Harder to manage pediatric and adolescent patients achieve 74%
Time in Range, and 82% overnight Time in Range, well surpassing
clinical consensus guidelines for glycemic control
DUBLIN, Oct. 19, 2021 /CNW/ -- Medtronic plc (NYSE:
MDT), a leading global healthcare technology company, recently
announced one-year, real-world clinical data on 3,211 pediatric and
adolescent patients with type 1 diabetes 15 years old and below
using the MiniMed™ 780G system1 with the Guardian™
Sensor 3. Data on this subset of patients on the system in
Europe showed an average Time in
Range of 74% — surpassing Clinical Consensus Guidelines and closely
mirroring Time in Range for adults at 77%. Overnight Time in Range
of 82% also mirrored that of adults (82%) demonstrating that the
Advanced Hybrid Closed Loop (AHCL) algorithm offers even stronger
glycemic control and protection against lows while children are
sleeping. The MiniMed 780G system delivers near real-time basal
insulin and auto correction boluses (every 5 minutes) to address
underestimated carb counts and occasional missed meal doses to
deliver more Time in Range.
"These results are extremely encouraging. Glycemic control has
been much harder to achieve in children due to unpredictable
factors common in this age group, including physical growth and
development, hormonal changes and active lifestyles. In fact, young
adults around the age of 15 have the highest reported A1C in the
T1D Exchange Registry, which includes data on over 31,000
individuals with type 1 diabetes and demonstrates the unique
challenges in younger populations. Because the algorithm in the
MiniMed 780G system adjusts basal and correction insulin doses in
near real-time every 5 minutes thereby providing near real-time
course correction, it helps make up for underestimated carbohydrate
counting and occasional late or missed meal doses," said Robert
Vigersky, M.D., chief medical officer of the Diabetes business at
Medtronic. "The Medtronic AHCL algorithm offers advanced protection
and permits unprecedented personalization in insulin delivery by
offering a wide range of Active Insulin Time settings and three
different glucose targets. These improvements reinforce that the
MiniMed 780G system is a better alternative than previous therapy
these patients were on, even for those who were relatively
well-controlled."
From an experience perspective, younger users remained in
Advanced Hybrid Closed Loop (AHCL) mode, also referred to as the
SmartGuard™ algorithm, for an average of 93% of the time, similar
to the 92% observed in users over 15 years old. When the pediatric
group set a blood glucose target of 110mg/dL (6.1 mmol/L) and an
Active Insulin Time (AIT) of two hours, they achieved an average
Time in Range of 77% and a Glucose Management Indicator (GMI) of
6.7%. With these settings, they only spent 2.7% of their time
<70 mg/dL (5.9 mmol/L).
The real-world performance analysis aggregates information from
children 15 years old and below whose caregivers agreed to allow
Medtronic to use anonymized data that was automatically uploaded
their data to CareLink™ Personal from August
27, 2020 to July 22, 2021. A
large majority of pediatric users included in the analysis are
achieving glycemic goals recommended by major diabetes professional
organizations, including:
- 75.3% of pediatric users had a Glucose Management Indicator
(GMI) less than 7%, which mirrors the average A1C level that would
be expected based on mean glucose.
- 69.6% of pediatric users had a Time in Range above 70%.
- 67.5% of pediatric users achieved both, a GMI less than 7% and
a Time in Range above 70%.
A sub-analysis of patients 15 years old and younger with at
least 10 days of CGM data both pre- and post-AHCL initiation
(n=661) showed substantial improvements across both Time in Range
and GMI – even among those who were relatively well controlled at
baseline. This group saw a 12% increase in Time in Range, to 74% on
average — equivalent to an additional 2.8 hours/day in the target
range. From a user experience perspective, results also showed
patients were able to stay in AHCL mode 93% of the time once it was
initiated.
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Pre-AHCL Initiation
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Post-AHCL
Initiation
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Change
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Number of users,
n
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661
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|
661
|
|
|
Total Daily Dose
(of insulin), units
|
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30.5
|
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34.6
|
|
+ 4.1*
|
Time in AHCL,
%
|
|
-
|
|
92.8
|
|
|
Mean SG,
mg/dL
|
|
163
|
|
146
|
|
- 17*
|
GMI, %
|
|
7.2
|
|
6.8
|
|
- 0.4*
|
Overall Time in Range,
%
|
|
62.1
|
|
73.8
|
|
+11.7*
|
Users with GMI <7%,
%
|
|
37.8
|
|
72.5
|
|
+ 34.7*
|
Users with TIR >70%,
%
|
|
31.3
|
|
67.6
|
|
+ 36.3*
|
The MiniMed 780G system's SmartGuard algorithm (also referred to
as the AHCL algorithm) automates the delivery of insulin every five
minutes — personalizing these doses to auto-correct highs and lows
24 hours a day based on CGM readings.2,3 Autocorrection
dosing is designed to correct highs that may result from forgetting
to bolus insulin prior to eating a meal, missing it altogether or
underestimating the carbohydrate content in the meal resulting in
an inaccurate dose of insulin. This feature offers an additional
layer of protection and provides extra coverage to help reduce the
burden associated with diabetes management and improve outcomes by
bringing users closer to the target range throughout the day and
night.
"We know that adolescents in particular lead very active lives
and often eat on the go — running from one activity to the next.
This system was designed to help individuals living with diabetes
have some extra coverage and protection when life gets in the way
and they're not able to manage their diabetes in the way they'd
like to," said Julie Foster, vice
president of Customer Experience for the Diabetes business at
Medtronic. "We're confident we've designed a system that keeps
lifestyle and experience front and center as we work to help make
life easier for people living with diabetes."
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). The MiniMed 780G system is now
available in 38 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.
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
Bold thinking. Bolder actions. We are
Medtronic. Medtronic plc, headquartered in Dublin, 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 90,000+ passionate people
across 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 all. In everything we do, we are engineering the
extraordinary. For more information on Medtronic (NYSE: MDT), visit
www.Medtronic.com and follow @Medtronic on Twitter and
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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1 Not
approved by FDA and not for sale in the U.S.
|
2 Carlson, A.L. et al. Safety and
glycemic outcomes during the MiniMed™ Advanced Hybrid Closed-Loop
system pivotal trial in adolescents and adults with type 1
diabetes. Diab Tech Ther 2021; in press.
|
3 Collyns.O. et al Improved Glycemic
Outcomes With Medtronic MiniMed Advanced Hybrid Closed-Loop
Delivery: Results From a Randomized Crossover Trial Comparing
Automated Insulin Delivery With Predictive Low Glucose Suspend in
People With Type 1 Diabetes. Diab Care 2021, 44:
969-975
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|
Contacts:
|
|
Kendra
Cassillo
|
Ryan
Weispfenning
|
Public
Relations
|
Investor
Relations
|
+1-818-576-5611
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+1-763-505-4626
|
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SOURCE Medtronic plc