Post-market Review Products Used in the Management of Diabetes Report to Government Stage 2: Insulin Pumps February 2015


Appendices Appendix A – Information on insulin pumps available under the Prostheses List as at February 2014



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Appendices

Appendix A – Information on insulin pumps available under the Prostheses List as at February 2014


Model Name/No.

DANA IIS Insulin Pump

DANA R Diabecare Insulin Pump

Accu-Chek: Combo System

Medtronic Minimed Paradigm Veo MMT-554

Medtronic Minimed Paradigm Veo MMT-754

Animas: Vibe & CGM
System


Pump Sponsor/
Manufacturer


Managing Diabetes Pty Ltd / SOOIL Development CO. Ltd

Managing Diabetes Pty Ltd / SOOIL Development CO. Ltd

Roche Diagnostics Australia Pty Ltd

Medtronic Australasia Pty Ltd

Medtronic Australasia Pty Ltd

Australasian Medical & Scientific Pty Ltd/
Animas

Minimum Benefit on Prostheses List4

$4,000

$8,950

$8,950

$9,500

$9,500

$8,950

Main Function

Continuous insulin infusion pump with 300 unit reservoir.

Insulin infusion pump with an integrated blood glucose meter and remote control via Bluetooth communication. 300 unit reservoir.

Insulin infusion pump with remote control via the blood glucose meter. Meter includes integrated bolus advisor. 3.15 mL insulin unit reservoir and occlusion detection.

Insulin delivery, automatic adjusting, and with remote control. 180 unit reservoir.

Insulin delivery, automatic adjusting, and with remote control. 300 unit reservoir.

Insulin infusion pump (incl. sensor / transmitter).

CGM capable/ready

No

Yes

No

Yes

Yes

Yes

Basal increments (u/hour)

0.01 - 0.1

0.01 - 0.1

0.01 - 0.1

0.025 - 0.1

0.025 - 0.1

0.025

Max # of basal rate profiles

4

4

5

3

3

4

Temporary basal rate adjustments

0-200% for 1-12 hours

0-200% for 1-12 hours

0-250% in 10% increments, for 15 min - 12 hours in 15 min intervals (-500% via Configuration Software).

30 min – 24 hours

30 min – 24 hours

10% - 200% for 30 min – 24 hours

Max # of basal rate programmes / 24 hours

24

24

24

48

48

12

Extended or multiwave bolus available (to assist with irregular eating patterns)

Extended bolus (30 min - 8 hours)

Extended bolus (30 min - 8 hours)

Extended and multiwave bolus from 15 min - 12 hours (up to 50 hours via Configuration Software).

Extended (can be cancelled) and multiwave bolus.

Extended (can be cancelled) and multiwave bolus.

Combo bolus allows some insulin to be delivered immediately (normal bolus) and remainder over time (extended bolus).

Bolus algorithm

Variable bolus delivery speed (1 unit bolus duration: 12 - 56 seconds).

Bolus calculator using target blood glucose, correction factor and carbohydrate to insulin ratio. Also considers active insulin from calculations.



Variable bolus delivery speed (1 unit bolus duration: 12 - 56 seconds).

Bolus calculator using target blood glucose, correction factor and carbohydrate to insulin ratio. Also considers active insulin from calculations.



Fully customisable bolus calculator.
Bolus Advice function - considers 'active insulin', blood sugar level, carb intake, and additional variables such as exercise, stress, illness, premenstrual.

Allows different bolus dose rates to be set over a 24 hour period.

Active Insulin Onboard - Informs user of active insulin remaining from previous bolus.


Bolus Wizard(R) - suggests bolus dose based on personal settings, food intake and current blood glucose value.



Allows different bolus dose rates to be set over a 24 hour period.

Active Insulin Onboard - Informs user of active insulin remaining from previous bolus.


Bolus Wizard(R) - suggests bolus dose based on personal settings, food intake and current blood glucose value.



Calculate a bolus amount to cover the carbs in food (ezCarb).
Automatically calculate a correction dose of insulin based on the latest blood sugar reading (ezBG).

The “Insulin on Board”* feature tracks active insulin in the body to help prevent hypoglycaemia due to “stacking” (unnecessary additional insulin).



Additional features

Not available

Blood glucose measurement in remote controller.

Bluetooth communication to Android mobile phone. Can utilise the mobile phone for all pump settings and to discreetly deliver boluses.



Blood glucose meter can be used to remotely control pump and has colour display, logbook, trend graphs, target report, and standard week and standard day reports.
Date reminders (e.g. infusion set change) and alarm clock reminders (up to 8 per day).

Activity guard available to protect the pump from disconnecting.

CGM using 6-day disposable sensors connected to transmitter. Transmitter provides readings to pump at 5-minute intervals.




Activity guard available to protect the pump from disconnecting.

CGM using 6-day disposable sensors connected to transmitter. Transmitter provides readings to pump at 5-minute intervals.




High-contrast colour screen.

Trends and rates.

CGM with Animas® Vibe™ is only indicated for patients 18 years or older.


Safety - Maximum Qty delivered at a single fault condition

Customisable for patient doses.

Customisable for patient doses.

Maximum bolus – customisable to 25U (50U via Configuration Software).

Maximum basal rate – customisable to 62.5U/h (250U via Configuration Software).

Max qty delivered at a single fault ≤1.0 units.


Maximum Bolus – customisable to 75U.

Maximum Basal Rate – customisable.

Maximum Delivery Exceeded – to prevent multiple small boluses within one hour.


Maximum Bolus – customisable to 75U.

Maximum Basal Rate – customisable.

Maximum Delivery Exceeded – to prevent multiple small boluses within one hour.


Maximum prime dose is 20U. Total Daily dose is set by patient. A maximum 2 hour dose limit is set. Bolus & basal limits are user selected.

Response to single fault condition depends on circumstances.



Safety lock to prevent accidental insulin delivery

Button-Lock mode to prevent unintended operation.

Button-Lock mode to prevent unintended operation.

Key lock function and automatic shutdown (customisable 1-24 hours, 1 hour steps).

Child block - disables buttons to prevent accidental delivery.

Keypad lock – prevent accidental button pressing.



Child block - disables buttons to prevent accidental delivery.

Keypad lock – prevent accidental button pressing.



Tamper resistant "Locked" feature.

Alerts

Audible reminders of bolus insulin/carbohydrate ratio for certain periods - post meal.

Low battery, low reservoir, occlusion.



Audible reminders of bolus insulin/ carbohydrate ratio for certain periods - post meal.

Low battery, low reservoir, occlusion.



Audible and vibration notifications of blood glucose test reminders*, infusion set change, errors and occlusion in infusion set.

Low battery, battery empty, low reservoir, reservoir empty, automatic off, temporary basal rate over, bolus cancelled, mechanical error, electronic error, bluetooth fault, power interrupt, infusion set not primed, cartridge error, data interrupted, end of warranty.

High/low blood glucose*.


High and Low Glucose, Predictive, rate of change, and trend arrows alerts*.

Low Glucose Suspend alerts – will suspend delivery for a maximum of 2 hours in times of hypoglycaemia when user does not respond to alert*.

Auto Off – alert and Suspend feature when no button has been pressed for a pre-determined duration of time.
Low battery, low reservoir.
Missed meal bolus reminder.

Alerts with * available only with pump and glucose monitor turned on.



High and Low Glucose,

Predictive, rate of change and trend arrows alerts*.


Low Glucose Suspend alerts – will suspend delivery for a maximum of 2 hours in times of hypoglycaemia when user does not respond to alert*.

Auto Off – alert and Suspend feature when no button has been pressed for a pre-determined duration of time.


Low battery, low reservoir.
Missed meal bolus reminder.

Alerts with * available only with pump and glucose monitor turned on.



High/low blood glucose*.

Turnaround time for back-up or loan pump and other customer service features

Loan pumps are available 24/7 in Sydney, Brisbane, Newcastle, Coffs Harbour and Victoria. Outside these centres it is likely to be a next business day courier.

Free batteries for the life of the pump.



Loan pumps are available 24/7 in Sydney, Brisbane, Newcastle, Coffs Harbour and Victoria. Outside these centres it is likely to be a next business day courier.

Pump comes with batteries incl. Free batteries with every box of reservoirs.



Replacement pump if standard pump is not functioning.

Next working day delivery for metropolitan areas.

2-3 day delivery for regional areas.


For loan pump, dispatch is within 24 hours of receiving written notification and delivery within a further 24-48 hours.

For other situations (e.g. pump needed for travel) turn-around time is dependent on patient requirements.



For loan pump, dispatch is within 24 hours of receiving written notification and delivery within a further 24-48 hours.

For other situations (e.g. pump needed for travel) turn-around time is dependent on patient requirements.



Faulty product in replaced within 2 business days.

Training support (user manual, online training)

User manual and online demonstration, pre-pump training and support.

User manual and online demonstration, pre-pump training and support.

Pump experts provide pre-pump faced to face training. User manuals and handbooks. Quick reference guides.

Online training tool with animation and quizzes. Video demos showing how to set basal rates and use the pump.



 User manuals are available online. Online learning modules are available for patients.

 User manuals are available online. Online learning modules are available for patients.

Training provided by company personnel. Diabetes Educators and user manual provided.

Freecall 24 Hour Hotline

Yes

Yes

Yes

Yes

Yes

Yes

Repair/replacement policy

Any impact damage may be deemed as negligent and the manufacturer can decline warranty repair.

Any impact damage may be deemed as negligent and the manufacturer can decline warranty repair.

Faulty pumps are replaced and not repaired.

Repair or replace. Does not cover dropping, improper storage or submersion in water.

Repair or replace. Does not cover dropping, improper storage or submersion in water.

Faulty pumps are replaced and not repaired.

Warranty length

4 years

4 years

4 years

4 years

4 years

4 years

Product Recalls and Safety Alerts

Nil

Nil

Roche Alert with TGA 24 October 2013
Software synchronization issue with ACCU-CHEK Combo system. In rare cases, when the “Manual Pump” option is chosen on the ACCU-CHEK Aviva Combo meter, there is a possibility of receiving an incorrect bolus advice recommendation that may cause a temporary under delivery of insulin.

The product was not physically recalled.



TGA Medtronic paradigm insulin pump Safety Advisory 10 April 2013
Three rare issues required update of information manual only:
- Loose drive support cap (may deliver too much insulin if pushed)
- Sensor graph timeout (can delay re-start of insulin following a low glucose suspension)
- water damage (can stop the pump working if immersed)

The product was not physically recalled.



TGA Medtronic paradigm insulin pump Safety Advisory 10 April 2013
Three rare issues required update of information manual only:
- Loose drive support cap (may deliver too much insulin if pushed)
- Sensor graph timeout (can delay re-start of insulin following a low glucose suspension)
- water damage (can stop the pump working if immersed)

The product was not physically recalled.



Nil

Waterproof

3m for 24 hours (IPX8)

3m for 24 hours (IPX8)

2.5m for 1 hour

IPX7, rated water resistant.

IPX7, rated water resistant

3.6m for 24 hours

External software that links to device

No

DANA manager program (PC): download records of bolus, daily total, blood glucose and carbohydrate from insulin pump to PC and upload records to ubiquitous system server.

Supported by AccuCheck 360 Diabetes Management Software. Also supported by Accu-Check Pump Configuration Software for programming and upload of settings.

Medtronic CareLink® software allows insulin pump, CGM and blood glucose meter data to be uploaded to a secure online server and generate reports. Data can also be shared with healthcare providers remotely.
Can receive readings from meters with wireless technology.

Medtronic CareLink® software allows insulin pump, CGM and blood glucose meter data to be uploaded to a secure online server and generate reports. Data can also be shared with healthcare providers remotely.
Can receive readings from meters with wireless technology.

Diasend software, a customisable food database for accurate carbohydrate counting.

Remote control available

No

Yes

Yes – through blood glucose meter with full range of additional functions.

Yes - to deliver bolus and to suspend pump.

Yes - to deliver bolus and to suspend pump.

No

Data transfer to/from blood glucose meter

Not available

From blood glucose meter via radio frequency.

Two-way Bluetooth between the Spirit Combo pump and Performa Combo Blood Glucose Meter.

Data transferred from blood glucose meter via radio frequency.

Data transferred from blood glucose meter via radio frequency. 

Diasend software food database upload into pump.

Range of carrying devices and pouches

Leather case, bra pouch, shower pouch, shoulder pouch.

Leather case, bra pouch, shower pouch, shoulder pouch, outer case, travel case and transparent case.

Various cases including bra and leg pouches.

Range of pouches and carrying devices available.

Range of pouches and carrying devices available.

Range of pouches and carrying devices available.

Personalisation (colours/skins)

Five colour options.

Five colour options.

One colour and thirty 'skins' available.

Five colour options and five 'skins'.

Five colour options and five 'skins'.

Five colours available and protective skins


Notes: *Requires use of continuous glucose monitoring.

Information in this table was initially gathered from publicly available sources. The relevant pump manufacturers/sponsors were then given the opportunity to provide any corrections or additional information.



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