The Journal of the American Medical Association Publishes Medtronic's Hybrid Closed Loop System Pivotal Trial Results
September 15 2016 - 8:30AM
DUBLIN - September 15, 2016 -
Medtronic plc (NYSE:MDT), the global leader in medical
technology, today announced the publication of its Hybrid Closed
Loop system pivotal trial results in the Journal
of the American Medical Association (JAMA). The data
presented the safety of the system and showed that patients on the
therapy experienced less glycemic variability, more time in the
target range, less exposure to hypoglycemia and hyperglycemia, and
reduced A1c compared to baseline data using sensor augmented
pumps.1 The data was
concurrently presented at the 52nd annual
meeting of the European Association for the Study of Diabetes
(EASD) in Munich, Germany.
"This large at-home study demonstrated that
participants with Medtronic's Hybrid Closed Loop system experienced
improved glucose control and did not demonstrate any safety issues;
during the study phase, there were no episodes of severe
hypoglycemia or ketoacidosis in patients with type 1 diabetes on
the therapy," said Richard M. Bergenstal, M.D., principal
investigator of the study and executive director of the
International Diabetes Center in Minneapolis. "The data is
compelling and shows that the system's ability to automate insulin
dosing 24 hours a day has the potential to impact patients' lives
in a very meaningful way - particularly at night when it's most
challenging to maintain target blood glucose levels."[i]
Medtronic's Hybrid Closed Loop study is the first
pivotal U.S. trial of closed loop technology, and the largest and
longest at-home closed loop study with over 12,000 days included in
the evaluation. The system is designed to automate basal insulin
delivery to maximize the time glucose levels are in a healthy range
throughout the day and night. This multicenter study enrolled 124
people with type 1 diabetes >=14 years of age at 10 centers
(nine in the U.S. and one in Israel).1 Participants
in the study were required to enter their mealtime carbohydrates
and exercise information, and periodically calibrate the
sensor.
"We are pleased with the progress we have made in
automating basal insulin delivery and that each new advancement in
our phased approach delivers increased automation and greater peace
of mind by helping to simplify diabetes management," said
Alejandro Galindo, president of the Intensive Insulin Management
Diabetes business at Medtronic. "We are committed to
developing meaningful solutions like this to enable greater freedom
and better health so people with diabetes and their caregivers can
spend less time managing the disease and more time enjoying life's
everyday moments."
Medtronic submitted a Pre-Market Application (PMA)
for the Hybrid Closed Loop system to the U.S. Food and Drug
Administration in June 2016, for the evaluation of safety and
efficacy of the system. The system is investigational and not
approved for commercial sale anywhere in the world.
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 88,000 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-
1 Bergenstal
RM, Garg S, Weinzimer SA, et al. Safety of a hybrid closed-loop
insulin delivery system in patients with type 1 diabetes. JAMA. Published on-line ahead of print September 15,
2016 at jama.com (Online First).
[i] Bergenstal RM, Garg S, Weinzimer SA, et al.
Safety of a hybrid closed-loop insulin delivery system in patients
with type 1 diabetes. JAMA. Published on-line
ahead of print September 15, 2016 at jama.com (Online First).
Contacts:
Janet Kim
Public Relations
+1-+1-818-576-5014
Ryan Weispfenning
Investor Relations
+1-763-505-4626
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Medtronic plc via Globenewswire
Medtronic (NYSE:MDT)
Historical Stock Chart
From Mar 2024 to Apr 2024
Medtronic (NYSE:MDT)
Historical Stock Chart
From Apr 2023 to Apr 2024