DOCUMENT 14 FOI 24/25-0889
Research – Feasibility of NDIS providing insulin pumps as a way to reduce expensive nursing supports as well as optimising the independence of participants
Date April 23, 2021
[s47F - personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Craig ‐ Senior Technical Advisor (TAB) Requester(s) s47F - personal p Julie – Assistant Director (TAB)
s47F - person Researcher Craig ‐ Tactical Research Advisor (TAB/AAT)
s47F - personal priv Cleared Jane ‐ Research Team Leader (TAB)
Research Brief
Research into the suitability of insulin pumps for NDIS participants.
The participants that might benefit from this technology would be insulin dependent diabetic participants who require nursing support for daily checking of BGL’s and insulin administration who have the cognitive ability to access this technology (e.g. amputees)
I would like to investigate the feasibility of NDIS providing insulin pumps possibly as a way to reduce the expensive nursing supports as well as optimising the independence of participants.
Cost of pumps, types of pumps, do they differ and what features do they offer?
What is the anticipated lifespan of pumps, do they require ongoing review and intervention to keep running – who is the likely person/party to do this?
Is there other technology which is required to use the device – i.e. do you need a smart phone or watch to use the device? Cost of consumables – how does this compare to administration via needles?
Do any other systems fund consumables with pumps? What is the estimated annual cost of consumables?
Other notes from requester: Many of our participants require assistance with checking BGL’s and administering insulin. Currently we receive multiple requests for nurses to help manage diabetes (BGL checking and insulin administration. These seem to average 1 ‐2 hours per day. These are very expensive supports, often costing in the 10s of $1000’s for what is a relatively simple procedure. Technology has improved (e.g. these devices can now communicate with remote devices) however the price of these devices has remained around the $5000 ‐ $7000 mark. I personally believe that these devices, matched to the right participant will not only save money but will provide more independence and freedom (i.e. not having to be in the same place every day waiting for a nurse). It is a relatively simple procedure to insert the catheter…the device sits on the belt like a pager with a subcutaneous catheter in the abdomen. Insulin pumps have been shown to offer increased flexibility, improved glucose levels and improved quality of life. I also accept that insulin pumps are not suitable for all of our participants who require assistance, as they require cognitive input and a little motivation.
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Insulin pumps have been particularly effective in the following situations:
• hypoglycaemia unawareness (inability to detect ‘hypos’) • severe and frequent hypoglycaemia • frequent night time hypoglycaemia • gastroparesis (delayed emptying of the stomach) • an unpredictable lifestyle or daily routine (e.g. working nightshifts) • extreme insulin sensitivity • dawn phenomenon (rising blood glucose early in the morning) • planning for, and during, pregnancy.
Please note:
The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision‐making.
Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.
The Research Team are unable to ensure that the information listed below provides an accurate & up‐to‐date snapshot of these matters.
1 Contents
2 Summary ……………………………………………………………………………………………………………………….. 4
3 What is an Insulin Pump ………………………………………………………………………………………………….. 5
3.1 Overview ………………………………………………………………………………………………………………… 5
3.2 How they work ………………………………………………………………………………………………………… 5
3.2.1 Overview …………………………………………………………………………………………………………. 5
3.2.2 Automatic Insulin Pumps / Smart Pumps [4] ………………………………………………………… 6
4 Advantages and disadvantages of Insulin Pumps as opposed to multiple daily injections ………… 6
4.1 Advantages ……………………………………………………………………………………………………………… 6
4.2 Disadvantages …………………………………………………………………………………………………………. 7
4.3 Australian Insulin Pump User Data …………………………………………………………………………….. 8
5 Types and Features of Insulin Pumps ………………………………………………………………………………… 9
5.1 Types ……………………………………………………………………………………………………………………… 9
5.2 Features ……………………………………………………………………………………………………………….. 10
5.3 Insulin Pump products available in Australia ……………………………………………………………… 11
6 Continuous Glucose Monitoring Systems and Insulin pumps …………………………………………….. 11
6.1 Overview ………………………………………………………………………………………………………………. 11
6.2 Types of continuous glucose monitoring systems ………………………………………………………. 12
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6.3 Continuous glucose monitoring system products available in Australia ………………………… 12
7 Other technology and equipment required to use an insulin pump or continuous glucose monitoring systems ………………………………………………………………………………………………………………. 13
8 Evidence‐Based Clinical Guidelines for Diabetes and Insulin Pumps ……………………………………. 13
9 Cohorts suitable for insulin pump use ……………………………………………………………………………… 15
9.1 Overview ………………………………………………………………………………………………………………. 15
9.2 Cognitive, Visual and Hearing Impairments ……………………………………………………………….. 16
9.3 Prescription of Insulin Pumps and Continuous Glucose Monitoring Systems …………………. 17
10 Funding schemes for Insulin Pumps, Continuous Glucose Monitoring Systems and Consumables ……………………………………………………………………………………………………………………….. 17
10.1 Insulin Pumps ………………………………………………………………………………………………………… 17
10.1.1 Australian Government’s Insulin Pump Program ………………………………………………… 17
10.1.2 Health Insurance …………………………………………………………………………………………….. 17
10.1.3 Medtronic Bridging the Gap Program ………………………………………………………………… 18
10.2 Continuous Glucose Monitoring System …………………………………………………………………… 18
10.2.1 National Diabetes Services Scheme (NDSS) ………………………………………………………… 18
10.3 Consumables …………………………………………………………………………………………………………. 19
10.3.1 National Diabetes Services Scheme …………………………………………………………………… 19
10.3.2 Medtronic Pump Consumables Grant………………………………………………………………… 19
11 Lifespan, warranty, maintenance, upgrade and service of Insulin Pumps …………………………. 19
11.1 Lifespan ………………………………………………………………………………………………………………… 19
11.2 Warranty ………………………………………………………………………………………………………………. 19
11.3 Maintenance, Upgrade and Service ………………………………………………………………………….. 20
12 Insulin Pump Users and Health Professional Support and Training ………………………………….. 21
13 Costs of Insulin Pumps and Continuous Glucose Monitoring Systems ………………………………. 21
13.1 Insulin Pumps and consumables ………………………………………………………………………………. 21
13.2 Continuous Glucose Monitoring Systems and consumables ………………………………………… 21
14 Cost Effectiveness of Insulin Pumps as opposed to Multiple Daily Injections …………………….. 22
15 Cost of nursing supports in providing daily insulin administration and checks …………………… 22
15.1 Multiple Daily Injections by Nurse or Support Worker? ‐ NDIS Practice ………………………… 22
15.2 Approximate cost per annum for support ‐ Nurse ……………………………………………………… 23
15.3 Approximate cost per annum for support – Support Worker ………………………………………. 24
16 Cost savings between the use of Insulin Pumps and Nursing Supports …………………………….. 25
17 Other cost considerations …………………………………………………………………………………………… 26
18 Conclusion ………………………………………………………………………………………………………………… 26
19 References ……………………………………………………………………………………………………………….. 27
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2 Summary
Insulin pumps are more cost effective than providing nursing supports. However, the participant’s functional capacity to use an insulin pump would need to be assessed.
If a participant who would normally require 2 daily support visits for insulin administration (Multiple Daily Injections (MDI)), were to use an automated insulin pump with continuous glucose monitoring, over a 12 month period a saving of $47,703 can be achieved if an enrolled nurse was initially used for the MDI, or a saving of $28,627 if a support worker was initially used for the MDI.
Advantages of insulin pumps as opposed to multiple daily injections (MDI) appear to outweigh the disadvantages.
There are a variety of insulin pumps by different manufacturers available on the market. All pumps work in the same basic manner but vary in specific functions and features.
Continuous Glucose Monitoring Systems (CGMS) which measure glucose levels continuously, can be worn as a separate device to the pump, or may be combined within the pump as a single device unit.
Both insulin pumps and CGMS require consumables.
Insulin pumps and CGMS may require other technology and equipment for their use, such as a mobile phone and internet access.
Insulin pumps may not be suitable for those with cognitive or visual impairments.
For diabetes type 1, evidence‐based guidelines recommend the use of insulin pumps rather than MDI, automated pumps rather than non‐automated pumps, and CGMS rather than self‐monitoring of blood glucose levels (BGL).
Evidence‐based guidelines suggest choice of technology type is highly dependent on personal preference and users should discuss suitability with their health professional.
Insulin pumps are covered by gold tier private health insurance. The Australian Government’s Insulin Pump Program offers subsidies to children with type 1 diabetes from low income families.
Consumables for insulin pumps are subsidised by the National Diabetes Services Scheme (NDSS) at around 91% of cost to the user.
Lifespan of insulin pump devices and CGMS could not be determined. Warranty periods for insulin pumps by all TGA approved devices is four years. Insulin pumps and CGMS appear to
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not require servicing and maintenance is covered under warranties.
Cost of insulin pumps range from $8950 to $9500 depending on the type and brand.
3 What is an Insulin Pump
3.1 Overview
Insulin pump therapy is also known as continuous subcutaneous insulin infusion (CSII) therapy [1]. In Australia, insulin pumps are almost entirely used for the management of people with type 1 diabetes. In the USA, in addition to those with type 1 diabetes, there are a significant number of people with type 2 diabetes who use insulin pumps [2].
An insulin pump is a small battery‐operated electronic device that holds a reservoir of insulin. It is about the size of a mobile phone and is worn 24 hours a day. The pump is programmed to deliver insulin into the body through thin plastic tubing known as the infusion set or giving set. The pump is worn outside the body, in a pouch or on a belt. The infusion set has a fine needle or flexible cannula that is inserted just below the skin where it stays in place for two to three days [3].
3.2 How they work
3.2.1 Overview
Only fast acting insulin is used in the pump such as NovoRapid® and Humalog®, therefore replacing the need for long‐acting insulin such as Lantus®, Levemir® or Protophane® [4]. Whenever food is eaten the pump is programmed to deliver a surge of insulin into the body, similar to the way the pancreas functions in people without diabetes [3]. Between meals a small and steady rate of insulin is delivered [3]. The pump delivers insulin continuously (basal) and on demand (bolus) to account for carbohydrates in meals or high BGLs [4]. A small motor inside the pump controls the delivery of insulin. Insulin is delivered from the reservoir/cartridge through flexible tubing fitted with a small Teflon® (or metal) cannula that is inserted subcutaneously (under the skin) and held in place with special adhesive tape [4]. Together, the tubing and cannula are called an infusion set. The cannula is easily inserted and removed by the user; it is not surgically implanted [4]. An introducer needle allows the cannula to be inserted under the skin. The needle is then removed leaving behind the cannula only [4]. For users who do not want to insert the needles manually, there are disposable and reusable devices to assist with cannula insertion [4]. The cannula must be changed every two to three days. Metal cannulas may need to be changed every one to two days [4]. The most common site to place infusion sets is in the abdomen (easy to access) but they can also be placed in the upper buttock, upper outer thigh, hip or upper arm [4].
The image below shows how the MiniMed 770G Insulin Pump provides insulin to the body [5].
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3.2.2 Automatic Insulin Pumps / Smart Pumps [4]
Most pumps will calculate the insulin dose for each meal or snack based on the insulin to carbohydrate ratio programmed into the pump. This ratio is calculated with the user’s diabetes educator or endocrinologist. The user needs to know the carbohydrate content of the meal or snack they intend to eat so that you can enter the amount of carbohydrate into the pump. The pump will calculate the insulin dose required for the meal. ‘Smart pumps’ can also add a correctional bolus of insulin at this time if user’s pre‐meal BGL is out of the target range. Although it is possible to rely on a ‘smart pump’ to calculate the insulin dose required, it is important that the pump user understands the basis of the calculation so that the dose recommended by the pump can be verified.
4 Advantages and disadvantages of Insulin Pumps as opposed to multiple daily injections
4.1 Advantages
Unlike insulin pens or injections, data can be uploaded from most insulin pumps via web‐ based software. The data relating to glucose concentrations and insulin delivery can be
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reviewed by the health professional in conjunction with the patient [2].
Meta‐analyses and randomised controlled trials have reported improvements in glycaemic control using insulin pump therapy compared to multiple daily injections [2, 6]. These include reductions in blood glucose, reduced hypoglycaemia (both frequency and severity), lower glycated haemoglobin (HbA1c), lower insulin requirements, and improved quality of life [2].
Provides insulin delivery that better mimics normal pancreatic function [2].
Uses rapid‐acting insulin only and minimises glucose peaks and absorption‐related variability [2].
Built‐in bolus algorithms to suggest bolus doses based on user‐estimated carbohydrate content and blood glucose [2].
Increased flexibility with day‐to‐day activities e.g. exercise, mealtimes, travel, shift work [2].
Can be integrated with continuous glucose monitoring to provide real‐time glucose information [2].
Potential for advanced features e.g. low‐glucose suspend, predictive low‐glucose suspend [2].
4.2 Disadvantages
External device attached to the body 24 hours a day [2].
Potential for mechanical malfunction such as blockage or kinking in the infusion set which can lead to diabetic ketoacidosis [2].
Potential for insertion site problems such as skin infections or local irritation [2].
Need to learn how to carbohydrate count prior to using a pump [7].
May require a full day of training to use the pump [7].
High cost and limited access for uninsured patients [2].
Patients have to be willing and able to manage the technology [2].
Requires motivation, regular blood glucose checking, and the willingness to keep in regular contact with diabetes educator or endocrinologist for review and adjustment of pump rates [3].
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4.3 Australian Insulin Pump User Data
The most recent information regarding the number and characteristics of people using insulin pumps in Australia, is a 2011 report by the Australian Institute of Health and Welfare (AIHW) examining the use of insulin pumps by people with Type 1 diabetes. Findings were based on administrative data supplied by Diabetes Australia and data from the Insulin Pump User Survey, conducted by the AIHW [1].
The AIHW survey resulted in the advantages indicated by respondents as follows. Further details of the survey are in the table below [1].
86% indicated that it fitted in with their lifestyle. The other important benefits were the achievement of better diabetes control (83%). Relocating a cannula was better than having several daily injections (76%). It was convenient (71%). 29% of respondents considered that they had benefited through a greater awareness of their low blood sugar levels.
The AIHW survey resulted in the disadvantages indicated by respondents as follows. Further details of the survey are in the table below [1].
On the whole, survey respondents did not consider they had many problems with their insulin pumps, with an average of one problem selected by each respondent. When compared with the
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average of five beneficial factors indicated by each respondent, this figure emphasises the level of satisfaction of most insulin pump users [1].
The biggest issue for insulin pump users was the cost of the pump with 32% of respondents indicating that they were too expensive. 16% had problems with relocating the cannula or tubing. 15% did not like wearing an insulin pump. Pump breakdown was considered a problem for 6% of respondents.
5 Types and Features of Insulin Pumps
5.1 Types
There are two types of pump devices [8]:
- Traditional Insulin pumps have an insulin reservoir (or container) and pumping mechanism, and attach to the body with tubing and an infusion set. The pump body contains buttons which allow the user to program insulin delivery for meals, specific types of basal rates, or suspend the insulin infusion, if necessary.
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- Insulin patch pumps are worn directly on the body and have a reservoir, pumping mechanism, and infusion set inside a small case. Patch pumps are controlled wirelessly by a separate device that allows programming of insulin delivery for meals from the patch.
Many pumps connect wirelessly with blood glucose meters, which measure blood sugar levels using a drop of blood from your fingertip. Some pumps connect wirelessly with continuous glucose monitoring devices, which are inserted under the skin and monitor blood sugar levels all day long [8].
5.2 Features
There are a variety of insulin pumps by different manufacturers on the market. All pumps work in the same basic manner but will vary in their specific functions and features. Following is a summary of functions and features available on insulin pumps [4]:
Calculating insulin
Pumps calculate the amount of insulin required to cover the carbohydrate eaten (using rates set by your diabetes educator or endocrinologist). Pumps also calculate the insulin dose required to correct any high BGL entered in the pump that is outside the users target range.
Tracking active insulin
Pumps have a feature that prevents the user from ‘stacking’ or giving too much insulin. When the user enters their BGL and carbohydrate intake, the pump will calculate the dose required after considering the insulin still active or ‘on board’ from a previous bolus. This may assist with avoiding hypos.
Bolus types
Pumps can be programmed to deliver a meal bolus in different ways. A meal bolus may be delivered, for example, over a period of two hours rather than all at once. These different bolus types can make eating a variety of foods and eating out much easier.
Insulin delivery
Pumps vary in the increments of the basal rate and bolus dose that can be delivered. If the user has a very small total daily dose of insulin or is very insulin sensitive (e.g. small children) then small delivery doses will be important.
Insulin reservoir/cartridge size
The reservoir/cartridge size varies between pumps, so depending on the user’s daily dose of insulin some pumps will be more suitable than others.
Infusion sets
Not all infusion sets are suitable for everybody. Some people with very little subcutaneous fat will need a different type of infusion set to those with more. Some people have skin sensitivities so will require a set with little tape in contact with the skin.
Insertion devices
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Some infusion sets have an insertion device that assists the user to insert the cannula with its introducer needle. This can make infusion set changes much easier, especially for children.
Computer software
All pumps have software that allows the user to upload pump activity into a program that can analyse the data. The program can save the data in a format that makes it suitable for sharing electronically with diabetes health professionals.
Food database
Pumps with a food database allows the user to store the carbohydrate content of a large range of foods that they commonly eat for easy reference.
Water resistance
Some pumps are splash resistant and others are waterproof to certain depth specifications.
Continuous glucose monitoring systems
Some pumps are continuous glucose monitoring system (CGMS) ready, and can display real‐time glucose information on the monitor. Some can automatically halt insulin delivery for a couple of hours if the system detects that the user’s glucose level has fallen below a pre‐set threshold and they do not respond. CGM can be useful especially at night when the user is asleep.
5.3 Insulin Pump products available in Australia
As of December 2020, the following six pumps could be purchased through private health insurance in Australia [9]. A regularly updated list of TGA approved pumps can be found on the department of health prosthesis list [10] .
Accu‐Chek Combo Accu‐Chek Solo Tandem t:slim X2 YpsoPump Medtronic 670G, Medtronic 770G
There are also older model pumps still available for purchase [9]:
Medtronic 640G Medtronic Paradigm and Veo DANA R and RS
6 Continuous Glucose Monitoring Systems and Insulin pumps
6.1 Overview
CGMS is a means of measuring glucose levels continuously in order to gain insight into patterns and
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trends in glucose levels throughout the day and night. A CGMS sensor is worn separately to the pump, inserted under the skin, and measures the level of glucose in the interstitial fluid (fluid in the tissue). The sensor is disposable and changed according to manufacturer recommendations [4].
The image below shows the CGMS used in conjunction with the insulin pump [2].
6.2 Types of continuous glucose monitoring systems
Currently there are two types of CGMS products available in Australia [4]:
-
One type of CGMS product includes a sensor and a separate unit of similar appearance to a normal blood glucose meter (worn separately in a similar fashion to a pump). This type does not communicate with the pump and, therefore, can be used by people who do not have an insulin pump (those on multiple daily injections) or who use an insulin pump that does not include continuous sensing.
-
The other type of CGMS product combines CGMS with an insulin pump. A sensor and an attached transmitter are worn separately to the pump and transmit glucose levels to the insulin pump (not a separate unit) via radio frequency.
More recent advances in technology have allowed for insulin pumps to automatically shut off insulin delivery for two hours in the event of hypoglycaemia (‘low‐glucose suspend’) or predicted hypoglycaemia (‘predictive low‐glucose suspend’) [2].
6.3 Continuous glucose monitoring system products available in Australia
Diabetes Australia suggest that there are several continuous glucose monitoring systems available in Australia [11]. These include:
Dexcom G5 MiniMed 640G
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Medtronic 670G Guardian Connect CGM
7 Other technology and equipment required to use an insulin pump or continuous glucose monitoring systems
Internet connection
Depending on the type of insulin pump an internet connection is required. The pump will have connectivity via a mobile phone app which will alert the use of their BGL via mobile phone notifications.
Mobile Phone and phone application
Depending on the type of insulin pump, and the need to alert BGL to the user, the user will require a mobile phone with internet connectivity, with a mobile phone application installed.
Computer and Software
To view and monitor the progress of the users pump therapy, a software application will need to be installed on the user’s computer which will need an internet connection. The user will attach a USB type device into the computer to upload the data to produce reports which can be accessed by the user and the user’s health professional [12‐14].
Consumables
Various consumables are required for the pump and CGMS. For pumps these include: serters, insulin reservoir cartridges and infusion sets [15]. For CGMS these include: sensors, transmitter and serters [16].
Accessories
There are various optional accessories available from manufactures including mini storage charging units, equipment cases, silicone pump case, bra pouches, waste pouches, and waist bands [17].
8 Evidence-Based Clinical Guidelines for Diabetes and Insulin Pumps
For type 1 diabetes, the Australian Evidence‐Based Clinical Guidelines for Diabetes (V1.2 published 27/11/20) [18] recommends:
Insulin pumps over the use of MDI for children, adolescence and adults.
Automated insulin pumps rather than non‐automated pumps to optimise glycaemia for children, adolescents and adults.
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CGM devices rather than self‐monitoring of blood glucose alone for all adults treated with multiple daily injections.
The guidelines were generated as a result of collaboration between the Australian Diabetes Society, the Australian Diabetes Educators Association, the Australasian Paediatric Endocrine Group and Diabetes Australia, with representation from the Royal Australian College of General Practitioners, the Australian Government Department of Health and Cochrane Australia (the Australian Living Evidence Consortium) [18].
The purpose of the guidelines are to provide an up‐to‐date, evidence‐based resource that health professionals and people living with diabetes can use to guide shared decision making in the treatment of diabetes [18].
When addressing medical device technology for the management of type 1 diabetes, the guidelines addressed the following clinical questions [18]:
Should you use continuous glucose monitoring (CGM) with/without alerts or self‐monitored blood glucose (SMBG) alone in conjunction with MDI in adults?
Should you use CSII pumps (with or without continuous glucose monitoring) or MDI (with or without continuous glucose monitoring) in children, adolescents and adults?
Should you use non‐automated CSII pumps with CGM (including low‐glucose insulin suspend systems), or automated CSII pumps with closed‐loop systems in children, adolescents and adults?
Below is a table with a brief summary of the recommendations contained in the guidelines. The guidelines gave “Conditional Recommendations” for all of the clinical questions. A conditional recommendation is given when it is considered that the benefits of the intervention are greater than the disadvantages, or the available evidence cannot rule out a significant benefit of the intervention while assessing that the adverse effects are few or absent. This recommendation is also used when people with diabetes’ preferences vary [18].
With reference to the recommendations, the guidelines comment that:
The choice of what technology type to use is highly dependent on personal preference. Health professional discussions with people with type 1 diabetes should include:
o The use and potential benefits of the technology type and considerations of personal preferences. o The value of the different options, available resources, and the importance of high level engagement with the technology and health services.
Conditional Treatment Remark Recommendation
Insulin Pumps ‐ We suggest CSII or MDI CSII improves glycaemia (lowers HbA1c) which could ultimately lead Children and treatment for children to decreased microvascular complications. However, there is a Adolescent and adolescents with paucity of studies examining the long term impact of CSII on
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Conditional Treatment Remark Recommendation
(CSII) type 1 diabetes based on microvascular complications, diabetic ketoacidosis, mortality and the preference of the quality of life. There is also little current evidence to demonstrate person with diabetes that CSII decreases weight. Variation in preference for CSII is (and carer). anticipated in light of the higher treatment intensity required and costs associated with its use to manage type 1 diabetes.
Insulin Pumps ‐ We suggest CSII rather CSII improves glycaemia (lowers HbA1c) which could ultimately lead Adults than MDI treatment for to decreased microvascular complications. However, there is little adults with type 1 current evidence examining the impact of CSII on microvascular (CSII) diabetes based on the complications, diabetic ketoacidosis, and mortality. There is also preference of the person little current evidence to demonstrate CSII decreases severe with diabetes. hypoglycaemia and weight gain or improves quality of life. Variation in preference for CSII is anticipated in light of the higher treatment intensity required and costs associated with its use to manage type 1 diabetes.
Insulin Pumps ‐ We suggest AutoCSII AutoCSII technologies are relatively new, with the first randomised Automated treatment rather than clinical trial being reported in 2014, and are distinct to previous non‐automated CSII nonautomated CSII systems which function solely using manual (Automated treatment to optimise insulin pump settings with or without suspension of basal insulin in continuous glycaemia for children, response to actual or predicted low glucose (also known as subcutaneous adolescents and adults ‘(Predictive) Low Glucose Suspend’ systems). Use of AutoCSII results insulin infusion with type 1 diabetes in further improvements to glycaemia compared to non‐automated (AutoCSII)) CSII. It was not possible to evaluate the age groups separately as most trials incorporated people across both paediatric and adult age ranges. The generalisability of benefits from AutoCSII to children under six years old is limited given the lack of evidence in this young group. It is anticipated that future AutoCSII systems may use more refined automated insulin delivery algorithms (including automatic bolus delivery in addition to automatic basal delivery) and potentially dual hormone treatment (e.g. insulin and glucagon).
CGMS We suggest CGM rather CGM devices provide a large amount of real‐time data and summary than self‐monitoring of glycaemic data (e.g. modal day reports) which can be highly valuable blood glucose alone for for both the person with diabetes and their healthcare providers. all adults with type 1 Higher proportions of time spent actively using and responding to diabetes treated with CGM data are consistently associated with glycaemic improvements multiple daily injections. such as lower HbA1c concentrations and increased time within an appropriate glucose range (3.9‐10.0 mmol/L). A conditional recommendation for use of CGM in type 1 diabetes was based on low‐moderate certainty of evidence for favourable outcomes.
9 Cohorts suitable for insulin pump use
9.1 Overview
Diabetes Australia suggest that pump therapy “is not a cure for people who require insulin to manage their diabetes but a way of delivering insulin”, and that the therapy is not suitable for everyone, and its use should be first discussed with a doctor or credentialed diabetes educator [3]. The Australian Evidence‐Based Clinical Guidelines for Diabetes stresses that health professional discussions with people with type 1 diabetes should include the importance of high level engagement with the technology and health services with regard to the use of insulin pumps [18].
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Diabetes Australia suggests that insulin pump therapy is not recommended for people who [4]:
Are not performing or are not willing to perform frequent blood glucose checks. Are not willing or able to calculate the amount of carbohydrate in meals and snacks. Are not able to detect air bubbles in the infusion line (vision impaired). Are not able to hear the alarms (hearing impaired), although most modern pumps have a vibration alarm as well as an audible alarm. Are not able to press the buttons on a pump (e.g. severe arthritis). Are not able to manage possible problems which may arise, including site infections and blocked lines. Are not willing or able to keep in regular contact with their diabetes educator or have regular reviews by their endocrinologist. Are in any way unable to manage the pump functions.
9.2 Cognitive, Visual and Hearing Impairments
Literature sourced suggests that those with cognitive, visual or hearing impairments may have difficulty using insulin pump technology.
Cognitive impairment is a common, underdiagnosed complication of diabetes that can interfere with the ability to adequately perform required daily self‐management behaviours [19]. Insulin pumps may be appropriate for these cohorts if the caregiver is available and well educated in its use [19]. A system that stresses a user’s visual and cognitive abilities can generate use‐related errors which have a negative impact on usability. For example, programming a standard bolus into the pump to deliver insulin in anticipation of an impending consumption of carbohydrates through food intake should consist of a task sequence that can easily be learned and remembered. In insulin pump therapy, it is a task that precedes several daily events that require a user to calculate the amount of carbohydrates to be consumed. The amount then needs to be entered into the programming interface to prompt the system to deliver additional insulin to equalize blood glucose to a pre‐set normal level. Any system constraint during such a common procedure can lead to use‐related errors that affect the accuracy of insulin therapy for a patient [20, 21]. Users with vision problems have trouble with unlocking the pump, and should have a good support system to help them manage the pump [20]. Insulin pumps may not be suitable for those not able to hear the alarms (hearing impaired), although most modern pumps have a vibration alarm as well as an audible alarm [4]. Pump users need to be able to “read” the measurement results. For visually impaired patients pump systems should have a sufficiently large display with good backlight ‐ there should be a good contrast of the number on the display, allowing good readability even under less than optimal lighting conditions or under strong light [22]. When handling insulin pumps it is important for visually impaired or blind patients that the pumps can guide the user through the various menus and so on with suitable tones [22].
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9.3 Prescription of Insulin Pumps and Continuous Glucose Monitoring Systems
No published guidelines could be sourced with regard to professionals most suitable to prescribe insulin pumps or CGMS.
For eligibility of the NDSS CGM scheme, the person will need to be assessed by an authorised health professional to determine whether they meet specific eligibility criteria and to ensure that they know how to best use CGM or Flash GM in the management of their diabetes.
The NDSS suggests that only the following health professionals can perform these assessments and are authorised to certify eligibility to access the CGM scheme [23]:
Endocrinologists Credentialed diabetes educators Other health professionals specialising in diabetes (physicians, paediatricians or nurse practitioners).
10 Funding schemes for Insulin Pumps, Continuous Glucose Monitoring Systems and Consumables
10.1 Insulin Pumps
10.1.1 Australian Government’s Insulin Pump Program
The Australian Government’s Insulin Pump Program [24]:
Offers subsidies to low income families who have children with type 1 diabetes.
Aims to improve access and affordability of insulin pumps for limited income families who have children (up to 18 years of age) with type 1 diabetes, and do not have access to other means of reimbursement, such as private health insurance.
Offers families with a combined annual income of up to $109,610 eligibility to apply for a pump subsidy under the program, subject to meeting the program criteria.
As of 1 July 2017, the following pumps are available under the Insulin Pump Program [3]:
o Accu‐Check Spirit Combo o MiniMed 640G o Paradigm Veo
10.1.2 Health Insurance
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Gold Tier private health insurance policies cover insulin pumps [3].
Under the Private Health Insurance Act 2007, private health insurers can cover the cost of insulin pumps under their Hospital or General Treatment policies. If an insulin pump is provided as part of an episode of hospital treatment and the patient has an appropriate hospital policy, private health insurers are required to pay benefits towards the cost of the pump, as well as the hospital accommodation fees and the doctor’s fee [25].
10.1.3 Medtronic Bridging the Gap Program
Insulin pump product manufacturer Medtronic offers a pump loan arrangement for users under their Bridging the Gap program where successful applicants will have access to a Medtronic insulin pump for the remainder of their health fund waiting period (a maximum of 12 months) [26]. To be eligible the applicant must:
Have private health cover. Be in the interim 12‐month waiting period for private health cover benefits. Have been diagnosed with Insulin Dependent diabetes. Meet the NDSS criteria for insulin pump consumables (for details, visit NDSS). Be under supervision from healthcare professionals, including a diabetes educator and endocrinologist or paediatrician, for insulin pump therapy.
10.2 Continuous Glucose Monitoring System
10.2.1 National Diabetes Services Scheme (NDSS)
The Australian Government provides access for eligible people to fully subsidised CGM and Flash GM products through the CGM Initiative as part of the NDSS to assist users with type 1 and 2 diabetes [23].
Eligibility [27]:
Live in Australia or are visiting from a country with which Australia has a Reciprocal Health Care Agreement on an applicable visa. Have been diagnosed with any type of diabetes by your doctor; or have other eligible conditions requiring regular monitoring of blood glucose levels. Hold (or are eligible to hold) a Medicare card or Department of Veterans’ Affairs card.
Users are not eligible to register if they have impaired glucose tolerance or impaired fasting glycaemia, sometimes referred to as pre‐diabetes.
Non Eligibility [27]:
Users with impaired glucose tolerance or impaired fasting glycaemia, sometimes referred to as pre‐diabetes.
The following devices are available under the scheme:
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Dexcom G4 Platinum Dexcom G5 Mobile Dexcom G6
10.3 Consumables
10.3.1 National Diabetes Services Scheme
People with type 1 diabetes registered with the NDSS can gain access to insulin pump consumables.
The cost of an insulin reservoir/cartridge is about $1 per unit. Batteries and other pump accessories are not subsidised by the scheme [4].
In certain circumstances, people who have been diagnosed with ‘other diabetes’ and ‘hard to manage’ type 2 diabetes can request special consideration from the Department of Health to access consumables through the NDSS [28].
10.3.2 Medtronic Pump Consumables Grant
For type 2 diabetes pump users, Medtronic offer a consumables grant with savings of up to 90% on RRP consumables [29].
Number of grants are limited to 250 Applicants must have a suitable level of hospital cover with a private health insurance fund.
11 Lifespan, warranty, maintenance, upgrade and service of Insulin Pumps
11.1 Lifespan
The lifespan of an insulin pump or CGMS could not be precisely determined. There are many variables which can impact the lifespan of a device, and they can be broadly placed into two areas:
• Usage environment • Usage patterns and treatment • Engineering/product design.
11.2 Warranty
Warranty information for TGA approved pumps referenced above is in the table below, where the warranty period for all products is four years. Information for Medtronic products [30] and the
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Tandem t:slim X2 [31] is available on the manufacturer’s websites, and YpsoPump [32] and Accu‐ Chek [33] information was sourced via phone calls to the manufacturer/distributor. Note that guarantees for products are protected under Australian Consumer Law [34].
During a warranty period the manufacturer will usually repair or replace the device when there are defects in materials and workmanship. Replacement may include either a new or recertified device. In such cases warranties will not be extended but will continue from the date of the initial warranty period.
NOTE: The TAB Research Team is currently working on research surrounding the potential need to replace out of warranty assistive technology which is currently well functioning, to reduce the risk of catastrophic failure and potential harm to participants and responsibility risk to the agency.
Product Warranty Period Date Period Commences
Medtronic Pump ‐ 4 years Date of purchase Insulin Pump Remote control ‐ 2 years
Medtronic Transmitter ‐ 1 year Date of purchase Guardian™ Connect Continuous Glucose Monitoring System
Medtronic 3 days Date of package opening, provided product was Infusion Sets/Reservoirs shipped to end‐user less than 6 months beforehand
Medtronic 1 year Date of purchase MiniLink™ Transmitter
Medtronic Monitor ‐ 1 year Date of purchase CareLink™ iPro™2 System Dock ‐ 1 year
Medtronic 6 months Date of purchase CareLink™ USB
NOTE: The Medtronic Warranty does not apply to batteries, glucose sensors and accessories, and is additional to the rights of the consumer under Australian Consumer Law [30].
AMSL Diabetes 4 years Once product leaves warehouse Tandem t:slim X2
mylife DiabetesCare 4 years Time of sale YpsoPump
Accu‐Chek 4 years – pumps Time of sale 2 years ‐ Metres
11.3 Maintenance, Upgrade and Service
According to Diabetes Australia, some people upgrade their pumps after a number of years (usually four or five years) to a new pump, and each private health insurer has specific criteria to qualify for
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a pump upgrade [4]. Health funds will not upgrade the pump because a newer model is available. The pump must be out of warranty and faulty [4].
Manufacturer’s warranties generally state that they will either repair or replace any defective products or part thereof at no charge to the purchaser for parts or labour during the warranty period. Warranties will generally exclude wear and tear and cosmetic damage [30, 31].
It appears insulin pumps do not require periodic servicing. No information could be sourced on this topic.
12 Insulin Pump Users and Health Professional Support and Training
Although insulin pumps are user‐friendly in terms of programming and daily use, they still require a certain level of skill to program and make changes to basal rates, set bolus doses, alarms etc. The user also needs to learn to change cartridges and infusion sets [4].
Pump users will need at least one intensive training session with their diabetes educator when they are first fitted with a pump. There is also a lot of ‘on‐the‐job training’ as the user gets to know their pump in the first few weeks [4], and they will need to keep in regular contact with their diabetes educator or endocrinologist for review and adjustment of pump rates [3].
Users in remote and regional areas may also have insufficient access to training and support for optimal implementation of insulin pump therapy [18].
13 Costs of Insulin Pumps and Continuous Glucose Monitoring Systems
13.1 Insulin Pumps and consumables
The cost of insulin pumps are not promoted on the product manufacturer or distributor’s websites, and manufacturers and distributors were not contacted to determine costs.
Diabetes Australia suggests the cost of an insulin pump can range from $8950 to $9500, depending on the brand [4].
The cost of consumables for insulin pumps is around $270 per month ($3,240 per year) as suggested by Diabetes Australia [4].
13.2 Continuous Glucose Monitoring Systems and consumables
According to Diabetes Australia the cost of CGMS including consumables (sensors) is around $5,000 per year [11].
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14 Cost Effectiveness of Insulin Pumps as opposed to Multiple Daily Injections
Australian evidence‐based clinical guidelines for diabetes, suggest that CSII may be cost‐effective particularly among those who gain significant improvement in glycaemic blood glucose management and quality of life [18].
There is a significant expense associated with the use of insulin pumps [18, 35]. The purchase price for individual pumps range from $8950 to $9500 [4], with consumables purchased through the NDSS costing the consumer an average of over $340 per year above the 91% Government subsidy provided through NDSS. The annual cost of insulin varies based on requirements. Individuals who administer insulin via MDI are required to pay the costs of insulin only, as syringes and pen needles are provided at no cost through the NDSS [18].
From a government funding perspective, review of international economic evaluations found that CSII with SMBG may be cost‐effective in comparison to MDI particularly among those who gain significant improvement in blood glucose management and quality of life [18].
In more detail, cost‐effectiveness analyses aim to assess the differences between costs of therapy balanced against the differences in health outcomes. Incremental cost‐effectiveness ratios are used in cost effectiveness analyses and represent the difference in costs of treatments and outcomes between two interventions divided by the difference in quality adjusted life years over a predefined period of time, or time horizon. While the acquisition costs of CSII therapy are significantly larger than SMBG for example, economic evaluations assess whether fewer complications of diabetes due to glycaemic improvement from CSII might offset these costs. The evidence‐based guidelines found nine economic evaluations that compared CSII and SMBG therapy against MDI and SMBG [18]. Five studies concluded CSII was cost‐effective while the other four did not [18].
15 Cost of nursing supports in providing daily insulin administration and checks
15.1 Multiple Daily Injections by Nurse or Support Worker? ‐ NDIS Practice
As per the NDIS Practice Guide – Diabetic Management Supports (V2.0 2020‐07‐02) [36], MDI can be administered by a nurse or support worker under delegated care, depending on the complexity of the participants needs.
Skilled Personnel: Insulin administration is a procedure that is required to be performed by skilled personnel that are trained appropriately. The personnel can be a registered nurse, enrolled nurse or attendant carer. Maintenance procedures can be delivered by non‐skilled personnel to NDIS participants who have reached a point of stability and require routine maintenance (i.e. considered to be part of the usual daily personal care routine). This can include some aspects of the day‐to‐day care related to subcutaneous injections such as insulin for an insulin dependent diabetic. Registered nurses and local medical officers would be responsible for overseeing the medication management and health of the participant
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[36].
Funding of Training: The NDIS would be responsible for funding the provision of care, training and supervision of a delegated worker to deliver these maintenance supports which are integral to a person’s ongoing care and support to live in the community, participate in education and employment as well as social and recreational activities [36]. When required the NDIS would fund a suitable number of hours as per delegation of care for a support worker to attend training that is [36]:
o Provided by the health treatment team or a registered nurse responsible for development of the Diabetes management plan and funded by NDIS.
o Specific to the implementation of the participant’s management plan.
o Required to ensure that the support worker is able to perform day‐to‐day maintenance and care.
Complex Support: For participants with complex health and disability care needs, a registered nurse may be required to administer insulin. However, usually a support worker with appropriate competency would provide assistance with the administration of routine, non‐complex insulin. (Documentation needs to be provided to the NDIS that clearly explains why this task cannot be delegated such as evidence that the participant has unstable diabetes with a registered nurse required to assess and determine the level of insulin to be administered) [36]. Note: certified training of support workers does not include insulin management as part of the curriculum [37].
15.2 Approximate cost per annum for support ‐ Nurse
Costing nursing supports depends on the support frequency of a nurse or support worker required by the participant’s condition being either complex or routine non‐complex. The calculations below are based on a support period of 12 months where a participant with Acquired Brain Injury requires:
2 visits per day by an Enrolled Nurse (EN) 4 visits per year for assessment by a Registered Nurse (RN) Travel within metropolitan area
Costings are per the current NDIS Price Guide and Support Catalogue 2020‐21 [38].
Support Item/Line Number Time Visits Rate (s) TOTAL ($)
Assessment Weekly Daytime – RN 1 Hour 4 107.25 429.00 01_606_0114_1_1
Weekday Daytime – EN 30 minutes 502 41.31 21,741.62 01_600_0114_1_1
Saturday – EN 30 minutes 104 61.79 6,426.16 01_602_0114_1_1
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Support Item/Line Number Time Visits Rate (s) TOTAL ($)
Sunday – EN 30 minutes 104 71.03 7,378.12 01_603_0114_1_1
Public Holiday – EN 30 minutes 20 80.26 1,605.20 01_604_0114_1_1
Travel ‐ Rate1 ‐ Weekday – RN 15 minutes 4 26.81 107.24 01_606_0114_1_1
Travel ‐ Rate1 ‐ Metro Weekday Daytime – EN 15 minutes 502 21.66 10,873.32 01_600_0114_1_1
Travel ‐ Rate1 ‐ Metro Saturday Daytime – EN 15 minutes 104 30.89 3,212.56 01_602_0114_1_1
Travel ‐ Rate1 ‐ Metro Sunday Daytime – EN 15 minutes 104 35.51 3,693.04 01_603_0114_1_1
Travel ‐ Rate1 ‐ Metro Public Holiday – EN 15 minutes 20 40.13 802.60 01_603_0114_1_1
Consumables (NDSS or PBS funded) N/A N/A N/A N/A
TOTAL 56,277.86
15.3 Approximate cost per annum for support – Support Worker
Using the same participant example as the above, the calculations below are based on a support period of 12 months where a participant with ABI requires:
2 visits per day by a Support Worker (SW). 4 visits per year for assessment by a RN. Travel within metropolitan area.
Costing are as per the current NDIS Price Guide and Support Catalogue 2020‐21 [38], where it has been determined that a level 1 support worker has the capacity to provide Assistance With Self‐Care Activities with High Intensity Daily Personal Activities [36, 38, 39].
Support Item/Line Number Time Visits Rate (s) TOTAL ($)
Assessment Weekly Daytime – RN 1 Hour 4 107.25 429.00 01_606_0114_1_1
Weekday Daytime – SW 30 minutes 502 27.73 13,922.97 01_300_0104_1_1
Saturday – SW 30 minutes 104 38.90 4,046.12 01_302_0104_1_1
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Support Item/Line Number Time Visits Rate (s) TOTAL ($)
Sunday – SW 30 minutes 104 50.08 5,208.32 01_303_0104_1_1
Public Holiday – SW 30 minutes 20 61.25 1,225.10 01_304_0104_1_1
Travel ‐ Rate1 ‐ Weekday – RN 15 minutes 4 26.81 107.24 01_606_0114_1_1
Travel ‐ Rate1 ‐ Metro Weekday Daytime – SW 15 minutes 502 13.86 6,960.23 01_300_0104_1_1
Travel ‐ Rate1 ‐ Metro Saturday Daytime – SW 15 minutes 104 19.45 2,022.80 01_302_0104_1_1
Travel ‐ Rate1 ‐ Metro Sunday Daytime – SW 15 minutes 104 25.04 2,604.16 01_303_0104_1_1
Travel ‐ Rate1 ‐ Metro Public Holiday – SW 15 minutes 20 30.63 612.50 01_304_0104_1_1
Consumables (NDSS or PBS funded) N/A N/A N/A N/A
TOTAL 37,201.44
16 Cost savings between the use of Insulin Pumps and Nursing Supports
In considering the cost savings between insulin pump usage and the provision of nursing supports to a participant, the following comparisons will be used and calculations worked out over a one year and four year period.
A four year comparison period has been selected as warranties for all TGA approved pump devices referenced in this document is four years. Whether or not NDIS may replace a device after the warranty period is yet to be determined. Note that repair costs are provided under the warranty
Nursing costs are calculated according to the current NDIS price guide (as per the tables above), so it should be considered that these cost may rise over the next four years.
Nursing costs are calculated according to the example participant given above, who requires two visits per day by an EN including travel, and four assessments per year by an RN including travel.
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The potential cost of training a support worker for the appropriate competency has not been included in the calculations
The device cost is based on the Medtronic 770G [5] which is a relatively new device which features continuous glucose monitoring as well as automatic insulin delivery, at a cost of $8574.00. (This was sourced from a quote submitted for NDIS funding dated 22/12/20 which was referenced in a recent TAPS advice provided to the TAB research team)
Consumables are not included in the calculations as these are funded by the NDSS or PBS
Insulin Pump Device Nursing costs Nursing costs Period costs ($) (Enrolled Nurse) ($) (Support Worker – Level 1) ($)
1 Year 8574.00 56,277.86 37,201.44
A cost saving of $47,703.86 (65%) A cost saving of $28,627.44 (43%)
4 Years 8574.00 225,111.44 148,805.76
A cost saving of $216.537.44 A cost saving of $140.283.60
17 Other cost considerations
Internet access cost for participant to upload device data to be reviewed by health professionals.
Computer/laptop cost in order for the participant to access the internet to upload data.
Where the type of device gives the user mobile phone monitoring (e.g. glucose levels) or notifications (e.g. if levels are reaching high/low), the participant would require a mobile phone with an internet data plan. The Medtronic 770G [5] device referred to in the costings above has these features.
Items regarded as accessories to the devices may bring ease of use to the participant such as bra and waste pouches to house the device, and waist bands. These have varying costs [17]
Users would require an intensive training session when first being introduced to an insulin pump.
18 Conclusion
Insulin pumps are more cost effective than providing nursing supports. However, the participant’s functional capacity to use an insulin pump would need to be assessed.
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19 References
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- Jayne Lehmann – Edhealth Australia. Module 3: Insulin Support and Administration for Support Workers 2021 [Available from: https://www.edhealth.com.au/Modules/diabetes‐care‐in‐ the‐community‐for‐support‐workers‐insulin‐support‐and‐administration/.
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NDIS. The NDIS Price Guide and Support Catalogue 2020‒21 2020 [Available from:
https://www.ndis.gov.au/providers/price‐guides‐and‐pricing. 39. NDIS. SOP ‐ Add self‐care and community access supports (V1.0 2020‐10‐26).
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