Data Were Presented at the American Diabetes Association
81st Scientific Sessions
DUBLIN, June 28, 2021 /CNW/ -- Medtronic
plc (NYSE:MDT), the global leader in medical technology, today
announced key clinical data from the virtual 81st annual
American Diabetes Association Scientific Sessions. The
presentations illustrated increases in Time in Range when using an
InPen™ smart insulin pen, safety of an extended-wear infusion set
that lasts up to 7 days, and patient satisfaction with the
longer-wear infusion set.
InPen Smart Insulin Pen Data
Medtronic presented
real-world clinical results that compared glycemic outcomes for
1,736 individuals before and after using the InPen
smart1 insulin pen for 90 days with a glucose
monitor (CGM). Data showed an increase in Time in Range of 2.3% for
people whose glucose management indicator (GMI) was >8% and an
increase of 5% Time in Range for people whose GMI was >9.5%. In
both groups, people did not experience any increase in Time Below
Range2 (hypoglycemia) during the study period.
Using InPen smart insulin pen also provided improved insulin
dosing decision support for those in the study as demonstrated by
fewer total doses per day with simultaneously improved glycemic
control. The average daily insulin bolus frequency decreased (from
3.7 to 3.6/day and 3.3 to 3.2/day, respectively, for each group)
and total rapid acting daily dose of insulin increased (from 26.29
to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each
group). This real-world performance analysis aggregates information
from individuals who uploaded their data from January 2018 to October
2020. A minimum of 30 days of CGM data pre- and post-InPen
start were required to be part of the analysis.
"Smart insulin pens that automatically track insulin doses and
calculate active insulin are emerging as important advances in
diabetes management technology because they increase the amount of
time spent in the preferred glucose range without increasing
hypoglycemia," said Dr. Anders
Carlson, medical director of the Park Nicollet International
Diabetes Center (IDC) in Minneapolis,
Minn. "It's encouraging to see that positive clinical gains
are possible with the use of consumer-friendly diabetes technology,
such as InPen, that makes it simple for patients to track insulin
dosing, calculate doses and receive reminders and other decision
support that allows them to manage their diabetes more effectively
without adding a lot of complexity."
Medtronic Extended Infusion Set Data
Medtronic also
presented U.S. pivotal trial data on the Medtronic Extended
infusion set, the first and only infusion set that can be worn for
up to seven days. The study evaluated the safety and performance of
259 individuals aged 18 to 80 who wore traditional 2- or 3-day
infusion sets with the MiniMed™ 670G system for two weeks followed
by twelve consecutive wears of the Medtronic Extended infusion set.
The study showed no significant increase in total daily dose of
insulin. This indicates that the Medtronic Extended infusion set
delivers insulin successfully throughout the seven-day wear of the
infusion set. In addition, there were no severe adverse events
observed.
During the pivotal study, the same group of patients compared
their experience of wearing a 2- or 3-day set to wearing the new
7-day Medtronic extended infusion set. Overall, patients preferred
the longer-wear set, rating it higher on ease of insertion, comfort
of wear, duration of wear, time required to change infusion set and
convenience.
"For decades, insulin infusion sets needed to be changed every
two to three days. So, the development of an extended infusion set
that can be worn for up to seven days represents a significant
improvement in the patient experience," said Bruce Buckingham, M.D., emeritus professor of
pediatrics and endocrinology at Stanford. "The pivotal trial demonstrated the
safety of the new infusion set as well as increased satisfaction
from being able to wear it longer. Alleviating the burden of
changing infusion sets every two to three days is a very meaningful
improvement in the overall pump experience. This important
innovation in the infusion set will make insulin pump therapy feel
easier for many patients."
* In the United States,
Medtronic Extended infusion set is limited to investigational use
only and not approved for sale, while in Europe it is already CE marked.
Definitions
- 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.
- Glucose Management Indicator (GMI) – GMI mirrors
the A1C level expected based on average glucose measured using
continuous glucose monitoring (CGM) values.
- InPen - The InPen is the first and only smart insulin
pen that's integrated with real-time CGM via one convenient
smartphone app. The smart multiple daily injection (MDI) system
automatically records insulin doses, tracks active insulin, and
recommends mealtime and correction doses. By combining the InPen
system with the Guardian™ Connect CGM system, individuals have
access to everything they need to manage their diabetes in one
place. Rather than switching between apps, users will have the
ability to see real-time glucose readings and alerts as well as
insulin dose information in real-time, in one view — making it
easier to make informed dosing decisions to manage their glucose
levels.
- Medtronic Extended Infusion Set - The Medtronic Extended
infusion set is the first and only infusion set that can be worn
for up to 7 days. The innovative design of the Medtronic Extended
infusion set, which is designed and manufactured in collaboration
with Unomedical, leverages advanced materials that help reduce
insulin preservative loss and maintains insulin flow and
stability.
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 Smart insulin pens connect to a mobile app to
provide dosing calculations, reminders and CGM system
integration.
2 Time Below Range is time spent below 70
mg/dl.
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SOURCE Medtronic plc