- Available for purchase today at Stelo.com for people in the
U.S. 18 and older not using insulin
- Provides 24/7 powerful and personalized glucose insights
directly to a smartphone,* revealing how food, exercise and sleep
can affect glucose
- Tracking glucose just got easier, with no prescription and no
fingersticks, ever
- Specifically designed to help people with Type 2 diabetes not
using insulin and those with prediabetes reach their A1c goals and
potentially slow the progression of diabetes.†,1-3
DexCom, Inc. (NASDAQ:DXCM), the global leader in real-time
continuous glucose monitoring for people with diabetes, announced
today that Stelo, the first over-the-counter glucose biosensor in
the U.S., is now available for purchase without a prescription4 at
Stelo.com.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240826019839/en/
Stelo is designed to help people with
Type 2 diabetes not using insulin and those with prediabetes.
(Photo: Dexcom)
Stelo is a small biosensor worn on the back of the upper arm
that leverages Dexcom’s most accurate glucose sensing technology.5
It is specifically designed to provide the 125 million Americans6
with Type 2 diabetes not using insulin and those with prediabetes
with powerful, personalized glucose insights sent directly to a
smartphone,* revealing how food, exercise and sleep can affect
glucose – all without painful fingersticks.
“Dexcom has been at the forefront of glucose biosensing for 25
years. With the launch of Stelo, we’re defining a brand-new
category and once again setting the gold standard for people to
easily take control of their health,” said Jake Leach, executive
vice president and chief operating officer at Dexcom. “Now,
millions more have access to 24/7, easy-to-understand glucose
insights that can inform their daily lifestyle choices and support
behavior modification.”
The benefits of glucose biosensing have been shown when used
alone, or alongside other diabetes and weight management
medications.7 Studies show the use of Dexcom glucose biosensing by
people with Type 2 diabetes is associated with clinically
meaningful improvement in time in range, A1c and quality of
life.8-11
“Dexcom glucose biosensors are an essential and proven tool for
diabetes management – driving strong clinical outcomes regardless
of medication use9 and even potentially slowing the progression of
diabetes,†,1-3” said Thomas Grace, MD, head of clinical advocacy
and outcomes at Dexcom. “In a world where GLP-1 use is becoming
increasingly more common, glucose biosensors like Stelo can help
make those medications more effective.12”
Key features of Stelo
- No fingersticks, ever: The only over-the-counter glucose
biosensor designed for people with diabetes that doesn’t require
any fingersticks.
- Up to 15-day wear time‡ and waterproof§: The
longest biosensor wear time on the market‡ with the highest
waterproof rating.
- A personalized, easy-to-use app4: Provides daily, weekly
and session summary insights that can help form healthier
habits.
- Spike and pattern detection4: The only over-the-counter
glucose biosensor for people with diabetes featuring spike
detection, designed to identify meaningful glucose variability as
it happens so users can make informed changes.
- Proven results with Dexcom glucose sensors†: Using
Dexcom glucose sensors like Stelo helps lower A1c†,1,10, 13-19 for
people with Type 2 diabetes and may help slow the progression of
diabetes.†,1-3 Only Dexcom glucose sensors have been associated
with significant improvements in glucose and cardiovascular risk
reduction measures as early as three months.||,13
Effortless ordering, delivered directly to your door
Stelo improves access to critical health technology for people
with Type 2 diabetes not using insulin and those with prediabetes
who might not have insurance coverage for prescription glucose
biosensors. Stelo is currently available for purchase in the U.S.
at Stelo.com and is FSA and HSA eligible.
- Pay-as-you-go: Pay $99 for a single pack of two sensors
(total wear time up to 30 days‡).
- Monthly subscription: Subscribe and save 10%. Pay $89
per month for an ongoing subscription, with two sensors (total wear
time up to 30 days‡) delivered every 30 days.
Stelo is now part of Dexcom’s overall portfolio of glucose
biosensors, with a user base of more than 2.5 million people
globally. The Dexcom portfolio in the U.S. consists of the Dexcom
G6 and Dexcom G7 Continuous Glucose Monitoring Systems, and now
Stelo, collectively designed to address the needs of people with
all types of diabetes and prediabetes.
Each product in the portfolio is built for the people who use
them, making it easier than ever for healthcare providers to get
patients started with the glucose biosensor best for them. Dexcom
G6 and Dexcom G7 are designed for people with diabetes using
insulin or who are at risk of hypoglycemia and who have insurance
coverage for glucose biosensors. Both systems require a
prescription and are reimbursed by 97% of commercial insurers in
the U.S., Medicare nationally and Medicaid in most states.5 Stelo
is designed for adults with Type 2 diabetes not using insulin or
prediabetes who seek behavior change and optimized health and who
do not have insurance coverage for glucose biosensors.
Visit Stelo.com today to get started with
Stelo, or do a benefits check to see if you are eligible for Dexcom
G7 at Dexcom.com/Start.
About DexCom, Inc.
DexCom, Inc. empowers people to take control of health through
innovative continuous glucose monitoring (CGM) systems.
Headquartered in San Diego, Calif., and with operations across
Europe and select parts of Asia/Oceania, Dexcom has emerged as a
leader of diabetes care technology. By listening to the needs of
users, caregivers and providers, Dexcom works to simplify and
improve diabetes management around the world. For more information
on Dexcom, visit https://www.dexcom.com/about.
*Smart device sold separately. For Stelo app compatibility
information, visit stelo.com/compatibility. †Results obtained from
previous Dexcom device(s) in people with diabetes who may be on
insulin. ‡A study was conducted to assess the sensor life where
77.9% of sensors lasted the full 15 days. In other words, when
using the product per the package labeling, approximately 20% of
sensors may not last for the full 15 days, 10% of these sensors may
last less than 12 days. §The Stelo biosensor is waterproof and may
be submerged under eight feet of water for up to 24 hours without
failure when properly installed. If you are in or near water, your
smartphone may need to be closer than 20 feet to get readings. If
you are in water, you may not get readings until you get out.
||Cardiovascular risk refers to 10-year ASCVD risk. Visit
https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/
to access the American College of Cardiology ASCVD Risk Estimator
Plus.
1 UKPDS Group. Lancet.1998;352(9131):837-53. 2 Battelino T, et
al. Diabetes Care. 2019;42(8):1593-603. 3 Vigersky RA, et al.
Diabetes Technol Ther. 2019;21(2):81-85. 4 Stelo User Guide. 5
Dexcom, data on file, 2024. 6 Centers for Disease Control and
Prevention. National Diabetes Statistics Report.
https://www.cdc.gov/diabetes/php/data-research/index.html. Accessed
on August 12, 2024. 7 Grace T, Salyer J. Diabetes Technol Ther.
2022 Jan;24(1):26-31. 8 Cox DJ, Banton T, Moncrief M, et al. J
Endocr Soc 2020;4(11):bvaa118. 9 Hannah K, Nemlekar P, Norman G.
Improved glycemic control after real-time continuous glucose
monitor (rtCGM) initiation in patients with type 2 diabetes (PWT2D)
stratified by insulin therapy and race/ethnicity. Presented at the
17th International Conference on Advanced Technologies &
Treatments for Diabetes (ATTD 2024), March 6-9, 2024, Florence,
Italy and online. 10 Jepson LH, Welsh J, Green CR, et al. Diabetes
2023;72(Supplement_1):941-P. 11 Layne J, Jepson, Thomas R, et al.
Non-insulin treated adults with type 2 diabetes benefit from CGM
use: real-world data. Presented at the 17th International
Conference on Advanced Technologies & Treatments for Diabetes
(ATTD 2024), March 6-9, 2024, Florence, Italy and online. 12
Nemlekar et al. Diabetes. 2024; 73 (Supplement_1): 1914–LB. 13 Reed
J, et al. Diabetes Obes Metab. 2024;26(7):2881-9. 14 Polonsky W, et
al. ATTD. 2024;O013(535). 15 Beck RW, et al. JAMA.
2017;317(4):371-378. 16 Beck RW, et al. Ann Intern Med.
2017;167(6):365-374. 17 Martens T, et al. JAMA.
2021;325(22):2262-2272. 18 Laffel LM, et al. JAMA.
2020;323(23):2388-2396. 19 Welsh JB, et al. J Diabetes Sci Technol.
2024;18(1):143-7.
STELO IMPORTANT INFORMATION: Consult your healthcare provider
before making any medication adjustments based on your sensor
readings and do not take any other medical action based on your
sensor readings without consulting your healthcare provider. Do not
use if you have problematic hypoglycemia. Failure to use Stelo and
its components according to the instructions for use provided and
to properly consider all indications, contraindications, warnings,
and cautions in those instructions for use may result in you
missing a severe hypoglycemia (low blood glucose) or hyperglycemia
(high blood glucose) occurrence. If your sensor readings are not
consistent with your symptoms, a blood glucose meter may be an
option as needed and consult your healthcare provider. Seek medical
advice and attention when appropriate, including before making any
medication adjustments and/or for any medical emergency.
INDICATIONS FOR USE: The Stelo Glucose Biosensor System is an
over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM)
intended to continuously measure, record, analyze, and display
glucose values in people 18 years and older not on insulin. The
Stelo Glucose Biosensor System helps to detect normal (euglycemic)
and low or high (dysglycemic) glucose levels. The Stelo Glucose
Biosensor System may also help the user better understand how
lifestyle and behavior modification, including diet and exercise,
impact glucose excursion. The user is not intended to take medical
action based on the device output without consultation with a
qualified healthcare professional.
Dexcom, Dexcom Clarity, Dexcom Follow, Dexcom One, Dexcom Share,
Stelo, and any related logos and design marks are either registered
trademarks or trademarks of Dexcom, Inc. in the United States
and/or other countries. ©2024 Dexcom, Inc. All rights reserved.
Category: IR
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version on businesswire.com: https://www.businesswire.com/news/home/20240826019839/en/
Media Contact James McIntosh
619-884-2118 james.mcintosh@dexcom.com
Investor Contact Sean
Christensen 858-203-6657 sean.christensen@dexcom.com
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