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Tandem Diabetes Care Announces Publication of PROLOG Study Results in Diabetes Care Journal

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Study Demonstrates Significant Reduction in Hypoglycemia without
Rebound Hyperglycemia

Tandem Diabetes Care®, Inc. (NASDAQ:TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps with continuous
glucose monitoring (CGM) integration, today announced the online
publication of results from the PROLOG (PLGS for Reduction of Low
Glucose) study of the t:slim X2™ Insulin Pump with Basal-IQ™ predictive
low glucose suspend technology in the medical journal Diabetes Care.
The study demonstrated that the t:slim X2 Pump with Basal-IQ Technology
significantly reduced hypoglycemia without rebound hyperglycemia,
compared to time on a t:slim X2 Pump with integrated CGM and no
automated insulin suspension. No severe adverse events were observed in
the study during use of the Basal-IQ feature.

"The results seen in the PROLOG study demonstrate that an automated
insulin delivery system can have a significant impact on glycemic
control without being overly complicated or burdensome for the patient,"
said Dr. Greg Forlenza, principal investigator for the Barbara Davis
Center for Diabetes at the University of Colorado School of Medicine.
"We think the t:slim X2 Insulin Pump with Basal-IQ Technology will be a
welcome addition for healthcare providers and clinics looking for a
simple-to-teach system that can help reduce the risk of hypoglycemia
without significantly increasing the training and support demands on
their practice."

Basal-IQ Technology uses CGM readings to predict glucose levels 30
minutes ahead. If the glucose level is predicted to be less than 80
mg/dL, or if a CGM reading falls below 70 mg/dL, insulin delivery is
suspended. Insulin delivery resumes as soon as sensor glucose values
begin to rise.

"Subjects in the PROLOG study adopted the Basal-IQ system quickly and
easily. There was also no evidence of alarm fatigue, since alerts
related to insulin suspension and resumption are optional, allowing the
feature to operate quietly in the background," said Dr. Jordan Pinsker,
senior research physician at Sansum Diabetes Research Institute in Santa
Barbara, California. "The high usability scores are remarkable and match
the level of positive user experience feedback we received from
participants over the course of the study."

Results from this study supported a regulatory filing for the t:slim X2
Pump with Basal-IQ Technology to the U.S. Food and Drug Administration
(FDA). The study was conducted using Dexcom G5® Mobile CGM technology,
but the system was also designated by the FDA as compatible with
integrated CGM (iCGM) devices at the time of approval in June 2018. The
Company is planning for commercial launch of the Basal-IQ feature in
August 2018 with Dexcom G6® CGM integration, the first FDA-approved iCGM
device, which requires no fingersticks for calibrations or mealtime
dosing and allows users to share data with up to five followers.*

Summary of Data Published in Diabetes Care1

Reductions in hypoglycemia – Use of the
t:slim X2 Pump with Basal-IQ Technology in the PROLOG study reduced the
number of sensor glucose readings below 70 mg/dL by 31 percent compared
to the control period without automated insulin suspension. The
reduction of time spent in low glucose was accomplished without any
increase in the rate of hyperglycemia. Participants with higher
hypoglycemia entering the study saw the largest improvement. A
significant hypoglycemia reduction was seen with Basal-IQ Technology in
all groups, irrespective of age, baseline HbA1c, or baseline
hypoglycemia rates.

Usability – The t:slim X2 Pump with
Basal-IQ Technology scored very high on the System Usability Scale
survey, a standardized 10-item questionnaire that measures the perceived
usability of a system, often used to evaluate non-medical consumer
electronics. 93 percent of participants thought the system was easy to
use, and 97 percent indicated they felt confident using the system.

Study adherence – Overall study adherence
was high, with 99 percent of those enrolled completing the trial, and
with the system active for 95 percent of the time during the Basal-IQ
period. Median CGM use during the study periods was 95 percent when
using Basal-IQ and 94 percent when using the pump without automated
insulin suspension.

Insulin suspensions and insulin use – The
mean suspension duration was 18 minutes per event, with a mean pump
suspension time of 104 minutes per day. Mean daily bolus insulin amounts
were identical between study phases. The basal insulin dose was reduced
by approximately four percent in the Basal-IQ phase compared with the
control period without automated insulin suspension. Mean basal insulin
delivery was 1.2 units per day lower when using the Basal-IQ feature (P
< 0.001).

Safety/adverse events – No severe
hypoglycemic events were observed in the Basal-IQ phase of the study.
There was one severe hypoglycemic event in the study phase without
automated insulin suspension. There was no significant difference in the
appearance of ketones between the two treatment phases.

The PROLOG study was a multi-center, randomized, crossover clinical
trial comparing two three-week periods of at-home insulin pump use, one
period using the t:slim X2 Pump with Basal-IQ Technology, and another
period using a CGM-integrated t:slim X2 Pump without automated insulin
suspension. The study included 102 participants with type 1 diabetes
ages 6 to 72 at four research centers across the United States and was
coordinated by the Jaeb Center for Health Research in Tampa, Florida.

t:slim X2 Insulin Pump with Basal-IQ Technology Coming Soon

The t:slim X2 Insulin Pump with Basal-IQ Technology can be ordered today
and is anticipated to begin shipping in August 2018. For additional
product and safety information, or to begin the order process, visit www.tandemdiabetes.com/tslimX2,
or call (877) 801-6901, Monday – Friday between 6:00am and 5:00pm
Pacific Time.

Free Software Update for Current t:slim X2 Pump Users

All in-warranty t:slim X2 Pump users in the United States have the
option to add the Basal-IQ feature free of charge via a software update
using a personal computer. Expected to release in August 2018, the
Basal-IQ feature update will require a new prescription and completion
of a 45-minute online training module. Internet and computer access are
required for pump updates. Information about the requirements and update
process is available at www.tandemdiabetes.com/X2update.

Free Basal-IQ Technology Demo App

Tandem's free t:simulator™ App lets users experience the touchscreen
interface of the t:slim X2 Insulin Pump with Basal-IQ Technology
directly on a mobile device. For more information and to download the
app, visit http://www.tandemdiabetes.com/tsimulator.

About Tandem Diabetes Care, Inc.

Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company dedicated to improving the lives of people
with diabetes through relentless innovation and revolutionary customer
experience. Tandem takes an innovative, user-centric approach to the
design, development and commercialization of products for people with
diabetes who use insulin. Tandem manufactures and sells the t:slim X2™
Insulin Pump with Basal-IQ™ Technology. The t:slim X2 Pump is capable of
remote feature updates using a personal computer and is the first
insulin pump designated as compatible with integrated continuous glucose
monitoring (iCGM) devices. Tandem is based in San Diego, California.

Tandem Diabetes Care is a registered trademark, and t:slim X2, Basal-IQ
and t:simulator are trademarks of Tandem Diabetes Care, Inc. Dexcom,
Dexcom G5 and Dexcom G6 are registered trademarks of Dexcom, Inc. All
other trademarks are the property of their respective owners.

Forward Looking Statement

This press release contains "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, that
concern matters that involve risks and uncertainties that could cause
actual results to differ materially from those anticipated or projected
in the forward-looking statements. These forward-looking statements
relate to, among other things, the anticipated launch of the t:slim X2
Insulin Pump with Basal-IQ Technology in August 2018 and the ability to
provide the Basal-IQ feature update to existing t:slim X2 users via a
software update. These statements are subject to numerous risks and
uncertainties, including the risk that Tandem may encounter other
challenges that may delay the commercial launch of the t:slim X2 Pump
with Basal-IQ Technology or the company's ability to deliver software
updates to existing t:slim X2 users, as well as other risks identified
in Tandem's most recent Annual Report on Form 10-K and Quarterly Reports
on Form 10-Q, respectively, and other documents that we file with the
Securities and Exchange Commission. Readers are cautioned not to place
undue reliance on these forward-looking statements, which speak only as
of the date of this release. Tandem undertakes no obligation to update
or review any forward-looking statement in this press release because of
new information, future events or other factors.

* If glucose alerts and CGM readings do not match symptoms or
expectations, use a blood glucose meter to make diabetes treatment
decisions. Dexcom G6 CGM sold separately. Separate Follow App required.

Reference:

  1. Forlenza GP, Li Z, Buckingham BA, Pinsker JE, et al. Predictive low
    glucose suspend reduces hypoglycemia in adults, adolescents, and
    children with type 1 diabetes in an at-home randomized crossover
    study: Results of the PROLOG trial. Diabetes Care. 2018 [In Press].

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