Minimed Paradigm

Image:Minimed 515 and Silhouette Infusion set.jpg

Image:Insulin basal bolus.png

Insulin pumps are drug delivery devices used to treat patients with type 1 and type 2 diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006, uses tubing and a reservoir with rapid-acting insulin. This "infusion set" is patient-connected via a catheter to the abdomen region. The infusion set can remain in the place for three days while the pump is clip-belt worn. There is a quick-disconnect feature for the tubing. The pump delivers insulin in two modes. In basal rate mode, the delivery is continuous in small doses similar to a pancreas, for example 0.15 units per hour throughout the day. Basal rates are set to meet individual metabolic rates. In bolus mode, the delivery is programmed to be a one-time delivery prior to eating or after an unexpected high, for example 18 units spread out to several hours. This type of continuous treatment is in contrast to traditional multiple daily injections (MDI) that use slower-acting insulin. Continuous treatment reduces glucose variability.{{Cite web|url=https://www.bcbsal.org/providers/policies/final/046.pdf|title=Medical and Drug Policies}}

The Paradigm system consists of two basic parts: an insulin pump and an optional glucose sensor CGM worn for up to three days. The disposable sensor is subcutaneously-placed to make glucose measurements{{Cite web |url=http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=54140 |title=Accuracy of Real-Time Continuous Glucose Monitoring in the MiniMed Paradigm System – DiabetesPro – American Diabetes Association |access-date=2009-07-20 |archive-url=https://web.archive.org/web/20071018153637/http://professional.diabetes.org/Abstracts_Display.aspx?TYP=1&CID=54140 |archive-date=2007-10-18 |url-status=dead }} in interstitial fluid every five minutes and transmit the reading via low power radio frequency (ISM band) to the pump for realtime display. However, insulin therapy may be conducted without CGM and although there is not yet an automated insulin-regulation feedback mechanism between measure and infusion to control the amount and timing of insulin, this is clearly a future objective. Any change in basal or bolus is patient-driven by programming the pump using the Bolus Wizard. The latest model pumps are the MiniMed Paradigm 522 and 722, which differ in reservoir size, 176 versus 300 units, respectively. In 2007 the FDA approved a pediatric model for patients 7 to 17 years old.{{Cite web |url=http://www.ingentaconnect.com/content/adis/end/2003/00000002/00000001/art00002?crawler=true |title=Ingentaconnect Insulin Pump Therapy in Childhood Diabetes Mellitus: Guidelines F |access-date=2009-07-19 |archive-url=https://web.archive.org/web/20110607094337/http://www.ingentaconnect.com/content/adis/end/2003/00000002/00000001/art00002?crawler=true |archive-date=2011-06-07 |url-status=dead }}

The development history of the Minimed pump goes back to the 1980s.{{Cite web|url=https://www.medtronicdiabetes.com/about-medtronic-innovation/what-sets-us-apart|title=About Us | Medtronic Diabetes|website=Medtronicdiabetes.com|date=14 December 2012}}

• 1983 – 1st Pump MiniMed 502 (Eli Lilly makes synthetic insulin){{Cite web |url=http://www.accessexcellence.org/RC/AB/BC/1977-Present.php |title=Biotechnology Timeline 1977 - 1999 |access-date=2009-07-30 |archive-url=https://web.archive.org/web/20090425005513/http://www.accessexcellence.org/RC/AB/BC/1977-Present.php |archive-date=2009-04-25 |url-status=dead }}
• 1985 – MiniMed 504 Insulin Pump
• 1992 – Launch Of MiniMed 506 Insulin Pump
• 1996 – Introduction of MiniMed 507 Pump
• 1999 – Launch of the Model 507C
• 1999 – Introduction of MiniMed 508 Insulin Pump
• 2002 – Inauguration of the MiniMed Paradigm 511
• 2003 – 1st Wireless MiniMed Paradigm 512/712 (followed by 515/715)
• 2006 – MiniMed Paradigm REAL-Time 522/722
• 2010 – MiniMed Paradigm REAL-Time Revel 523/723{{Cite web|url=http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-overview|title=Overview | Medtronic|website=Newsroom.medtronic.com}}

The Food and Drug Administration has at least six classifications for the various parts of the Minimed Paradigm System.

Competitive devices include Deltec Cozmo, Animas Ping, Tandem Diabetes Care, Inc., Insulet OmniPod, Accu-chek Spirit Combo, and Sooil DiabecareIIS.{{Cite web|url=http://www.diabetesnet.com/diabetes-technology/insulin-pumps/current-pumps/pump-comparison|title=Comparison of Current Insulin Pumps|date=November 22, 2010|website=Diabetesnet.com}}

Currently, Medtronic has the following research and development projects in its pipeline: Next Generation REAL-Time Continuous Glucose Monitoring System; Next Generation Insulin Pump; Pre-filled Insulin Reservoirs; Implantable Insulin Pump; and Artificial pancreas (Semi-Automated System & Closed-Loop System). The industry trend in portable devices has piggybacked on the success of wireless technology{{Cite web|url=https://metapress.com/|title=Metapress | A Fast Growing Resource for Young Entrepreneurs|date=December 14, 2017}} but not on the success of other disciplines, such as dynamical system, Cybernetics and adaptive systems, for root cause solutions

{{Buzzword|date=August 2022}}

to close the "true" loop.{{Cite web |url=http://www.google.com/patents/about?id=M293AAAAEBAJ |title = Patent US7029455 - Devices, systems and methods for patient infusion … |archive-url=https://archive.today/20130124210822/http://www.google.com/patents/about?id=M293AAAAEBAJ |archive-date=24 January 2013 |url-status=dead}} While the slow-responding dynamics in the physiology of glucose regulation is not beyond the mathematics of PID controllers, 50 years of patient-perspective "advancement" says it is beyond the corporate, congressional, and lobbying leaders. Also, the accuracy of existing continuous glucose monitoring systems poses a problem for an artificial pancreas.

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