Tandem Diabetes Care, Inc. (NASDAQ: TNDM), a leading insulin
delivery and diabetes technology company, today presented positive
real-world data from ongoing use of the t:slim X2™ insulin pump
with Control-IQ® advanced hybrid closed-loop technology,
demonstrating statistically significant improvements in glycemic
and patient-reported outcomes. Emphasis was placed on qualitative
experiences as well as insights from diverse populations using the
system. The data was presented this week during the 81st Scientific
Sessions of the American Diabetes Association.
“People living with diabetes are benefiting from our Control-IQ
technology across diverse populations and therapeutic backgrounds,
which supports our mission to improve the lives of people living
with diabetes,” said John Sheridan, president and CEO of Tandem
Diabetes Care. “In addition to improved glycemic control, the data
presented this week demonstrated holistic improvements in people’s
lives including decreased diabetes burden and improved quality of
life.”
ADA PRESENTATION
SUMMARIES
Glycemic Outcomes by Ethnicity in Adults with Type 1 Diabetes
Using Control-IQ Technology: Early Results from the CLIO Study
Oral Presentation (217-OR) Session: Insulin Delivery Systems
This presentation reported outcomes from the ongoing Control-IQ
Observational (CLIO) study evaluating real-world use of the t:slim
X2 insulin pump with Control-IQ technology in diverse groups of
people with type 1 diabetes. At baseline, Black participants
reported the highest HbA1c (8.1%) compared to participants from
other ethnic cohorts. Using Control-IQ technology, Glucose
Management Indicator (GMI) at 21 days reflected significant
glycemic improvements across all ethnic groups with Asian
participants showing the lowest GMI (6.8%) followed by Caucasian
participants (7.0%). At 21 days, the median sensor time in range
(TIR) of Black participants (62.7%, IQR=53.4-74.7) was
significantly lower than for Caucasian participants (75.1%,
IQR=70.3-81.0) while controlling for age, gender, reported
exercise, annual income, and prior therapy. Baseline HbA1c was the
key factor predicting sensor TIR, followed by exercise, annual
income, and multiple daily injections (MDI, prior therapy).
Disparities in glycemic outcomes across socioeconomic and
demographic groups recorded at baseline remained after initiating
an automated insulin dosing system. However, Control-IQ technology
significantly improved glycemic outcomes for all ethnic groups.
Insulin Delivery Patterns Vary Across Age Groups with Use of
Control-IQ Technology* Poster Presentation (92-LB) Category:
Clinical Therapeutics/New Technology—Insulin Delivery Systems
— Recipient of the American Diabetes
Association’s Diabetes Technology Interest Group 2021 Abstract
Award in the Category of Clinical Therapeutics/New
Technology—Insulin Delivery Systems. —
This presentation reported insulin use on the t:slim X2 pump
with Control-IQ technology from the ongoing CLIO Study evaluating
real-world use of the t:slim X2 insulin pump with Control-IQ
technology in a large, diverse cohort with type 1 diabetes. Study
sample included 1,499 participants who had uploaded at least 21
days of pump data to Tandem’s t:connect® web application and had
75% CGM use during this time. Insulin delivery during the study was
compared to standard formulas for predicting correction factor (CF
= 1,800/total daily dose) and carbohydrate ratio (CR = 450/total
daily dose). Results demonstrated that insulin use with the t:slim
X2 pump with Control-IQ technology differed from standard
prediction formulas across age groups, in that the correction
factor prediction factor (CFPF) was significantly greater in
children and teenagers. CFPF was lowest in children aged 6-9 and in
adults aged 66 and above. Additional study is recommended, with
comparison to final glycemic outcomes, to determine ideal insulin
delivery settings with Automated Insulin Dosing, as examination of
insulin use patterns may assist in optimizing outcomes.
* Lead author, Dr. Jordan Pinsker, is currently the Medical
Director at Tandem Diabetes Care. This study was completed during
Dr. Pinsker’s employment at Sansum Diabetes Research Institute
prior to joining the company.
“I Feel Human, I Feel Normal”: A Qualitative Study of
Experiences with Control-IQ Technology in Early Adopters Poster
Presentation (531-P) Category: Psychosocial, Behavioral
Medicine
This presentation reported results from qualitative analyses of
semi-structured interviews conducted with adult (N=27) early
adopters of Control-IQ technology to understand their experiences
of initiating and continued use of this technology. Improved sleep
quality, glycemic control, and sensor time in range were common
themes reported by participants along with reduced burden of
diabetes management. Overall, participants described valuable
improvements in their quality of life, including reduced stress and
decision-making around diabetes management, and increased freedom
and spontaneity in daily life with continued use of Control-IQ
technology.
Real-World Evaluation of Glycemic Outcomes by Prior Therapy
for People with Type 1 and Type 2 Diabetes Onboarding to Control-IQ
Technology Poster Presentation (710-P) Category: Clinical
Therapeutics/New Technology—Insulin Delivery Systems
This presentation examined retrospective analysis of real-world
glycemic outcomes by previous therapy between people with type 1
and type 2 diabetes over a period of six months after they
onboarded to Control-IQ technology (excluding individuals who had
undergone a software update from a previous Tandem system). After
180 days of starting Control-IQ technology, for prior pump users
with type 1 diabetes, sensor TIR was 74% (median, IQR 65-81%) and
time below <70mg/dL was 1.2% (IQR 0.6-2.1%). For prior pump
users with type 2 diabetes, sensor TIR was 76% (IQR 69-82%) and
time below <70mg/dL was 0.5% (IQR 0.2-1.0%). For participants
transitioning from MDI, Control-IQ technology resulted in sensor
TIR of 74% (IQR 64-83%) and 0.9% time below <70mg/dL (IQR
0.4-1.7%) for people with type 1 diabetes and 74% TIR (IQR 63-84%)
and 0.3% time below <70mg/dL (IQR 0.1-0.6%) for people with type
2 diabetes. Using Control-IQ technology, both type 1 and type 2
diabetes participants (irrespective of prior therapy) achieved the
recommended sensor TIR and time below <70mg/dL outcomes.
About Control-IQ Advanced Hybrid Closed-Loop
Technology
The t:slim X2 insulin pump with Control-IQ technology uses
Dexcom G6 CGM values, in conjunction with other variables such as
insulin on board, to predict sensor glucose levels 30 minutes ahead
and adjust insulin delivery accordingly.1,2,3 Control-IQ technology
is designed to increase sensor time in range by automatically
increasing, decreasing, or stopping insulin delivery, or giving an
automatic correction bolus based on predicted glucose levels.
Control-IQ technology also offers optional settings for sleep and
exercise that will change treatment values to better match the
different physiologic needs during these activities.
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. The Company 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 Control-IQ technology. The t:slim
X2 pump is capable of remote feature updates using a personal
computer and is the only automated insulin dosing device approved
for children as young as six years old. Tandem is based in San
Diego, California.
Responsible Use Statement
Control-IQ technology does not prevent all high and low blood
glucose events, and is not a substitute for meal boluses and active
self-management of diabetes. Control-IQ technology will not be able
to predict sensor glucose values and adjust insulin dosing if a
user’s CGM is not working properly or is unable to communicate with
their pump. Users should be instructed to always pay attention to
their symptoms and blood glucose levels and treat accordingly.
Please visit tandemdiabetes.com/tslimX2-use for more
information.
Important Safety Information: RX ONLY. The t:slim X2 pump
and Control-IQ technology are intended for single patient use. The
t:slim X2 pump and Control-IQ technology are indicated for use with
NovoLog or Humalog U-100 insulin. t:slim X2 insulin pump: The
t:slim X2 insulin pump with interoperable technology is an
alternate controller enabled (ACE) pump that is intended for the
subcutaneous delivery of insulin, at set and variable rates, for
the management of diabetes mellitus in people requiring insulin.
The pump is able to reliably and securely communicate with
compatible, digitally connected devices, including automated
insulin dosing software, to receive, execute, and confirm commands
from these devices. The t:slim X2 pump is indicated for use in
individuals six years of age and greater. Control-IQ technology:
Control-IQ technology is intended for use with a compatible
integrated continuous glucose monitor (iCGM, sold separately) and
ACE pump to automatically increase, decrease, and suspend delivery
of basal insulin based on iCGM readings and predicted glucose
values. It can also deliver correction boluses when the glucose
value is predicted to exceed a predefined threshold. Control-IQ
technology is intended for the management of Type 1 diabetes
mellitus in persons six years of age and greater.
WARNING: Control-IQ technology should not
be used by anyone under the age of six years old. It should also
not be used in patients who require less than 10 units of insulin
per day or who weigh less than 55 pounds.
Control-IQ technology is not indicated for use in pregnant
women, people on dialysis, or critically ill patients. Do not use
Control-IQ technology if using hydroxyurea. Users of the t:slim X2
pump and Control-IQ technology must: use the insulin pump, CGM, and
all other system components in accordance with their respective
instructions for use; test blood glucose levels as recommended by
their healthcare provider; demonstrate adequate carb-counting
skills; maintain sufficient diabetes self-care skills; see
healthcare provider(s) regularly; and have adequate vision and/or
hearing to recognize all functions of the pump, including alerts,
alarms, and reminders. The t:slim X2 pump, and the CGM transmitter
and sensor must be removed before MRI, CT, or diathermy treatment.
Visit tandemdiabetes.com/safetyinfo for additional important safety
information.
© 2021 Tandem Diabetes Care, Inc. All rights reserved. Tandem
Diabetes Care, t:slim X2, Control-IQ, and t:connect are either
registered trademarks or trademarks of Tandem Diabetes Care, Inc.
in the United States and/or other countries. Dexcom and Dexcom G6
are either registered trademarks or trademarks of Dexcom, Inc. in
the United States and/or other countries. All third-party marks are
the property of their respective owners.
1 If glucose alerts and CGM readings do not match symptoms or
expectations, use a blood glucose meter to make diabetes treatment
decisions. 2 Dexcom G6 CGM sold separately. 3 The Dexcom G6 CGM
transmitter can only be paired with one medical device (either a
Dexcom receiver or t:slim X2 pump) and one consumer device (phone
or tablet) at the same time.
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version on businesswire.com: https://www.businesswire.com/news/home/20210627005025/en/
Media: Steve Sabicer, 714-907-6264, ssabicer@thesabicergroup.com
Investors: Susan Morrison, 858-366-6900 x7005,
IR@tandemdiabetes.com
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