Minimed 530 G

Introducing the MiniMed® 530G with Enlite

Introducing MiniMed® 530G with Enlite®

Featuring the world's first breakthrough in Artificial Pancreas Technology*

MiniMed® 530G with Enlite®
Threshold Suspend Automation
The MiniMed 530G system features Threshold Suspend, which automatically stops insulin delivery when sensor glucose values reach a preset low threshold.
Better Protection with Enlite1
Enlite sensor is our most accurate glucose sensor.**, 2, 3
 
*  that is approved by the United States Food and Drug Administration. Medtronic has a similar product already approved in Europe.
** 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.
 

Threshold Suspend Automation

A diabetes management tool that mimics some of the functionality of a healthy pancreas:
  • Threshold Suspend automatically stops insulin delivery when sensor glucose values reach a preset low threshold.
  • Threshold Suspend* can take action for your patient when they are unable to respond to Threshold Suspend alarm.
  • Patients who use the threshold suspend automation feature feel more confident in managing their diabetes.1
  • MiniMed 530G with Enlite is the first and only diabetes management system in FDA's new class: "Artificial Pancreas Device System, Threshold Suspend."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.
 
* When you become aware that Threshold Suspend has triggered, you should check your BG by fingerstick and manage your diabetes accordingly.
1 User evaluations. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
2 The Artificial Pancreas Device System (APDS). Available at: FDA site. Accessed August 2013.
 

Better 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
 
1 Paradigm REAL-Time Revel User Guide
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 use3*
  • 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.
3U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA.
*Versus Sof-sensor
 

Carelink Pro Software

CareLink® Pro Therapy Management Software

Threshold Suspend now 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 makes therapy adjustments more precise
  • 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.
Scroll Down
 

Compare Insulin Pumps and Continuous Glucose Monitoring (CGM)

See how your patients can achieve better glucose control with the MiniMed 530G system

†Manually injected insulin will not be tracked by the pump
** When you become aware that Threshold Suspend has triggered, you should check your BG by fingerstick and manage your diabetes accordingly.
1 The Artificial Pancreas Device System (APDS).
  Available at:
  http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ArtificialPancreas/default.htm.
  Accessed August 2013.
2 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.
3 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.
4 U.S. Enlite Clinical Study Customer Satisfaction Survey. Data on file, Medtronic MiniMed, Inc., Northridge, CA. .
5 Enlite® Sensor Performance Clinical Appendix.
6 Data on file, Medtronic MiniMed, Inc., Northridge, CA.
7 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.
8 Accu-Chek® Aviva Combo Advanced Owner’s Booklet.
9 Animas® OneTouch® Ping® Owner’s Booklet.
10 Insulet OmniPod® Next Generation User’s Guide.
11Dexcom G4™ PLATINUM User’s Guide.
12TANDEM® t:slim® User’s Guide
13http://www.tandemdiabetes.com/About-Us/News-Room/?id=497

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.
Scroll Up