FDA approves Medtronic MiniMed™ 780G system
For most of the 48 years that Terry Weland1 has lived with type 1 diabetes, he felt like he was just trying to survive. That has changed since he’s been part of the MiniMed™ 780G system clinical trial.
And now, with FDA approval in the United States, 1.5 million Americans like Weland living with type 1 diabetes can experience the same.
“It lets me live my life normally,” he said.
The MiniMed™ 780G system brings us one step closer to technology that mimics a healthy pancreas by automatically adjusting insulin every five minutes – and even taking action when carbs are under counted or a meal is occasionally missed§.
While dozens of factors can affect sugar levels, mealtimes are cited as one of the biggest challenges for diabetes management.
This is the only system with meal detection technology* that makes automatic adjustments and corrections† to sugar levels every five minutes§.
“A lot can happen to blood sugars in the span of an hour, so we’ve designed our system for real life,” said Que Dallara, EVP and President of Medtronic Diabetes. “We built in features informed by extensive customer feedback, and we’re excited to deliver a system with ease of use at the forefront.”
The system also has a more seamless overall pump experience with our latest extended infusion set. Historically, infusion sets – the tubing that connects an insulin pump to the body and helps deliver insulin – require changing every two to three days, but this is the first and only infusion set designed for up to seven days, which doubles wear time**.
“Our goal is to take the burden of making many of these decisions away. Quite simply – we want to make our system do more, so users are doing less,” Dallara said. “That’s what our Minimed™ 780G system is designed to do.”
And for Weland, that’s exactly the case.
“I don’t stress over my diabetes like I used to because I know the system has my back,” he said.
Learn more about Medtronic Diabetes.
1. Thoughts and opinions are his own. Individual results vary.
**Taking a bolus 15 – 20 min 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
**The extended wear infusion set can be worn for up to 7 days. Current infusion sets are recommended for up to 3 days of wear
IMPORTANT SAFETY INFORMATION:
MINIMED™780G SYSTEM WITH SMARTGUARD™ TECHNOLOGY WITH GUARDIAN™ 4 SENSOR
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™ 780Gsystem 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™ 4 transmitter, the Guardian™ 4 sensor, 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™ 4 sensor is intended for use with the MiniMed™ 780G system and the Guardian 4 transmitter to monitor glucose levels for the management of diabetes. The sensor is intended for single use and requires a prescription. The Guardian™ 4 sensor is indicated for up to seven days of continuous use.
The Guardian™ 4 sensor is not intended to be used directly to make therapy adjustments while the MiniMed™ 780G 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™ 4 sensor. The Guardian™ 4 sensor has been studied and is approved for use in patients ages 7 years and older and in the arm insertion site only. Do not use the
Guardian™ 4 sensor in the abdomen or other body sites including the buttocks, due to unknown or different performance that could result in hypoglycemia or hyperglycemia.
WARNING: Do not use the SmartGuard™ feature for people who require less than 8 units ormore 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 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: Extended Wear Infusion Set (EIS)
The Extended Infusion Set is indicated for up to 7 days of wear for the subcutaneous infusion of insulin from an infusion pump. It is NOT indicated for intravenous (IV) infusion or the infusion of blood or blood products. Inaccurate medication delivery, infection and/or site irritation may result from improper insertion and maintenance of the infusion site. Before insertion, clean the insertion site with isopropyl alcohol. Remove the needle guard before inserting the infusion set. If using this infusion set for the first time, do the first set-up in the presence of your healthcare professional. Do not leave air in the infusion set. Prime completely. Check frequently to make sure the soft cannula remains firmly in place as you may not feel pain if it pulls out. The soft cannula must always be completely inserted to receive the full amount of medication. If the infusion site becomes inflamed, replace the set, and use a new site until the first site has healed. Replace the infusion set if the tape becomes loose, or if the soft cannula becomes fully or partially dislodged from the skin. Regularly replace the infusion set as indicated in the instructions for use, or per the insulin labeling, whichever duration is shorter. For more details, see https://