Month: August 2018

Medtronic 670G System Closer to Approval in Australia

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Medtronic Diabetes made an announcement last week regarding their 670G hybrid closed loop system, and last week I had a chance to catch up with the team at the Australasian Diabetes Congress to clear up some of the confusion.

Medtronic’s 670G hybrid closed loop system consists of an insulin pump and a CGM that, when combined, will automatically adjust basal insulin based on CGM readings to regulate blood glucose levels. Of the many hybrid closed loop systems currently in development, Medtronic’s is likely the closest to hitting the market.

Last week’s announcement was the approval of the 670G insulin pump. What has not been approved, however, are the CGM sensors that are compatible for use with the 670G pump. Without approval of the sensors, the system is not yet available for use in Australia.

It’s hard not to overlook the fact that AMSL were also launching the Tandem t:slim at the time of Medtronic’s announcement. We have relatively new options in Cellnovo and YpsoPump, that are also shaking up the pump landscape here in Australia.

Medtronic’s hybrid system is now available in the US. Clinical trials undertaken with this system have been going on in Australia for quite some time. Melbourne endo David O’Neal presented some early clinical trials back at Diabetes Advocates Day last year. I have spoken with a few people who have trialled this system – both blinded and unblinded – and their reactions have clearly been life changing.

The 670G system can be used in both manual and auto (hybrid closed loop) mode. My understanding is that the user will need to use the pump in manual mode for a few days for the system to collect insulin data, before being able to switch to auto mode.

Most notably, this system will only correct blood glucose levels to a target of 6.6mmol/L. For some, this target will be fantastic, while for others it won’t be acceptable. I see this reason as twofold. Firstly, this ‘safer’ target range likely makes a system of this nature easier to receive approval. Secondly, this will also pave the way for Medtronic to sell an enhanced system down the line with a better blood glucose target. I believe that there is a 690G system in the pipeline already!

During the Congress, several clinical trials undertaken using the 670G were referenced. CDE Sue Wyatt told us that there was still another six months to go in a study she was referencing with the 670G system, which was rather telling about a timeframe for approval of these 670G compatible sensors.

Medtronic are currently offering new customers who take up insulin pump therapy (currently a 640G system) a free upgrade to the 670G system when it is approved for use in Australia. New pumpers are also being offered six months of free Continuous Glucose Monitoring with no further obligation, which can be used anytime between now and March 2019.

Despite being told that Medtronic were committed to making the latest technology available to people with diabetes, this offer excludes existing Medtronic customers – including our very own DAPeoplesVoice team member Melinda Seed. Having recently upgraded her pump, she will have to wait four years before having the option of this system available to her. Shall we start a #670GForMelinda?

Another criticism would definitely have to be the size of this pump. Many users have expressed disappointment that Medtronic have been making their insulin pumps larger than previous iterations. After briefly holding the 640G pump on show, it stacked up bigger than my late Animas Vibe, YpsoPump and t:slim I played with last week.

I also don’t regret highlighting to Medtronic the importance of not making Multiple Daily Injections feel shameful in marketing their products. Admittedly, it has been some months since I have seen such material surface and I do feel that they are taking this feedback on board.

One year ago, the insulin pumping landscape was looking very dire for people with diabetes. Today, we have a several choices for people considering insulin pump therapy here in Australia.

At the end of the day, more choice for people with diabetes is always a good thing.

Disclosure: Diabetes Australia covered my travel, accommodation and registration to attend the Australasian Diabetes Congress. My time, including the annual leave I had taken from work to attend, was my own. These opinions are also my own and do not reflect those of Diabetes Australia.

Tandem t:slim X2 Insulin Pump Launches in Australia!

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Tandem’s t:slim X2 insulin pump officially hit Aussie shores last week at the Australasian Diabetes Congress. It will be distributed by AMSL Diabetes here in Australia as a successor to Animas, which is in the process of exiting the pump market. AMSL invited me to a launch dinner in Adelaide last week, where I had the opportunity to play with (but not keep) this new diabetes toy.

AMSL diabetes will be upgrading all of their customers with an existing, in warranty Animas Vibe insulin pump to the t:slim over the course of the next 12 months at no extra cost. Customers will need to return their old Animas pumps within one week as a condition of receiving the upgraded pump. This is a part of AMSL’s contract with Animas.

This upgrade is basically treated as a replacement for the pump I have already paid for two years ago. Then, in two years when my warranty period is up, I will be eligible for another through my private health insurance. It makes complete sense. Besides, AMSL will only have limited capacity to service Vibe pumps now that Animas have gone out of business.

AMSL have a dedicated transition team looking after upgrades, and they will be getting in touch with eligible customers over the next twelve months. You will need to go through a healthcare professional, which is regulatory, but frustrating considering I already know how to use an insulin pump! I hear that upgrades are expected to commence in October, however customers who wish to remain on an Animas Vibe will also be supported.

During the evening we heard from Aymeric Lecanu-Fayet, Senior Director at Tandem Diabetes Care in the States. The t:slim was designed based on over 6,000 interviews of people with diabetes, attempting to close the gaps that prevented people from using an insulin pump. Things like making it look modern like a smartphone, easy to use and easy to learn.

Kerri Bandelin, International Clinical Manager at Tandem then took us through a workshop with the pump.

The tslim has the option of integration with a Dexcom CGM, and the battery is rechargeable. The charge will last for 5 days if you’re using it with CGM integration, or 7 days if you’re using it standalone. The rechargeable battery is also covered under warranty in the off chance that it does get damaged. Those non diabetic lines sure are something to envy!

Users are normally encouraged to recharge their pumps while they’re in use. Suggestions were while on the couch, in front of a computer or while in the shower. We were also told that there is no such thing as over charging this pump, something I’m always mindful of when leaving my iPhone plugged in for too long. A full charge takes 1.5 hours on a dead battery, but I also got the impression that short charges of 15 minutes won’t do any damage to the pump’s battery.

We were told that the pump can be used with Animas infusion sets, but not insulin cartridges. Tandem consumables are on the ship as we speak, and I’m pleased to hear that there will be an option of angled sets. I was also pleased to hear that Australia will be receiving t:slim pumps with an updated algorithm that won’t trigger unnecessary occlusion alarms.

Insulin goes into a black hole, which is a bit concerning for detecting air bubbles. The minimum fill is 95 units, with the cartridge having a capacity of 300 units. We were told that there is also a thermometer inside the cartridge which can alert to risks of spoiled insulin. Carb ratios could be adjusted in increments of 0.1 when going past the 1:10g mark. There are also 6 different basal profiles with 16 different time segments.

The most promising feature for me is the ability to receive upgrades to this pump in the same fashion as upgrading your iPhone’s software. Basal IQ with Dexcom G6 is expected to launch this Australian summer, but is not yet approved. The system predicts glucose levels 30 minutes ahead and suspends insulin if levels are expected to drop below 4.4mmol.

We were told that this upgrade would be free, however I wasn’t impressed to hear that I would have to go through a healthcare professional every time there is an upgrade. I know there are regulations. But considering I already know how to use an insulin pump and spend relentless hours managing my diabetes on my own, it definitely feels like an insult to my lived experience.

Also in the pipeline is Control IQ. This upgrade would automatically adjust basal insulin levels in response to CGM readings, as well as deliver automated correction boluses. I would stress that this is only in its infancy, with a current 6 month study happening in Germany. Tandem would also not confirm whether this update would be free or not. I also got the impression (not an official comment) that the blood glucose target on this system would be better than the 6.6mmol target on the Medtronic 670G.

We were told that the pump would fit inside the coin pocket of a pair of jeans. What I didn’t like was the bulky case with a clip that added significant bulk to the pump. It was heavier than the YpsoPump at 113g, and here’s how it stacks up against the late Animas Vibe that I was wearing. We were told it is the size of a credit card.

It felt refreshing being able to type in numbers, rather than scrolling through until reaching your desired number. Nice and modern and sleek to use, just like the YpsoPump.

While I don’t think CGM will be in my budget anytime soon, I do feel hopeful that we are getting close to finally closing the loop.

Finally, we have a hashtag happening. A completely selfish one.

It’s #TslimForFrank.

Please jump onto social media and use it generously.

I have been dreaming of this little pump hitting our shores since forever, and I would love nothing more than to provide you with a user experience.

Disclosures: AMSL Diabetes hosted me at a dinner on Wednesday evening with a group of other Aussie diabetes bloggers. I was already in Adelaide for the Diabetes Congress as a guest of Diabetes Australia. I was fed and watered across the duration of the evening, and received a small bag containing a powerbank, information packets and an AMSL penguin. There was no expectation that I would blog about the t:slim. My opinions and my time, including the annual leave I had taken from work to be there, are my own. 

Championing the Consumer Voice

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I walked away from the Australasian Diabetes Congress feeling that consumers had an even bigger impact than last year.

This was my second year attending the joint Annual Scientific Meeting of the Australian Diabetes Society (ADS) and the Australian Diabetes Educators Association (ADEA). Diabetes Australia pioneered a fantastic initiative called the ‘People’s Voice,’ which brought the voices of a few bloggers and consumer advocates to the Congress.

I don’t, for a minute, ever pretend to be representing anyone other than myself at events like these. I fully accept the privilege I have, knowing that I do not even come close to representing all people out there with diabetes. I’m super proud of all of the people with diabetes in attendance who drove this narrative home to the delegates, speakers and pharmaceuticals in attendance. In particular those with gestational diabetes, those with type 2 diabetes and those who are not as engaged as we are.

On Wednesday afternoon, I was lucky enough to contribute to a session which presented case studies on ‘co designing’ diabetes services with the involvement of people with diabetes. I spoke about my involvement with Perth Diabetes Care through the Young Adult Diabetes Committee. For more of a taste of what we do, you can find our Facebook page here. Melinda Seed at Twice Diabetes also spoke about her involvement with Reality Check and the resources that she helped to develop for people with diabetes.

As I said last year, I was so humbled to be in the presence of so many people that simply wanted to learn from us. The idea of this session was to plant ‘seeds’ in the minds of delegates, and we really did delve deep into some of the issues that were prohibiting the engagement of people with diabetes. I spoke about how big of a step it was for me to come along to a gathering of people with diabetes for the first time, and also sharing how much of a ‘slow burn’ some of our work in this space can truly be.

I have personally found the Diabetes Educators to be the most supportive, open minded and willing to learn from us. They are truly the people who approached me the most during the course of the week, and hopefully they will only bring more healthcare professionals and researchers along for the ride with us. I really do apologise for our narrative that, at times, can come across as assuming that all healthcare professionals are not person centred. We really are just passionate about person centred care!

The consumer voice was also championed on Friday morning during a technology symposium. As Professor Anthony Russell presented a narrative about the administration of insulin in a hospital setting, the dialogue that followed on Twitter was more interesting.

One of the biggest issues that I have heard from other people with diabetes is the forced relinquishment of self management in a hospital setting. People with diabetes are forced to relinquish their insulin. People have had to fight for the right to hold onto their insulin pumps or CGMs. Highly capable people with diabetes are often treated as incapable of self managing a condition that they spend relentless hours managing on their own.

I really hope to see a resource developed around the rights of people with diabetes to self manage in a hospital setting. If there are two organisations that I would like to see tackle this issue, it would have to be the Australian Centre for Behavioural Research in Diabetes (ACBRD) and Diabetes Australia.

People with diabetes also slayed the Twitter conversation. In a short two years, it really does make you wonder what they ever did without us? Ashley Ng ran a Twitter masterclass with the support of ADEA, encouraging healthcare professionals to get online. Just look at these amazing stats!

I am super proud of everything that the people with diabetes in attendance achieved throughout the week. I truly feel that the consumer voice was championed, and that we have proven our worth.

This is EXACTLY why we need to be at events like these.

Disclosure: Diabetes Australia covered my registration, travel and accommodation costs to attend the Australasian Diabetes Congress. My opinions and my time, including the annual leave I took from work to attend, are my own.

Day 3 at the Australasian Diabetes Congress

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Day 3 at the Australasian Diabetes Congress kicked off today with breakfast at the Adelaide Central Markets. I was absolutely flattered that Renza sacrificed participating in the 6.45am Novo Nordisk Fun Run to join myself, Ashley and Bionic Wookiee David for the best brekky in Adelaide! 

Class convened at 9am with a symposium on diabetes technology that, quite frankly, could have gone on for hours. Diabetes Australia CEO Greg Johnson was first up onto the stage to share an update on diabetes technology, much of which I had already heard at Abbott’s DX2Sydney event back in May. 

Diabetes Australia advocated for CGM funding for high risk and high need groups, with no age limits. Advocacy had also focussed on co-payments, as has been the case with insulin pump consumables and test strips. The federal government’s announcement of fully subsidised CGM was a complete surprise and will make advocacy more complicated going forward. 

Over 9,000 people have taken up CGM since the federal government’s full subsidy launched in April 2017. I also felt slightly patriotic as Professor Johnson highlighted that our NDSS should be the universal access pathway for diabetes technologies. 

There is also a product tender of syringes, test strips and urine ketone strips currently listed on the NDSS. It is expected that lower volume items will be removed to reduce costs, with an expected implementation date of December 1. 

We are also still waiting on an outcome on the subsidy (not reimbursement!) of Flash Glucose Monitoring. A public health consultation commenced in July 2017. Despite many healthcare professionals spreading Chinese whispers that the FreeStyle Libre will be subsidised soon, a final decision rests with the department of health. This really is anyone’s guess! 

Jane Speight of the Australian Centre for Behavioural Research in Diabetes took to the stage next to present some of the research into the psychosocial issues around Diabetes technology. My takeaways were that the tech is only as beneficial as the commitment from the person using it. The studies also prove that technology won’t be for everyone. It all comes down to individual choice.

Sue Wyatt rounded out our session, pursuing the topic of how well we have closed the loop. Although not made clear, the research presented referred to clinical trials in Medtronic’s 670G hybrid closed loop system only. 

Closed loop systems automatically adjust basal insulin based on CGM readings in order to regulate blood glucose levels. The system had a blood glucose target of 6.6mmol, with a target of 8.3mmol set during exercise. This is disappointing, and I know for a fact that these targets wouldn’t be suitable for many people with diabetes. 

However, I completely get that this blood glucose target may help to get a hybrid closed loop system as such approved for use sooner. I also expect there’s a commercial motivation for this as well, with the ability to sell an upgraded or enhanced hybrid system down the line. 

The major benefit of Medtronic’s 670G was seen in overnight blood glucose levels. Interestingly, we were told that this 6 month study was only in its infancy. It leaves a lot to be said about the timing of approval for Medtronic’s 670G system (the 670G pump has been approved, the 670G compatible CGM sensors are yet to receive approval).

Congratulations to Amy Rush of the Telethon Type 1 Diabetes Family Centre, who was awarded Credentialed Diabetes Educator of the year. Go, WA! 

I was also delighted to hear that SA based CDE Jayne Lehman was also awarded an honorary life membership to the Australian Diabetes Educators Association (ADEA). Well done, Jayne! 

The day rounded out with a debate on whether diabetes technology was helpful or harmful. This was a complete letdown, given that people with diabetes were on the affirmative side and people without diabetes were on the negative side. Without technology, we’d all be living in caves!

I would like to extend a massive thank you to Diabetes Australia for inviting me to be part of the ‘Peoples Voice’ team once again this year. While they covered my travel, accommodation and registration costs to attend the Congress, they did not pay for my opinions or my time. While I certainly don’t claim to represent anyone other than myself, I hope that I have been able to bring a consumer voice to the Congress. 

My gratitude also extends to joint Congress hosts – the Australian Diabetes Educators Association (ADEA) and the Australian Diabetes Society (ADS) – for their support of Diabetes Australia’s ‘People’s Voice’ initiative. 

Finally, a massive thank you to my amazing tribe of people with diabetes that made my week so special. I feel so privileged to spend time in your company call you all friends.

It’s been an insanely busy week with long days and late nights attending product launches, networking and blogging. I haven’t even began to scratch the surface of the exciting developments that have come out of this week.

I’m homeward bound as we speak and look forward to sleeping in my own bed tonight, having a coffee machine at my disposal tomorrow morning, and spending my weekend recouperating.

Stay tuned.

Day 2 at the Australasian Diabetes Congress

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Day 2 of the Australasian Diabetes Congress kicked off with a Plenary session covering communication in diabetes care. Even though she was only the understudy stepping in, I couldn’t think of a better person to cover this issue than Jane Speight of the Australian Centre for Behavioural Research in Diabetes (ACBRD). Much of the ACBRD’s research simply speaks to me, because they truly get how people with diabetes think and feel. Much of their awesome work is used to support policy and resource development over at Diabetes Australia.

Jane championed the ‘Language Matters’ movement, urging clinicians to enhance their communication skills when talking about and to people with diabetes to improve consultation outcomes. This video has been doing the rounds recently and it is absolutely amazing!

The theme of consumers carried onto the next speaker in this session, Elissa Renouf, wife and mother to four men with type 1 diabetes. It was so powerful hearing Elissa speak about doing everything she could to ensure that her three sons would grow up to live a healthy life. While she never deprived her boys of anything because of their diabetes, she did put a big focus on ensuring they performed the necessary diabetes management tasks before doing so.

After morning tea I attended the Australian Diabetes Research Foundation showcase, where I was able to hear about some of the outstanding research that had been funded. The awesome Kirstie Bell recounted her research into fat and protein bolusing, which you can read more about here.

Tammie Choi delivered an insightful presentation on her project ‘Not Scared of Sugar,’ a program which was designed to empower self care in a way that resonated with Chinese culture. We were told that Chinese culture preferred to hear from an authoritative figure when learning, and Tammie expressed that the Chinese did not respond well to an ambiguous answer!

Finally, Steve Trawley linked in by video to talk about his research into blood glucose testing prior to getting behind the wheel. The most interesting point highlighted was that Vic Roads does not endorse the use of blood glucose monitors or CGMs while a vehicle is in use. Bionic Wookiee David Burren and I both questioned the impact of not being able to know our blood glucose data while behind the wheel, and how the integration of smartphones with diabetes management might influence future regulations.

After lunch I had an extended wander through the exhibition hall, and I have been posting digests on both my Facebook and Instagram pages of what’s new in diabetes technology. Head on over for Cellnovo and Medtronic news!

The afternoon rounded out with a session on exercise and diabetes. While I proclaim to the world that Frank does not ‘do’ exercise, the reality is that physical activity is integral to my day job. The most valuable speaker in this session was Carmel Smart, providing some nutrition guidelines to minimise hypoglycaemia both during and after physical activity. It was interesting to hear how protein was recommended to replace glycogen stores following intense activity, and also as a way to prevent hypoglycaemia many hours after exercise.

I did wonder why the guidelines were so reliant on ingesting carbohydrate – and significantly large amounts – to avoid hypoglycemia. How would the person feel trying to exercise after ingesting all of those carbs? I know that many low carb people use ‘fat adaption’ to navigate physical activity, and I think this would be an interesting avenue for further research.

That’s day 2! I’m struggling to zip my suitcase shut for the journey home tomorrow evening, but not before another jam packed agenda for the final day of the Congress here in Adelaide!