- Centralized experience supports diabetes self-management
through medication reminders, education resources and insulin dose
logging
- Data shared through platform interface may help healthcare
providers make data-driven decisions± about care for
adults treated with select Lilly insulins
- Offers compatibility with the Dexcom® Continuous
Glucose Monitoring Systems, *,∞ the Tempo
Blood Glucose Monitor (BGM) and other compatible BGMs, as well as
wearable devices from Fitbit®, Garmin®,
Google Fit® and the Apple Health app
INDIANAPOLIS, Nov. 7, 2022
/PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) will begin
rollout of its first connected platform, the Tempo®
Personalized Diabetes Management Platform, later this year in the
U.S. The technology aims to help adults living with type 1 or type
2 diabetes and clinicians make informed, data-backed decisions to
manage treatment with Lilly insulins.±
The platform consists of three key components – the Tempo Smart
Button®; a compatible app, TempoSmart™; and a prefilled
insulin pen, Tempo Pen® – which work together to deliver
personalized guidance for adults with diabetes. The Smart Button
was cleared by the U.S. Food and Drug Administration on
September 16. The compatible app was
developed in partnership with Welldoc® and is a
private label iteration of the company's BlueStar®, a
diabetes management app, customized to receive insulin dose-related
data from the Tempo Smart Button.
Healthcare providers will have access to a clinician hub, Tempo
Insights™, where they can access data shared by their patients
through the app and track patients' progress.
"Lilly has over a century of knowledge of insulin and its
complexities, and recognizes the emotional impact of managing
diabetes1,2," said Kevin
Cammack, Head of Connected Care, Lilly Diabetes. "Launching
this platform is an opportunity for us to more broadly support
those who rely on our insulins."
Here's how the platform works: The Tempo Smart Button is a
reusable medical device that attaches to the top of a Tempo Pen ―
Lilly's prefilled, disposable insulin pens approved in 2019 and
2020. When paired via Bluetooth® wireless technology,
the Smart Button is intended to detect, store and transfer insulin
dose-related data to the compatible app. The app, TempoSmart, will
record insulin dose information and facilitate data sharing between
adults with diabetes and the healthcare providers who treat
them.
Adults with diabetes can access insulin dose information and
advanced features through TempoSmart, including:
- Medication reminders, personalized education resources and
feedback on blood glucose levels.
- Integration with Dexcom Continuous Glucose Monitoring (CGM)
Systems∞ via secondary display,*
as well as the Tempo Blood Glucose Monitor (BGM) and other
compatible BGMs.
- Compatibility to sync data with wearable devices from
Fitbit®, Garmin®, Google Fit® and
the Apple Health app.
"Despite technological advancements, people continue to
experience challenges with the complexities of insulin
dosing,3" said Cammack. "Using the learnings from early
adopters of Tempo, we look forward to continually innovating our
technology to aid those who use Lilly insulins to manage their
diabetes."
Lilly will conduct a phased rollout for the platform to select
clinics starting later this year, followed by national availability
targeted for 2023. The Tempo Pen is currently available for
Lyumjev® (insulin lispro-aabc) injection, 100 units/mL,
BASAGLAR® (insulin glargine) injection, 100 units/mL,
and Humalog® (insulin lispro injection) 100 units/mL.
Lilly continues to work with Welldoc to integrate additional
features for TempoSmart in future software updates.
Outside of the U.S., Lilly received CE (Conformité Européenne or
European Conformity) marking certification for the Tempo Smart
Button on August 10 and plans to
begin small-scale pilots in selected countries through partnerships
with existing diabetes management ecosystems.
Lilly is committed to helping people access the medicines they
need and will work with insurers, health systems and providers to
help enable patient access to the Tempo Personalized Diabetes
Management Platform. Lilly will be offering a savings card for the
platform for people who qualify. For more information, connect with
our Tempo Customer Support Service by calling 1-855-Lilly-Tempo.
Text TEMPO to 85099 for alerts and updates on the Tempo
platform.
± Warning: The Tempo
Personalized Diabetes Management Platform is intended to help
support the management of your diabetes. You must continue to
independently manage your blood glucose values and your prescribed
regimen with support from your healthcare practitioner.
*Secondary display is available with 3-hour delay in the
TempoSmart App.
∞ Warning: Do not make
dosing decisions based on CGM data from the TempoSmart App. Follow
instructions on your CGM system.
Tempo Smart Button Intended Use
The Smart Button is
intended to detect, store, and transfer insulin dose-related data
from a Tempo Pen to a compatible application (App). The Smart
Button is indicated for single-patient use by patients 18 years or
older who are diagnosed with type 1 or type 2 diabetes mellitus,
using prefilled insulin Tempo Pens, and using a compatible App.
Important Safety Information for Tempo Personalized Diabetes
Management Platform
DO NOT start over, skip, or repeat your
injection when using the Tempo Personalized Diabetes Management
Platform if you are not sure you took your insulin or if you are
not sure your insulin dosing information is correct. Instead,
monitor your blood glucose and consult your Healthcare Provider.
Call 911 if you are experiencing a medical emergency. Ensure you
work with your Healthcare Provider on a backup diabetes management
plan if your Tempo Smart Button or TempoSmart App stops working.
Having a backup plan and supplies can help avoid severe low and
high glucose. Keep the Tempo Smart Button away from children. For
product and safety information, including Warnings and Cautions,
read the Tempo Smart Button Instructions for Use, TempoSmart App
User Guides and Tempo Welcome Kit and Tempo Refill Kit
Instructions.
INDICATION AND SAFETY
SUMMARY
Lyumjev® (LOOM-jehv)
and Humalog® (HU-ma-log)
- Lyumjev is a fast-acting insulin used to control high blood
sugar in adults and children with diabetes. Humalog is a
fast-acting insulin. Humalog is used to control high blood sugar in
adults and children with diabetes.
- Lyumjev comes in two strengths: U-100 (100 units per
milliliter) and U-200 (200 units per milliliter). Lyumjev U-200
contains 2 times as much insulin in 1 milliliter as Lyumjev
U-100. Humalog U-100 contains 100 units of insulin per milliliter.
The dose window of the pen shows the number of insulin units to be
delivered.
- It is not known if Humalog is safe and effective for children
with type 2 diabetes or for children younger than 3 years of age
with type 1 diabetes as there were no studies done with Humalog in
these groups of children. If your doctor decides to give your child
any insulin products, he or she may give you special
instructions.
All Lyumjev and Humalog products contain insulin lispro.
Warnings - Do not take Lyumjev or Humalog if you
have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to insulin lispro-aabc, Humalog, or any of the
ingredients in Lyumjev or Humalog.
Do not reuse needles or share your insulin injection supplies
with other people. This includes your:
- prefilled pen for use by a single patient
- cartridges
- reusable pen that works with Lilly 3mL cartridges available for
Humalog
- needles
- syringes
You or the other person can get a serious infection. This can
happen even if you change the needle.
Do not change the type of insulin you take or your
dose unless your doctor tells you to. This could cause low or high
blood sugar, which could be serious.
Do not use a syringe to remove Lyumjev or Humalog
from your prefilled pen. This can cause you to take too much
insulin. Taking too much insulin can lead to severe low blood
sugar. This may result in seizures or death.
Lyumjev and Humalog may cause serious side effects. Some of
these can lead to death. The possible serious side effects
are:
- Low blood sugar. This can cause:
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• dizziness or
lightheadedness
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• sweating
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• confusion
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• headache
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• blurred
vision
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• slurred
speech
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• shakiness
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• fast
heartbeat
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• anxiety
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•
irritability
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• mood
change
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• hunger
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If you are at risk of having severely low blood sugar, your
doctor may prescribe a glucagon emergency kit. These are used when
your blood sugar becomes too low and you are unable to take sugar
by mouth. Glucagon helps your body release sugar into your
bloodstream.
- Low potassium in your blood. This can lead to
severe breathing problems, irregular heartbeat, and death.
- Severe allergic reaction.
Get emergency help right away if you have:
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• a rash over your
whole body
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• trouble
breathing
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• a fast
heartbeat
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• sweating
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• a faint
feeling
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• shortness of
breath
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• extreme
drowsiness
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• dizziness
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• confusion
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• swelling of your
face, tongue,
or throat
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- Heart failure. Taking diabetes pills called
thiazolidinediones (thIE-uh-zOH-li-dEEn-dIE-OHns), or "TZDs," with
Lyumjev or Humalog may cause heart failure in some people. This
includes people who do not have any heart problems. If you have
heart failure, it may get worse if you take TZDs with Lyumjev or
Humalog. Tell your doctor if you have any new symptoms of heart
failure, or if they get worse. Some symptoms of heart failure
include: shortness of breath, swelling of ankles and feet, and
sudden weight gain. Your doctor may need to change or stop
treatment with TZDs and your insulin lispro product.
- Sudden onset of high blood sugar and high amounts of ketones
in your blood or urine. You can have these serious side
effects when your insulin pump or infusion set is not working the
right way, if there are handling errors, or if your insulin is no
longer effective. For these reasons, you may not get the right
amount of insulin, so always keep extra insulin and injection
supplies with you.
Common side effects
The most common side effects of Lyumjev
and Humalog are:
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• low blood
sugar
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• allergic
reactions
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• reactions or pain at
the injection or infusion site with insulin pump use
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• skin thickening or
pits at the injection or infusion site
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• itching
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• rash
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• weight
gain
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Other most common side effects with Humalog include swelling of
your hands or feet.
These are not all of the possible side effects. Tell your
doctor if you have any side effects. You can report side effects at
1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage
it. Also tell your doctor:
- about all of the medicines you take, including over-the-counter
medicines, vitamins, and herbal supplements.
- about any other prescription medicines you take, especially
ones called TZDs.
- about all of your medical conditions, including if you have
heart failure or other heart, liver, or kidney problems.
- if you are pregnant, breastfeeding, or plan to become pregnant
or breastfeed.
How to take
Read the Instructions for Use that come with your
Lyumjev or Humalog. Be sure to take your Lyumjev
or Humalog and check your blood sugar levels exactly as
your doctor tells you to. Your doctor may tell you to change your
dose because of illness, increased stress, or changes in your
weight, diet, or physical activity level. He or she may also tell
you to change the amount or time of your dose because of other
medicines or different types of insulin you take.
Before injecting your Lyumjev or Humalog
You can inject your insulin dose yourself, or you can have a
trained caregiver inject it for you. Make sure you or your
caregiver:
- Check the insulin label before each injection. This will help
you make sure that you are taking the correct insulin.
- Use a new needle for each injection. You can get a serious
infection or the wrong dose of insulin if you reuse needles.
- Change (rotate) where you inject your insulin with each dose.
This can reduce your chance of getting pits, lumps, or thickened
skin where you inject your insulin. Do not inject your
insulin into the exact same spot or where the skin has pits or
lumps. Avoid injecting into thickened, tender, bruised,
scaly, hard, scarred, or damaged skin.
- Monitor injection and infusion sites closely when initiating
therapy with Lyumjev in children. Contact a healthcare provider if
persistent injection or infusion site reactions occur.
When you are ready to inject
- Inject Lyumjev under your skin at the beginning of a meal or
within 20 minutes after you start eating a meal.
- Inject Humalog under your skin within 15 minutes before or
right after you eat a meal.
Staying safe while taking your Lyumjev or Humalog
To stay safe while taking your insulin, be sure to never
inject Lyumjev U-200 in your vein, muscle, or with an insulin
pump. Also be sure not to:
- mix Lyumjev with other insulins or liquids
- drive or use heavy machinery until you know how your Lyumjev or
Humalog affects you.
- drink alcohol or use other medicines that contain alcohol when
taking your Lyumjev or Humalog.
Learn more
Lyumjev and Humalog are prescription medicines. For more
information, call 1-800-545-5979 or go to www.Lyumjev.com or
www.humalog.com.
This summary provides basic information about
Lyumjev and Humalog. It does not include all information known
about these medicines. Read the information that comes with your
prescription each time your prescription is filled. This
information does not take the place of talking with your doctor. Be
sure to talk to your doctor or other healthcare provider about your
insulin lispro product and how to take it. Your doctor is the best
person to help you decide if these medicines are right for you.
UR HI CON BS 14OCT2022
Please see Lyumjev Full Prescribing Information including
Patient Prescribing Information
Please see Humalog Full Prescribing Information including
Patient Prescribing Information
Lyumjev® and Humalog® are
registered trademarks owned or licensed by Eli Lilly and Company,
its subsidiaries, or affiliates.
INDICATION AND SAFETY SUMMARY
BASAGLAR® (bāz-a-glar) is a long-acting
insulin used to control high blood sugar in:
- adults with type 1 or type 2 diabetes
- children with type 1 diabetes
It is not known if BASAGLAR is safe and effective in children
with type 2 diabetes or in children younger than 6 years with type
1 diabetes. There were no studies done with BASAGLAR in these
groups of children. If your doctor decides to give your child
BASAGLAR, he or she may give you special instructions.
BASAGLAR is not used to treat diabetic ketoacidosis.
Warnings - Do not take BASAGLAR if you have:
- symptoms of low blood sugar (hypoglycemia)
- an allergy to BASAGLAR or any of its ingredients
Do not reuse needles or share your BASAGLAR prefilled pen
with other people. You or the other person can get a serious
infection. This can happen even if you change the needle.
Do not change the insulin you use or your dose,
unless your doctor tells you to. This could cause low or high blood
sugar, which could be serious.
BASAGLAR may cause serious side effects. Some of these can
lead to death. The possible serious side effects of BASAGLAR
are:
- Low blood sugar. This can lead to:
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• dizziness or
light-headedness
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• sweating
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• confusion
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• headache
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• blurred
vision
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• slurred
speech
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• shakiness
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• fast
heartbeat
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• anxiety
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•
irritability
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• mood
change
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• hunger
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- Severe allergic reaction.
Get emergency help right away if you have:
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• a rash over your
whole body
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• trouble
breathing
|
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• a fast
heartbeat
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• swelling of your
face, tongue, or throat
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• sweating
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• shortness of
breath
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• extreme drowsiness,
dizziness, or confusion
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- Low potassium in your blood. This can lead to severe
breathing problems, irregular heartbeat, and death.
- Heart failure. Taking diabetes pills called
thiazolidinediones /thIE-uh-zOH-li-dEEn-dIE-OHns/ (TZDs) with
BASAGLAR may cause heart failure in some people. This includes
people who do not have any heart problems. If you have heart
failure, it may get worse if you take TZDs with BASAGLAR. Tell your
doctor if you have any new symptoms of heart failure, or if they
get worse. These are: shortness of breath, swelling of the ankles
or feet, and sudden weight gain. Your doctor may need to change or
stop treatment with TZDs and BASAGLAR.
Common side effects
The most common side effects of BASAGLAR are:
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• low blood
sugar
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• allergic
reactions
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• minor reactions where
you have injected BASAGLAR
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• changes in fat tissue
where you have injected BASAGLAR
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• itching
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• rash
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• swelling
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• weight
gain
|
These are not all of the possible side effects. Tell your
doctor if you have any side effects. You can report side effects
at 1-800-FDA-1088 or www.fda.gov/medwatch.
Before using
Talk with your doctor about low blood sugar and how to manage
it. Tell your doctor:
❑ about all of the medicines you take, including
over-the-counter medicines, vitamins, and herbal supplements.
❑ about any other prescription medicines you take, especially ones
called TZDs.
❑ about all of your medical conditions, including if you have heart
failure or other heart, liver, or kidney problems. If you have
heart failure, it may get worse while you take TZDs with
BASAGLAR.
❑ if you are pregnant, breastfeeding, or plan to become pregnant.
It is not known if BASAGLAR may harm your unborn or breastfeeding
baby.
How to take
The BASAGLAR prefilled pen is a disposable insulin delivery
device for use by a single patient to inject BASAGLAR. Read the
Instructions for Use that come with your BASAGLAR prefilled
pen. These instructions provide details on how to prepare and
inject a dose of BASAGLAR, and how to throw away used BASAGLAR
prefilled pens and needles.
Be sure to check your blood sugar levels and use BASAGLAR
exactly as your doctor tells you to. Your doctor may tell you to
change your dose because of illness, increased stress, or changes
in your weight, diet, or level of physical activity or exercise. He
or she may also tell you to change your dose because of other
medicines you take.
Before injecting your BASAGLAR
You can inject BASAGLAR
yourself, or you can have a trained caregiver inject it for you.
Make sure you or your caregiver:
- Check your insulin label each time you give your injection.
This will help you make sure that you are using the correct
insulin.
- Use a new needle for each injection. You can get a serious
infection or the wrong dose of insulin if you re-use needles.
When you are ready to inject
- Take BASAGLAR once a day, at the same time each day.
- Change (rotate) where you inject your insulin with each dose.
This can help reduce your chance of getting pits, lumps, or
thickened skin where you inject your insulin. Do not inject
your insulin into the exact same spot or where the skin has pits or
lumps. Avoid injecting into thickened, tender, bruised,
scaly, hard, scarred, or damaged skin.
Staying safe while taking your BASAGLAR
To stay safe
while taking BASAGLAR, be sure you only use BASAGLAR that is
clear and colorless and does not have any particles.
Be sure you do not:
- mix BASAGLAR with any other type of insulin or solution.
- drive or use heavy machinery until you know how BASAGLAR
affects you.
- drink alcohol or use other medicines that contain alcohol when
taking BASAGLAR.
Learn more
BASAGLAR is a prescription medicine. For
more information, call 1-800-545-5979 or go to
BASAGLAR.com.
This summary provides basic information about
BASAGLAR but does not include all information known about this
medicine. Read the information that comes with your prescription
each time your prescription is filled. This information does not
take the place of talking with your doctor. Be sure to talk to your
doctor or other health care provider about BASAGLAR and how to take
it. Your doctor is the best person to help you decide if BASAGLAR
is right for you.
BV CON BS 14SEP2022
Please see BASAGLAR Full Prescribing Information including
Patient Prescribing Information
BASAGLAR® is a registered trademark owned
or licensed by Eli Lilly and Company, its subsidiaries, or
affiliates.
About Lilly
Lilly unites caring with discovery to create medicines that make
life better for people around the world. We've been pioneering
life-changing discoveries for nearly 150 years, and today our
medicines help more than 47 million people across the globe.
Harnessing the power of biotechnology, chemistry and genetic
medicine, our scientists are urgently advancing new discoveries to
solve some of the world's most significant health challenges,
redefining diabetes care, treating obesity and curtailing its most
devastating long-term effects, advancing the fight against
Alzheimer's disease, providing solutions to some of the most
debilitating immune system disorders, and transforming the most
difficult-to-treat cancers into manageable diseases. With each step
toward a healthier world, we're motivated by one thing: making life
better for millions more people. That includes delivering
innovative clinical trials that reflect the diversity of our world
and working to ensure our medicines are accessible and affordable.
To learn more,
visit Lilly.com and Lilly.com/newsroom or
follow us on Facebook, Instagram, Twitter and
LinkedIn. P-LLY
About Welldoc
Welldoc® is revolutionizing chronic disease
management to help transform lives. BlueStar®, an
FDA-cleared digital health solution, guides individuals through the
complicated journey of living with diabetes by enabling them to
self-manage their conditions and enhancing connections to their
healthcare team. Welldoc streamlines the relationships between
payers, employers and healthcare systems resources, with the goal
of improving population health and reducing the costs of chronic
diseases. For more information on Welldoc, including BlueStar
indications of use, visit www.welldoc.com. TempoSmart does not
include the prescription features of BlueStar Rx. For full labeling
information, visit www.welldoc.com.
Lilly Cautionary Statement
Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that
term is defined in the Private Securities Litigation Reform Act of
1995) about Lilly and Welldoc's collaboration and licensing
agreement, including commercialization strategies, and reflects
Lilly's current beliefs and expectations. However, as with any such
undertaking, there are substantial risks and uncertainties in the
process of commercializing pharmaceutical products and medical
devices. Among other things, there is no guarantee that Lilly will
realize the expected benefits from the collaboration and license
agreement, that Lilly's connected insulin solutions will be
commercially successful, that Lilly will meet the anticipated
timelines described in this release, or that Lilly will execute its
strategy as expected. For further discussion of these and other
risks and uncertainties, see Lilly's most recent Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly undertakes no duty to
update forward-looking statements to reflect events after the date
of this release.
References
- Polonsky WH, Henry RR. Poor medication adherence in type 2
diabetes: recognizing the scope of the problem and its key
contributors. Patient Prefer Adherence. 2016;10:1299-1307.
doi:10.2147/PPA.S106821. <p1302/col2/para2/ln1-4;
ln15-19>2.
- American Diabetes Association. 5. Facilitating Behavior Change
and Well-being to Improve Health Outcomes —2022. Diabetes Care.
2022;45(suppl 1):S60-S82. doi:10.2337/dc22-S005.
- Peyrot M, Barnett AH, Meneghini LF, Schumm-Draeger PM. Insulin
adherence behaviours and barriers in the multinational global
attitudes of patients and physicians in insulin therapy study.
Diabet Med. 2012;29(5):682-689.
doi:10.1111/j.1464-5491.2012.03605.x.
Tempo®, Tempo Smart Button®, Tempo
Pen®, and the Tempo logo are registered trademarks, and
TempoSmart™, and Tempo Insights™ are trademarks of Eli Lilly and
Company, its subsidiaries or affiliates. The Tempo Rings (in whole
or part) are the property of Eli Lilly and Company. All rights
reserved. The Bluetooth® word mark and logos are
registered trademarks owned by Bluetooth SIG, Inc. and any use of
such marks by Eli Lilly and Company is under license.
Dexcom is a registered trademark of Dexcom, Inc. in the U.S.,
and may be registered in other countries. All rights reserved.
Other trademarks are property of their respective owners.
PP-TM-US-0217 11/2022 © Lilly USA, LLC 2022. All rights reserved.
Refer to:
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Kristiane Silva Bello;
bello_kristiane@lilly.com; (317) 315-9052 (Lilly Media)
|
|
Joe Fletcher;
jfletcher@lilly.com; (317) 296-2884 (Lilly Investors)
|
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SOURCE Eli Lilly and Company