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
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)
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
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
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
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!