25
KIT
by Digostics, is currently the only
regulatory-approved home-use
OGTT. It combines new testing
technologies and communication
wireless functionality that enables
test data to be sent immediately to
the care team via a smartphone. The
kit, which is mailed to the expecting
mother so she can test on a day of
her choosing, contains a novel test
device, a glucose drink, and finger
prickers. To deliver the results, the
woman can either scan a snap-off
fob attached to the test device with
a smartphone using a mobile app
or mail back the fob in a supplied
prepaid envelope for processing.
Announcing the pilot trial of
the new programme, UHS said: "In
taking the oral glucose tolerance
test (OGTT) to the patient, UHS
aim to improve diabetes screening
and healthcare equity of access
by identifying the presence of
GDM earlier in the pregnancy and
eliminating barriers commonly
associated with in-clinic testing."
www.digostics.com
Insulet
Insulet recently announced FDA
clearance of its Omnipod GO, an
insulin delivery device cleared for use
for people with Type 2 diabetes age
18 or older who would typically take
daily injections of long-acting insulin.
Omnipod GO is a standalone,
wearable, insulin delivery system that
provides a fixed rate of continuous
rapid-acting insulin for 72 hours. It
features a tubeless and waterproof
Pod and seven different preprogrammed
daily rates, ranging
from 10 to 40 units per day, and
operates without the need for a
handheld device to control the
Pod. It has been cleared for use
with the following U-100 insulins:
NovoLog, Fiasp, Humalog, Admelog,
and Lyumjev.
The product was developed to
serve people with Type 2 diabetes
earlier in their treatment journey
by starting them on Pod therapy for
their insulin delivery, rather than
daily injections. If a person becomes
insulin-intensive, meaning they
require both basal and bolus insulin,
the transition to another Omnipod
product would be seamless.
Meanwhile, Insulet has also
announced that its newly UKlaunched
Omnipod 5 is makes
progress with making it compatible
to Abbott's FreeStyle Libre 2 (FSL2).
Speaking at the American Diabetes
Association (ADA) 83rd Scientific
Sessions in San Diego in late June
2023, Jim Hollingshead, Insulet
president and CEO, commented,
"Insulet's flagship product, Omnipod
5, is having an incredible impact
on people with diabetes, including
improved glycemic outcomes
and better quality of life. We are
thrilled with the opportunity to
present real-world evidence from
the first year on Omnipod 5 in the
US, and further educate diabetes
clinicians on how they can improve
care for their patients using
our tubeless automated insulin
delivery technology."
The company said that it
submitted its Omnipod 5 App
for iPhone to the FDA for 510(k)
clearance. The company aims to
provide smartphone control for iOS
mobile technology users. It also said
it enhanced its app's user interface to
align with the iOS operating system.
It also added a new custom food
feature for the iPhone app.
The company also reported
progress toward its goal of giving
Omnipod 5 users a choice over
the sensor that accompanies their
pump. Currently, Omnipod 5 works
in conjunction with the Dexcom
G6 continuous glucose monitor
(CGM). Insulet said it expects to
soon begin enrollment for a clinical
study integrating Omnipod 5 with
the Abbott FreeStyle Libre 2 sensor.
This study aims to recruit up to 200
participants with Type 1 diabetes,
both in the adult and paediatric age
groups. It spans the UK, France and
Belgium. Insulet said it hopes to
demonstrate superior efficacy with
Omnipod 5 compared to multiple
daily injections.
www.massdevice.com
Know Labs
As reported by Sean Whooley at
Drug Delivery Business, Know
Labs has unveiled a Gen-1 noninvasive
glucose monitor prototype.
The Seattle-based company has
incorporated its Bio-RFID tech into
a sensor. This uses spectroscopy
to direct electromagnetic energy
through a substance or material,
thereby capturing a unique
molecular signature. This noninvasive
technology demonstrated
technical feasibility and stability
in blood glucose measurements
in a lab environment. Now, the
company revealed this technology
incorporated in a portable device.
According to Know Labs, no
medical-grade, commercially
available non-invasive means of
measuring blood glucose exist
currently. The company hopes to
deliver the first FDA-cleared noninvasive
blood glucose monitor for
those with diabetes and pre-diabetes.
www.knowlabs.co
Image courtesy of Know Labs.