One question that often reaches the Diabetes NSW & ACT Credentialled Diabetes Educators through their Helpline is what new technology is available, or coming to the market. Carolien Koreneff, CDE-RN, FADEA has taken a closer look at what companies across the world are working on at the moment.
The Dexcom G6 was launched in Australia in July. Some of the benefits of the Dexcom G6 are:
The Dexcom G7 is expected to be launched in the USA some time in 2021. The company is currently conducting trials to determine the final design for the G7. It will be some time before this system is available in Australia.
The Eversense is the first of implantable CGM systems. The under-the-skin sensors last 90-days and would be inserted under local anaesthetic by your diabetes healthcare provider. The system also includes a removable and rechargeable transmitter and an app for real-time diabetes monitoring and management. It is not yet available in Australia.
Freestyle Libre 2
Abbott Diabetes Care has developed a new version of the Freestyle Libre; the Freestyle Libre 2. Although visually both systems look the same, the Libre 2 system seems to be more accurate. The main difference is that the Libre 2 provides customisable, optional alarms for low and high glucose, as well as a technical feature that can notify you of signal loss, through sound or vibration (based on user preferences). It is not yet known when the Freestyle Libre 2 will be available in Australia.
A number of companies worldwide seem to be working on developing non-invasive glucose monitoring systems; systems that do not require to pierce the skin in order to get blood glucose results. It is our understanding that it will, unfortunately, be quite some time before any of these systems will be available commercially in Australia.
What is available at the moment is some systems that convert the Libre sensor (which is a Flash Glucose Monitor or FGM) into a Continuous Glucose Monitor (CGM). We found 3 such systems on the market (overseas):
They are reusable and rechargeable devices that sit on top of the Libre, so you don’t need to manually scan each time for a reading, but you can see it see it automatically updated on your phone, every 5 minutes. You can set up high and low blood glucose alarms (and catch them before they actually happen!) and share your BG data in real time. You will need to download a specific app to your smart device to make it work.
Accuchek Solo Micropump
The Accu-Chek Solo Micropump is a tubeless insulin pump worn as a patch directly on the body. The pump is controlled from a wireless handheld device called The Diabetes Manager which also doubles as a bolus insulin calculator, hence allowing for discreet insulin delivery. The Solo is “semi-disposable” and includes a reusable pump component that lasts four months and disposable components (including the micropump holder, infusion cannula and 200-unit reservoir) that are replaced every two to three days. This system is currently being introduced into Australia.
Medtronic has launched trials of their 780G pump. The 780G is an advanced hybrid closed-loop system that uses a new algorithm, which is said to be one step closer to a true closed-loop automated insulin pump system (artificial pancreas). The 780G will provide automatic correction bolus deliveries, will automatically adjust for missed meals and allow an adjustable glucose target down to 5.5mmol/L (compared to the 670G’s set target at 6.7mmol/L). The 780G will allow for remote software uploading (as offered by AMSL’s t:slim X2) and will have the built-in Bluetooth Low Energy (BLE) necessary for data-sharing connectivity. It also aims to achieve 80% user Time in Range (compared to 71% TIR on the 670G).
The Omnipod DASH System is a wearable insulin pump that delivers up to 200 units of insulin through customisable basal rates and bolus amounts. The system consists of the Personal Diabetes Manager (PDM) and the Pod, which is worn on body (similarly to the Accu-chek Solo mentioned above) and delivers non-stop insulin for three days.
The makers of the Omnipod Dash are also working on the Omnipod Horizon. The Horizon is the first Automated Insulin Delivery (AID) system that can be controlled from a smartphone, rather than via an app and separate handheld control devices. The intended design of the Horizon is to form a hybrid closed loop system when used with a CGM. The Omnipod Horizon is currently still being trialled in the USA, and is expected to be launched there in 2021, which means it will take a while longer before we will have access to this system here in Australia.
Tandem Basal IQ
Basal-IQ technology with Predictive Low Glucose Suspend allows you to sync your Dexcom G6 CGM with your t:slim X2 insulin pump. This software upgrade helps reduce the frequency and duration of low-glucose events by predicting glucose levels 30 minutes ahead and suspending insulin if it is expected to drop below 4.4mmol/L, or if a CGM reading falls below 3.9mmol/L. It is easy to use, from 17th August 2020 it comes with all new t:slim X2 purchases and will be available free of charge to those with a t:slim X2 in warranty from about the end of August.
Control-IQ is upgrade software that combines the t:slim X2 pump with Dexcom G6 CGM and not only auto-adjusts basal rates for both high and low blood glucose levels, but also allows for automatic corrections for unexpected highs. Although the Control-IQ is the not the first FDA-cleared closed-loop system on the market, it is the first system that adjusts background basal rates as well as support automatic food or correction boluses, making it the most advanced commercial “closed loop” system available to date. Control IQ is not yet available in Australia.
The Tandem t:sport is a new mini pump, which will be roughly half the size of the current t:slim X2. It is a sort of patch pump without a display, but with a choice of using either a smartphone app or a separate receiver. Tandem will submit an application to the FDA later this year, so it will be some time before we see this device appear in Australia.
Just as with the CGM systems, a number of other companies worldwide are working on developing version of an “artificial pancreas”. Watch this space for further updates.
Afrezza is a man-made, inhaled, rapid-acting insulin with a very fast onset (the time it takes for insulin to start working) and fast offset (the time it takes for insulin to finish working). Its blood-glucose-lowering action peaks just 12 minutes after inhaling, compared to over 30 minutes for typical rapid-acting mealtime insulins such as Novorapid, Humalog and Apidra. It is generally used in conjunction with long-acting insulin, but unfortunately it is not recommended in people who smoke or have recently stopped smoking (less than 6 months).
Afrezza is currently available in the USA for adults only, a paediatric version may be available in the future as Phase 3 clinical trials will soon commence in the USA.
A biosimilar medicine is a highly similar version of a reference biological medicine. The processes that produce biological and biosimilar medicines are naturally variable as the come from living cells; this means that no two batches are ever exactly the same. Biosimilar medicines have been tested and proven to be as safe and effective as the reference biological medicine.
Lantus is a biological medication that has been used successfully for many years. However, Lantus Solostar and Lantus insulin glargine 100 IU/mL products will be unavailable on the Australian market from 1 July 2020. If you are using either of the two Lantus products you will need to change to another insulin glargine injection. There are currently 2 options:
Optisulin is the same formulation as Lantus and is available in two delivery methods: a prefilled disposable injector pen (Optisulin Solostar) and cartridges for use in reusable injector pens (AllStar, AllStar Pro, JuniorStar or ClikStar).
Semglee is a biosimilar insulin Glargine U-100 which is only available in pre- filled disposable pens. It has been listed and marked as “equivalent for the purposes of substitution for Lantus” on the PBS since 1 October 2019. Talk to your doctor before changing from Lantus to Semglee as these 2 insulins are similar, but not exactly the same.
Fiasp is a variation of insulin aspart, better known as Novorapid, but is absorbed faster as it has niacinamide (vitamin B3) and arginine (an amino acid) added. Fiasp has a faster onset and faster, higher peak than Novorapid and thereby provides quicker insulin cover at meals, whilst the duration of action is similar to Novorapid. This means that Fiasp allows you to delay the injection of this insulin until the first bite of your meal or within 20 minutes of starting a meal, which allows you to decide how much you are going to eat and dose accordingly.
Fiasp has been on the PBS for about one year, it is available at the same cost as other rapid acting insulins.
Ryzodeg® 70/30 is not so new anymore, it has been available on the PBS since August 2018, but we thought it is worth a mention here anyway. Ryzodeg 70/30 contains two types of insulin: a basal (or background) insulin called insulin degludec and rapid acting insulin called insulin aspart (this part is more commonly known as Novorapid). Compared to other basal insulins (such as insulin detemir (Levemir) which lasts around 20 hours or insulin glargine (see above) which works for up to 24 hours), Degludec has a duration of action beyond 42 hours and this means that there is less variation in your blood glucose levels from one day to the next, even if you change the timing of your injections from one day to the next.
Tresiba is a single ingredient insulin degludec and has been available in the UK and USA since 2015. It was approved for use by adults by the Australian TGA at the same time as Ryzodeg in November 2017; however, Tresiba is not yet subsidised by the PBS.
Glucagon-like peptide-1 (GLP-1) receptor agonists work by stimulating the release of insulin by the pancreas after eating, even before the blood glucose levels start to rise. At the same time GLP-1 inhibits the release of glucagon by the pancreas, which slows down the release of stored glucose from the liver. Thirdly, GLP-1 slows the absorption of glucose into the blood stream, by slowing stomach emptying; this makes you feel fuller for longer (and hence can aid weight reduction if used in combination with a suitable diet and exercise program).
The chemical structure of GLP-1 and duration of action is different for different brands. There are several GLP-1 receptor agonists available to people with type 2 diabetes, though only four of them are currently available in Australia, 3 of which are on the PBS. GLP-1 is mostly an injectable medication (but it is not insulin) that generally comes in a pre-filled, multi-dose, disposable injection pen device.
There are 2 honourable mentions for other GLP-1 preparations:
Rybelsus is the first pill in the class of drugs called glucagon-like peptide approved for use in the United States. The generic name is semaglutide. However, it appears that this medication has some significant risks as recent studies have shown that it may cause certain thyroid tumours and can cause inflammation of the pancreas, kidney injury, vision loss and hypoglycaemia (low blood glucose levels) and so it will remain to be seen if it ever makes it into Australia.
The makers of Optisulin (formerly known as Lantus, insulin Glargine U-100) have created a 2-in-1 medication which includes both insulin Glargine and Lixisenatide. Sanofi has submitted an application with the PBS for this medication to be available on the Australian market in the not too distant future.
In the last 12 months we have seen the addition of a new sodium-glucose co-transporter-2 (SGLT-2) inhibitor called Steglatro (Ertugliflozin) added to the list of PBS medications. SGLT2 inhibitors help lower blood glucose levels in people with type 2 diabetes by removing glucose from the body through the urine. Other SGLT-2 medications available in Australia include dapagliflozin (Forxiga) and empagliflozin (Jardiance).
Steglujan is a combination medication of the aforementioned SGLT-2 inhibitor ertugliflozin and a dipeptidyl peptidase-4 inhibitor (DPP4-inhibitor) sitagliptin (also known as Januvia).
Segluromet also has two active drugs, they are the SGLT-2 inhibitor ertugliflozin and metformin (also known as Diabex or Diaformin), which is a common medication and belongs to a group of medications called biguanides.
Trijardy XR is the first triple-combination medication that has been approved by the FDA; it contains empagliflozin (Jardiance), linagliptin (Trajenta), and extended-release metformin hydrochloride (Diabex XR or Diaformin XR). Although it has FDA approval, it is yet to make its way across to Australia.
Almost any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG)before it can be supplied in Australia. The Australian Therapeutic Goods Administration (TGA) carry out a range of assessment and monitoring activities to ensure therapeutic goods (such as continuous glucose monitoring (CGM) systems or insulin pumps) available in Australia are of an acceptable standard. The TGA generally has it as a pre-requisite that products are approved by the US Food and Drug Administration (FDA), or their European counterpart the European Medicines Agency (EMA), before testing can commence in Australia.