SmartGuard Technology Helps People with Diabetes Worry Less About Lows

SmartGuard Technology Helps People with Diabetes Worry Less About Lows

Diabetes is a complex disease to manage, and it can be extremely challenging to keep blood sugar levels within an ideal target range. While reducing high blood sugar (hyperglycemia) is important, as it can lead to long-term complications, reducing low blood sugar (hypoglycemia) can be a matter of life or death.

Low blood sugar can cause confusion, disorientation, loss of consciousness, or worse. The average person with type 1 diabetes has two lows a week that they’re aware of – and untold ones they’re not – with more than half experiencing lows at least once a night.[1]

Phyllis Kaplan of Boston has had type 1 diabetes for most of her life and has firsthand experience with hypoglycemia. “I have a history of severe lows at night, when it’s most challenging to manage my glucose levels,” Kaplan says. “It was very scary thinking that I was lucky to wake up.”

“Low blood sugar at night is of particular concern, as that is when up to 75 percent of severe hypoglycemia occurs and patients are unlikely to be aware of symptoms while they are asleep,” says Dr. Satish Garg of the University of Colorado Denver, Barbara Davis Center for Childhood Diabetes.

Our SmartGuard™ technology is helping to address this reality and reduce lows*. Designed to pause insulin delivery if the user does not respond to their glucose levels going below a preset limit, SmartGuard technology is the only feature available in the U.S. that takes action against lows*.

A study published in the New England Journal of Medicine demonstrated that SmartGuard technology not only reduces the number of low* events per week by a third, but also shortens the length/intensity of those events at night by 37.5 percent without increasing A1C**.[2]

“The ability to automate the suspension of insulin is an important feature, particularly at night, as prolonged hypoglycemia could be life threatening,” Dr. Garg says.

Kaplan has been using an insulin pump for 16 years, and started using a MiniMed insulin pump with SmartGuard technology two years ago. She says SmartGuard technology has had a major impact on her diabetes management.

“My MiniMed insulin pump with SmartGuard technology has offered me flexibility and confidence in managing my diabetes so I can just live my life,” Kaplan says. “Now I have greater peace of mind.”

In August 2016, we introduced our most advanced insulin pump system in the US, the MiniMed 630G system, which combines SmartGuard technology and an enhanced glucose sensor. The features of this insulin pump are based on feedback from more than 1,000 people with diabetes, and include a new, user friendly pump design that is waterproof***, has the ability to administer boluses of insulin remotely, and features a high definition, full color screen that supports easy navigation and enables increased customization with more intuitive menus.

On the heels of the MiniMed 630G system launch, we announced FDA approval for the MiniMed 670G system, our latest insulin pump system advancement and the first hybrid closed loop system in the world. The MiniMed 670G system leverages the same hardware platform as the MiniMed 630G system, however includes advanced SmartGuard technology – SmartGuard HCL, and a new glucose sensor – Guardian Sensor 3. These features improve accuracy and performance while allowing people with diabetes and providers to choose from increasing levels of automation that best fit their diabetes management needs.

Like any new technology, the new insulin pump delivery system will require an appropriate level of training for new users. For this reason, customers on a MiniMed 630G system are eligible for the Priority Access program as a pathway to the MiniMed 670G system, as their experience with the latest hardware platform will facilitate an optimal transition. Through our StartRight program, all customers also have access to our dedicated team of onboarding specialists to ensure they receive the best training possible and experience a quick and smooth transition onto our latest insulin pump systems. The MiniMed 670G system will be commercially available spring 2017.

IMPORTANT SAFETY INFORMATION

The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen 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 670G System includes SmartGuard HCL technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values.

The Medtronic MiniMed 670G System consists of the following devices:

MiniMed 670G insulin pump, the Guardian Link (3) transmitter, the Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 glucose meter. The system requires a prescription.

The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home blood glucose monitor and not on values provided by the Guardian Sensor (3).

WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.

The MiniMed 670G system is not approved for use in pregnant women and patients with impaired kidney function. For complete warnings, precautions, and contraindications, please consult the User Guide.

The MiniMed 630G system with SmartGuard™ is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of diabetes mellitus in persons, sixteen 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 630G system includes SmartGuard, which can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value.

The MiniMed 630G system is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the MiniMed 630G system.

The MiniMed 630G system is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the SmartGuard suspend on low alarm to take measures to prevent or treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be administered according to the recommendations of the user’s healthcare provider.

Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms.

WARNING: Do not use the suspend on low feature to prevent or treat low glucose. The suspend on low feature is designed to suspend insulin delivery when you are unable to respond to the suspend on low alarm. Always confirm your sensor glucose reading using your BG meter, and follow the instructions of your healthcare professional. Using suspend on low to prevent or treat low glucose may result in prolonged hypoglycemia.

Please visit www.medtronicdiabetes.com/importantsafetyinformation for more details.

References:

[1] Seaquist ER, Anderson J, Childs B, Cryer P, Dagogo Jack S, Fish L, Heller SR, Rodriguez H, Rosenzweig J, Vigersky R. Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Diabetes Care. 2013 May;36(5):138495.

[2] Bergenstal RM, Klonoff DC, Garg SK, et al. Threshold based insulin pump interruption for reduction of hypoglycemia. N Engl J Med. 2013;369(3):224–232.

*Measured as low sensor glucose events ≤65 mg/dL.

**Based upon limited sample size and duration of ASPIRE In Home study.

***The pump is protected against the effects of continuous immersion in up to 12 feet (3.6 meters) of water for up to 24 hours at a time at the time of manufacture. This is classified as IPX8 rating.

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