This information is intended for media professionals and investors

Medtronic Paradigm® REAL-Time System Fact Sheet

MiniMed Paradigm® REAL-Time System
– Major step towards the creation of an artificial pancreas –

The MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring System is the first and only FDA-approved integrated insulin pump and continuous glucose monitoring system.  This system empowers patients through the use of REAL-time glucose readings, trend graphs, arrows and alarms to better manage their diabetes in ways never before possible.  The MiniMed Paradigm REAL-Time System marks a major step toward the development of a “closed-loop” insulin delivery system that mimics some of the functions of a natural pancreas

System Components

The MiniMed Paradigm® REAL-Time System is made up of the following technology components: a REAL-Time continuous glucose sensor, a radio frequency transmitter and a “smart” insulin pump.

Glucose Sensor

• The glucose sensor is a tiny electrode worn by the patient for up to three days.
• The glucose sensor is easily inserted by patients, caregivers or healthcare professionals into the skin (subcutaneous tissue) using the Sen-serter® automatic insertion device.
• Following a two-hour initialization period, the glucose sensor measures glucose levels in the interstitial fluid, which is where cells get oxygen and nutrients, including glucose.
• The glucose sensor produces an electronic signal which is proportional to the amount of glucose present in the blood.
• As many as 288 glucose readings are recorded by the sensor each day – nearly 100 times more information than three daily fingerstick measurements.

MiniLink Transmitter

• The radio frequency MiniLink transmitter connects to the glucose sensor and attaches to the skin by an adhesive patch.
• Using radio frequency, the transmitter sends glucose values from the sensor to the monitor every five minutes.
• Because the transmitter is waterproof, patients can shower, bathe or swim while wearing both the transmitter and the glucose sensor.

MiniMed Paradigm Insulin Pumps

• The MiniMed Paradigm REAL-Time insulin pump serves two important functions: it displays REAL-time glucose values every five minutes, and delivers insulin in a way that more closely matches the functioning of a human pancreas.
• Trend graphs as well as arrows indicate how fast – and in which direction – glucose is moving.
• Alarms (sound or vibrating) will alert patients to potentially dangerous hypoglycemia (low glucose levels) and hyperglycemia (high glucose levels) episodes.
• The patented Bolus Wizard® calculator simplifies complex diabetes math and recommends insulin dosages based upon glucose levels, food intake and information preset by the user (target blood glucose, insulin sensitivity and insulin-to-carbohydrate ratios).
• The insulin pump also tracks how much insulin is “still active” in the body to help patients avoid delivering too much insulin.
• A minimum of two fingerstick are required each day (one every 12-hours) to calibrate the continuous glucose monitor, and a confirmatory fingerstick is required prior to making a self-management decision.
• MiniMed Paradigm insulin pumps are water resistant and can be splashed or temporarily dunked in water. Patients should disconnect from their insulin pump prior to participating in water activities.

Indications

Insulin Pump

• The MiniMed Paradigm 522/722 insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Sensor and transmitter

• The sensor and transmitter system components are indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).
• It alerts if a glucose level falls below or rises above preset values.
• Values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the Paradigm 522/722 pump system values.

Contact 1-800-MINIMED (800-646-6433) or visit our website: www.medtronicdiabetes.com for more information.