Minimed 530 G

Introducing the MiniMed® 530G with Enlite

MiniMed® 530G System

Featuring Exclusive SmartGuardTM Technology for Advanced Protection against Lows*.

MiniMed® 530G with Enlite®
SmartGuard™ Technology
The MiniMed 530G system is an insulin pump that is fully integrated with a glucose sensor to provide advanced diabetes control. It is the only diabetes management system with Threshold Suspend – SmartGuard™ technology that takes action and automatically suspends insulin delivery when sensor glucose values reach a preset low threshold.
Better Protection with Enlite1 Sensor
  • Enlite sensor is our most accurate glucose sensor.**, 2, 3
  • The Enlite sensor drives action to keep patients within their target range.
 
*  Measured by sensor glucose values.
** Approved by the FDA in the United States
1 Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy:
  a randomized controlled trial. Diabetologia. 2012;55:3155-3162.
2 Paradigm® REAL-TIme Revel™ User Guide.
3 Enlite® Sensor Performance Clinical Appendix.
 

SmartGuard Technology

SmartGuard Technology:
Advanced protection against lows
  • SmartGuard technology automatically stops insulin delivery when sensor glucose values reach a preset low threshold.
  • SmartGuard technology* can take action for your patients when they are unable to respond to Threshold Suspend alarm.
  • Patients who use the MiniMed System with SmartGuard technology experience about 50% fewer nighttime lows* than those using a pump and sensor alone.1
  • Patients who use SmartGuard Technology with the threshold suspend automation feature feel more confident in managing their diabetes. In fact, 93% of MiniMed 530G system users say the Threshold Suspend feature lets them feel more secure in treating their diabetes.2
Watch how threshold suspend automation
How it works:
User settable: On/Off
Threshold range: 60 - 90 mg/dL
Suspends at threshold for up to 2 hours
During suspend:
  • No boluses can be administered
  • Patient can resume basal insulin delivery at any time
If sensor glucose value is below threshold at 4 hours after resuming from a full 2-hour suspend, pump re-suspends insulin delivery after the set Low Repeat time has been reached.

Download Brochure

 
* Measured as sensor glucose values.
** Data from only the voluntary CareLink® Personal Uploads from MiniMed 530G system in US available from Oct 15, 2013 to Jun 25, 2015 evaluated.
^ 26,053 patients kept SmartGuard™ feature ON 100% of time and 4,817 patients kept SmartGuard™ feature OFF 100% of time. 8,349 patients had time in both ON and OFF. SmartGuard™ techology includes Threshold Suspend. 13,166 patients had SmartGuard™ feature OFF.
1 Dexcom data from poster. Nakamura K. et al. Poster Presented at ADA 2015, June 6, 2015. Boston, MA
2 User evaluations. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
 

Advanced Protection

An integrated system that is clinically proven:
  • to lower A1C without increasing risk of going low1, 2
  • to offer better control than Multiple Daily Injections (MDI) or conventional insulin pumps1, 2

Get the complete glucose picture with Continuous Glucose Monitoring (CGM)
  • Identify trends and make therapy adjustments
  • Have greater confidence with real-time alerts3
  • Gain insights about your patients' glucose trends
 
Study used previous generation SAP pumps without Threshold suspend feature versus MDI.
1 Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med.
  2010;363:311–320.
2 Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy:
  a randomized controlled trial. Diabetologia. 2012;55:3155-3162.
3 User evaluations. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
 

Pump Settings

Only 5 settings need to be programmed into the insulin pump to begin therapy

Settings calculated using standard formulas

  • Basal Rate
  • Insulin-to-Carb Ratio (ICR)
  • Insulin Sensitivity Factor (ISF)
MiniMed 530G Insulin Pump
MiniMed 530G Insulin Pump
Settings determined using patient history / clinical judgment

  • Blood Glucose (BG) Target Range
  • Active Insulin Time
 
 

Pump Features

MiniMed® 530G insulin pump has 3 features to help patients achieve better glucose control1

MiniMed 530G Insulin Pump
MiniMed 530G Insulin Pumps
Rapid-acting insulin
  • Small doses of rapid-acting insulin, in immediate succession, maintain consistent pharmacodynamics
Bolus Wizard calculator
  • Calculates the amount of insulin needed for boluses (food and correction)
  • Tracks 'active' insulin
Delivers insulin in 2 ways:
BASAL INSULIN DELIVERY:
  • Replaces long-acting insulin
  • Covers hepatic glucose production and maintains glycemic stability in fasting states (between meals and overnight)
  • Automatically delivers precise, programmed dose
  • Adjustable to match diurnal variations

BOLUS INSULIN DELIVERY:
  • Covers food intake and corrects high Blood Glucose (BG) levels
 
1 User evaluations. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
 
 

The NEW Enlite™ Sensor

The New Enlite® Sensor

Provide your patient with an enhanced Continuous Glucose Monitoring (CGM) experience with the new Enlite sensor designed for comfort and performance.
Improved Performance
  • 31% improvement in overall accuracy over Sof-sensor®
  • Overall Mean Absolute Relative Difference (MARD) of 13.6%1,2
  • Features a Hypo Detection Rate of 93.2%2, *
  • Up to six days of use

Sensor performance data reported here is when used with MiniMed 530G system.

1 Paradigm REAL-Time Revel User Guide with Sof-sensor
2 Enlite® Sensor Performance Clinical Appendix.
* When calibrating 3-4 times a day and predictive and low alerts both turned on. There are times the system will falsely alert
  (alerts when the blood glucose level is above the alert setting)

The New Enlite® Sensor

Increased Comfort
Enlite®
Sof-sensor®
Enlite sensor is smaller and more comfortable for a better patient experience.
  • thin, flexible design
  • One-third the size of Sof-sensor glucose sensor1
  • 38% shorter sensor under the skin1
  • 85% of patients said Enlite was comfortable under the skin2*
1 Data on File, Medtronic.
2 U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
* Clinical trial users

The New Enlite® Serter

Large button for use with either hand; thumb or forefinger
Non-slip, comfortable outer sleeve
Button and sleeve features indicate insertion location
Easy Insertion
The new Enlite serter helps simplify sensor insertion for a virtually pain-free experience for your patients1

  • Completely hidden needle
  • 38% shorter insertion needle2
  • 78% of patients stated the insertion device was easy to use1,*
  • Silver Winner of the 2012 International Design Excellence Awards®
International Design Excellence Awards 2012
1 U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
2 Data on File, Medtronic.
*Versus Sof-sensor

SmartGuard Technology

SmartGuardTM Technology

Better Control. Fewer Lows*.
With a System that Takes Action


The Impact Of Hypoglycemia
  • Hypoglycemia can be a burden to your patients and your practice
  • 57% of patients experience hypoglycemia at least once per night1
  • 74% of Patients with type 1 diabetes often adjust their insulin dose due to a fear of hypoglycemia1
  • This can prevent them from meeting their A1C goals
  • 47.5% of people with diabetes do not achieve their A1C goals 2

Advanced Protection For Your Patients
  • SmartGuard™ technology can suspend insulin delivery for up to two hours, giving patients time to recover.
  • It steps in and takes action for your patients if their sensor glucose values reach a preset limit, and they don’t respond to alerts.
  • Exclusive to MiniMed, SmartGuard™ technology is proven to reduce the time spent low.
  • MiniMed integrated insulin pump and continuous glucose monitoring system can diminish your patients’ fears and positively impact their A1C goals. It can give them the confidence they need to succeed and to live their exceptional lives.

SmartGuard Technology

Download Brochure

* Measured by sensor glucose values.
1 Raju B, Arbelaez AM, Breckenridge SM, Cryer PE. Nocturnal hypoglycemia in type 1 diabetes: an assessment of preventive bedtime treatments. J Clin Endocrinol Metab. 2006;91(6):2087-2092.
2 Casagrande SS, JE Frandkin, SH Saydah et al. The Prevalence of Meeting A1C, Blood Pressure and LDL Goals Among People with Diabetes 1988-2010. Diabetes Care 36:2271–2279, 2013.

MiniMed Connect

The MiniMed® Connect App

Better Data. Better Care.


Managing patients is easier with the MiniMed® Connect App
Managing diabetes is complicated. You need every spare minute to focus on patient care. Now you can make office visits more efficient with MiniMed Connect – and help your patients more easily manage their diabetes.

Automatic uploads to CareLink® Personal software
The MiniMed Connect App links a MiniMed 530G pump and CGM system to an iPhone® or iPod touch®. Your patients’ data is automatically sent to CareLink Personal software.

With daily uploads to CareLink Personal software, your office can easily access the data – eliminating the need for manual pump downloads during visits.

MiniMed Connect

Diabetes data in easy reach for your patients
The MiniMed Connect App lets your patients check their sensor glucose levels discreetly and conveniently on their mobile device. The more they see their levels, the more they can adjust for better control.

Your patients can also allow caregivers to see their CareLink Personal reports and receive text messages when glucose levels are outside of the set range.

Carelink Pro Software

CareLink® Pro Therapy Management Software

Threshold Suspend displays on CareLink Pro reports

Comprehensive reports that help simplify diabetes management

Gain insights for more informed treatment decisions
  • CareLink will help you identify glucose trends so you can optimize your patients' therapy
  • CareLink can help you make more precise therapy adjustments
  • Make better therapeutic decisions with comprehensive clinical data
Obtain greater efficiency in your practice
 
  • CareLink collects and organizes information from the pump, CGM and meter in one set of reports
  • Provides therapy considerations enabling you to spend less time interpreting data and more time discussing solutions with your patients
 

Click here for more information on CareLink® Pro »

 
CareLink Pro Software - Graph
1
Sensor Overlay
  • Shows how glucose control, insulin delivery, and key settings align over a 24-hour period.
  • Helps you easily identify possible cause-and-effect relationships.
2
Pattern Identification
  • Identifies the exact times of highs and lows to eliminate guesswork.
  • Prioritizes patterns so you know which times of day are most challenging for your patient.
3
Action Plan
  • Allows you to record notes for patient records, patient instructions, or health insurance documentation.

STAR 3 Study

STAR 3 Study on Sensor-Augmented
Pump Therapy for A1C Reduction

The most wide-ranging clinical implications about the use of integrated insulin pump therapy comes from the STAR 3 study, published in 2010 in the New England Journal of Medicine.

Purpose

To examine the effectiveness of sensor-augmented pump (SAP) therapy in subjects transitioning from previously optimized multiple daily injections (MDI) to SAP therapy for 6 months and the glycemic benefits of sustained use of SAP for 18 months.

Conclusions
  • The continuation phase results support and extend the findings of the study phase.
  • Switching from optimized MDI to SAP therapy allows for rapid and safe A1C reductions.
  • Glycemic benefits of SAP persist for at least 18 months.
  • Maximal glycemic control is associated with more frequent wearing of the CGM sensor.
 

1Bergenstal RM, Tamborlane WV, Ahmann A, et al. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month
  continuation phase. Diabetes Care. 2011;34:2403-2405.
 

Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study:

Results from the 6-month continuation phase

Purpose
  • To examine the effectiveness of sensor-augmented pump (SAP) therapy in subjects transitioning from previously optimized multiple daily injections (MDI) to SAP therapy for 6 months and the glycemic benefits of sustained use of SAP for 18 months.
Endpoints
  • The primary endpoint was the change in A1C from 12 months to 18 months in the two treatment groups: cross-over and sustained SAP use.
  • The primary safety measure was the difference in the rates of severe hypoglycemia between the two groups.
Methods
  • Subjects aged 7-70 years of age were randomized to either SAP therapy with insulin aspart or MDI using insulin aspart and insulin glargine.
  • Other eligibility criteria included: use of MDI with a long-acting insulin analog, A1C between 7.4% and 9.5% and less than 2 severe hypoglycemic episodes over the previous year.
  • Subjects randomized to MDI were placed on individualized regimens by their respective investigator-physicians. All subjects were trained on the use of CareLink® Therapy Management Software for Diabetes.
  • Quarterly visits provided for individual therapy optimization and A1C measurements. Training and visit schedules were identical after the first 5 weeks, during which SAP patients completed device training.
  • All subjects completed blinded baseline CGM studies. CGM studies were also performed at 6 and 12 months for all subjects; the MDI group was blinded to the results.
  • Following completion of the 12-month study, there was an optional 6-month, single, crossover continuation phase. In the continuation phase, SAP subjects could continue on SAP, those on MDI could switch to SAP for the 6-month study period (crossover group).
  • The complete study design has been reported elsewhere.1
Results
  • 443 subjects completed the study phase. Of those, 420 enrolled in the continuation phase: 204 of 216 (94%) SAP subjects and 190 of 204 (93%) MDI crossover to SAP subjects, completed both phases of the study.
  • There was a significant decrease in A1C from 12 months to 15 and 18 months in the crossover group (8.0 ± 0.1% vs. 7.6 ± 0.1%, P<0.001, respectively) (Fig A).
  • The significant decrease in A1C values in the crossover group was seen in adults (n=141, Fig B) and children (n=63, Fig C).
  • Maximum glycemic improvements in the crossover group were seen in those with sensor wear times >60%.
  • In the continuation phase, mean sensor wear times were greater among adults (61 ± 24% of the time) than in children (45 ± 24% of the time) (P<0.001).
  • Improvement in A1C levels in the SAP group was maintained during the continuation phase (Fig A). There was no significant difference between the 12 month A1C value in this group and the 15 and 18 month A1C values.
  • Subjects in the SAP group that maintained their A1C values used CGM sensors >40% of the time. Subjects who used sensors less often experienced slight deteriorations in glycemic control.
  • There was no significant difference in the rates of severe hypoglycemia between the SAP and crossover groups during the continuation phase (2.8% vs. 1.0%, respectively, P>0.05).
1Bergenstal RM, Tamborlane WV, Ahmann A, et al. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month
  continuation phase. Diabetes Care. 2011;34:2403-2405.
 

Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) Study:

Results from the 6-month continuation phase

A. All Subjects
All Subjects

B. Ages 19-70
Ages 19-70
C. Ages 7-18
Ages 7-18

Author's Conclusions

The continuation phase results support and extend the findings of the study phase.
Switching from optimized MDI to SAP therapy allows for rapid and safe A1C reductions.
Glycemic benefits of SAP persist for at least 18 months.
Maximal glycemic control is associated with more frequent wearing of the CGM sensor.

1Davis SN, Horton ES, Battelino T, Rubin RR, Schulman KA, Tamborlane WV. STAR 3 randomized controlled trial to compare sensor-augmented insulin
  pump therapy with multiple daily injections in the treatment of diabetes: research design, methods, and baseline characteristics of enrolled subjects.
  Diabetes Technol Ther. 2010;12:249-255.
2Bergenstal RM, Tamborlane WV, Ahmann A, et al. Sensor-augmented pump therapy for A1C reduction (STAR 3) study: results from the 6-month
  continuation phase. Diabetes Care. 2011;34:2403-2405.

Bayer's New Contour® Next Link

Bayer's NEW CONTOUR NEXT LINK meter is part of the MiniMed 530G system, transmitting accurate blood glucose results wirelessly to the insulin pump for seamless integration.

CONTOUR NEXT LINK is the only meter that is labeled for use with the MiniMed 530G system. One will be included with all new insulin pump orders.

  • Wirelessly transmits BG results with proven accuracy1 to the insulin pump
  • Exclusively used with high performance CONTOUR NEXT tests strips for results you can count on
  • Accurate blood glucose results1 help to ensure accurate calibration of the Enlite sensor
  • Bayer's No Coding technology eliminates inaccurate blood glucose results due to miscoding
  • Easy-to-read color display with large, clear numbers which allows for testing in dark
  • Tiny 0.6µl sample size and fast 5-second countdown
  • USB connector allows you to connect directly to your computer, to allow for easy downloading to CareLink software, as well as recharging the battery
1Bernstein R, Parkes JL, Goldy A, et al. A new test strip technology platform for self-monitoring of blood glucose.
  J Diabetes Sci Technol. 2013;7(5):1386-1399.
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Competitive Matrix1

See how your patients can achieve better glucose2,3 control with the MiniMed 530G system

Compare MiniMed 530G with EnliteMINIMED® 530G WITH ENLITE® VS
Download the Entire Competitive Comparison ChartDownload the Entire Competitive Comparison Chart » OR
† Manually injected insulin will not be tracked by the pump.
*MiniMed 530G System User Guide.
**User evaluations. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
1. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
2. Agrawal P, Welsh J, et al. Usage and Effectiveness of the Low Glucose Suspend Feature of the Medtronic Paradigm Veo Insulin Pump. Diabetes Sci and Tech. 2011;5:1137-1141.
3. The Artificial Pancreas Device System (APDS). Available at: http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/default.htm. Accessed August 2013.
4. Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010;363:311–320.
5. Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1 diabetes treated with insulin pump therapy: a randomized controlled trial. Diabetologia. 2012;55:3155-3162.
6. U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
7. Enlite® Sensor Performance Clinical Appendix.
8. Corriveau EA, Durso PJ, Kaufman ED, et al. Effect of CareLink, an internet-based insulin pump monitoring system, on glycemic control in rural and urban children with type 1 diabetes mellitus. Pediatric Diabetes. 2008;9(Part II):360–366.
9. Animas® Vibe™ Owner’s Booklet
10. Animas® OneTouch® Ping® Owner’s Booklet
11. Asante Snap Insulin Pump User Manual
12. Available at: http://www.snappump.com/node/125. Accessed November 20, 2014
13. Available at: http://investing.businessweek.com/research/stocks/private/snapshot.asp?privcapId=6313519. Accessed November 20, 2014.]
14. Accu-Chek® Aviva Combo Advanced Owner’s Booklet
15. Insulet OmniPod® Next Generation User’s Guide
16. Dexcom G4™ PLATINUM User’s Guide
17. Tandem Diabetes Care™ Launches t:slim™ Insulin Delivery System. Available at: http://www.tandemdiabetes.com/News/2012/Tandem-Diabetes-Care%E2%84%A2-Launches-t-slim%E2%84%A2-Insulin-Delivery-System


MiniMed, Paradigm, MiniLink, Bolus Wizard, and CareLink are registered trademarks, and Enlite and Revel are trademarks of Medtronic MiniMed, Inc. OneTouch and Ping are registered trademarks of Animas, Inc. Omnipod is a registered trademark of Insulet Corporation. G4 is a trademark of Dexcom, Inc. Contour Next Link is a registered trademark of Bayer Healthcare LLC.
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