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Insulin Pump Device

Insulin Pump Device. By: Angelica Beckmann Engr 296Y Summer 2006. Topics Covered. Device Purpose Diabetes Definition Potential Market Insulin Pump Mechanism and Components Insulin Pump Device – Advantages and Disadvantages Insulin Pump Manufacturers Regulatory Status

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Insulin Pump Device

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  1. Insulin Pump Device By: Angelica Beckmann Engr 296Y Summer 2006

  2. Topics Covered • Device Purpose • Diabetes Definition • Potential Market • Insulin Pump Mechanism and Components • Insulin Pump Device – Advantages and Disadvantages • Insulin Pump Manufacturers • Regulatory Status • Related Clinical Trials • Future Direction • Conclusion

  3. Device Purpose • An Insulin Pump is a device used for administering insulin in the treatment of diabetes.

  4. What is Diabetes? • Diabetes is a metabolic disorder, it is a disease in which the body does not produce or properly use insulin. • Insulin is a hormone that is needed to convert sugar, starches and other food into energy needed for daily life.

  5. Types of Diabetes • Type I: results from the body's failure to produce insulin. • Type II: results from insulin resistance (when the body fails to properly utilize insulin), combined with a relative insulin deficiency. • Gestational diabetes - affects about 4% of all pregnant women. • Pre-diabetes - a person's blood glucose levels are higher than normal but not high enough for a diagnosis of type 2 diabetes.

  6. Potential Market • U.S. Market • 20.8 million children and adults in the United States, or 7% of the population have diabetes. • 1.5 million people aged 20 or older were diagnosed with diabetes. • 5-10% of Americans who are diagnosed with diabetes have type 1 diabetes. • Worldwide • In 2000 - 171 million people. • In 2030 expected to reach 366 million.

  7. Insulin Pump Mechanism • The Insulin Pump delivers rapid- or short-acting insulin 24 hours a day through a catheter placed under the skin. Your insulin doses are separated into: • a basal (small) dose that is delivered constantly. • a bolus dose that is delivered before meals, after meals or to correct high blood glucose levels. • Corrective or supplemental doses.

  8. Insulin Pump Components • The device consists of three principle parts : • The pump itself includes controls, processing module, and batteries. • Delivery tube to carry the insulin. • Needle or more commonly a catheter inserted into the body subcutaneously.

  9. Insulin Pump Device

  10. Insulin Pump Advantages • Convenience • Fewer injections • Match insulin doses precisely to need • Correct the Dawn Phenomenon • Less hypoglycemia & hypoglycemia unawareness • Reduce insulin quickly for exercise • Provide better health through better control

  11. Insulin Pump Disadvantages • Can cause weight gain. • Can cause diabetic ketoacidosis(DKA) if your catheter comes out and you don’t get insulin for hours. • Can be expensive. • Can be bothersome since you are attached to the pump most of the time. • Can require a hospital stay or maybe a full day in the outpatient center to be trained.

  12. Insulin Pump Manufacturers IR-1250 by Animas/ J&J Paradigma by MiniMedi/ Medtronics Cozmo by Deltec/Abbott Diabetes Care Spirit by Disetronic/Roche

  13. Regulatory Status • Insulin Pump Device is a Class II device • Approval by the FDA since July 1983. • Medtronic obtained the PMA for its first Pump and Monitoring System in July 2005. And PMA Supplemental Approval in Jun 2006. • This System is Class III device.

  14. Related Clinical Trials • There are 6 clinical trials registered with the FDA involving Insulin Pumps which are currently recruiting patients in the USA. • An example: • The study by Medtronic Diabetesto determine whether Type 1 Diabetic subjects using the Paradigm 722 System, which is a glucose sensor-augmented insulin pump, can improve glycemic control when compared to subjects using the Paradigm 715 insulin pump only. • Study start: June 2005 • Expected completion: September 2007

  15. A) Insulin Pump B) Cannula C) Sensor D) Transmitter Future DirectionPump and Monitoring System

  16. Future DirectionImplantable Artificial Pancreas

  17. Conclusion • The Insulin Pump is not a mind reader. It cannot decide how much insulin you need or when you need it, which makes the person running it the most important part of this device. Every action a pump makes starts with the user. • Continuous improvement of the presently available technologies and development of totally implantable artificial pancreas will make a huge difference in the way people are able to manager their diabetes.

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