diabetes in people age 7 to 80 years. The system enables the
personalization of glucose goals with an adjustable target setting
as low as 100 mg/dL (5.5 mmol/L) — lower than any other insulin
pump system. The MiniMed 780G system is now available in 30
countries across Europe, the
Middle East and Africa, and is currently being reviewed by the
Food and Drug Administration (FDA) for approval in the U.S.
The real-world performance analysis aggregates information from
individuals who uploaded their data to CareLink™ Personal from
August 27, 2020 to March 3, 2021. A large majority of real-world
users studied are achieving glycemic goals shared by major diabetes
professional organizations, including:
- 79% of individuals had a Glucose Management Indicator (GMI)
less than 7%, which mirrors the average A1C level that would be
expected based on mean glucose.
- 77.3% of individuals had a Time in Range above 70%.
- 74.1% of individuals achieved both, a GMI less than 7% and a
Time in Range above 70%.
In addition to the data reported from the overall cohort of
4,120 individuals, a smaller cohort of 812 individuals was
analyzed, to compare the difference in outcomes as individuals move
from pre-AHCL initiation (also referred to as open loop) to
post-AHCL initiation. Within that cohort, individuals experienced
an average Time in Range increase of 12.1% (from 63.4% to 75.5%), a
15.7 mg/dL or 0.9 mmol/L drop in mean sensor glucose (from 162.2
mg/dL to 146.5 mg/dL or 9.0 mmol/L to 8.1 mmol/L), and a 0.4% drop
in GMI (from 7.2% to 6.8%) post AHCL initiation.
"The MiniMed 780G system is doing the job we built it to do –
automatically correcting for high glucose when carbs are
miscalculated or individuals forget to take extra insulin with
their food," said Sean Salmon,
executive vice president and president of the Diabetes business at
Medtronic. "Our goal with all diabetes technology is to maximize
clinical outcomes while making the solutions easier to use so that
people can feel their best, reduce risk of complications and live
their lives with diabetes in the background, instead of the
forefront."
Time in Range
Clinical consensus regarding Time in
Range means that a person living with diabetes should be in the
recommended range of 70-180 mg/dL (3.9 – 10 mmol/L) for at least
70% of time to be well-controlled. This may increase the likelihood
that short and long-term complications of this chronic disease can
be avoided.
About the Diabetes Business at
Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change
the way people manage diabetes. The company aims to transform
diabetes care by expanding access, integrating care and improving
outcomes, so people living with diabetes can enjoy greater freedom
and better health.
About Medtronic
Medtronic plc (www.medtronic.com),
headquartered in Dublin, Ireland,
is among the world's largest medical technology, services and
solutions companies – alleviating pain, restoring health and
extending life for millions of people around the world. Medtronic
employs more than 90,000 people worldwide, serving physicians,
hospitals and patients in approximately 150 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
* Due to inherent study limitations, caution is advised when
attempting to extrapolate these results to new patients. There
could be significant differences.
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.
1 Carlson, A.L. et al. 97-P- Safety and
glycaemic outcomes of the MiniMed™AHCL System in subjects with T1D.
80th ADA International Conference, June
2020, Chicago
2 Collyns .O. et al. 199-OR- Improved glycaemic
Outcomes with MiniMed™ AHCL Delivery. 80th ADA International
Conference, June 2020, Chicago
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SOURCE Medtronic plc