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:
- 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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version on businesswire.com: https://www.businesswire.com/news/home/20180808005175/en/
Tandem Diabetes Care Contact Information:Media:Steve
Sabicer, (714)
907-6264ssabicer@thesabicergroup.comorInvestors:Susan Morrison,
(858) 366-6900 x7005smorrison@tandemdiabetes.com
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