Insulin Pump Device

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Insulin Pump Device

• By
• Angelica Beckmann
• Engr 296Y
• Summer 2006

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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

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Device Purpose

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

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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.

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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.

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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.

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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.

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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.

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Insulin Pump Device
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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

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Insulin Pump Disadvantages

• Can cause weight gain.
• Can cause diabetic ketoacidosis (DKA) if your
  catheter comes out and you dont 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.

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

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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 Diabetes to 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

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Future Direction Pump and Monitoring System

• A) Insulin Pump
• B) Cannula
• C) Sensor
• D) Transmitter

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Future Direction Implantable Artificial Pancreas
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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.