Data Presented at ATTD 2017 Demonstrate Clinical Advantages of Tandem Diabetes Care Sensor-augmented Pump (SAP) over Medtronic MiniMed SAPs
- Additional Presentation of Self-reported Data Demonstrates Reduced
Risk of Hypoglycemia with Tandem Pumps Compared to Previous Therapy -
SAN DIEGO--(BUSINESS WIRE)--
Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and
manufacturer of the only touchscreen insulin pumps available in the
United States, today presented study results comparing retrospective
user data from sensor-augmented pumps (SAPs) made by Tandem Diabetes
Care and Medtronic Minimed®. SAPs receive continuous glucose monitoring
(CGM) data from a wearable sensor. The Tandem SAP demonstrated
statistically significant clinical advantages, including reduced
hypoglycemia, increased time in range, and improved overall glycemic
control, despite approximately half of Medtronic SAP users actively
using a feature that suspends insulin delivery if blood glucose falls
below a preset threshold. These data were presented during a poster
session at the 10th Annual Advanced Technologies and
Treatments for Diabetes (ATTD) International Conference in Paris, France.
"This study suggests that our simple-to-use touchscreen interface may
translate to improved clinical outcomes for people with diabetes," said
Betsy Dokken, PhD, Director of Clinical Affairs at Tandem Diabetes Care.
"The data reinforces our assertion that not every insulin pump delivers
the same benefits, and that choice in therapy options is important for
the diabetes community."
A retrospective study was conducted in which de-identified Tandem SAP
user data from the period of October 2015 - August 2016 were collected
from the t:connect® Diabetes Management Application for analysis
(n=3,046). These findings were compared to similar data collected from
the CareLink® Therapy Management System between September 2011 and
October 2013.1 Both the Tandem and the Medtronic data sets
utilized the same inclusion criteria: people with type 1 and type 2
diabetes using a SAP, at least 6 months of sensor use, and more than 15
days of CGM use during the first 6 months. Compared with Medtronic SAP
user results, those using the Tandem SAP demonstrated:
Reduced Hypoglycemia - Tandem SAP users
showed reduced time in each of the hypoglycemic ranges. The effect
size is large and persists regardless of the frequency of sensor usage.
Increased Time in Range - Tandem SAP
users who utilized the sensor at least 25% of the time showed
increased time in range relative to Medtronic SAP users with the same
sensor usage time.
Improved Overall Glycemic Control - The
Tandem SAP demonstrated improved control across all glycemic ranges
for subjects using the sensor at least 75% of the time. These users
spent less time both hypoglycemic and hyperglycemic when compared to
users of the Medtronic SAPs.
Based on earlier data demonstrating a greater ease-of-use and lower rate
of error for the t:slim® Insulin Pump2, the current results
may be related to the usability benefits introduced by the touchscreen,
suggesting that the intuitive user interface of the Tandem SAP
translates into better outcomes in everyday life.
In a second poster presentation, data were presented from a study
demonstrating a reduced risk of hypoglycemia associated with Tandem pump
use compared to previous methods of diabetes therapy. Data were
collected from patients with either type 1 (90%) or type 2 (10%)
diabetes who had been using a Tandem pump for at least 1 year (N =
1,370). Participants voluntarily filled out an online survey with
questions about the occurrence of mild hypoglycemic events (able to
treat the low themselves), medium hypoglycemic events (needed assistance
from someone but did not need to go to the hospital) and severe
hypoglycemic events (needed assistance from a medical professional
and/or needed to go the hospital). Questions focused on both the year
before starting a Tandem pump (using previous method of diabetes
therapy) and the past year using their Tandem pump. Results demonstrated
that, even when controlling for CGM usage, Tandem pump users reported a
52% reduction in severe hypoglycemia, a 31% reduction in medium
hypoglycemia, and a 15% reduction in mild hypoglycemia, compared to
previous methods of diabetes therapy. Furthermore, there was a
statistically significant reduction in ambulance rides due to severe
hypoglycemia of 58% and in days spent at the hospital due to severe
hypoglycemia of 50%.
About Tandem Diabetes Care, Inc.
Tandem Diabetes Care, Inc. (www.tandemdiabetes.com)
is a medical device company with an innovative, user-centric and
integrated approach to the design, development and commercialization of
products for people with diabetes who use insulin. The Company
manufactures and sells the t:slim X2™ Insulin Pump, the slimmest and
smallest durable insulin pump currently on the market, the t:flex®
Insulin Pump, the first pump designed for people with greater insulin
requirements, and the t:slim G4™ Insulin Pump, the first continuous
glucose monitoring-enabled pump with touchscreen simplicity. Tandem is
based in San Diego, California.
Any forward-looking statements are subject to risks and uncertainties
including those identified in the Company's most recent Annual Report on
Form 10-K and Quarterly Report on Form 10-Q, as well as other documents
that the Company files with the Securities and Exchange Commission.
Actual results may differ materially from those anticipated or projected
in this release.
Follow Tandem Diabetes Care on Twitter @tandemdiabetes; use #tslimX2,
#tslimG4, #tflex, #tconnect, and $TNDM.
Follow Tandem Diabetes Care
on Facebook at www.facebook.com/TandemDiabetes.
Tandem Diabetes Care on LinkedIn at https://www.linkedin.com/company/tandemdiabetes.
t:flex and Tandem Diabetes Care are registered trademarks, and t:slim X2
and t:slim G4 are trademarks of Tandem Diabetes Care, Inc. Medtronic,
Minimed and Carelink are registered trademarks of Medtronic, Inc.
1 Battelino T, Liabat S, Veeze HJ, Castañeda J, Arrieta A,
Cohen O. Routine use of continuous glucose monitoring in 10 501 people
with diabetes mellitus. Diabet Med. 2015;32:1568-1574.
Schaeffer, N. E., Parks, L. J., Verhoef, E. T., et al. Usability and
training differences between two personal insulin pumps. J Diabetes Sci
Technol, March 2015 vol. 9 no. 2 221-230.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170215005304/en/
Tandem Diabetes Care, Inc.
Susan Morrison, 858-366-6900 x7005
Source: Tandem Diabetes Care, Inc.
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