Insulin pump, Tadem Diabetes Care, Tandem t:slim insulin pump

LIVINGLIVING

KIT THAT'S COMING SOON...

TANDEM T:SLIM X2

An new insulin pump gets set to create a stir, bringing a slim,

simple and sophisticated option to the choice currently available.

At the end of April

American-based

Tandem Diabetes Care, a

medical device company

and manufacturer of

touchscreen insulin pumps announced

receipt of CE mark approval for its t:slim

X2 insulin pump with Dexcom G5 Mobile

continuous glucose monitoring (CGM)

integration.

The pump is due to become available

in the UK over the summer, with the

company confirming a distribution

agreement soon. The touchscreen insulin

pumps have been available in the United

States since 2012, having gained U.S.

Food and Drug Administration (FDA)

approval of the t:slim X2 insulin pump

with Dexcom G5 Mobile CGM integration

in August 2017.

The pump includes advanced features

such as a large colour touchscreen,

rechargeable battery, USB connectivity

and watertight construction. It is the only

pump that integrates with Dexcom G5

Mobile CGM, and the first CGM-enabled

pump approved to let users make

treatment decisions without needing a

blood test to be done before dosing (i.e.

to read from GCM alone). The t:slim X2

Pump is up to 38% smaller than many

other insulin pumps and yet holds up to

300 units of insulin.

Kim Blickenstaff, President and CEO

of Tandem Diabetes Care commented on

gaining the CE Mark, "As our first product

KIT

REPORT

to receive CE mark, this milestone is key

to the fulfilment of our vision to bring the

features and benefits of our unique insulin

pump technology to people outside of

the United States. Our plans to launch

the t:slim X2 Pump internationally in the

second half of this year is of particular

strategic importance during this time

where insulin pump options are becoming

increasingly limited."

Fewer hypos

In a recent trial, the PROLOG (PLGS for

Reduction Of LOw Glucose) trial, it was

shown that users experienced reduced

time in hypo using t:slim X2 insulin pump

with predictive low glucose suspend

(PLGS), called Basal-IQ technology. Data

from the trial showed that the system

reduced time spent in hypo compared to

sensor-augmented pump (SAP) therapy

alone.

The t:slim X2 with Basal-IQ technology

uses Dexcom G5 Mobile CGM sensor

values to suspend insulin delivery

when low blood glucose is predicted.

It then automatically resumes insulin

delivery when glucose levels begin to

rise. The trial has users on system for

a 3-week period while at home (so not

in a clinical environment) and reduced

the number of sensor glucose readings

below 3.9mmols/L by 31% compared

to the control period using a standard

CGM-integrated t:slim X2 Pump

without automated insulin suspension.

Importantly, this marked reduction of time

spent in low glucose was accomplished

without any increase in the rate of

hyperglycaemia (being too high) and

therefore improved overall time in range,

decreasing patients' daily burden of

diabetes as well as reducing the changes

of long-term complications.

About the study Blickenstaff adds,

"Reducing the risk of hypoglycaemia

has been the most requested feature

of automated insulin delivery in our

market research, due to the severity of

the complications when left untreated.

The data from this study supports our

mission to improve the lives of people

with diabetes through new innovations."

* The PROLOG study was a multicentre,

randomized crossover clinical trial

and included 103 participants with Type 1

diabetes aged between 6 to 72 years of

age at four research centres across the US

and was coordinated by the Jaeb Center

for Health Research in Tampa, Florida.

The mean A1C of participants entering the

study was 7.3%, with the majority already

using a pump (83%) and/or CGM (84%).

The primary endpoint of the study was to

demonstrate a reduction in the percentage

of CGM values below 3.9mmol/L when

using Tandem's PLGS feature.

News of a UK distributor for the Tandem

t:slim pump is hotly anticipated and we'll

report on it as soon as we hear anything!

www.tandemdiabetes.com

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