Medtronic Minimed Continuous Glucose Monitoring System
WHAT IS CGM?
Continuous Glucose Monitoring is an advanced way for people living with diabetes to check glucose levels in real-time or monitor sugar levels over a period of time. By using a continuous glucose monitor, your CGM system will automatically receive glucose levels every 5 minutes allowing you to fingerstick less often. CGM can be used with or without an pump.¶
What is Smart CGM?
Smart CGM predicts future high and low sensor glucose events up to 60 minutes in advance and provides access to additional algorithms and insights that can inform you of clinically relevant glucose patterns.†
BENEFITS OF CGM.
A blood glucose meter only provides a brief "snapshot" of your glucose level at a single moment in time. A CGM system gives you a greater view of your glucose trends. CGM can provide valuable information1 at crucial points during the day, including before and during exercise, prior to driving, before test/exam-taking, and in the middle of the night.
An average of 72% Time in Range and 98% improved HbA1c versus MDI* as part of a CGM system2,4
94% of lows were detected using CGM3
The direction your glucose levels are going
Early notification of oncoming lows and highs throughout the day and night
Visibility of time spent high, low, and within a healthy glucose range of 3.9 – 10 mmol/L
Insights into how food, physical activity, medication and illness impacts your diabetes1
Medtronic's (real-time) continuous glucose monitoring (CGM) products are indicated for use by people living with type one diabetes. Guardian™ Sensor 3 may be used as part of the Guardian™ Connect and MiniMed® 640G systems for ages 2 and up. Sensor is indicated for use on arm and abdomen. Guardian™ Sensor 3 may also be used as part of the MiniMed® 670G system for people living with type 1 diabetes age 7 and up. Sensor is indicated for use on abdomen only. Enlite™ Sensors are indicated for use with Guardian™ Connect, Paradigm™ VEO and MiniMed® 640G systems for people living with type 1 diabetes, age 7 and up. Sensor is indicated for use on abdomen, buttock and upper buttock.
IS CGM FOR ME?
Medtronic offers CGM systems for people living with type 1 diabetes that want better glucose control. CGM is especially beneficial for people who:4
- Aren't meeting their Time in Range or A1C goal2,4
- Have frequent low glucose levels
- Are unaware of their low blood sugars
- Want to reduce their A1C targets without increasing hypoglycaemic events (low blood glucose)
- Have widely variable blood sugar levels
- Are children or adolescents who are willing to use the device every day5
CGM OPTIONS TO FIT
YOUR LIFESTYLE.
Whether you manage your diabetes with a pump, multiple daily injections, oral medications or through diet and exercise, Medtronic offers CGM products and pump systems that give you, your loved ones and healthcare professionals the insights to track and manage your diabetes on your terms.
An pump combined with a CGM can enable your pump to automatically2 adjust your basal (background) every five minutes based on your CGM readings#.
MiniMed® 780G system includes our newest and most advanced CGM, the Guardian™ Sensor 3 and the Guardian™ Link 3 transmitter. It automatically monitors your glucose levels and adjusts the delivery for you, 24/7. 1,2
LEARN MORE
^Components are sold separately. Automated insulin delivery is made possible through combining Medtronic insulin pump and continuous glucose monitoring technology.
1 Carlson, A.L. et al. 97-P- Safety and glycaemic outcomes of the MiniMed™ AHCL System in subjects with T1D. 80th ADA International Conference, June 2020, Chicago+E24
2 Collyns, O. et al. 199-OR- Improved glycaemic Outcomes with MiniMed™ AHCL Delivery. 80th ADA International Conference, June 2020, Chicago
Guardian™ Connect SMART CGM
The Guardian™ Connect CGM monitors your glucose levels day and night and alerts you of highs or lows before they happen. You can set alerts anywhere from 10 to 60 minutes, getting notified exactly when you want. The system includes a small sensor worn up to seven days and a slim, discreet Bluetooth® transmitter. They work together to send precise glucose readings automatically to your phone every five minutes.
Guardian™ Connect CGM has you covered — and looks ahead — so you can focus on living your life, instead of watching your glucose levels.
LEARN MORE
iPro™2 PROFESSIONAL CGM
A simple way to better control your diabetes.
The iPro™2 Professional CGM system records your glucose levels 24 hours a day for up to six days. Used intermittently, the iPro™2 system provides your physician with insights into how the nutrition plan, medication regimen and daily activities affect your glucose levels, enabling them to make more informed decisions regarding your diabetes management.
LEARN MORE
Request a call today, to discuss the benefits of Guardian™ Connect with a Medtronic Diabetes Therapy Consultant.
Be sure to discuss questions specific to your health and treatments with a healthcare professional.
References
† Smart CGM predicts future high and low sensor glucose events up to 60 minutes in advance and provides access to additional algorithms and insights that can inform users of clinically relevant glucose patterns
¶ Only Guardian® Connect Smart CGM and iPro2™ Professional CGM can be used without an pump.
1 The system is intended to complement, not replace, information obtained from standard blood glucose monitoring devices. All therapy adjustments should be based on measurements obtained from standard blood glucose monitoring devices and not on values provided by the system. 2 Refers to Auto Mode. Some interaction required. Individual results may vary. 3 Guardian® Sensor 3 Performance for the MiniMed® 670G Pump. Sensor calibrated every 12 hours; within 30 minutes of event, both Low Threshold and Low Predictive alerts ON; with 41.7% false alert rate if the patient is unable to respond to the Suspend on Low alarm. 5 MiniMed® 670G system is indicated for persons seven years of age and older. The Guardian® Connect CGM system is indicated for persons age 7 and up
Clinical references
2. Bergenstal, R. M. et al. Jama. 2016; 316 (13): 1407 – 1408
3 Guardian™ Sensor 3 Performance for the MiniMed™ 670G Pump. Sensor calibrated every 12 hours; within 30 minutes of event, both Low Threshold and Low Predictive alerts ON; with 41.7% false alert rate if the patient is unable to respond to the Suspend on Low alarm.
4. Stone, 2018, Retrospective Analysis of CareLink (670G)
5. The people shown are living with type one diabetes in the USA, using the Guardian Connect system.
4 Grunberger G, Bailey TS, Cohen AJ, et al; and AACE Pump Management Task Force. Statement by the American Association of Clinical Endocrinologists Consensus Panel on pump management. Endocr Pract. 2010;16(4):746-762.
MiniMed® 670G System
Indications
The MiniMed 670G system is intended for continuous delivery of basal (at user selectable rates) and administration of boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons age seven and older requiring as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal based on continuous glucose monitoring (CGM), and can suspend delivery of when the SG value falls below or is predicted to fall below predefined threshold values. The Guardian Sensor (3) is 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 glucose monitor and not on values provided by the Guardian Sensor (3).
Warnings
Important Safety Information: MiniMed™ 670G System
The safety of using Auto Mode, Suspend before low, and Suspend on low in people who have no pump experience is not known. Auto Mode, Suspend before low, and Suspend on low should not be used if pump settings have not been previously established. pump settings include
basal rates, to carb ratio, or sensitivity factors. Always discuss with your healthcare professional before using Auto Mode, Suspend before low, or Suspend on low.
Do not make treatment decisions, such as determining your dose for meals, using the MiniMed 670G system CGM values, as they are not intended to be used to make such treatment decisions. The MiniMed 670G system CGM does not replace a BG meter. Always use the values from your BG meter for treatment decisions. BG values may differ from SG values. Using the SG readings for treatment decisions could lead to high or low BG.
Do not use Auto Mode for a period of time after giving a manual injection of by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much . Too much may cause hypoglycaemia. Consult with your healthcare professional for how long you need to wait after a manual injection of before you resume Auto Mode.
The MiniMed 670G system is intended for continuous delivery of basal (at user selectable rates) and administration of boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons age seven and older requiring as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes SmartGuard technology, which can be programmed to automatically adjust delivery of basal based on continuous glucose monitoring (CGM), and can suspend delivery of when the SG value falls below or is predicted to fall below predefined threshold values.
The Guardian Sensor (3) is 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 glucose monitor and not on values provided by the Guardian Sensor (3).
Contraindications
Medtronic performed an evaluation of the MiniMed 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.
MiniMed® 640G System
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://medtronic-diabetes.com.au/support/guides-and-manuals
iPro™2 Professional Continuous Glucose Monitoring (CGM) System
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://medtronic-diabetes.com.au/support/guides-and-manuals
Guardian Connect CGM System
Indications
The Guardian Connect app is intended for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in persons with diabetes mellitus. The Guardian Connect app is intended for use with a compatible consumer mobile electronic device. It allows users to track patterns in glucose concentrations and to possibly identify episodes of low and high glucose. The Guardian Connect app displays alerts if a glucose level reaches, falls below, or rises above set values. Sensor glucose values displayed on the screen are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a meter blood glucose measurement may be required.
Warnings
Important Safety Information: Guardian® Connect CGM System
The Guardian Connect system requires a prescription and is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (age 2 and up) with diabetes mellitus. If the mobile device is not set up or used correctly, you may not receive sensor glucose information or alerts. For complete details of the system and its components, including warnings, contraindications, and precautions, please consult the user guide at https://medtronic-diabetes.com.au/support/guides-and-manuals.
ALWAYS READ THE INSTRUCTIONS FOR USE (IFU)
For detailed information regarding indications, contraindications, warnings, precautions, and potential adverse effects, please consult the IFU. Always consult a Health Care Professional before making treatment decisions, and to see if this product is suitable for you.
Source: https://www.medtronic-diabetes.com.au/products/continuous-glucose-monitoring
0 Response to "Medtronic Minimed Continuous Glucose Monitoring System"
Post a Comment