Diabetes tech




CE marks & FDA approvals

Diabetes tech innovations and approvals are coming along thick

and fast these days. Here are some of the recent ones.

In Europe, the CE Mark (Conformité

Européenne) is used to indicate that

a product conforms with relevant EU

directives regarding health and safety

and can therefore be sold. In the US,

medical devices cannot be sold unless

they gain approval from the Federal Drugs

Administration (FDA).


Dexcom has received CE Mark for its

Dexcom G6 System for people with

diabetes ages two years and up. John

Lister, Dexcom's General Manager for

EMEA, says, "The Dexcom G6 represents

the future of diabetes management. Not

only does the product eliminate the need

for fingersticks, but it also maintains the

performance, connectivity and accuracy

that the diabetes community has come

to expect from Dexcom CGM. The

groundbreaking Dexcom G6 will be

available in the U.K. and Ireland this

month. Dexcom G6 encompasses new

features that empower users to take

control of their diabetes."

As per our Kit That's Coming Soon

report in the last issue of this magazine,

the new G6 has several improvements

and new features over the previous

generations of the technology, including

eliminating the need for a blood test to

calibrate and 10-day sensor wear.

Doctor Nick Oliver from Imperial

College London, says of the new sensor,

"For many years, fingerstick blood glucose

testing has been a critical component of

diabetes self-management. However, the

self-monitoring, which can sometimes

mean testing blood up to ten or more times

a day, can be time-consuming, painful and

difficult to fit into a busy day. The Dexcom

G6 presents a major advancement for the

continuous glucose monitoring category.

With Dexcom G6, people with diabetes

now have the freedom to live without

routine fingersticks and can rely on their

CGM data to make treatment decisions,

enabling more personalised and effective


Available now, the Dexcom G6 is 28%

cheaper than the previous G5 model. The

system includes a new G6 transmitter and

sensors. The new touch screen receiver is

optional for international users and can be

purchased separately. Users will need a

touchscreen receiver or compatible smart

device and the G6 app, along with the

new G6 sensors and transmitter.



Meanwhile, more news from Medtronic.

The MiniMed 670G system - the world's

first self-adjusting insulin pump system -

has been CE Mark approved.

Alejandro Galindo, president of the

Advanced Insulin Management division

within the Diabetes Group at Medtronic

comments, "We're proud to introduce our

most advanced SmartGuard Auto Mode

algorithm outside of the United States,

which not only helps to prevent lows but

works to drive Time in Range - a most

important measure of the effect of diabetes

management on a patient's glucose levels

- by decreasing time in hyperglycemia.

The MiniMed 670G system advances

our ability to automatically suspend and

resume insulin delivery to the next level

by automating self-adjusting basal insulin

delivery every 5 minutes based on sensor

glucose values - providing the most

advanced algorithm available to deliver

leading clinical outcomes."

Doctor Pratik Choudhary, senior

lecturer and consultant in diabetes at

King's College London adds,"We have

seen that this innovation offers great

promise for better glucose control

and improved quality of life for those

living with Type 1 diabetes," said "The

ability of the MiniMed 670G system to

stabilize glucose levels automatically is

an important advancement, and I look

forward to introducing it to my patients in


Medtronic will begin commercial

release of the MiniMed 670G system in

select countries in Europe in the autumn

of 2018, subject to local regulatory

requirements. The company's UK office

has issued a comment stating, "We are

working hard to have this product available

in the UK and Ireland this autumn."


The Omnipod DASH system has gained

FDA clearance. This insulin management

system is a tubeless, on-body insulin

pump that delivers continuous insulin

therapy through customizable basal rates

and bolus amounts. The system consists

of a waterproof Pod and a Personal

Diabetes Manager (PDM), a handheld

device used to wirelessly control the Pod.

The PDM has a colour touch-screen


The system will also feature a suite

of mobile applications for smartphones.

The company will be conducting a sixmonth, limited

market release of the

Omnipod DASH System in the United

States. A wider commercial release of the

Omnipod DASH System is anticipated for

early 2019. www.myomnipod.com


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