New Pediatric At-Home Study of MiniMed(TM) 670G System Demonstrates Positive Results in Children Ages 7 to 13
February 15 2018 - 11:20AM
DUBLIN and VIENNA - February 15,
2018 - Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced that new data from its at-home
pediatric study of the MiniMed(TM) 670G system in patients 7-13
years of age were presented at the Advanced Technologies &
Treatments for Diabetes (ATTD) 11th
International Conference in Vienna, Austria. Study results mirror
data from the pivotal trial of the system in adults and adolescents
(14 and above), showing patients spent more Time in Range,
experienced less glycemic variability, less exposure to
hypoglycemia and hyperglycemia, and reduced A1C compared to
baseline data using sensor-augmented pumps. The MiniMed 670G system
is currently FDA approved in the U.S. for people with type 1
diabetes 14 years of age and older. Data from this study was
included in an FDA application in late January to seek future
expansion of the current indication to include children 7-13 years
of age. Medtronic is also evaluating the system in children 2-6
years of age and will present data from this trial at a future
date. However, product labeling currently warns that the system may
not be safe for children under age 7 or patients using less than 8
units of insulin per day. See http://bit.ly/670gRisks.
"It is incredibly rewarding on both a professional
and personal level to evaluate a therapy that has the potential to
alleviate the enormous weight of responsibility experienced by
parents and caregivers of children with type 1 diabetes." said Dr.
Kevin Kaiserman, primary study investigator at the Southern
California Diabetes Center. "I'm very pleased to see that the
positive results observed in the pivotal trial studying older
patients were also sustained in this study."
The at-home, multi-center study enrolled 105
participants ages 7-13 and included a 2-week run-in phase, followed
by a 3-month study phase. Over 15,353 patient days were included in
the evaluation with 97 percent of participants opting to continue
using the system as part of a Continued Access Program.
Participants in the study were required to enter their mealtime
carbohydrates and periodically calibrate the sensor.
"This important data shows that the MiniMed 670G
system can lead to more time in the desired glucose target range in
school-aged children, while it reduces both time spent in
hypoglycemia and hyperglycemia," said Francine Kaufman, M.D., chief
medical officer of the Diabetes Group at Medtronic. "This hopefully
should enable children with type 1 diabetes to decrease the risk of
experiencing short and long term diabetes complications."
A subset of data from this study of 7-13 year old
patients, also presented at ATTD on Thursday, February 15, 2018,
reinforced the significant benefits of the SmartGuard(TM) Suspend
before low feature available in both the MiniMed 670G system
and MiniMed(TM) 640G system. The MiniMed 640G system is approved
for use outside of the U.S. but is not approved in the U.S.
SmartGuard technology is the proprietary algorithm from Medtronic
that powers its advanced MiniMed insulin pump systems. Each
advancement in the company's phased approach to developing a closed
loop system enables increased automation of SmartGuard technology
so the system takes on more of the work associated with daily
diabetes management - helping to improve quality of life and
overall glucose control for patients.
The MiniMed 670G system is the world's first
and only commercially available hybrid closed loop system and
features the company's new Guardian(TM) Sensor 3 and most advanced
SmartGuard Auto Mode algorithm, which allows the system to automate
the delivery of basal insulin to help maximize Time in Range
throughout the day and night.
Time in Range
Time in Range refers to the percentage of time people with type 1
diabetes spend in the optimal glycemic range of 70-180 mg/dL. The
goal with diabetes management is to increase time spent in this
healthy range and to minimize high and low sugar levels, which can
lead to both immediate and long-term complications such as damage
to blood vessels - increasing the risk of coronary artery disease,
heart attack, and stroke. Damage to blood vessels can also lead to
loss of vision, kidney disease, and nerve problems. Increasing the
"Time in Range" over the long-term can best be accomplished by
using advances in diabetes therapies, like the MiniMed 670G system
with SmartGuard technology, that automates basal insulin.
About the Diabetes Group 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 84,000 people worldwide, serving physicians,
hospitals, and patients in approximately 160 countries. The company
is focused on collaborating with stakeholders around the world to
take healthcare Further, Together.
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.
-end-
Contacts:
Janet Kim
Public Relations
+1-818-576-5014
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
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information contained therein.
Source: Medtronic plc via Globenewswire
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