Paradigm REAL-Time System

Frequently Asked Questions
MiniMed Paradigm Real-Time System

Frequently Asked Questions About the MiniMed Paradigm® REAL-Time System

INSULIN PUMP

How small is the MiniMed Paradigm insulin pump?

The MiniMed Paradigm 522 insulin pump, the smallest full-featured insulin pump currently available from Medtronic Diabetes, is about the size of a personal pager. The MiniMed Paradigm 522 insulin pump measures just 5.08 x 7.62 x 2.03 centimeters. The 722 model is about 1.5 centimeters longer in length than the 522 insulin pump: exact dimensions are 5.08 x 9.14 x 2.03 centimeters.

How light is the MiniMed Paradigm insulin pump?

A MiniMed Paradigm 522 insulin pump with a full reservoir weighs just 106.5 grams. The MiniMed Paradigm 722 insulin pump with a full reservoir is just 108.2 grams.

What is the MiniMed Paradigm insulin pump's reservoir size?

The MiniMed Paradigm 522 reservoir has a maximum capacity of 176 units, which meets the needs of most people who use up to 50 units of insulin daily. The MiniMed Paradigm model 522 insulin pump offers the benefit of a small-sized insulin pump that people want with a reservoir size that most people need. The MiniMed Paradigm 722 insulin pump can hold up to 300 units of insulin; it can also use either of the two MiniMed Paradigm reservoirs -- the 1.76 ml or the 3.0 ml reservoir.

Please note: Insulin requirements may change over time, in particular during pregnancy and in adolescence. Therefore, you are encouraged to discuss this decision with your healthcare professional.

What is the difference between the MiniMed Paradigm model 522 and 722 insulin pumps?

MiniMed Paradigm 522 and 722 insulin pumps share the same primary features and capabilities. The primary difference between the two insulin pumps is the size reservoir each can hold. The MiniMed Paradigm 722 insulin pump can accommodate either a 3.0 ml reservoir, which holds 300 units of insulin, or a 1.76 ml reservoir, which holds 176 units of insulin. The MiniMed Paradigm 522 insulin pump can accommodate only the 1.76 ml reservoir.

How do I determine which MiniMed Paradigm insulin pump is right for me?

Please note: Discuss this decision with your healthcare professional since it relates to your insulin use.

We have designed the MiniMed Paradigm 722 insulin pump for patients who use more insulin or anticipate using more insulin - specifically, more than 50 units daily. The MiniMed Paradigm 722 insulin pump can hold up to 300 units of insulin; it can also use either of the two MiniMed Paradigm reservoirs -- the 1.76 ml or the 3.0 ml reservoir. Therefore, if you are anticipating or experiencing life changes such as pregnancy or adolescence, you may appreciate the flexibility to upsize or downsize your reservoir. If you currently use more than 50 units daily, you may want to consider the MiniMed Paradigm 722 for its larger reservoir capacity.

The MiniMed Paradigm 522 insulin pump can accommodate our 1.76 ml reservoir, and it holds up to 176 units of insulin. It is ideal for people who require less than 50 units of insulin per day. In addition, it is the best choice for people who want the maximum discretion offered by the smaller, lighter-weight member of the MiniMed Paradigm insulin pump family.

What is the programming unit for basal rates on the MiniMed Paradigm insulin pump?

The MiniMed Paradigm insulin pump can be programmed in 0.05 unit basal increments.

What infusion sets are available for MiniMed Paradigm insulin pumps?

We offer a wide variety of infusion sets for use with the MiniMed Paradigm insulin pump. Every MiniMed Paradigm infusion set can be used with a Serter™ auto-insertion device for reliable, fast, easy and virtually painless insertion.

Quick-set® infusion set (10/box)

MMT-396

110cm tubing with 9 mm cannula

 

MMT-397

60cm tubing with 9 mm cannula

 

MMT-398

110cm tubing with 6 mm cannula

 

MMT-399

60cm tubing with 6 mm cannula

Silhouette® infusion set (10/box)

MMT-377

110cm full set (10 complete sets)

 

MMT-379

110cm combo set (10 sites/5 tubing sets)

 

MMT-378

60cm full set (10 complete sets)

 

MMT-380

60cm combo set (10 sites/5 tubing sets)

Sof-Set Ultimate QR® infusion set (12/box)

MMT-317

107cm Quick Release soft plastic 9mm cannula set

 

MMT-318

61cm Quick Release soft 9mm plastic cannula set

Sof-Set Micro QR® infusion set (12/box)

MMT-324

107cm Quick Release soft plastic cannula set (6mm catheter)

 

MMT-325

61cm Quick Release soft plastic cannula set (6mm catheter)

How do I decide which set is right for me?

Your Clinician / Diabetes Educator will suggest the most suitable type of infusion set for you. Information on each type of infusion set is available on this website.

Can I use sets from other manufacturers with the MiniMed Paradigm insulin pump?

It is important to understand that we do not test reservoirs and infusion sets from other manufacturers. As a result, we cannot, and do not, guarantee or warrant the performance of reservoirs and infusions sets not designed by Medtronic, and your warranty may not cover damage or malfunction of your insulin pump that has been caused by a ‘non Medtronic’ reservoir or infusion set.

Can I swim or bathe while wearing a MiniMed Paradigm insulin pump?

No, the insulin pump is water resistant, which means that it is designed to survive only an accidental immersion or splash. You should disconnect temporarily from your MiniMed Paradigm insulin pump while bathing or if you plan to be active in or near water. Talk with your healthcare professional to establish a plan for diabetes management while you are disconnected if you plan to remove it regularly for swimming or other activity.

The Truth About Watertight

How much continuous glucose monitoring (CGM) system data can the insulin pump store?

The insulin pump stores the last 90 days of CGM system data, which can be downloaded for historical analysis.

MINILINKTMTMTRANSMITTER

What is the MiniLink transmitter?

Our new transmitter - called the MiniLink REAL-Time Transmitter – is sleek and discreet.  It makes the MiniMed Paradigm REAL-Time System so much easier because you simply wear a tiny transmitter, which automatically transmits glucose information to a MiniMed Paradigm 522/722 insulin pump. Your insulin pump will display a dashboard of glucose information, providing you with greater insights in to how diet, exercise, medications and lifestyle affect your glucose levels.

The MiniLink REAL-Time Transmitter is comfortable, discreet, waterproof and long-lasting (it’s rechargeable)!

COMFORTABLE:

MiniLink is comfortable because it is small, lightweight, ergonomically shaped therefore it will not tug, pull or pinch with movement. It is also designed to minimise skin irritation.

DISCREET:

MiniLink has a low-profile. It lays flat against your skin without a bulge and only takes a small amount of skin area. It is also easy to hide under your clothing.

WATERPROOF:

When the glucose sensor is connected to the transmitter, it is fully immersible and can be worn at a depth of 2.4 meters for 30 minutes. You can swim on the surface of a pool or shower as long as you want. There is no need to tape over the transmitter to hold it down or to keep it dry like other products might require.

LONG-LASTING:

MiliLink is rechargeable. The charger is powered by one AAA (alkaline) battery.

 What is the size and weight of the MiniLink transmitter?

The MiniLink is about the size of a 20 cent coin.

Exact dimension: 3.6 x 2.8 x 0.9cm
Weight: 5.4 grams
Thickness: approximately 0.9cm

 How does the MilLink attach to my body?

The transmitter simply snaps onto the glucose sensor (after the glucose sensor is inserted under the skin). The transmitter is very light weight so there should be no need to add “over tape” to keep it in place.

What type of batteries does the MiniLink use?

The MiniLink REAL-Time Transmitter has a self-contained battery, which cannot be changed, but it can be recharged using the battery-powered MiniLink charger.

The MiniLink has a Lithium polymer battery which operate best if they are recharged frequently. We recommend recharging after each glucose sensor use for optimal battery longevity.

Before using the MiniLink for the first time, you must fully charge the MiniLink battery which may take up to 8 hours.

If the battery is fully depleted, it may take up to 2 hours after the initial charge.

As the MiniLink contains a rechargeable battery, which if incinerated, could explode. We recommend that the MiniLink should not be disposed in the sharp containers.

How long the MiniLink last once recharged?

The fully charged transmitter will last up to 14 days of continuous use.

For a quick recharge (20 minutes), the transmitter will last up to 3 days of continuous use.

To save MiniLink battery life, it is recommended not to leave the tester plug connected.

If you do not plan to use your MiniLink in the next 30 days, connect it to the charger for storage.

 What type of batteries does the charger use?

The charger uses an AAA battery which contains enough power to recharge the MiniLink about 40 times (based on three-day glucose sensors).

How will I know when the MiniLink REAL-Time Transmitter battery is getting low?

When the MiniLink REAL-Time Transmitter reaches a low battery condition, it will notify the insulin pump. The insulin pump then displays a "LOW TRANSMTR" notification.

From the first "LOW TRANSMTR" notification of a low battery, you have about five days of continuous use before the battery is completely depleted. You will then receive a "BAD TRANSMTR" notice which means the transmitter battery has been used up.

What is the operating range between the MiniLink REAL-Time Transmitter and the insulin pump?

The MiniLink REAL-Time Transmitter and the insulin pump must be within 2.4 metres of each other for wireless transmission to occur.

 What happens when the MiniLink REAL-Time Transmitter and insulin pump move out of range?

If the MiniLink REAL-Time Transmitter and insulin pump are too far apart (about 2.4 metres), an alert will sound and either a "WEAK SIGNAL" or "LOST SENSOR" message will appear on the screen. Once the transmitter and insulin pump are within 2.4 metres of each other, simply press Select, “Find Lost Sensor” to get the devices to communicate again.

The MiniMed Paradigm REAL-Time System allows the user to set the period of time the insulin pump will wait before alerting you of a failed reception of continuous glucose monitoring (CGM) data from the transmitter to the insulin pump. The delay can be set for anywhere from 5 minutes to 40 minutes. The default setting is 30 minutes.

 How much data does the MiniLink REAL-Time Transmitter store? If I move outside of the 2.4 metres transmission range – will I lose my data?

When the MiniLink REAL-Time Transmitter is separated from the insulin pump for more than 2.4 metres, the transmission is considered "out of range." The transmitter holds 40 minutes worth of memory, so even though your system is "out of range," continuous glucose monitoring (CGM) data can be re-populated in the insulin pump.

If your system is out-of-range for longer than 40 minutes, when reviewing historical reports you would notice "data gap" where information is missing during this period of time.

 Can I swim, shower, or bathe with the MiniLink Transmitter?

The transmitter is waterproof, so you can swim, shower, or bathe with the transmitter and glucose sensor connected (DO NOT immerse the transmitter in water if the glucose is not attached). Connecting the glucose sensor with the MiniLink creates the watertight seal.

The transmitter with the glucose sensor connected can be worn for a depth of 2.4 metres for 30 minutes. However we do not recommend immersing them in very hot water (like a Jacuzzi or hot spa) as this may shorten the glucose sensor life. Both transmitter and sensor has a waterproof IPX8.

There should be no problems due to rain, splashing, or the accidental submersion in water. To participate in water activities, you can easily disconnect from your insulin pump.

If you are swimming on the surface of the water or showering, there is no time limit. You may wish to get out of the water to re-establish communication with the insulin pump every 30 to 40 minutes so that no glucose data is lost.

GLUCOSE SENSORS

What is a glucose sensor?

The glucose sensor is a tiny electrode worn for up to 3 days. Following a 2-hour initialisation period, the glucose sensor measures glucose levels in the interstitial fluid which is where cells get oxygen and nutrients, including glucose. The glucose sensor is easily inserted by patients, caregivers or healthcare providers into the skin (subcutaneous tissue) using the Sen-serter® automatic insertion device. Like many types of infusion sets, a needle is used to introduce the glucose sensor but the needle is then removed leaving a tiny flexible electrode just under the skin. The glucose sensor is then connected to the transmitter so the readings from the glucose sensor can be transmitted to your insulin pump.

Does the glucose sensor infuse insulin?

The glucose sensor measures glucose levels in your body's interstitial fluid (fluid between the cells). It does not infuse insulin, nor does the measurement automatically cause the insulin pump to infuse a certain amount of insulin. Insulin is administered through a traditional infusion set that should be inserted at least 5 centimeters away from the glucose sensor site. The Bolus Wizard® calculator will help you decide on insulin doses during the day, after you enter a glucose reading from a confirmatory fingerstick measurement.

Do I need to refrigerate my glucose sensors?

Glucose sensors are shipped in a protective foam container containing chilled gel packs designed to protect glucose sensors from temperature changes during shipment.

You should immediately refrigerate your glucose sensors upon receipt. We recommend keeping glucose sensors in the refrigerator at a storage temperature between 40C and 230C. Glucose sensors must also not be frozen.

Prior to inserting a glucose sensor, allow it to warm up to room temperature (may take approximately 15 minutes).

What happens if the glucose sensor is left out of the refrigerator?

A glucose sensor can be left out of the refrigerator at room temperature for up to one week and it would still be acceptable to use the glucose sensor. Do not use the glucose sensor if it has been left in the sun (or extreme heat) or conversely if it has been exposed to extreme cold.

How long do glucose sensors last? Do they expire?

Glucose sensors have a six month expiration date from the time they are manufactured. An expiration date will appear on the outside of the glucose sensor box and on each individual glucose sensor package.

Where are the preferred body locations for wearing a glucose sensor?

Placement of the glucose sensor may be affected by clothing, comfort, individual preference or experience. In the case of people using insulin, users may want to avoid recent infusion sites. While many people choose the abdominal stomach area, an alternative location is on the upper buttocks. This location is less likely to be bumped or affected by clothing at the waistline.

DIFFERENCES BETWEEN BLOOD GLUCOSE METER AND CONTINUOUS GLUCOSE MONITORING READINGS

Why can't I use a sensor glucose reading to treat my diabetes?

Patients and clinicians have a lot of experience with blood glucose meters, however they do not have not nearly as much experience with REAL-Time continuous glucose monitoring. The diabetes community is just beginning to learn about this new therapy option.

It is important that you continue to use your meter to confirm sensor readings before treatment.

It is important to recognise the value of REAL-Time CGM systems. The System helps you discover when is the best time to take a fingerstick.

An important benefit of using a CGM system is REAL-Time readings and trend graphs. They allow you to be proactive in your diabetes treatment so you can avoid severe high and low blood glucose levels. You can see if your glucose is trending up or trending down and take action much earlier. With this information, you will be able to confidently make changes to your daily glucose management to improve your heath.

Do I enter the fingerstick reading or the continuous glucose monitoring reading into the Bolus Wizard calculator?

You should enter the fingerstick reading into the Bolus Wizard calculator.

The continuous glucose monitoring readings do not match my meter readings. Should I be concerned about this?

No, the important thing about REAL-Time CGM systems is the trend information as opposed to the actual numbers. If you are comparing numbers, you may want to consider that even though meters have been the standard for treating diabetes their readings vary. For example, it is unlikely that two consecutive meter readings from the same blood sample will match. The odds are worse if you compare readings from two different meters. Perfectly matched readings – whether they come from meters or CGM systems, are unlikely to happen.

If your sensor reading differs greatly from your meter readings, your glucose may be changing rapidly. It could be that you have recently eaten something. In about an hour, you will probably find that your glucose sensor and meter readings are more closely aligned.

The advantages of REAL-Time CGM are the trend graphs. The trend graphs allow you to see when glucose is trending up or trending down and how fast it is moving. All of these things help you manage your diabetes more effectively so you can live a healthier life.

REAL-TIME ALARMS

What are the high and low glucose alarm thresholds that I can set?

High alarm thresholds can be set as high as 22.2 mmol/L (400 mg/dL) and the minimum low alarm threshold can be set as low as 2.2 mmol/L (40 mg/dL). High and low threshold ranges can be customised by the user. You should discuss your personal threshold levels and alert settings with your healthcare provider.

The high and low glucose alarms have to be at least 0.6 mmol/L (10 mg/dL) apart. If you set your high glucose limit at 5.6 mmol/L (100 mg/dL), then you cannot set your low glucose limit greater than 4.9 mmol/L (90 mg/dL). Conversely, if you set your low glucose limit at 2.8 mmol/L (50 mg/dL) then you cannot set your high limit lower than 3.3 mmol/L (60 mg/dL).

Is there anything I can do to reduce the number of alarms I get?

Yes, you can reduce the number of alarms you get by adjusting your user settings.

For example, you can change your high and low alarm thresholds to levels that are appropriate for you. In addition, you can disable the "high glucose" alarm when you know you are going high. Another example is to adjust the time duration of the "snooze alarm" so that you receive fewer reminders. Other alerts can be avoided by taking action before they occur, such as doing your calibration on a regular schedule and keeping your transmitter within 2 metres of the insulin pump so that synchronisation is not lost.

You will still get alarms, but it is important to know that each alarm serves a meaningful purpose. You need to pay attention to the number and type of alerts you receive so that you can fine tune your settings and optimise your therapy.

How loud are the alarms? I'm a sound sleeper, will it wake me up while I sleep?

The alarm is loud enough to wake a person to take action. The system emits alarms of more than 50 decibels at 1 metre.

Sometimes when I enter a meter reading, the system displays a CAL ERROR. What is a CAL ERROR and what should I do when I get one?

A CAL ERROR happens when a meter reading vastly differs from a CGM reading. There are three main reasons this can happen:

  1. If you have an inaccurate meter reading, or a long delay between taking your fingerstick and entering your meter value into the CGM system, or if you use more than one blood glucose meter to calibrate

  2. If you calibrated when your glucose is changing rapidly – such as after a meal

  3. If there is something wrong with the sensor

If you get a CAL-ERROR, you should wait at least 15 minutes (or longer if you are in a circumstance of rapidly changing glucose values) before calibrating with a new meter reading. This will rule out whether the first meter value was accurate or not. And, if your glucose was changing rapidly, waiting awhile to calibrate allows your glucose to stabilise a bit so that does not cause another error.

If the new meter reading is still really different from the CGM reading, the sensor may need to be replaced. If this is the case, the system will display a second CAL-ERROR message, followed by a "SENSOR END" message. If this happens, you need to replace the sensor.

I wear a MiniMed Paradigm REAL-Time System and sometimes I get a WEAK SIGNAL or a LOST SENSOR message. What does this mean?

In order to receive signals, your transmitter and insulin pump must be within 2 metres of each other. If they are outside of this range, you may lose your signal. Sometimes if you are too close to certain devices, such as mobile phones, cordless phones, wireless networks, televisions and radios – they can interfere with your transmitter signal. If your signal is completely lost for about 45 minutes you will receive the LOST SENSOR message.

CALIBRATION

Does the MiniMed Paradigm REAL-Time System replace fingerstick measurements?

You still need to use your blood glucose meter to confirm a continuous glucose monitoring (CGM) reading before treating or to calibrate the CGM system.

Why do I have to calibrate?

Calibration is like buying a watch and setting the time for the first time. Glucose sensors are similar in nature. To initialise a glucose sensor, you need to enter a meter reading to give the system a starting point. And, just as a watch needs to be adjusted occasionally, so does a glucose sensor. You need to enter at least two meter readings a day – once every 12 hours. This aligns the glucose sensor with the meter so that continuous glucose monitoring (CGM) readings are representative of your blood glucose level.

How often do I have to calibrate the system?

The MiniMed Paradigm REAL-Time System must be calibrated a minimum of twice a day (once every 12 hours). This is done by entering a fingerstick value into the insulin pump. However for best results, the System should be calibrated 3 to 4 times per day, with the calibrations spread throughout the day at periods when glucose is not changing rapidly.

If I calibrate more often, will the glucose sensor be more accurate?

Not necessarily. The best practice is to calibrate 3 to 4 times per day. You need to spread your calibrations throughout the day.

When should I calibrate?

It is best to calibrate when your blood glucose level is not changing rapidly. We recommend that you calibrate on a routine schedule, for instance when you first wake up, before a meal, or before your bedtime snack. Try to find a time during the day when your blood sugar is stable. Make sure you do not calibrate when your blood sugar is changing rapidly, like within the first hour after a meal.

It is important to calibrate when glucose values are not changing rapidly (for example glucose is more stable before a meal. After a meal, it is more likely that glucose will change rapidly to adjust for the food being digested).

THERAPY MANAGEMENT SOFTWARE

What software can I use to download data from the MiniMed Paradigm REAL-Time System?

You are able to download data from the System using the Solutions® Software. It transforms insulin pump, CGM readings and meter data, as well as self-reported information, into a series of customised treatment reports. The software is available upon request for Medtronic pump users.

Is there software that will allow me to back-up my insulin pump settings?

Yes, ParadigmPAL™ 3.0 Software is available upon request for Medtronic pump users. It enables you to review, modify, back-up, and reprogram your insulin pump settings using a computer. It is currently only compatible with Windows 98SE, ME, 2000 and XP.

TRAVEL AND ENVIRONMENTAL EXPOSURE

Will MRI or X-ray equipment interfere with the system?

If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, please take off your insulin pump, transmitter, and sensor and remove them from the area.

Is the MiniMed Paradigm REAL-Time System affected by computers, mobile phones or airport detectors?

The MiniMed Paradigm REAL-Time System is designed to withstand common electromagnetic interference, including airport security systems.

Can I use the MiniMed Paradigm REAL-Time System on an airplane? Must I turn off the radio frequency during flight?

International standards regulations require that devices using radio frequency capabilities should not be used on an aircraft. As a result, you must disconnect the transmitter from the glucose sensor while travelling on an airplane; however you can continue using the insulin pump. It is not sufficient to simply turn the continuous glucose monitoring (CGM) feature off on the insulin pump, the transmitter will continue to transmit on the RF frequency and must be disconnected from the glucose sensor to stop.

While in flight, you need to manually test your glucose levels using a standard meter. When downloading data and reviewing historical reports, you will notice ‘data gap’ where information is missing during this period of time.

How do you turn off the transmission from the transmitter to the insulin pump?

The transmitter starts to transmit as soon as a sensor is connected to it. The transmitter will transmit even if the continuous glucose monitoring (CGM) feature is turned off on the insulin pump. Patients should physically disconnect the glucose sensor from the transmitter. If convenient, it is possible to leave the glucose sensor inserted in the skin.

Click Here for additional Travel Tips

AVAILABILITY...COLOURS...PRICE

Will my insurance cover the entire MiniMed Paradigm REAL-Time System? Private health insurance (hospital cover) will, in most circumstances, rebate the full cost of the pump. ‘Extras’ cover is not required. It is necessary to meet any requirements by the individual health funds relating to pre-existing illness and qualifying periods before being eligible for a rebate on an insulin pump. In addition, your policy may include an excess.

To ensure that you will not experience any out of pocket expenses when you are fitted with a pump it is advisable that you check with your private health insurer about your level of cover and the rebate they will provide for an insulin pump.

Members should also bear in mind that, under legislative changes which took effect on 1st January 2006, private health insurance is more portable as outlined below.

Portability – General Principles

According to the Department of Health press release (number ABB151/05) on 1st December 2005, Minister for Health and Ageing, Tony Abbot MHR stated that The Commonwealth Government has strengthened the protection for members of private health insurance funds. This will ensure policies remain fully portable.

Six fundamental principles cover portability are as follows:

  1. Health fund members are entitled to transfer their cover without penalty to another fund if they are in any way dissatisfied with the quality or range of their cover. This includes matters relating to the competence or quality of the service provided by their health fund or the price of their cover.

  2. The only qualifications on this entitlement, for hospital cover, are that:

    1. Normal waiting periods that apply at the time of transfer should be served out; and

    2. Any additional benefits that were not included in the old cover may be subject to a waiting period. (Differences in specific contractual or funding arrangements with individual health providers should not be regarded as additional benefit.)

  3. Benefit limitation periods in transferring members' cover are prohibited.

  4. A fund member has no obligation to give his or her fund reasons for his or her decision to transfer.

  5. There must be no discrimination against a transferring member by a receiving fund on the basis of his or her health status or degree of potential financial risk to the receiving fund.

  6. Health cover exists for the protection and benefit of patients, not providers or funds. Fund and provider self-interest must never be allowed to influence a person's decision about his or her health cover choices.

How can I get the MiniMed Paradigm REAL-Time System?

The MiniMed Paradigm REAL-Time System - consisting of the MiniMed Paradigm 522 and 722 insulin pumps with optional continuous glucose monitoring components – is available by prescription for purchase. Please contact your Healthcare Providers for more information.

What colours do the MiniMed Paradigm Insulin pump come in?

The Paradigm insulin pumps come in four colours:

  • Translucent Blue
  • Clear
  • Translucent Purple
  • Smoke

 

Does the MiniMed Paradigm insulin pump come with a remote?

Yes, the remote control is supplied with your pump upon request, and it is compatible with both the MiniMed Paradigm model 522 and 722 insulin pumps.