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General Tempo Platform Information
- What is the Tempo™ Personalized Diabetes Management Platform?
Tempo is a personalized diabetes management platform that combines the Tempo prefilled insulin pen, diabetes management devices, and app-driven support to deliver personalized guidance for people with diabetes.
The Tempo Platform consists of:
- Tempo Smart Button™: When attached to a Tempo Pen™, the Tempo Smart Button detects, stores, and transfers insulin dose-related data, which the TempoSmart™ App uses to display the brand of insulin, dose amount, date, and time via Bluetooth® wireless technology. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually
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Tempo Pen: Compatible with the Tempo Smart Button and prefilled with select Lilly insulins
The following TempoSmart features require a prescription:
For bolus insulin users with type 1 and type 2 diabetes, TempoSmart includes an Insulin Dose Calculator (IDC) to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value from a blood glucose meter (BGM).
When connected to a compatible FDA-cleared integrated continuous glucose monitor (iCGM) and if an insulin-to-carb ratio plus correction factor insulin regimen is prescribed, TempoSmart includes a CGM IDC. The TempoSmart CGM IDC is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The TempoSmart CGM IDC allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and insulin on board (IOB).
For basal insulin users with type 2 diabetes, TempoSmart includes a basal titration feature which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the basal titration feature and configure it for patient-specific parameters.
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump. - What is the Tempo Smart Button?
The Tempo Smart Button is a reusable device that attaches to the top of a Tempo Pen and is used to detect insulin dose-related data, which the TempoSmart App uses to display brand of insulin, dose amount, date, and time of dose. Using Bluetooth® wireless technology, the Tempo Smart Button transfers captured data to the TempoSmart App. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually.
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.
The Tempo Smart Button may be used for up to 8 months if users:
- Do not frequently press the Tempo Smart Button without dosing insulin
- Do not store the Tempo Smart Button with the button pressed
- Do not use the Tempo Smart Button outside of room temperature range, which is 59 °F (15 °C) to 86 °F (30 °C)
- Do not store the Tempo Smart Button outside the temperature range of 41 °F (5 °C) to 104 °F (40 °C)
The Tempo Smart Button uses a light system to indicate different actions or issues:
- 1 green flash: The Tempo Smart Button is entering the app-pairing mode
- 3 green flashes: The Tempo Smart Button is now paired with the app. Three green flashes also indicate that dosing data has been tracked and stored
- 3 amber flashes: The Tempo Smart Button could not pair with the app
- Amber and green flashes: The Tempo Smart Button will need to be replaced in 2 weeks or less because the battery is beginning to run low
- No light flash: if there is no light ring flash after use while attached to a Tempo Pen, the Tempo Smart Button is not working. The Tempo Smart Button will only flash if it has enough battery life and is attached to a Tempo Pen. It is important to ensure that the Tempo Smart Button is fully attached to a Tempo Pen
- What is the Tempo Pen?
The Tempo Pen is an insulin pen that functions similarly to the Lilly KwikPen® and is modified to work with the Tempo Smart Button. It is available prefilled with these 3 Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro) injection 100 units/mL.
When the Tempo Smart Button is attached, insulin dose-related data—which the TempoSmart App uses to display brand of insulin, dose amount, date, and time—is detected, stored, and transferred from the Tempo Smart Button to the TempoSmart App via Bluetooth® wireless technology. To transfer insulin dose-related data automatically, the Tempo Smart Button must be connected to the app and within 9 feet (3 meters) of the Bluetooth® enabled mobile device. Insulin dosing information can also be entered manually.
- What is the TempoSmart App?
TempoSmart™ is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart automatically receives insulin dose-related data when connected to a compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The following TempoSmart features require a prescription:
For bolus insulin users with type 1 and type 2 diabetes, TempoSmart includes an Insulin Dose Calculator (IDC) to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value from a blood glucose meter (BGM).
When connected to a compatible FDA-cleared integrated continuous glucose monitor (iCGM) and if an insulin-to-carb ratio plus correction factor insulin regimen is prescribed, TempoSmart includes a CGM IDC. The TempoSmart CGM IDC is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The TempoSmart CGM IDC allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and insulin on board (IOB).
For basal insulin users with type 2 diabetes, TempoSmart includes a basal titration feature which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the basal titration feature and configure it for patient-specific parameters.
Tempo Insights™ is the healthcare provider–facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Patients can customize reminders and receive data from compatible blood glucose meters. If patients are using a Dexcom CGM System, G6 or G7, they can connect the TempoSmart App to receive real-time data from their device via cloud-based integration.
- What blood glucose meters (BGMs) are compatible with the Tempo Platform?
The following BGMs are currently approved for use with the Tempo Platform:
- Tempo™ Blood Glucose Meter
- AgaMatrix Jazz™ Wireless 2
- Contour® next ONE
- CVS Health Advanced Bluetooth Glucose Meter
- CVS Health True Metrix® Air
- OneTouch® Verio Flex Meter
- OneTouch® Verio Reflect Meter
- ReliOn™ Premier BLU
- RITE AID True Metrix Air
- Roche Accu-Check® Guide
- Roche Accu-Check® Guide Me
- Walgreens True Metrix Air
- What is Tempo Insights?
Tempo Insights is the healthcare professional–facing component of the TempoSmart App.
Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. Decisions regarding diagnosis or treatment will be made solely by the healthcare providers.
- What resources are available if me and my patients would like to learn more about the Tempo Platform?
In addition to the user guides that accompany each component, the following materials are available for reference:
- Tempo Platform: You can refer to the “How to Use” video on the Getting Started portion of the Tempo patient website at LillyTempo.com for further guidance on how the platform works
- Tempo Insights: The Tempo Insights brochure provides information regarding the use of the Tempo Insights web portal. To register for a Tempo Insights account, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area
- Tempo Smart Button: An Instructions for Use (IFU) document is provided in the box that contains the Tempo Smart Button. For further details, IFUs are available on the website (LillyTempo.com)
- What is the intended use for the Tempo Smart Button, and what are the indications for use for the TempoSmart App and Tempo Pen?
The Tempo 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.
TempoSmart™ is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart automatically receives insulin dose-related data when connected to a compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The following TempoSmart features require a prescription:
For bolus insulin users with type 1 and type 2 diabetes, TempoSmart includes an Insulin Dose Calculator (IDC) to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value from a blood glucose meter (BGM).
When connected to a compatible FDA-cleared integrated continuous glucose monitor (iCGM) and if an insulin-to-carb ratio plus correction factor insulin regimen is prescribed, TempoSmart includes a CGM IDC. The TempoSmart CGM IDC is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The TempoSmart CGM IDC allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and insulin on board (IOB).
For basal insulin users with type 2 diabetes, TempoSmart includes a basal titration feature which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the basal titration feature and configure it for patient-specific parameters.
Tempo Insights™ is the healthcare provider–facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Tempo Pens are available prefilled with these 3 Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, and Humalog® (insulin lispro) injection 100 units/mL.
Lyumjev is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
BASAGLAR® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Limitations of Use: BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Humalog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus.
Lyumjev, Humalog, and BASAGLAR are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.
To learn more about Lyumjev, BASAGLAR, and Humalog, visit their respective websites.
- Can the TempoSmart App connect to other smart devices (eg, Apple Watch®) or software?
The TempoSmart App is compatible with several smart devices, including activity trackers and Dexcom Continuous Glucose Monitoring (CGM) Systems.
If your patients have an activity tracker such as Fitbit® or Garmin®, the Apple Health app (iOS devices), or the Google Fit™ app (Android™ devices), then your patients can connect it to sync their data.
- Is Tempo available only by prescription? How do I get my patients started?
The components of the Tempo Platform, and some features of the App are available only by prescription. The Refill Kit does not require a prescription. You may still prescribe the Refill Kit in order for insurance to be billed.
To get patients started, you'll need them to have both a Tempo Pen and a Tempo Smart Button.
To obtain the Tempo Smart Button, you can prescribe the Tempo Welcome Kit, which includes a Tempo Smart Button as well as a compatible BGM and other supplies. You can also prescribe the Tempo Smart Button by itself if your patient already has a compatible BGM or Dexcom CGM.
- Can the TempoSmart App connect to my electronic health records (EHRs)?
No, but this functionality may be available in the future. To learn more about EHR integration, please contact your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area.
- Will my patients get a new Tempo™ Welcome Kit every year?
No. The Tempo Welcome Kit is available as part of onboarding to provide patients with a Tempo Smart Button and compatible BGM. You can also prescribe the Tempo Smart Button by itself if your patient already has a compatible BGM or Dexcom CGM.
- How can I request more information or a demo of components within the Tempo Platform?
The Tempo website offers more in-depth information about the Tempo Platform, including details about:
- Tempo Smart Button
- Tempo Pen, prefilled with one of the following Lilly insulins: Lyumjev® (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® (insulin glargine) injection 100 units/mL, or Humalog® (insulin lispro) injection 100 units/mL. To learn more about each insulin, visit the respective websites for those insulins
- TempoSmart App
- Tempo Insights web portal
- Tempo Welcome Kit and Tempo Refill Kit
To schedule a demo of the Tempo Platform, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983).
- How can I get access to Tempo Insights?
To create a Tempo Insights account, please connect with your sales professional or call 1-855-LILLY-TEMPO (1-855-545-5983) to find a sales professional in your area.
- How can I request a demo of the Tempo Platform?
A sales professional can visit your office with a demo of the Tempo Platform to explain what patients receive when they get started with the platform.
To request a demo of the Tempo Platform or to connect with a sales professional, please call 1-855-LILLY-TEMPO (1-855-545-5983). You may also be able to schedule a demo of the Tempo Pen, as well as the Tempo Smart Button.
- How do I authorize the TempoSmart App’s bolus Insulin Dose Calculator?
The bolus Insulin Dose Calculator feature in the TempoSmart App is only available to patients by prescription, which is authorized through Tempo Insights. It is only available for use with the following products, each of which also requires a prescription:
- Lyumjev® Tempo Pen™ (insulin lispro-aabc) injection 100 units/mL and Tempo Smart Button
- Humalog® Tempo Pen™ (insulin lispro) injection 100 units/mL and Tempo Smart Button
Warning: Using the Insulin Calculator with an incorrect dosing regimen may result in unsafe recommendations, which could lead to severe hyperglycemia, hypoglycemia, or injury. Carefully review insulin dosing regimen before authorizing the Insulin Calculator.
To authorize the Insulin Calculator:
1. Log in to Tempo Insights and complete the following steps from the Patient List:
For new patients:
- Select Add Patient
- Enter the required patient data and indicate that the patient will be using the Insulin Calculator for Bolus Insulin program
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Note: If you fill in the optional field with your patient’s mobile number, the Telephone Consumer Protection Act (TCPA) consent must be selected (Agree or Decline) by the patient in-office.
- Your patient will receive an email invitation (and SMS text, if a mobile number was provided) to download the TempoSmart App and register
- Until your patient registers, you will see them in the Pending Registration tab. You can click Resend Invitation to send another email. Once registered, the patient will appear in the Patient List tab
For existing patients:
- Find and open the patient’s record
- Click the Insulin Program tab
- Select Set Up Insulin Calculator
2. Follow the onscreen prompts to set up the dosing regimen and Duration of Insulin Action (DIA) for Insulin on Board (IOB).
Please note that IOB is defaulted to enabled and DIA is defaulted to 5 hours for lispro, aspart, or glulisine; and 4 hours for lispro-aabc.
3. Review the brand of insulin, dosing regimen, and DIA. If correct, click Authorize Now.
Once authorized, your patient will receive an email about the Insulin Calculator activation. Prior to first use of the Insulin Calculator, your patient will be required to complete in-app training.
Patients can adjust the parameters within their authorized dosing regimen, but changing the dosing regimen requires a new authorization.
Note: Only prescribing healthcare providers can authorize the Insulin Calculator for new or existing patients. Please refer to the Insulin Management Features User Guide in Tempo Insights for detailed information about configuring the Insulin Calculator.
- How do I initiate the TempoSmart App’s basal insulin titration program?
The basal Insulin Adjustment Program feature in the TempoSmart App is recommended for patients with type 2 diabetes and only available to patients by prescription, authorized through Tempo Insights. It is only available for use with the BASAGLAR® (insulin glargine) injection Tempo Pen and Tempo Smart Button, each of which also require a prescription.
To activate the Insulin Adjustment Program:
1. Log in to Tempo Insights and complete the following steps from the Patient List:
For new patients:
- Click Add Patient on the Patient List screen
- Enter the required patient data and indicate that the patient will be undergoing a basal Insulin Adjustment Program
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Note: If you fill in the optional field with your patient’s mobile number, the Telephone Consumer Protection Act (TCPA) consent must be selected (Agree or Decline) by the patient in-office.
- Your patient will receive an email invitation (and SMS text, if a mobile number was provided) to download the TempoSmart App and register
- Until your patient registers, you will see them in the Pending Registration tab. You can click Resend Invitation to send another email. Once registered, the patient will appear in the Patient List tab
For existing patients:
- Find and open the patient’s record
- Click the Insulin Program tab
- Select Set Up Insulin Adjustment Program
2. Follow the onscreen prompts within the Insulin Adjustment Program tab in your patient’s profile to set up preset evidence-based or custom titration parameters.
Note: You cannot modify the initial dose, interval, or max dose from preformatted values when selecting evidence-based titration parameters. Modifying any of these settings will set the titration parameters to Custom.
3. After you have entered the titration parameters, select Continue, verify parameters, and click Start Titration.
You can edit the titration parameters or discontinue the titration at any time. Your patients will be notified of the change through the app.
You will also receive safety notifications, such as if a patient experiences hypoglycemia or takes insulin doses that significantly differ from the recommended amount.
The insulin titration program is considered complete when your patient’s fasting blood glucose readings have been in target range for 3 consecutive intervals or at least 5 days. Insulin dose adjustments will be automatically discontinued.
Note: Only prescribing healthcare providers may initiate an Insulin Adjustment Program for new or existing patients. Please refer to the Insulin Management Features User Guide in Tempo Insights for detailed information about configuring the Insulin Adjustment Program.
Devices
- What is a Tempo Welcome Kit?
The Tempo™ Welcome Kit includes:
- Tempo Smart Button™
- Tempo™ Blood Glucose Monitoring System
- Tempo™ Lancets (Quantity: 100)
- Tempo™ Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
Tempo kits do not include insulin. Tempo Welcome and Refill Kits are prescribed separately. Refill Kits are also available over the counter.
- What is a Tempo Refill Kit?
The Tempo™ Refill Kit includes:
- Tempo™ Lancets (Quantity: 100)
- Tempo™ Blood Glucose Test Strips (Quantity: 100)
- Pen needles (Quantity: 100)
- Gauze pads (Quantity: 2)
Tempo kits do not include insulin. Tempo Welcome and Refill Kits are prescribed separately. Refill Kits are also available over the counter.
- Which blood glucose meters (BGMs) are compatible with the TempoSmart App?
Multiple BGMs are compatible with the TempoSmart App and can be paired through a Bluetooth® wireless connection. These include:
- Tempo™ Blood Glucose Meter
- AgaMatrix Jazz™ Wireless 2
- Contour® next ONE
- CVS Health Advanced Bluetooth Glucose Meter
- CVS Health True Metrix® Air
- OneTouch® Verio Flex Meter
- OneTouch® Verio Reflect Meter
- ReliOn™ Premier BLU
- RITE AID True Metrix Air
- Roche Accu-Check® Guide
- Roche Accu-Check® Guide Me
- Walgreens True Metrix Air
- Is the TempoSmart App compatible with continuous glucose monitors?
The TempoSmart App is compatible with Dexcom CGM Systems, G6 and G7. Patients will need to log in to their Dexcom accounts to connect their Dexcom CGM Systems with the TempoSmart App. When a patient connects a Dexcom CGM, they will be able to access real-time glucose data.
- Is there customer support for Dexcom Continuous Glucose Monitoring (CGM) Systems?
The Dexcom CARE team of trainers and Certified Diabetes Care and Education Specialists (CDCESs) are available to help patients. They provide live, interactive support.
To reach the Dexcom CARE team, please call their toll-free number at 1-888-738-3646, available Monday to Friday, 6 am to 5 pm PST (9 am to 8 pm EST).
- How do Dexcom Continuous Glucose Monitoring (CGM) Systems integrate with the TempoSmart App?
Patients will need to log in to their Dexcom accounts to connect their Dexcom CGM Systems, G6 and G7, with the TempoSmart App. Once their CGM data is showing in the app, they will receive real-time feedback about their glucose level and the recommended action.
Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers. Decisions regarding diagnosis or treatment will be made solely by the healthcare providers.
- How do my patients pair their Dexcom Continuous Glucose Monitoring (CGM) Systems with the TempoSmart App?
Your patients can pair their devices within the TempoSmart App by following these steps:
- At the bottom of the TempoSmart App screen, select More from the menu.
- Click on Connections and Devices.
- Click on Continuous Glucose Monitor.
- Click on CGM Data by Dexcom, and follow the directions provided.
- Will the Tempo Smart Button work with Lilly KwikPens?
The Tempo Smart Button does not work with Lilly KwikPens. It is designed to work with the Lyumjev® Tempo Pen™ (insulin lispro-aabc) injection 100 units/mL, BASAGLAR® Tempo Pen™ (insulin glargine) injection 100 units/mL, and Humalog® Tempo Pen™ (insulin lispro) injection 100 units/mL, which are Lilly KwikPens that have been modified for compatibility.
To learn about updates to Tempo Platform components, see What Is Tempo/Platform Overview.
- Who can my patients and I contact if we have questions about any of the Tempo Platform components?
Lilly Tempo Support can be reached at 1-855-LILLY-TEMPO (1-855-545-5983) to assist with questions related to components. The toll-free number is a service provided by Lilly USA, LLC and is not intended to replace medical advice.
Troubleshooting Tempo Platform Components
- If my patient's Tempo Welcome Kit is missing a component, or a component they received does not work, or one of the components stops working after initial setup, can they get a replacement?
Patients can contact the Lilly Tempo Support team and file a product complaint. Representatives will determine replacement eligibility once they have assessed the issue. Please have patients contact Lilly Tempo Support by dialing 1-855-LILLY-TEMPO (1-855-545-5983). The toll-free number is a service provided by Lilly USA, LLC and is not intended to replace medical advice.
Cost and Coverage
- Is there a savings card for Tempo Platform products?
To qualify for a Tempo Savings Card, your patients must be eligible, commercially insured residents of the United States or Puerto Rico and be aged 18 years or older. They CANNOT be enrolled in federal or state government–sponsored prescription programs (eg, Medicaid or Medicare Part D).
Lilly is continuously partnering with the Centers for Medicare and Medicaid Services (CMS) to gain availability and will provide updates to the Lilly Tempo Implementation Team as they become available.
Eligible patients can visit LillyTempo.com to download a copy of the Tempo Savings Card.
- How can my patients receive Tempo Platform products at a reduced cost?
Patients can visit the Tempo website to see if they’re eligible for the Tempo Savings Card. Advise your patients to visit LillyTempo.com to see if they qualify and to enroll.
- Are Tempo Platform products covered by Medicare?
Tempo Platform products are currently available for patients enrolled in federal or state government–funded prescription programs (eg, Medicaid or Medicare Part D), but this group of patients is not eligible for the Tempo Savings Card. Lilly is continuously partnering with the Centers for Medicare and Medicaid Services (CMS) to gain availability and will provide updates to the Lilly Tempo Implementation Team as they become available.
- Are Tempo Platform products covered by insurance?
Yes, the Tempo Platform products are covered by insurance. Please refer to the plan-specific formulary to determine if your patients are eligible for insurance coverage. Patients can also reach out to their insurance provider to confirm that they qualify for coverage.
- If some of my patients are not insured, can they still obtain Tempo Platform products?
Your patients do not need insurance coverage to obtain Tempo Platform products. You can write a prescription for the individual Tempo Platform devices, as there are several components within the Tempo Platform (eg, Tempo Smart Button, Tempo Pen, Tempo Welcome Kit, and Tempo Refill Kit,which is available over-the counter), but patients will have to pay the full list price of the individual products.
- If my patients change insurance providers, will this affect their access to Tempo Platform products?
If any of your patients change insurance providers, they will need to verify whether Tempo Platform products are covered under the new plan. Please have your patients contact their new provider to ensure that differences in the new plan won’t affect coverage.
- Can patients use different co-pay and savings cards to cover Tempo Platform products?
All Tempo products are covered by the Tempo Savings Card, which is available for commercially insured patients. Currently, only the Tempo Savings Card can be used to cover Tempo Platform products.
- Do Tempo Platform products come with a warranty?
There is no warranty program; however, the Tempo Smart Button has a replacement allowance if the product stops working or is damaged or broken within an 8-month time frame. This replacement also applies to other Tempo Platform products if the product is damaged or broken. Have patients contact Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) to report a product complaint and for guidance on how to obtain replacements.
Pharmacy
- What if my patient receives a prescription for a KwikPen along with components of the Tempo Platform?
Contact the prescriber to verify whether they intended to prescribe the Tempo Pen for the patient. If so, request a new prescription for a Tempo Pen they are taking.
- What if my patient receives a prescription for a Tempo Pen but no corresponding components of the Tempo Platform?
Contact the prescriber to verify whether they intended to initiate the patient on the Tempo Platform. To get patients started, you'll need them to have both a Tempo Pen and a Tempo Smart Button. To obtain the Tempo Smart Button, HCPs can prescribe the Tempo Welcome Kit, which includes a Tempo Smart Button as well as a compatible BGM and other supplies. HCPs can also prescribe the Tempo Smart Button by itself if your patient already has a compatible BGM or Dexcom CGM.
- What if my patient loses or damages their test strips, lancets, pen needles, or Tempo Smart Button?
Direct your patient to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983).
- What if my patient has been prescribed the Tempo Smart Button but does not have ongoing prescriptions for compatible devices and supplies for the components of the Tempo Platform?
Contact the prescriber to verify that the patient does not need their diabetic supplies through the Tempo Welcome Kit and Tempo Refill Kit offerings. If not, inform the prescriber that the patient will need continued prescriptions for supplies compatible with the Tempo Platform. If the prescriber intended the patient to also get their diabetic supplies through the Tempo Platform, ask them to prescribe the needed quantity of Tempo Welcome Kits and Tempo Refill Kits if using a Tempo Savings Card.
- What if my patient has issues with coverage, connectivity of the Tempo Platform, or technical issues related to the Tempo Platform?
Direct your patient to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983) to report a product complaint.
- Will my patients need to reactivate their Tempo Savings Card if they change to a new pharmacy?
No, but patients should be advised to bring their Tempo Savings Card to their new pharmacy. Direct patients to Lilly Tempo Support at 1-855-LILLY-TEMPO (1-855-545-5983).
Call Us
For support and information about Tempo™, please call 1-855-LILLY-TEMPO (1-855-545-5983) Monday to Friday, 9 ᴀᴍ to 5 ᴘᴍ ET.
If you need information about a Lilly product or want to report an adverse event or a product complaint, you may call 1-800-LillyRx (1-800-545-5979).
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.
TempoSmart and Tempo Insights Indications for Use and Contraindications
TempoSmart™ is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. TempoSmart automatically receives insulin dose-related data when connected to a compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. TempoSmart analyzes and reports glucose test results and supports medication adherence. In addition, TempoSmart provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
The following TempoSmart features require a prescription:
For bolus insulin users with type 1 and type 2 diabetes, TempoSmart includes an Insulin Dose Calculator (IDC) to allow patients to use their prescribed regimen to calculate a dose of bolus insulin for a given amount of carbohydrates and/or glucose value from a blood glucose meter (BGM).
When connected to a compatible FDA-cleared integrated continuous glucose monitor (iCGM) and if an insulin-to-carb ratio plus correction factor insulin regimen is prescribed, TempoSmart includes a CGM IDC. The TempoSmart CGM IDC is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The TempoSmart CGM IDC allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and insulin on board (IOB).
For basal insulin users with type 2 diabetes, TempoSmart includes a basal titration feature which calculates appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the basal titration feature and configure it for patient-specific parameters.
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart is not indicated for people with gestational diabetes or who use an insulin pump.
Important Safety Information for Tempo™ Personalized Diabetes Management Platform
When using the Tempo Personalized Diabetes Management Platform, if your patient is not sure if they injected their insulin or if their insulin dosing information is accurate, they should NOT start over or repeat the injection. Your patient should monitor their blood glucose per your instructions. Ensure your patient has a backup diabetes management plan if their Tempo Smart Button or TempoSmart App stops working. Having a backup plan and supplies can help avoid hyperglycemia and hypoglycemia. Using the Bolus Insulin Dose Calculator with an incorrect dosing regimen or without all the patient's recent insulin logged may result in unsafe recommendations, which could lead to severe hyperglycemia, severe hypoglycemia, or injury. Carefully review insulin dosing regimen before authorizing the Bolus Insulin Calculator. Keep the Tempo Smart Button away from children. For additional product and safety information, including Warnings and Cautions, consult the Tempo Smart Button Instructions for Use, TempoSmart App User Guides and Tempo Welcome Kit and Tempo Refill Kit Instructions.
Lyumjev® (insulin lispro-aabc) injection 100 units/mL
Indication
Lyumjev is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
Humalog® (insulin lispro) injection 100 units/mL
Indication
Humalog is a rapid-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
Important Safety Information for Lyumjev and Humalog
- Contraindications - Lyumjev and Humalog are contraindicated during episodes of hypoglycemia and in patients who are hypersensitive to these insulins or any of their excipients.
- Warnings and Precautions
Never Share a Lyumjev or Humalog Prefilled Pen, Cartridge, Syringe, or Humalog Reusable Pen Compatible with Lilly 3 mL Cartridges Between Patients, even if the needle is changed. Patients using Lyumjev or Humalog vials must never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Use caution and close medical supervision when making any changes in insulin regimen and increase the frequency of blood glucose monitoring. Due to reports of hyperglycemia and hypoglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant antidiabetic products may be needed.
Hypoglycemia: Severe hypoglycemia may be life threatening, may lead to unconsciousness, and can cause seizures or death. Hypoglycemia is the most common adverse reaction of Lyumjev and Humalog. Monitor blood glucose and increase monitoring frequency with changes to insulin dosage, coadministered medications, meal pattern, or physical activity; in patients with renal or hepatic impairment; and in patients with hypoglycemia unawareness.
Hypoglycemia Due to Medication Errors: Instruct patients to always check the insulin label before each injection to avoid medication errors. Do not transfer Lyumjev U-200 from the Lyumjev KwikPen® to a syringe and do not transfer Humalog U-200 from the Humalog KwikPen® to a syringe as overdose and severe hypoglycemia can occur.
Hypokalemia: Hypokalemia may be life threatening. Insulins, including Lyumjev and Humalog, cause a shift in potassium from the extracellular to intracellular space possibly leading to hypokalemia, which, if untreated, may result in respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia (e.g., patients using potassium-lowering medications or medications sensitive to serum potassium concentrations).
Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with Lyumjev and Humalog. If hypersensitivity reactions occur, discontinue the use of Lyumjev or Humalog and treat per standard of care until signs and symptoms resolve.
Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin, including Lyumjev and Humalog. This may lead to or exacerbate heart failure. Observe patients for signs and symptoms of heart failure and consider discontinuation or dose reduction of the PPAR-gamma agonist.
Hyperglycemia and Ketoacidosis Due to Insulin Pump Device Malfunction: Pump or infusion set malfunctions and insulin degradation can lead to a rapid onset of hyperglycemia and ketoacidosis. Prompt identification is necessary. Patients using subcutaneous insulin infusion pumps must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure. - Adverse Reactions
Adverse reactions associated with Lyumjev and Humalog include hypoglycemia, hypokalemia, allergic reactions, injection- or infusion-site reactions, lipodystrophy, localized cutaneous amyloidosis, pruritus, rash, weight gain, and peripheral edema. - Drug Interactions
Some medications may alter glucose metabolism, insulin requirements, and the risk for hypoglycemia or hyperglycemia. Signs of hypoglycemia may be reduced or absent in patients taking anti-adrenergic drugs. Particularly close monitoring may be required. - Pediatric Use
Lyumjev-treated pediatric patients reported a higher incidence of subcutaneous injection site-related reactions compared to Lyumjev-treated adults. It is expected that Lyumjev-treated pediatric patients who receive continuous subcutaneous insulin infusion (CSII) are more likely to have infusion site-related adverse reactions than those who receive subcutaneous injections. Monitor injection and infusion sites closely when initiating therapy with Lyumjev in pediatric patients. If persistent injection or infusion site reactions occur, discontinue Lyumjev and initiate therapy with an alternative insulin.
UR HI HCP ISI 14OCT2022
Please click to access Lyumjev Full Prescribing Information including Patient Information and Instructions for Use for the Lyumjev® Tempo Pen™.
Please click to access Humalog U-100 Full Prescribing Information including Humalog U-100 Patient Information and Instructions for Use for the Humalog® Tempo Pen™.
BASAGLAR® (insulin glargine) injection 100 units/mL
Indication
BASAGLAR® is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus.
Limitations of Use:
BASAGLAR is not recommended for the treatment of diabetic ketoacidosis.
Important Safety Information for BASAGLAR
Contraindications - BASAGLAR is contraindicated during episodes of hypoglycemia, and in patients with hypersensitivity to insulin glargine or any of the excipients in BASAGLAR.
Warnings and Precautions
BASAGLAR prefilled pens must never be shared between patients, even if the needle is changed. Sharing poses a risk of transmission of blood borne pathogens.
Changes in insulin strength, manufacturer, type, injection site, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes in insulin regimen should be made cautiously and only under close medical supervision, and the frequency of blood glucose monitoring should be increased. Due to reports of hypoglycemia and hyperglycemia, advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor blood glucose. For patients with type 2 diabetes, dosage adjustments of concomitant anti-diabetic products may be needed.
Hypoglycemia is the most common adverse reaction associated with insulins, including BASAGLAR. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death.
Accidental mix-ups between insulin products have been reported. To avoid hypoglycemia due to medication errors between BASAGLAR and other insulins, instruct patients to always check the insulin label before each injection.
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including BASAGLAR. If hypersensitivity reactions occur, discontinue BASAGLAR; treat per standard of care and monitor until symptoms and signs resolve. BASAGLAR is contraindicated in patients who have had hypersensitivity reactions to insulin glargine or one of the excipients.
All insulins, including BASAGLAR, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated.
Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. These patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of TZD must be considered.
Adverse Reactions
Adverse reactions commonly (>5%) associated with insulin glargine products are: hypoglycemia, allergic reactions, injection site reaction, lipodystrophy, pruritus, rash, edema, and weight gain.
Drug Interactions
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and close monitoring of blood glucose.
The risk of hypoglycemia may increase when antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), and sulfonamide antibiotics are co-administered with BASAGLAR.
The blood glucose lowering effect of BASAGLAR may decrease when co-administered with atypical antipsychotics, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. The blood glucose lowering effect of BASAGLAR may increase or decrease when co-administered with alcohol, beta-blockers, clonidine, lithium salts, and pentamidine.
The signs and symptoms of hypoglycemia may be blunted when beta-blockers, clonidine, guanethidine, and reserpine are co-administered with BASAGLAR.
BV HCP ISI 14SEP2022
For more information, please click to access Full Prescribing Information including Patient Information and Instructions for Use for the BASAGLAR Tempo Pen.