Medtronic MiniMed™ 780G System

The only system with meal detection technology* that provides automatic adjustments and corrections^† to sugar levels every 5 minutes^§

Specifications

Automatically delivers correction doses every 5 minutes, to help cover undercounted carbs and an occasionally missed meal dose^,4
Only system with flexible glucose targets as low as 100 mg/dL to more closely mirror the sugar levels of someone living without diabetes
No fingersticks** while using the system in automation with SmartGuard™ technology
Helps prevent highs and lows day and night, with less work for you to do

*Taking a bolus 15 – 20 minutes before a meal helps to keep blood sugar levels under control after eating.

† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off.

§ Refers to SmartGuard™ feature. Individual results may vary

**Fingersticks required in manual mode & to enter SmartGuard™. If symptoms don’t match alerts & readings, use a fingerstick. Refer to user guide. Pivotal trial participants spend avg of > 93% in SmartGuard™.

4 MiniMed™ 780G System SSED

Description

IMPORTANT SAFETY INFORMATION: MINIMED™ 780G SYSTEM WITH SMARTGUARD™ TECHNOLOGY WITH GUARDIAN™ SENSOR (3)
The MiniMed™ 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 780G system includes SmartGuard™ technology, which can be programmed to automatically adjust insulin delivery based on the continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the sensor glucose (SG) value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed™ 780G system consists of the following devices: MiniMed™ 780G insulin pump, the Guardian™ Link (3) transmitter, the Guardian™ Sensor (3), One-press serter, the Accu-Chek™ Guide Link blood glucose meter, and the Accu-Chek™Guide test strips. The system requires a prescription from a healthcare professional.

The Guardian™ Sensor (3) is intended for use with the MiniMed™ 780G system and the Guardian™ Link (3) transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian™ Sensor (3) is indicated for seven days of continuous use.

The Guardian™ Sensor (3) is not intended to be used directly to make therapy adjustment while the MiniMed™ 780G system is operating in manual mode. All therapy adjustments in manual mode should be based on measurements obtained using a blood glucose meter and not on values provided by the Guardian™ Sensor (3). The Guardian™ Sensor (3) is indicated for abdomen and buttock insertion for users ages 7-13 years, and abdomen and arm insertion for user ages 14 years and older.

WARNING: Do not use the SmartGuard™ feature for people who require less than 8 units or more than 250 units of total daily insulin per day. A total daily dose of at least 8 units, but no more than 250 units, is required to operate in the SmartGuard™ feature.

WARNING: Do not use the MiniMed™ 780G system until appropriate training has been received from a healthcare professional. Training is essential to ensure the safe use of the MiniMed™ 780G system.

WARNING: Do not use SG values to make treatment decisions, including delivering a bolus, while the pump is in Manual Mode. When the SmartGuard™ feature is active and you are no longer in Manual Mode, the pump uses an SG value, when available, to calculate a bolus amount. However, if your symptoms do not match the SG value, use a BG meter to confirm the SG value. Failure to confirm glucose levels when your symptoms do not match the SG value can result in the infusion of too much or too little insulin, which may cause hypoglycemia or hyperglycemia.

Pump therapy is not recommended for people whose vision or hearing does not allow for the recognition of pump signals, alerts, or alarms. The safety of the MiniMed™ 780G system has not been studied in pregnant women, persons with type 2 diabetes, or in persons using other anti-hyperglycemic therapies that do not include insulin. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with the system and its components, please consult https://www.medtronicdiabetes.com/important-safety-information#minimed-780g and the appropriate user guide at https://www.medtronicdiabetes.com/download-library

Important Safety Information for MiniMed™ 780G System:
“MiniMed™ 780G system is for type 1 ages 7 and over. Prescription required. WARNING: Do not use SmartGuard™ feature for people who require less than 8 units or more than 250 units of insulin/day. For details, see https://bit.ly/780gRisks

Introducing the new MiniMed™ 780G system

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Frequently Asked Questions

Who is responsible for getting the insurance authorizations for medical supplies?

CCS Medical has a team of experienced authorization specialists who will oversee the process. Our knowledgeable staff will contact the ordering physician when applicable and the insurance company to verify coverage and obtain authorization for the product.

Does the company provide service and supplies to Medicare and Medicaid patients?

Yes. We are a participating provider with Medicare as well as most Medicaid and many Managed Care plans.

Are you a participating provider with other insurance companies?

Yes. Our company is contracted with hundreds of insurance providers nationwide. Our knowledgeable customer service team works on a daily basis with hundreds of private health insurers. We add insurance company contracts on an ongoing basis and will be happy to contact any carrier necessary to assist you in meeting your supply needs.

Are all products covered by my insurance company?

Coverage varies from one insurance company to the next. As part of our service, we determine if a particular product will be covered.

How much will a patient have to pay for his or her product?

It depends on the insurance plan and the patient's policy. All patients will be responsible for any co-pays or deductibles that their insurance company may have in place. Our specialists will help explain the patient’s financial responsibilities.

Do I need to apply for Medicare when I turn 65?

No. If you are already getting social security or railroad retirement benefit payments, you will automatically receive a Medicare card in the mail about three months before your 65th birthday as part of an enrollment information package. The card will usually show that you are entitled to both Part A (hospital insurance) and Part B (supplementary medical services). It also indicates the beginning dates of your entitlement to each. If you do not want Part B, follow the instructions that come in the package.

Who can receive benefits for diabetes self-management training?

Individuals covered by Medicare who are at risk for diabetes-related complications and meet other requirements can receive training if it is requested by their doctor or other qualified provider.

How do I know my diabetes supplies are covered by Medicare?

CCS Medical will verify your eligibility and benefits prior to sending your first shipment to ensure your supplies will be covered by Medicare. Deductibles and co-pays may apply.

How much is reimbursed for each product?

After you have paid your annual Medicare Part B deductible, Medicare will reimburse 80% of allowed amount or 80% of the billed amount, whichever is lower.

Does everyone pay the same amount for the Part B premium?

The premium is usually paid by the individual, either through deductions from social security checks or direct billing. The state you reside in may pay Medicare premiums if your income is low enough. Most people pay the same premium amount.

Are there limits on the quantity of diabetes supplies that Medicare will reimburse?

Medicare establishes certain limits based on whether or not you use insulin injections to treat your diabetes. Your physician will indicate how often you should test. Medicare may cover additional testing supplies if your physician determines it is medically necessary.

How do I replace my Medicare card?

Log into (or create) your Medicare account at Medicare.gov to print an official copy of your Medicare card. You can also call 1-800-MEDICARE (1-800-633-4227) to order a replacement card. TTY users can call 1-877-486-2048.

If I am 65 and ready to retire and my employer is going to provide me with benefits, do I need Medicare?

Yes. Medicare pays first in all situations unless you (or your spouse) are eligible under an employer-sponsored group health plan. If you have other questions, visit medicare.gov to learn more.

Does Medicare cover my spouse and family?

In general, Medicare is “individual” insurance. However, sometimes spouses and children can become eligible for Medicare based on the wage earner's work record. For questions about Medicare eligibility, contact the Social Security Administration at 1-800-772-1213.

What is the difference between Medicare and Medicaid?

Medicare is the federal health insurance program. It primarily covers people over age 65, regardless of their income. It also serves younger disabled people and dialysis patients. Patients pay part of the costs through deductibles for hospital and other costs. Small monthly premiums are required for non-hospital coverage. Medicare is a federal program. It is run by the Centers for Medicare and Medicaid Services (CMS), an agency of the federal government, and is basically the same everywhere in the United States.

Medicaid is an assistance program. It serves low-income people of various ages. Medical bills are paid from federal, state and local tax funds. Patients usually pay no part of the costs or very little for covered medical expenses, although a small co-payment is sometimes required. Medicaid is a federal-state program. It is run by state and local governments within federal guidelines, so it varies from state to state.

Medicaid es un programa de asistencia. Atiende a personas de bajos ingresos de distintas edades. Las facturas médicas se pagan con fondos procedentes de los impuestos federales, estatales y locales. Los pacientes suelen pagar poco o nada por los gastos médicos cubiertos, aunque a veces se exige un pequeño copago. Medicaid es un programa federal-estatal. Lo gestionan los gobiernos estatales y locales dentro de las directrices federales, por lo que varía de un estado a otro.

Where should I send my Medicare premium payment?

Please visit https://www.medicare.gov/your-medicare-costs/how-to-pay-part-a-part-b-premiums to see your options for paying your Medicare premium bill.

Who can I contact for more information about Medicare eligibility?

Please visit https://www.medicare.gov/talk-to-someone or call 1-800-MEDICARE (1-800-633-4227). TTY users can call 1-877-486-2048.