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Medtronic Receives FDA Approval for Industry's Most Advanced Integrated System for Diabetes Management

Mar 22, 2010

This press release is an announcement submitted by Medtronic, and was not written by Diabetes Health.

Next Generation Integrated System: MiniMed Paradigm® REAL-Time Revel (TM) System

MINNEAPOLIS - March 17, 2010 - Medtronic, Inc. today announced it has received U.S. Food and Drug Administration (FDA) approval for the MiniMed Paradigm® REAL-Time RevelTM System, the next generation of the industry's only integrated diabetes management system (insulin pump therapy, continuous glucose monitoring (CGM) and diabetes therapy management software). The system incorporates new innovative CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

"Medtronic is extending its lead in the path towards the artificial pancreas with this next generation integrated system and our ongoing advancements in algorithm development," said Katie Szyman, president of the Diabetes business and senior vice president at Medtronic.  "We are excited to make these leading innovations available to improve patients' lives with the industry's only integrated system in the world today.  The MiniMed Paradigm Revel System can help a patient feel more secure by giving early warning of one of their greatest concerns, hypoglycemia, while continuing to simplify the complexity of diabetes management with easy-to-use features."

When using Medtronic's glucose sensors with Paradigm Revel Insulin Pumps, trend alerts can notify patients of rapid changes in glucose levels so that they can take immediate corrective or preventative action after confirming glucose levels with a fingerstick glucose measurement. Several new CGM features, including predictive and rate of change alerts, provide earlier warnings of potential glycemic excursions to help patients stay in their target range.  According to recent internal study, the use of predictive alerts improved hypoglycemic event detection by 36% compared to the standard low glucose alert.[1]  All alerts can be customized to suit a patient's lifestyle, such as creating different settings to accommodate for exercise or to manage nocturnal hypoglycemia.

New features in the insulin pump enable patients to tailor insulin delivery to meet their personal needs.  Patients who are sensitive to insulin, such as children with diabetes, now have the opportunity to deliver insulin in smaller increments (0.025 units per hour.)  In addition, insulin-using type 2 patients, who are often more insulin resistant, can more tightly control their glucose levels using the new 1:1 carbohydrate ratio.  The system also enables patients to set up missed meal bolus reminders.

"Recent clinical evidence clearly supports that insulin pump therapy combined with continuous glucose monitoring improves patients' A1C while reducing the relative risk of severe hypoglycemia," said William Tamborlane, M.D., professor of pediatrics and chief of pediatric endocrinology at Yale University School of Medicine. "Advances such as predictive alerts and smaller basal delivery rates can help physicians and patients customize therapy to meet individual needs. This ultimately simplifies some of the complexity of daily diabetes management."

There is a growing body of clinical evidence that continues to prove that the more often patients use Personal CGM, the greater average glucose control (A1C) they can achieve without increasing hypoglycemia, including the JDRF-Funded Studies and REAL TREND Study.[2] [3]  Today, insulin pumps are covered by nearly all commercial and government insurance programs in the United States, and nearly 90 percent of type 1 diabetes patients with commercial insurance coverage have access to CGM when medical criteria is met.  Personal CGM is approved for use by people ages 7 and older in the United States.

The MiniMed Paradigm REAL-Time Revel System is immediately available.  Information on how to purchase the system is available at www.medtronicdiabetes.com or by calling 1-800-646-4633.

About The MiniMed Paradigm REAL-Time Revel System

The MiniMed Paradigm REAL-Time Revel System is comprised of three key components: a "smart" insulin pump, CGM and CareLinkTM Therapy Management Software. CareLink software is a free online tool that helps diabetes patients and their healthcare providers analyze therapy and make adjustments through easy-to-read reports, charts and graphs.

  • [1] Keenan DB, Dartaya R, Mastrototaro JJ. Accuracy of a new real-time continuous glucose monitoring algorithm. J Diabetes Sci Technol 2010;4:111-118.
  • [2] The Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008;359:1464-1476.
  • [3] Raccah D, Sulmont V, Reznik Y, et al. Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study. Diabetes Care published ahead of print, online September 18, 2009.

 


Categories: A1c Test, Blood Sugar, CGMs, Diabetes, Diabetes, Food, Insulin, Insulin Pumps, Low Blood Sugar, Monitoring, Type 1 Issues, Type 2 Issues



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Comments

Posted by angivan on 24 March 2010

Does anybody know if the CGMS portion of the Revel has improved accuracy? I'm one of the many who has found their CGMS unusable due to wide calibration discrepancies and cal errors, despite working with their technicians at length. Would rather stay with Minimed but will try Dexcom soon because of the better reputation.

Posted by Rick on 24 March 2010

i have had a medronic insulin pump for three years and am very happy with it. i recently tried the medtroni cgm and was very disappointed with it. after ten days i quit using it. the numbers weren't even close to what my meter said. i was told it could be off by twenty. it was more often than not off by fifty or more. they should pay us to use this device. they're using us as test monkeys to perfect this on there way to an integrated device. no thanks.

Posted by Jody on 8 April 2010

Hello all. Blessings to you and may you have happy hearts and stable BS.

I have been using a medtronic paradigm 722 pump for about 4 yrs now. I have had very poor customer service from minimed in the past & currently. In the beginning I was informed that medtronic had a a special team that would help me with getting coverage for a cgm. After obtaining all of the necessary documentation: letter of neccesity, 6 mo. of BS showing repeated BS below 50, use of glucagon injections, 6 months of Drs notes from my chart, documentation from wearing a cgm for 7 days showing variations of BS, lab work with 1 yrs worth of A1c, I was told that medtronic minimed would no longer help with the insurance coverage. My Drs. mailed all of the forms on 3 different occasions and the ins co. stated that they would not cover a cgm in any way, shape or form, unless I had received the cgm and was billed for it. Medicare stated that they may consider coverage but that it was unlikely. I have hypoglycemic unawareness and have had type 1 for 40 yrs. This is my only complication after all this time.

i would love to have a closed loop system or even a cgm to work with my pump. I am at a loss as to how to afford one so that I would have my life back with less fear of hypos. I currently test my BS every 1 1/2 to 2 hrs, in order to prevent or avoid the lows.

At times I am so frustrated and I do not know where to turn for help.

Jody


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