Insulin Cooling Battles: BreezyPacks vs InsulinSaver

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My last cooling battle was about four years ago, comparing Frio with BreezyPacks’ Breezy Basic. With a new product on the market, InsulinSaver’s “The Bag”, I thought I would see how the products stack up. To better understand how the BreezyPacks and InsulinSaver bags resist the heating of the insulin pens, check out that last cooling battle link where I explain the role of PCMs and how they work similarly to the Frio but without the soaking.

Disclosures

In the battle, I will be evaluating three cooling bags:

I also have a BreezyPacks bag called the “Breezy Plus” which is the same size as the Basic but with more active material. However, this is no longer on sale at BreezyPacks so I have excluded it from the comparison.

The Breezy Basic (and Plus) I bought at full price online and I bought The Bag at full price while at ATTD2025. I informed BreezyPacks of my intention to do a comparison and I asked if they had data on the Extra or would be willing to provide one for the comparison and they generously sent me one.

Neither BreezyPacks or InsulinSaver are paying me to do this comparison or offering any other incentive.

Comparing the Bags

Website Price (ex. Tax/Shipping)Capacity (Insulin Pens)WeightMax. Temp (C)
Breezy BasicUS$33.903176g41
The BagUS$41.96 (36.90 Euros)6368g54
Breezy ExtraUS$43.9010267g46

In terms of price, the pricing scales with capacity. For shipping to Australia, Breezy is about US$7 and for InsulinSaver it is about US$14.

The weight is a rough indicator of PCM material being used (the substance that resists the change in internal temperature) and we can see The Bag has the most, but it should be noted, we do not know InsulinSaver and BreezyPacks are using the same material. I also weighed my Breezy Plus which came in at 25.1g, similar to the Breezy Extra.

The Bag is also rated for a higher temperature than the Breezys but all fit within the range of most temperatures the bags are likely to be exposed to under normal conditions.

Measuring the Changes in Temperature

To measure the change in temperature, I used my oven on the lowest temperature setting. On the dial this is 50C but, as measured at the end of the experiment, the oven temperature was closer to 36C. This is within the limits of the bags and equivalent to hot summer day here in Sydney, Australia.

As you can see above, the three temperature sensors I used are all measuring the same temperature (this was at the end of the experiment, outside of their bags), within half a degree of each other (about a degree in Fahrenheit).

To replicate the conditions of an insulin pen as closely as possible, I put the probes inside NovoRapid insulin pen containers, retaining the empty glass reservoir inside.

These were then placed in the three bags being tested, one pen per bag.

Finally, these were placed in the oven on the same rack with the fan force function operating to try and maintain as even a temperature as possible.

It was then a case of recording the temperature every 15 minutes until the bags went over 30C or until three hours had passed, whichever came first.

The Results

This result genuinely surprised me. With the additional active material, I expected The Bag temperature to stay flat, relative to the others, but it closely trailed the Breezy Basic. In the final 15 minutes, the Breezy Basic started rising while The Bag was stable and I suspect this was due to all of the active material being liquified and no longer providing protection. Certainly, giving each bag the ‘squeeze test’, the Breezy Basic was almost fully liquefied, the Breezy Extra less so but still containing a fair amount of liquid PCM while The Bag felt almost completely solid. This is either a function of the larger amount of material or confirms InsulinSaver uses a different PCM to BreezyPacks.

I have a hypothesis why the Breezy Basic and The Bag performed similarly while the Breezy Extra heated up quicker and it has to do with the cross-sectional/exposed areas.

The sides of the bags are full of active material, but the ends are not. We can also see the cross-sectional area of the Breezy Extra is about double of The Bag (the top part of the Breezy Extra is also largely unprotected). With possibly less active material than The Bag and a larger unprotected area, this meant the Breezy Extra heated up quicker as the heat came through the unprotected areas. With the smallest cross-section, the Breezy Basic was the best protected from this attack and, even though The Bag’s end area was bigger, this may have been offset by the protection of the additional material on the sides. Ultimately though, after three hours, the Breezy Basic ran out of active material and the temperature started going up.

The good news is, even at these high temperatures/extreme conditions, the Breezy Extra lasted over an hour (and did not go past 31C for three hours), and the other two lasted over three hours.

Conclusions

For the ability to protect, and pen capacity, it is hard to go past The Bag but all three are robust at protecting their contents. For two-week trips, like the one I just did to Europe and the USA, I can see The Bag being used for my backup insulin pens and the Breezy Basic being used for the Fiasp penfills I use to refill my pump. If I need more capacity (or need a bag with a handle) the Breezy Extra is also a great option. I can see myself using the Breezy Extra as a standalone bag with refills, pump sets, backup pens etc. for overnight trips, a bag for work, or day trips.

Product Review: Drew’s Daily Dose Pen Needles

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I got offered a box of Drew’s Daily Dose Pen Needles to try from the excellent Ash of Stripped Supply.

I had heard good things so I thought I would give them a go. My disclosures are:

The needles cannot be purchased from Drew’s web site but are purchased through the NDSS.

While I use an insulin pump and do not inject insulin, I do use Ozempic so I used the needles for that. When they ran out, I used the needles that came with Ozempic and a box of BD Ultra-Fine needles. Rather than weekly, I inject a scaled-down dose of Ozempic daily with a new needle, so it was not hard to go through the needle box.

Look and Feel

In the image above we have the Ozempic needle on the left, Drew’s needle in the middle and the BD needle on the right. As you can see, the design of the Ozempic needle and Drew’s needle are a lot similar than the BD needle. Looking at the packaging, the Ozempic needle is a NovoFine Plus 32G 4mm (same gauge and size as the other two needle types). The NovoFine Plus needles can also be purchased through an NDSS order but my understanding is supply can be problematic i.e. nonexistent.

Drew’s Claims

Drew makes a number of claims both on the box and on his web site. This seems like a good place to start the review.

Box Claim: Ergonomic

Ergonomic means “designed for efficiency and comfort in the working environment” which, in this case, presumably means when injecting. Certainly, I found the needles as comfortable on insertion as the other needles I used. Where it was slightly better was on holding the needle in the site for 10 seconds to allow the Ozempic to seep in. It is very easy for the injection pen to move around a little and, generally this did not hurt with the Drew needle, whereas there is sometimes pain with pen movement with the BD needle.

Box Claim: Reliable

I go through the entire box without issue but, then again, I can go through a BD box without issue as well so they perform as well as other needles in this regard.

Box Claim: High Flow

Given I was injecting relatively small amounts, I cannot say this was a major factor in my use. It may be something to consider, though, if you are finding issue with other needle brands.

Box Claim: 3 Bevel

I did not put the needle under the microscope to check but I have no reason to doubt the claim. A bit of Googling suggests NovoFine Plus needles and BD needles are also triple-beveled. Beveling the needle tip (cutting it at an angle) makes for a sharp point and allows the needle to go into the skin more easily.

Website Claim: Flat Hub Technology

It is easier to see what this is referring to if I show another picture without the needle caps on.

As you can see, the NovoFine Plus (Ozempic) needle (left) and Drew’s needle (middle) have a much wider base from which the needle protrudes than the BD needle (right). Based on this, Drew makes a few claims.

“Reduced Risk of Intra-Muscular Injection”. This is easier to explain with Drew’s diagram than in words.

While the needles may be the same length, the smaller width of the base allows for the skin to be pushed in more with a similar force. This, in turn, may mean the needle penetrates deeper and could hit muscle. Why is this important? Insulin disperses slowly from fat and much quicker from muscle. While generally not recommended, insulin hackers, looking to get a rapid drop in glucose levels, may choose to inject insulin into muscle, rather than fat. For the rest of us this just means less predictability and a higher risk of a hypo.

I did not notice any issue with Ozempic with either needle so I cannot say by how much the design reduces the risk but, again, if this is something you see with your current needle, this may be something to consider.

“Anti-tilt technology”. As I understand it, the idea here is that the wider base limits the pen moving around and reducing the risk of “bending and breakage”. It is true I have had a BD needle bend in site before and I have never had a Drew or NovoFine Plus needle do this. I am wondering if the anti-tilt technology also contributes to the reduced moments of pain, I mentioned earlier, when the pen moved around while the needle was in the injection site.

“Reduces Bruising and Indentation”. The claim is the reduced movement also reduces damage through needle movement, which can lead to bruising and skin distortion. I rarely bruise when injecting (I think this was more common when I first started) so this was not a differentiator for me in considering the different needle brands.

Reduces Needle-Stick Injuries

Again, this is easier to show than describe.

The idea is the green cap can be put into the back to prevent the back of the needle causing a stick injury and the bigger cap protects the front of the needle. Of the three designs, Drew’s is the only one which allows this, although it is a little fiddly. Very handy if you need to inject and you do not have a sharps container at hand.

My Overall Thoughts

The main reason I use the BD needles is because they are often available on the shelf of the chemist and it is a purchase of convenience. However, based on the above, the NovoFine Plus and Drew’s needles have superior aspects and Drew’s is the only one which is its own sharps container. While many of the claimed benefits do not speak strongly to me, this last one does, especially for travel, and for this reason, I will likely order Drew’s needles from now on as part of my NDSS pump supply orders.

If you are interested in getting the 32G*4mm needles for any of the brands mentioned, the NDSS numbers are:

  • NovoFine Plus: 165
  • Drew’s Daily Dose: 338
  • BD Ultrafine: 266

Looping/Automated Insulin Delivery: Does it Work? Commercial vs Open Source, Affordability, and How Professionals Can Support the Lived Experience

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I recently presented at the Australian Diabetes Educators Association NSW Branch Conference and wrote an article for the Australian Diabetes Educator journal on looping and how diabetes educators can support people with type 1 diabetes (PWDs) using looping systems, both open source and commercial. This is not a verbatim reproduction of the presentation or the ADEA article but does cover some of the key points which may be useful to PWDs and Health Care Professionals (HCPs). While the focus of the article is the Australian experience, there is value for international audiences as well.

What is Looping?

There are many terms for technologies allowing a Continuous Glucose Monitor (CGM) and an insulin pump to make blood glucose management decisions without the intervention of the PWD. Originally, when such technologies were ‘hacked’ together on the internet, it was referred to as looping. Now, with both open source (internet) and commercial versions available, and recognition in the academic literature, the more formal term Automated Insulin Delivery systems (AIDs) is used. For the rest of the article, this is the term I will use. Similarly, for simplicity, open source/internet systems I will refer to as ‘Open Source’ and commercial systems as ‘Commercial’. There are nuances which are lost in this broad classification but, for the purposes of this article, they are not overly important.

For a brief history of how the internet made the first AID, you can go to my other blog. These days, there are a variety of options for PWDs. In Australia, there are now four main Open Source systems: 

For Commercial systems, at the time of writing, Australia has three commercial looping systems available: 

  • Medtronic 780G + Guardian 4 Sensor 
  • Tandem t:slim X2 with Control IQ + Dexcom G6 
  • YpsoPump with CamAPS FX + Dexcom G6 

Open Source vs Commercial Systems

These days, I use a Commercial system (Ypsopump with CamAPS FX + Dexcom G6) but my first loop was Android APS using both the Libre 2 and Dexcom G6 CGMs and Omnipod pumps. Neither is better than the other but each system has their own features which are more or less appealing to each PWD.

Open Source Commercial 
Built by the wearer/user Commercially available software 
(Generally) The code which it is based on is available for review Proprietary i.e. the code is not available and how it works is often a trade secret
Very ‘tweakable’ Less flexibility/features 
Not formally approved by a government bodyApproved by a government body i.e. the Therapeutic Goods Administration

There is nothing illegal about using an Open Source AID. The lack of government approval means while they cannot be sold commercially, the law in Australia allows the personal use of unapproved medical technologies and devices. This means, while the software code is usually openly available, it is the PWD who must compile it (not as technically challenging as it sounds these days). The advantage of Open Source is that, because it does not have to go through formal approval processes every time a change is made, innovation comes faster with Open Source AIDs.

The advantage of a Commercial system is that it is largely ‘plug and play’. While PWDs need formal training on the use of the CGM and pump, the commercial software is often simpler to use and administer. Some consumers prefer to be hands-on with their technology while others prefer simplicity.

Do AIDs Work and What Are Their Limitations?

AIDs continue to improve but they do have their limitations. While it is possible for a PWD to modify their diet e.g. eat a Low Carb or Very Low Carb diet, and minimise their intervention with the AID, most PWDs will need to bolus for meals and take care during exercise. For tips on dealing with AIDs in exercise, refer to my exercise article.

My experience has been, being a LADA with some residual pancreatic function, I can skip a lot of bolusing and the AID is very good at keeping me in range. These days I bolus for very carby meals (say 45g or more) but do not need to declare/bolus the rest. Everyone’s experience will vary. One thing I never do are bolus corrections. If I do not declare, the AID keeps adding insulin to manage the carbs and automatically manages the ‘landing’, preventing a hypo. If I manually bolus too much, the AID will suspend basal insulin to ‘soak up’ the excess. No corrections means no stacking and while it can be tempting to bring my levels down quicker after a meal, I always try to let the AID do the work. Similarly, whatever my levels are when I go to bed I can, almost without fail, be assured I will wake up in range. As long as my pump has enough insulin and my CGM does not expire, I can be assured a good night’s sleep.

The other great thing about AIDs is they do not stop you from pulling other ‘levers’ in managing diabetes. If you want to eat a very low carb diet with an AID you can. I touch on this in my “Practical Diabetic Solution” article. In short, when the PWD is asleep or otherwise occupied, the AID takes care of glucose management, ensuring superior results compared to relying exclusively on the PWD to make all decisions 24-7.

A criticism sometimes made of AIDs, especially in the Commercial systems, are their high blood glucose targets (the Tandem, for example, does not allow for a target below 6.1mmol/L (110mg/dL)). The truth is not all AIDs are equal. Broadly speaking the Open Source systems allow for a more aggressive target than the Commercial systems but the system with the lowest possible target is the CamAPS system whose target can be made to go as low as 4.4mmol/L (80mg/dL) although I generally set mine to 5.5mmol/L (99mg/dL) as this is the average resting glucose of a person without diabetes.

To the question of how well these systems work, there is now a strong body of evidence that they do and, from a clinical perspective, outperform any other alternative. For example, here are the times in range for the Medtronic system across various regions of the world. As we can see, it is typical to be at least 70% in range (70-180mg/dL) with minimal lows. These results are consistent across the variety of AID systems and, as mentioned before, do not prevent even better results through the use of adjunct therapies such as medications and diet.

How Do People Decide on the Right System for Them?

There are four key factors to consider when choosing an AID:

  • Availability: Are the pump, CGM, phone and related consumables available? 
  • Accessibility: Are the pump, CGM, and phone usable by the individual? 
  • Adaptability: Can the AID system be extended, as desired? 
  • Affordability: Is the AID system affordable? 

In terms of affordability, Australia is unique in being ‘half-pregnant’ with their AID subsidies. For people with type 1 diabetes, CGMs are funded with a small co-payment by the PWD whereas pumps are effectively unfunded. To get an insulin pump, the PWD must either get private health insurance or pay the, say, $8,000 for the pump out of their own pocket. There is a petition urging the Australian government to change this inequity which I encourage you to sign.

For the other factors, considerations include:

  • More choice of glucose targets.: As mentioned, different systems have different target ranges which may be important to some 
  • Readability: For a user with vision impairment, a high-contrast screen or management via a mobile phone may be desirable. 
  • Connectivity to other devices: Being able to access functions via a watch or the internet may be useful. 
  • Form factor: Device size, whether it is tubed or tubeless, and whether it has an IP rating for water resistance can be key decision factors for some wearers

The available combinations are also important as it is likely a PWD is already using a specific CGM and may want to stay with that CGM as part of their AID system. In fact, there are limited combinations available for AIDs.

 Tandem t:slim X2 YpsoPump Omnipod Dash Medtronic 780G 
Dexcom G6 Android/iPhone (CGM only) Android via CamAPS Android/iPhone  
Medtronic Guardian    Samsung/iPhone (Monitor only) 
Abbott Libre 2   Android  

Above we can see the available Open Source and Commercial combinations in the Australian market for pumps and CGMs approved for use in Australia (Green = Commercial, Blue = Open Source). As we can see, for someone using a Libre 2, the only option available is an Open Source one. Similarly, while the next version of the Omnipod has an AID system (approved in Australia but not widely available), the main Omnipod version available in Australia, at the time of writing, does not with the gap being filled, again, with Open Source.

How HCPs Can Help?

There is understandably some nervousness with HCPS about supporting or recommending Open Source systems to PWDs. These are, almost by definition, unofficial/unapproved systems. On the other hand, to stay relevant to a PWDs care, they cannot remove themselves completely and let the internet and social media be a PWD’s only source of information. Thankfully, there is some guidance for HCPs out there.

Locally, guidance is limited. Diabetes Australia has a position statement on “People with type 1 diabetes and Do It Yourself (DIY) technology solutions” but it is over five years old, light on specific guidance and, arguably, out of date. In its statements around commercial systems it suggests “(In Australia) there is no approved product that is a fully closed-loop system”, and “there is currently no subsidy for the CGM component for adults over the age of 21 years”. Both statements are no longer correct.

Internationally, there are three published documents providing guidance to HCPs and applicable to the Australian context. These are:

These documents are comprehensive in their guidance and freely available to view and download at the above links. Their main points are: 

  • While there are legal complications in recommending Open Source systems, users still require support. Therefore, it makes sense for the HCP to learn about these systems to provide effective guidance. 
  • If the HCP is unable to learn and provide guidance, they should collaborate with individuals who can. 

Conclusions

AIDs provide a lot of value to PWDs and both Commercial and Open Source systems are valid options, depending on the PWD’s needs. While they have their limitations, in terms of bolusing and exercise, AIDs are proven to provide benefit in all global settings in terms of time in range and overnight management.

While it can be daunting for an HCP to provide guidance to PWDs using AIDs, especially if it is Open Source, it is important to provide a voice of reason when there can be a variety of information sources which are less informed or reliable. Thankfully, there are multiple peer-reviewed international guides for the HCP to provide precisely the support PWDs need.

Review: CareSens Dual

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I was recently asked to present at the NSW Branch Conference for the Australian Diabetes Educators Association (ADEA) on Looping/Automated Insulin Delivery and what it means for Diabetes Educators.

One of the perks of these conferences are the sponsor stands where various companies set up and offer freebies. One such stand was Pharmaco Diabetes with the CareSens Dual.

They actually had a range of glucometers but the Dual piqued my interest as it measures glucose and ketones. I have an Abbott Freestyle Optium Neo which was literally the first glucometer given to me seven years ago at diagnosis so, given its age, I thought road-testing a backup would be a good option.

The folks at Pharmaco were generous enough to send me one to try out so this is how it went.

What I Received

In the package was the meter box, a box of ketone strips, a guide for ketones, and some brochure-ware on the full range of meters and consumables.

One of the meters in the brochure which I thought was great was the CareSens N Voice which can speak the reading and a larger screen for people with visual impairment. This consideration of the user really impressed me.

The meter box came with the usual suspects (see image below). The one thing which surprised me was the logbook. Do PWDs still use a physical logbook? I was using the MySugr app almost from day one. These days I have Nightscout.

The warranty registration was interesting in that it was dual-country. The New Zealand one promised a free gift whereas the Australian one did not. The CareSens is essentially the only fully subsidised glucometer in New Zealand so New Zealand PWDs are very familiar with it. In Australia, if you are registered with the NDSS, you can get a free meter from a variety of manufacturers, including CareSens.

The instructions are pretty much the same for all these kinds of devices so nothing too unusual here. I did get a giggle out of the ‘do not insert the strip the wrong way round’ image. Rather than the lancet which comes with CareSens, if you fingerprick regularly, I recommend a Genteel which allows you to use any part of your palm, rather than the sensitive fingertips. This advice is not specific to CareSens; I am just not a fan of jamming a needle into one of the most sensitive parts of my fingers.

While it is not an issue for me, the glucometer allows you to press a button to eject the strip without touching it, and the same for the lancet in the finger-pricker. I guess there are people out there who feel squeamish about touching their own blood and, in these cases, the meter would be a great choice.

I have not had an opportunity to test for ketones (I do not run ketogenic and have not been near DKA since diagnosis) but the blood testing was within 10% of my CGM, which is good enough for me. I did look for online sources to validate the accuracy of the meter but could find nothing recent.

Conclusions

The meter will be a solid addition to my collection and provide me more than one device which can test for ketones. I am tempted to put one of my dual-sensor meters in my travel luggage so I can ketone test easily while away from home and have the other one easily available for home testing.

Thoughts on the Australian Government’s Inquiry into Diabetes

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This week, on the 3rd July, 2024, the Australian government released the 23 recommendations resulting from their Inquiry into Diabetes. This blog will review each recommendation and consider its impact on people living with diabetes, and how the Australian government manages diabetes in general. The blog is quite long, so if you want the short version, head on over to the tl;dr section.

Details of the Inquiry

The Inquiry kicked off back in 24 May, 2023 when the Honorable Mark Butler MP called for a committee to investigate and report on diabetes. The Terms of Reference for the inquiry were, according to the committee’s chair, Doctor Mike Freelander, “very broad” with a view to “get as much information as we can so we can get a plan for the future”. Reading the article, the motivation for the inquiry seemed to be the incidence of obesity and type 2 diabetes in Australia and coincided with the release of a study from Deakin University confirming an increase in the rate of type 2 diabetes in Australia.

This was not an inquiry targeted at type 1 diabetes, but at diabetes in general, with obesity and risk factors also being considered. This is reflected directly in the formal Terms of Reference for the inquiry:

“The Committee will investigate:

  • The causes of diabetes (type 1, type 2 and gestational) in Australia, including risk factors such as genetics, family history, age, physical inactivity, other medical conditions and medications used;
  • New evidence-based advances in the prevention, diagnosis and management of diabetes, in Australia and internationally;
  • The broader impacts of diabetes on Australia’s health system and economy;
  • Any interrelated health issues between diabetes and obesity in Australia, including the relationship between type 2 and gestational diabetes and obesity, the causes of obesity and the evidence-base in the prevention, diagnosis and management of obesity; and
  • The effectiveness of current Australian Government policies and programs to prevent, diagnose and manage diabetes.”

The problem I have with investigating the “interrelated health issues between diabetes and obesity” and “risk factors such as genetics, family history, age, physical inactivity…” is these do not apply to all diabetes types equally, and also apply to other diseases, such as breast cancer. As can also be seen in this last link, risk factors are often conflated with causation. Correlation is not the same as causation and, in the case of diabetes, leads to a lot of unnecessary blame and stigma (there are plenty of skinny type 2s, chubby type 1s, and muggles of both sizes, so broad correlations have limited application at the level of the individual, especially when a proven chain of causality has not been established.)

As it was a public inquiry, submissions and public hearings were part of the process giving a voice, to any interest group who felt the inquiry Terms of Reference related to them, for consideration. So, from the start, there was potential for recommendations which may address broad health issues in the Australian population but not necessarily address prevention of diabetes, treatment of diabetes, or improvements for those living with diabetes. As you will see below, this lack of focus in the Terms of Reference led to a lack of focus in the Recommendations with some having tenuous links to diabetes, at best.

Let us review the recommendations and consider their implications.

The 23 Recommendations

Recommendation 1: The Committee recommends that the Australian Government undertakes a comprehensive economic analysis of the direct and indirect cost of all forms of diabetes mellitus in Australia.

This is an excellent idea. Approval for subsidised medications, equipment, and treatments rely on favourable economic consequences. Approval may require a measure of economic return e.g. spend $1 and return $2 worth of productivity within a specific time period, or an estimation of the cost for ‘Quality-Adjusted Life Years’ (QALYs.) In the case of the NDSS subsidy for CGMs, the cost came in at around $35,000 per QALY, below the unofficial approval threshold of $50,000 per QALY. Subsidies for things like Type 2 CGMs or Type 1 Loops will need to go through a similar exercise. Basically, accurate economic analysis will lower the barriers for smart decisions to be made.

Recommendation 2: The Committee recommends that the National Health and Medical Research Council expedites a review of the Australian Dietary Guidelines, and ensures that the revised guidelines include adequate information for Australians living with diabetes.

Here we see the broader terms of the inquiry coming into play. I do not see a lot coming out of this other than education programmes for ‘guides to healthy eating’. I do not believe information access is the problem. I think we all know we need to move more and eat less, preferably eating food with lower energy density. I can almost guarantee any “adequate information for Australians living with diabetes” will concentrate on type 2 diabetes and its risk factors and largely ignore any other type whose needs are different (people with type 1 are less concerned with glycaemic index/load and more concerned with total carbohydrate count, for example.) The cynic in me has no expectation this level of nuance will be captured in any revisions and expect the guidelines will not go much deeper than “fat bad, protein good, but remember to eat some carbs.”

Recommendation 3: The Committee recommends that the Australian Government implements food labelling reforms targeting added sugar to allow consumers to clearly identify the content of added sugar from front-of-pack labelling. This food labelling initiative should be separate from the information regarding added sugar potentially being included in the Nutrition Information Panel.

This one has little to do with people living with diabetes, whose concerns are carbohydrates in general, rather than just added sugar. I see this adding no value to me personally and see it causing a lot of confusion for people with type 1 diabetes. When bolusing, the need of a person using insulin is for clear carbohydrate labelling. This should not be sacrificed for ‘added sugar’ warnings.

The other concern I have is this recommendation will be seen as ‘proof’ that eating sugar causes diabetes. The causes of diabetes types 1 and 2 are unknown i.e. the reason the immune system starts attacking the pancreas in type 1 is still not understood. Even the proof that sugar causes obesity is limited so, given the Terms of Reference, I think sugar was over-represented in this inquiry.

Recommendation 4: The Committee recommends that the Australian Government implements a levy on sugar-sweetened beverages, such that the price is modelled on international best practice and the anticipated improvement of health outcomes. The levy should be graduated according to the sugar content.

Sugar levies in other countries have shown a decrease in sugar consumption and a slowing of obesity rates in children but that is all the evidence shows so far. While reductions in rates of type 2 diabetes are predicted, using the risk correlations, there has not been enough time to confirm the prediction. I am not against the idea of a sugar tax (my secret hope being it will increase the variety of sugar-free drinks on the supermarket shelves), I am simply uncertain of its place in this inquiry. The hypothesis that sugar consumption leads to weight gain which may lead to an increased rate of obesity which may lead to an increase in the rate of type 2 diabetes seems tenuous to me in its relevance for an inquiry into diabetes of all types.

Recommendation 5: The Committee recommends that the Australian Government considers regulating the marketing and advertising of unhealthy food to children, and that this regulation should:

  • Focus on children defined as those aged 16 and under
  • Be applied to television, radio, gaming and online
  • Use definition of unhealthy food that has been independently developed.

More recommendations relating to general population health with little consideration for diabetes specifically. At least Recommendation 2 threw diabetes in at the end. Again, I am not against lumping in unhealthy food in with cigarettes and alcohol, in terms of advertising, I am simply struggling to link the recommendation to diabetes and the Terms of Reference. My guess is the link is unhealthy food may lead to obesity which increases the risk of type 2 diabetes but I am surprised there were not recommendations raised with a more direct link to diabetes prevention and management. For example, Teplizumab is proven to delay stage 3 type 1 diabetes by literally years so why has it been left out of the recommendations, but an unproven sugar tax included?

Recommendation 6: The Committee recommends that the Australian Government provides its response to the Australian Food Story: Feeding the Nation and Beyond report and considers a dedicated resource within the Department of Health and Aged Care to support access to healthy food to all Australian communities.

For the curious, the referenced report can be found here. The report is focussed on food production and food security but was not about links between food and health. In fact, the word ‘health’ gets mentioned only three times throughout the report’s recommendations. Once in reference to the National Health and Medical Research Council and, of the other two references, the first calls for a National Food Council to advise the government of food matters of which ‘Health and Nutrition’ was one of ten factors to be considered. The second reference called for changes to funding research on ‘food, health and nutrition.’

As we can see, there is a theme here that food, and specifically, sugar is considered the culprit to Australia’s health issues and incidence of diabetes (diabetes type be damned). There is no doubt that access to healthy food is a good thing for Australia in general but, for me, these food recommendations miss the mark for an inquiry on diabetes of all types.

Recommendation 7: The Committee recommends that the Australian Government, in consultation and cooperation with state and territory governments, develops a best practice framework to tackle the problem of obesogenic environments, including through better urban planning and the development of physical activity initiatives and supports efforts to increase access to regular exercise in schools and neighbourhoods as a matter of urgency.

This is a recommendation exclusively considering obesity. The Term of Reference for obesity was “Any interrelated health issues between diabetes and obesity in Australia, including the relationship between type 2 and gestational diabetes and obesity, the causes of obesity and the evidence-base in the prevention, diagnosis and management of obesity.” The recommendation implies that lowering the barriers to physical exercise in urban areas will impact obesity levels. It is a reasonable hypothesis but I could not find a lot of evidence to prove it, similar to the case with sugar leading to obesity and type 2 diabetes. So, again, I question the relevance of this recommendation to this inquiry.

The recommendation is another nice idea for general health improvement but, for tackling how Australia manages diabetes? For me, it seems a poor foundation to build on. Perhaps funding research to work out the causes, rather than acting on the correlations and hoping for the best, would be a better use of money. To mix metaphors, we want to smash the causal chain, not throw stuff at the wall and see what sticks.

Recommendation 8: The Committee recommends that the Australian Government explores the potential for effective national screening programs for all forms of diabetes, particularly Type 2 diabetes.

I appreciate I have not been completely glowing in my appraisal of the recommendations so far but this one strikes me as really ill-conceived. Screening for every type of diabetes except type 2 diabetes makes more sense. For type 1, for example, we recently saw the approval for a national screening program in Italy. So why not type 2? Because there is no simple test to definitively diagnose type 2 diabetes. For type 1 we can test for auto-antibodies (which appear years before symptoms) and for MODY we can conduct genetic testing but, for type 2, the test is the symptoms i.e. elevated blood sugars and their effects on the body. There is literally no test we can conduct on a baby to determine if they are going to get type 2 diabetes and even in adults, diagnosis is a series of tests, not some simple screener.

The best we could do would be to implement regular testing of HbA1c which tells us the person may have some form of diabetes but is certainly not definitive for type 2. An elevated HbA1c, in the absence of a diagnosis of diabetes, is referred to as Pre-Diabetes and it is estimated over 1/3 of the US adult population is pre-diabetic. That is a lot of noise to filter out to find the true type 2 diabetics.

The idea of screening for MODY and type 1 diabetes makes sense to me, assuming it is cost effective (see commentary of Recommendation 1). Screening for MODY makes sense to reduce the widespread misdiagnosis and resulting mistreatment, and screening for type 1 makes sense because immune interventions can delay the onset of symptoms for years. It is clear though, screening only makes sense if something is going to be done with a positive test. Unless medical interventions are part of the overall strategy, screening is useless.

Recommendation 9: The Committee recommends that the Australian Government implements a national public health campaign to increase public awareness of the early signs of all forms of diabetes mellitus.

By the early signs for all forms of diabetes, I assume they mean the “Four T’s” which indicate an insufficient amount of insulin in the blood. Certainly, prior to diagnosis, I had enough awareness of two of the T’s (Toilet and Thirst) to know I needed to see a doctor when I was permanently thirsty and peeing every 30 minutes. Given awareness could prevent DKA death in an undiagnosed type 1, I do have some sympathy for this recommendation, assuming it is cost effective.

Recommendation 10: The Committee recommends that the Australian Government funds the development of education-based obesity screening information and resources.

More obesity recommendations which, again, speak to the health of the general population, rather than at diabetes. As with the screening in Recommendation 8, it only makes sense if there is a resulting intervention strategy for those positively identified. While ‘resources’ suggests some level of funded intervention, it is a bit nebulous.

Recommendation 11: The Committee recommends that the Australian Government implements a national public health campaign to increase awareness of the importance of prevention, identification of early signs, and good management of all forms of diabetes mellitus.

This is similar or, at least, related to Recommendation 9 regarding early signs. Prevention is an interesting one. Again, we are predicating our actions off of correlations, given the causes of diabetes in many of its forms (including type 1 and 2) are unknown. If the cause is unknown, how can we prevent it and raise awareness on what is needed to prevent it? As alluded to earlier, the usual suspects for ‘prevention’ equally apply to other diseases as they do to diabetes.

“Good management”, I assume, means eating less and moving more. I doubt this will include, for example, a national public health campaign on the correct use of insulin or on the importance of a well-rounded health care team.

What this is really recommending is a public health campaign to improve the overall health of Australians.

Recommendation 12: The Committee recommends that equitable access to health care for people living with all forms of diabetes be improved through:

  • Access to longer appointments with a health care provider subsidised by the MBS
  • Access to case conferencing models of health care, especially in rural and remote areas
  • Access to telehealth services
  • Increase in the number of item numbers for allied health consultation for those with diabetes for diabetes educators and dieticians and other allied health providers
  • Access to diabetes educators, including in high-risk outer metropolitan, rural and remote communities.

Finally! A recommendation which actually considers diabetes specifically, rather than being about general population health and issues of sugar consumption, a lack of exercise, and obesity. We are about halfway through the recommendations and, by my reckoning, maybe three of the 12 recommendations are specifically targeted at diabetes, rather than general population health.

Longer appointments are a nice idea if there is something to talk about. I would personally like to see more research and effort being put into structuring the conversations with health care providers so they are more relevant to the person with diabetes (PWD) and deliver real value, rather than being a doctor taking twice as long to tell their client they need to use insulin properly, eat ‘healthier’ carbs, lose weight, and do more exercise. How about a session where the concerns of the PWD are discussed BEFORE the blood results? How about a discussion around the various technologies available and why they may or may not be relevant/desirable to the PWD? How about a discussion of the various medications available which may be of benefit? I am hoping to construct a framework for such a discussion applying corporate motivation theory but this takes time. You can read details of my idea here.

I had to look up “case conferencing” but, from what I can tell, it is health care professional speed dating. Basically, you round up a team of health care professionals (Endo, Dietician, Exercise Physiologist etc.) and have people meet with them as part of a single session. Given the lack of health care professionals in rural areas the organised corralling of them in one spot, and the recommendation for telehealth services make a lot of sense.

Assuming it is done with cultural consideration, I see this having a huge impact in rural aboriginal communities. Aboriginal people are four times more likely to have diabetes/pre-diabetes than their non-indigenous counterparts. Anything that can be done to lower the barriers to health care and education access for these disproportionately affected communities is a good thing.

Then we move on to diabetes educators, a topic of particular interest for me. Firstly, fixing the ‘item numbers’ for allied health professionals is a great idea. A key reason why I do not see my diabetes educator is Medicare and my private health insurance do not recognise the visits. My Diabetes Educator has a Provider Number but, for whatever reason, the visits fall between the cracks. My hope would be that this recommendation would fix that.

Access to diabetes educators (DEs) is a problem in Australia whether it is in urban or rural areas although other HCPs seem to cover the shortfall so that the health of PWDs does not suffer. The online forums constantly buzz with people craving access to a DE but they either do not have one in their area or the DEs are booked out. The pathway to becoming a DE is quite narrow in that you must have a health-related qualification (dietician, nurse etc.) before you can become accredited as a DE.

My personal belief is a person who has lived with diabetes for, say, ten years, could offer tremendous value to someone newly diagnosed but the prospect of studying for three years to obtain a health degree so they can then study to be a DE is a barrier too high for many. A solution might be for a sub-accreditation for non-HCPs where PWDs can assist the newly diagnosed in a structured manner. The pool of available talent would increase and, if managed properly, would not compromise the quality of service given.

Recommendation 13: The Committee recommends that the Australian Government reviews the limits for accessing juvenile mental health and diabetes services, with a view to enabling young people to continue receiving support for longer.

I am unsure which specific programs this relates to, but it sounds like there are specific programs where the recipients ‘age out’, similar to what used to happen with the CGM subsidies when it was limited to people with type 1 diabetes who were 21 years and under. I can see this being particularly important in the case of mental health services where suddenly cutting off the services because of a birthday could be disastrous. This being said, the supply of mental health professionals, such as psychiatrists, is very limited with many having waiting lists stretching for months.

It may also be alluding to the largely useless Insulin Pump Program which subsidises insulin pumps for people with type 1 diabetes under the age of 21. To date, the program has not had a significant impact so broadening the pool of potential recipients would be good.

Recommendation 14: The Committee recommends the Australian Government work with the state and territory governments to develop education tools and resources to support all staff across the health care system to improve understanding of diabetes, its different forms, the early signs and management. The Diabetes in Schools program should be funded to allow all schools to access it.

A high-level but reasonable recommendation. In fact, the NDSS already have the National Diabetes Nursing Education Framework which would go a long way to achieving this goal. The workbook associated to the program is an outstanding resource to give this baseline understanding.

I had to look up the Diabetes in Schools program but it sounds like a great initiative.

Recommendation 15: The Committee recommends that subsidised access to Continuous Glucose Monitors (CGMs) be further expanded. In the first instance, all access limitations in relation to patients with Type 1 diabetes should be removed. Furthermore, individuals with insulin-dependent Type 3c diabetes and patients with gestational diabetes should be made eligible for subsidised CGMs and for those with Type 2 diabetes requiring regular insulin. The Committee recommends prioritising the removal of age limitations on access to subsidised access for Type 1 diabetes patients.

This is a great recommendation. Type 3c diabetes is diabetes caused by physical damage to the pancreas. This may be as a result of an accident, surgery, or perhaps cancer. People with type 3c diabetes often fall through the cracks and have a difficult time accessing subsidy programs despite often having similar needs as people with type 1 diabetes. Expanding access to people with gestational diabetes and insulin-dependent type 2 diabetes also makes sense. This may also open up the door to extending CGM subsidies to the wider type 2 diabetes cohort in the future if evidence shows it is economically viable.

Recommendation 16: The Australian Government should explore expanding subsidised access to insulin pumps for all Australians with Type 1 diabetes. A gradual increase, such as expanding access to those aged 40 and under, would be useful as an initial step.

This is another issue I have strong thoughts on, and I was a co-author on this petition which describes why the current model is broken. I was also a signatory to the recently released Consensus Statement on Automated Insulin Delivery for Type 1 Diabetes in Australia.

A gradual increase makes sense although why it would be based on being less than 40 years of age mystifies me. As far as I know, there is no medical evidence to suggest 40 years has significance in the efficacy of pump use. For me, it would make more sense to roll it out in a manner similar to how the CGM subsidy was rolled out e.g. ((type 1 diabetes AND (21 years and under OR indigenous OR concession card holder)) OR (insulin-dependent gestational diabetes). The rest of us would access a pump in the same way as we do today and, over time, the program could expend where the evidence supports the case.

Recommendation 17: The Committee recommends that the Australian Government undertakes a review of the price and choice of insulin pumps in Australia.

I have no idea where this one is coming from. We have a pretty good choice of pumps in Australia so why fix something which is not broken? I hope this is not suggesting we have too much choice and implies we should go down a path similar to, say, New Zealand where only two pumps are funded. Choice is not a luxury; it ensures people are getting the right technology to maximise their prospect of success. Their job may mean a tubeless pump is a better choice. They may have sight impairment which means a pump which connects to a phone or which has a high-contrast screen is the best option. A wider choice ensures a broader set of people’s needs can be met.

Recommendation 18: The Committee recommends that the Australian Government, subject to a positive recommendation from the Pharmaceutical Benefits Advisory Committee, expands the eligibility criteria for Glucagon-like Peptide-1 (GLP-1) receptor agonists, particularly for high-risk patients.

Yes! A great recommendation. I talked about GLP-1s and their benefits for all types of diabetes around four years ago, based on the results coming out from international conferences. These results are now filtering down to the government subsidy level and, hopefully, will soon lead to wider availability for these powerful tools although, historically, supply has been an issue.

The next generation of GLP-1s are now coming out with even more impressive results in terms of weight loss and glucose management. The most well-known is arguably Tirzepatide (Mounjaro) which is approved for people with type 2 diabetes but not type 1. Upcoming trials hope to show it is of benefit to both types of diabetes.

Recommendation 19: The Committee recommends that the Australian Government establishes mechanisms for securing supplies of Glucagon-like Peptide-1 (GLP-1) receptor agonists for disadvantaged and remote communities, including Aboriginal and Torres Strait Island communities.

As mentioned in Recommendation 18, supply of GLP-1s worldwide has been an issue. Given their benefit for both weight loss and for people with diabetes, it is a good suggestion although it is not clear to me how it is to be implemented. If those of us in the cities are struggling to get supply, and the issue is worldwide, this makes access a non-starter for remote communities whose logistics challenges will only add to the problems.

Recommendation 20: The Committee recommends that the Australian Government considers expanding access to bariatric surgery within the public system for eligible patients.

For people with type 2 diabetes and obesity, bariatric surgery has an impressive remission rate of around 50-95%. In Australia, to be eligible for the surgery you must have a Body-Mass Index (BMI) of over 40, or type 2 diabetes and a BMI of over 35. The recommendation is not clear in which direction access should be expanded (lower BMI? different types of diabetes?) Also, only so many surgeries can be conducted in Australia annually and the government would need to provide significant funding to keep up with the current demand, let alone increased demand.

Recommendation 21: The Committee recommends that the Australian Government takes steps to manage diabetes research efforts through the Australian Centre for Disease Control (CDC) by coordinating with the peak bodies such as JDRF and Diabetes Australia research priorities with an emphasis on equitable access and prevention. The Committee also recommends that the Australian Government considers increased funding for Type 1 diabetes research and clinical trials.

All sensible recommendations. I assume coordination between the relevant bodies is not as efficient as it could be and thus the call for improvement. If it means better use of money to help people with diabetes, I am all for it.

Recommendation 22: The Committee recommends that the Australian Government undertakes a survey of current diabetes-related data, with a view to developing strategies for establishing new and improving current data sources and for establishing a national diabetes mellitus register within the CDC.

This is an interesting one as I thought, until recently, that Australia had pretty good data because of the NDSS diabetes database. However, when the register was first established, ‘best guesses’ were made to the type of diabetes people had, based on the information available at the time. This summary covers the history of the NDSS register and some of the problems in the quality of its data.

To give an idea of how, even today, poor data are being captured, according to the NDSS database there are literally no people with type 1 diabetes in Australia who are insulin independent. This means LADAs who, by definition, do not require insulin for at least six months after diagnosis, are lost in the system. Why is this the case? Because it is really hard to change the details in the NDSS database once a person is registered. This means all LADAs, including myself, are told to register as insulin-dependent so that access to subsidised resources is not an issue later on. In short, there is no formal recognition of LADA in Australia and certainly no data to ascertain the prevalence and characteristics of this type 1 sub-type.

Recommendation 23: The Committee recommends that the Australian Centre for Evaluation in the Department of Treasury commits to the ongoing assessment of any actions taken in respect of Committee recommendations made in this report.

This sounds more like bookkeeping than a specific diabetes-related recommendation. Accountability is good though, so I appreciate the value of it.

tl;dr

The recommendations of the inquiry are a bit of a mixed bag, driven by overly broad Terms of Reference and, arguably, pre-conceived notions on the causes of diabetes and, specifically, type 2 diabetes.

The recommendations fall into the following categories (23 is generic and has been left off):

Sugar Recommendations (3, 4)

In short, added sugar is the devil and should be treated as such (change food labelling to call out sugar has been added and tax it). No argument from me on that front but, for type 1 diabetes, total carbohydrates is the key piece of information. As long as that is not sacrificed, all good. As for a sugar tax, if in encourages more variety in sugar-free drinks, I am all for it.

Why is sugar being mentioned in an inquiry into diabetes? No idea. Sugar is not mentioned in the Terms of Reference and its inclusion will feed misconceptions about diabetes being caused by sugar eating.

Obesity Recommendations (7, 10, 20)

The obesity recommendations (design cities for exercise, screen for obesity, and make bariatric surgery more accessible) do not talk at the links between diabetes and obesity, as outlined in the Terms of Reference and tenuously relate to “the causes of obesity and the evidence-base in the prevention, diagnosis and management of obesity”. I would argue they miss this mark given there is limited evidence that city design improves obesity rates. As for the final two recommendations, without investment in what happens after a positive screening and in bariatric services, all we are doing is creating demand for a system which is not set up to serve it.

General Health Recommendations (2, 5, 6)

In short, review dietary guidelines, regulate the advertising of unhealthy food to children, and ensure access to healthy food. All great ideas, and all as relevant to diabetes as they are to many other diseases where diet is considered a risk factor. Should they be in the recommendations for an inquiry into diabetes? Is there evidence that any of these measures will impact diabetes in the Australian population? Do they align to the specified Terms of Reference? No.

Diabetes Recommendations (1, 8, 9, 11-19, 21, 22)

The remaining two thirds of the recommendations actually relate to diabetes, which is good. Economic rigour around the cost of diabetes is a great idea (1) and provides a foundation for smart, economically responsible decisions. Screening for diabetes (I have no idea why they focus on type 2 diabetes here) and increasing overall awareness to enable ‘self-screening’ (8, 9, 11) makes a lot of sense. Catching diabetes early in all of its forms improves outcomes for the individual and the country.

Improved access to health care professionals (12, 13) for all Australians is a good idea but the shortage of these professionals is not considered in the recommendations and risks straining an already strained system further.

The call for improved education of health care professionals in their knowledge of diabetes (14) is a great idea. Many people with diabetes (especially people with type 1 diabetes) actively avoid engaging with the health system because they know they will need to educate the HCP themselves and, often, their knowledge and experience will not be respected and ignored for a lecture received back in medical school decades earlier. Improved education is a tide which will raise all boats and improve the system for all.

Improved and subsidised access to proven medications and technologies (15, 16, 18, 19) is a great idea although I am concerned about the suggestion to review the choice of pumps (17) unless this is aimed at getting the most recent pumps into the country as Australia is a version behind in many CGM and pump systems. The suggestion to use a cut-off of 40 years of age for pump subsidy confounds me and is misaligned to previous Australian subsidy schemes and pump subsidy schemes being rolled out internationally.

Improved research funding administration and access to data (21, 22), as with Recommendation 1, will only improve the decisions made in the future. We can only set our direction when we know where we are, where we are wanting to get to and the means we have to get there, and while many of the recommendations make good guesses to the direction we should head, Recommendations 1, 21, and 22 enable a foundation for much smarter navigation.

Conclusions

There are some good ideas here but there are also missed opportunities and half-solutions. Screening for different diabetes types and for obesity is well and good but what then? The emergence of immune intervention treatments for type 1 diabetes e.g. Teplizumab is also a missed opportunity and a great solution to the question of screening next steps. The lack of health care professionals to service the diabetes community is also absent from the recommendations despite calls to increase demand.

I look forward to seeing how these recommendations are implemented and hope, the ones which are truly focussed on diabetes get the attention they deserve. Diabetes is a costly disease for both the individual and the country so smart, evidence-based decisions, will make a big difference.

Getting Medical Interventions Approved By Government

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Having played for a few years at the nexus of academia, big pharma, and government, it is interesting to watch how these three bodies orbit each other and interact (for those of you familiar with the Three-Body Problem you know such a system is often unstable, but I digress). It is often frustrating, being a person with type 1 diabetes, knowing there are, for example, medications out there with overwhelming evidence behind them but which are not funded by government national health programs. GLP-1s are a great example. These are well established to provide benefit to people with type 1 diabetes but are still, certainly in Australia, not covered and financially out of reach for those who would benefit.

So, what does it take to get something approved for government subsidy? I see four major factors which are necessary, and I thought I would write this article to describe them. For context, I will use the subsidy of continuous glucose monitors (CGMs) for people with type 1 diabetes (T1Ds) in Australia as a case example.

The ‘Ask’

The first step is a clearly articulated ask: “We would like the government to fund/subsidise <x>”. In the case of CGMs for T1Ds, the ask is “We would like the government to fund/subsidise CGMs for T1Ds”. In reality, the ask for was for a specific subset, and the program was expanded to all T1Ds over time (for reasons explained later), but I will keep things simple to illustrate the point.

It is, at this stage, where we can answer why GLP-1s are not available for T1Ds in Australia. The fact is, in the case of Ozempic, Novo Nordisk has not asked because they have no need to. Demand is outstripping supply such that Novo can set the price as they wish and run their factories at full speed. Asking will create a new audience which they cannot serve and force a negotiation on price. There is no motivation to do this until general demand abates or supply can be scaled up.

The Medical Benefit

The ‘Ask’ needs to be justified by a tangible benefit which can encompass quality of life measures and overall health measures. In the case of CGMs for T1D, subsidy would allow more people to access the technology and significantly reduce the need for finger pricking. Near-real-time tracking of glucose levels would reduce the risk of serious hypoglycaemia and hospitalisation. All good things and a great improvement for the lives of people living with type 1 diabetes.

The Medical Benefit provides the “So What?” element to the request and can be very emotive. A piece of wisdom often used in sales is people make decisions on how they feel about the purchase and justify it with logic after the fact. The Medical Benefit is the door to stirring the heart of government to act and, in turn, makes for an emotive tale for voters for justify the spend and show the government cares.

The Evidence

A good tale still needs evidence. Aristotle’s ‘Art of Rhetoric’ speaks of three key elements necessary to persuade:

  • Ethos: The argument should be from a credible body
  • Pathos: The argument should stir the emotions of the receiver
  • Logos: The argument should be based in reason

I have taken it as given that, if a request is being made, for it to get the ear of the government, it will need to be from a credible source (Ethos). The Medical Benefit is the key to providing Pathos and clinical/world evidence is the key to Logos. Without evidence, it is a stirring tale but an unjustified one. A government needs to back decisions on reason otherwise the opposition will exploit the weakness.

In the case of CGMs for T1Ds, there was a wealth of clinical evidence showing improved health outcomes with the use of CGMs. I gave an example of this back in 2021 in the context of PWD pregnancy and the use of CGMs.

The Economic Benefit

Governments are required to be fiscally responsible because of scarce resources. In short, if the government is to spend a dollar, it needs to do so on whatever yields the most benefit. For medical interventions, economic justification is usually measured in cost per QALY (Quality-Adjusted Life Years). Basically, a threshold needs to be met where the cost generates a minimum level of benefit which, in this case is a longer and better quality of life for the individual.

The threshold varies from country to country and, while there is no official limit in Australia, a general rule of thumb is government will consider a medical intervention which costs less than $50,000 per quality adjusted life year.

In the case of CGMs for T1D, the economic numbers came out at around $30-35k per QALY and the request was approved.

Case Example: Automatic Insulin Delivery for T1Ds

Let us consider a couple of items being discussed in the diabetes community at this time. The first is equitable access to insulin pumps and, by extension, looping (Automatic Insulin Delivery aka AID) for all Australians. In Australia, while CGMs are subsidised by the government for T1Ds, pumps are not and need to either be purchased directly or obtained through private health insurance. Given a pump costs literally thousands of dollars this puts it out of the reach of many Australians and I recently helped co-author a petition to help get this changed which I encourage you to sign (QR code below).

So, based on the four elements mentioned above, how would we expect the request to fare if raised by a credible body to government as part of, say, the Inquiry Into Diabetes?

The ‘Ask’: This is relatively straightforward i.e. “AID systems should be subsidized for T1Ds”

The Benefit: Lots of qualitative and quantitative benefits to AID systems such as better overnight control, improved HbA1c and Time in Range, and less manual intervention by the T1D.

The Evidence: Lots of clinical and real-world evidence to support this from companies such as Medtronic.

The Economic Benefit: While it would be great to subsidise AID systems for all T1Ds, to get the appropriate cost per QALY, it may be necessary to pick a sub-group e.g. children (who consistently have higher HbA1cs than their older counterparts in trials), T1Ds who are pregnant and so on. Generally, the cohort selection will be driven by The Evidence as this informs the economic modelling. In other words, if there are no studies of AID systems helping pregnant T1Ds, it will be harder to economically justify their inclusion.

Case Example: CGMs for People with Type 2 Diabetes (T2Ds)

On the back of the benefits seen in T1Ds with the use of CGMs it makes sense to expand the program to T2Ds.

The ‘Ask’: Again, this is relatively straightforward: “CGMs should be subsidised for T2Ds”

The Benefit: T2Ds being able to see how food affects them will inform eating habits and improve health outcomes.

The Evidence: There is some evidence of benefit for insulin dependent T2Ds but the body of evidence for general benefit is still being gathered with limited long-term studies to justify The ‘Ask’. To quote this last paper, literally written this year, “…few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes”

The Economic Benefit: Without evidence to act as a foundation for the modelling, it is harder (not impossible) to determine a cost per QALY. The best hope would be to exclusively focus on where there is evidence (insulin-dependent T2Ds) with the hope that, as more evidence is acquired, the program can be expanded to the wider T2D population.

Conclusions

It is easy for us to be frustrated with the glacial movement of governments to get behind the latest advances in technology and medicine when it is clear, for those of us at the coalface, there are benefits to many, many people. However, as we can see, with competing priorities, it is important government spending is used as effectively as possible.

The inclusion of medical interventions in national health programs requires collaboration of all three bodies (big pharma to provide the intervention, academia to show it works, and government to provide the funding) and the will by all of them to drive it. Without this willingness and the elements mentioned above it is hard, if not impossible, to achieve success.

ATTD2024: Analysing and Understanding Complex CGM Data for Informed Clinical Decision Making

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I had the opportunity this weekend to catch up on some of the presentations I missed at ATTD2024. I struck gold with the first one I watched. Dr Pratik Choudhary spoke on interpreting CGM data and, as I am in the process of building a bot to do this, it was a talk of great interest. The tips and tricks he gave for reading Ambulatory Glucose Profiles (AGPs) and the rest of the CGM report, I believe, are useful to anyone running a CGM.

Structural vs Behavioral Factors

Dr Choudhary considers two broad levers to improve what he sees in the data: Structural and Behavioral Factors.

For Structural Factors, Dr Choudhary applies general formulae to give a guide on what the values should tend towards if there is an issue.

For people who bolus for meals, his general rule is a 50:50 split of daily units used for bolusing and daily units used for basal insulin. He mentioned exceptions to this rule such as people running hybrid loops and low-carbers who will have a much higher percentage of basal and those who micro-manage their glucose levels, giving themselves boluses many times a day, who will have a higher bolus percentage. In these cases, if it is working, he leaves it alone but if it is not, the 50:50 rule is his guide.

For his benchmark carbohydrate ratio he uses 350 / Total Daily Dose and for the correction factor, 120 / Total Daily Dose. He refers to these are rules but ‘guideline’ is probably a better term.

Dr Choudhary’s Flowchart

His position is, if the Bolus/Basal doses are as expected, the levers to pull are likely to be behavioral.

Showing an example, he presented a report for a person with diabetes (PWD) with top-heavy bolusing, based on the 50:50 rule. His experience is for top-heavy ratios, the PWD will often have a lot of variability. Considering the actual basal (32u/day) vs expected (39u/day) it suggests there is not enough basal, putting upward pressure on the CGM, rising between meals, which is confirmed in the graph.

The Insulin to Carb Ratio (ICR) was 5g/U whereas the predicted was 4.5 g/U suggesting a unit of insulin does not cover as much of a meal as the PWD thought. The Insulin Sensitivity Factor/Correction Factor was 2 mmol/L (1 unit of insulin drops blood glucose by 2mmol/L) whereas the predicted Correction Factor was 1.5 mmol/L suggesting insufficient insulin is being given corrections.

Sure enough, we see that the PWD is going high in the day and staying there, likely because they are not administering sufficient insulin due to bad factors/ratios, with the problem amplified by insufficient basal.

Behavioral Indicators

Dr Choudhary mentioned that for people without diabetes typical glucose variability is usually 15-20%. For PWDs between 20-35% they are generally looping or bolusing well. For people with a variability of 35-50% Dr Choudhary suggests this is a mismatch between food and bolus and so, in the case of high variability, he believes changing settings is not going to help. He also mentioned that any time a PWD can bolus 15 minutes before a meal is ‘free HbA1c/Time in Range and lower variability’.

The light blue area of the AGP relates to events which happen once every week or every fortnight, suggesting they are behavioral (or lifestyle driven e.g. an exercise day/Sunday roast/takeout night) more than systematic. Dark blue is more common and therefore more influenced by structural factors.

Where to Set the High Alarm

A great tip Dr Choudhary gave for setting the high alarm is at the top of the dark blue region on the AGP. When your blood sugar goes over this it is, by definition, an unusual event which may need intervention whereas anything below this is business as usual.

For low alarms, he warned setting them too high as it encourages the PWD to stay high, costing Time in Range. For myself, I set it to 3.3mmol/L (59mg/dL). For the five years post-diagnosis that I was insulin-independent, I wore a CGM and often dipped into the high 3s (high 60s) and got as low as 3.4mmol/L but never any lower. Therefore, below 3.4mmol/L, for me, is abnormal and worthy of attention.

Good Numbers but at What Cost?

Dr Choudhary also showed someone with excellent control due to frequent management. His recommendation for someone bolusing is to “scan, inject, eat and forget” meaning that once you have bolused and eaten, the trajectory of the blood glucose is set and there is very little which can change it. If the peak occurs around one hour after eating, you matched the bolus to the food. The level after two hours will indicate whether the bolus was enough to cover the food. After three hours may show rises influenced by protein and fats but he suggested there was little point in monitoring glucose movement around meals more frequently than this.

He also suggested that frequent management driven by fear of long-term complication may be ill-founded in some cases. From the DCCT study he cited that if a PWD has not had complication interventions in 20 years since diagnosis, their change of getting a life-changing complication for the rest of their life (loss of organ/sight/limb) is negligible. Therefore, if a person with this level of aggressive management is burning out after 20 years of micro-management the evidence supports the option of relaxing the regimen somewhat without significant consequence.

How Do I Fare?

As it happens I have just seen my Endo and my HbA1c has crept up to 5.9% so I am keen for suggestions on improvement (even though I am still well below the threshold for significant risk of complication ).

In terms of the structural settings, my Total Daily Dose for the last 3 months averaged 88U/day. However, as I run my CamAPS Ypsopump completely closed I do not bolus for meals and let the pump take care of it. Therefore, I cannot assess whether I am near the suggested 50:50 ratio. However, based on my profile numbers, informed by Autotune, I am a lot more ‘basal heavy’ than the 50:50 guideline would suggest, backing up Dr Choudhary’s position that it does not strongly apply to loops.

For 88U, the expected ICR is 4.0 g/U and the ISF is 1.4 mmol/L. Again, as CamAPS has automatically adjusted these values for me automatically as part of the loop I cannot check it directly but these values closely align to the default profile values in my pump which I determined using Android APS and Autotune, prior to switching to Ypso a couple of years ago.

My Glucose Variability is currently 31% which is in the typical range for someone looping but, as it is towards the higher end of the range suggests a slight mismatch between bolus and food. Given I let the algorithm do it all, this makes sense as I do not even declare I am eating, letting the loop figure it out for itself.

Looking at the dark blue, we can see a mismatch between insulin and dinner. As the family has roughly the same dinner on a given night of the week it would be interesting to see if the light blue is caused by “Lomo Saltado Lunes”, “Taco Tuesday”, or “Takeout Friday”. I will have to see if it is possible to generate AGPs for a given day of the week over a period on Nightscout…

My Endo has suggested providing some intervention to help the loop with dinner. CamAPS has a Boost function which I will activate at the start of dinner for two hours, giving the loop permission to be more aggressive, to see if this helps. Failing this there are plenty more levers to pull (restricting carb intake or, heaven forbid, giving a bolus).

As mentioned, my low alarm is set to 3.3mmol/L. You will see in the above stats that in the last 3 months it recorded 99 hypo values. These are, almost without exception, a new G6 sensor needing calibration. On the rare occasion I skip a meal and confuse the loop, I might skim the low alarm but it is nothing a few jelly beans cannot fix.

At the moment, my high alarm is set to 15 mmol/L (270mg/dL) but, based on Dr Choudhary’s advice, it should probably come down to 10mmil/L (180 mg/dL) if I was planning to intervene (at this stage I do not do correction doses either).

Where to Find Australian Clinical Trials

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Ever since being diagnosed seven years ago, I have been keen to participate in trials of new treatments. Unfortunately, there are not a lot of trials for LADAs (at least, not in Australia). When I became insulin dependent, a couple of years ago, I thought things would change but either my age (I am 50) or my HbA1c excludes me (studies generally like higher HbA1cs and mine is too low). I do check for new studies every month or so and thought putting a list together of where people can go may be useful.

Diabetes Australia’s Research Opportunities

Current research opportunities | Diabetes Australia has a great list of research studies for all types across all of Australia

Disclosure: I am on the Diabetes Australia Community Advisory Council

JDRF’s Clinical Trials Archive

Clinical Trials Archive – JDRF lists trials specifically for type 1 diabetes all across Australia

Australia/New Zealand Clinical Trials Registry

ANZCTR search results | Australian Clinical Trials is an Australian Federal Government registry for many health conditions with filters to show only ones relating to diabetes. Despite the title it seemed to only show trials in Australia at the time of writing.

Baker Heart and Diabetes Institute Clinical Research Trials

Clinical research trials (baker.edu.au) covers all types of diabetes (or, at least, types 1 and 2). The Baker is based in Melbourne but my understanding is some of their trials do recruit outside of Melbourne.

Disclosure: I am a voluntary clinical affiliate with The Baker (basically I am on the books if they need Lived Experience input on a trial) and an Associate Investigator on their FAME-1 Eye trial.

Australasian Type 1 Diabetes Immunotherapy Collective (ATIC) Clinical Trials

Clinical Trials | ATIC (svi.edu.au) are studies focused on immune system mediation which means they generally relate to type 1 diabetes. Arguably this is the frontier of type 1 diabetes treatment and has recently seen exciting results with medications such as Teplizumab for delaying the onset of symptomatic type 1 diabetes. Recruitment is across Australia and, at the time of writing, there was even a study recruiting in New Zealand.

Disclosure: I am on the ATIC Community Engagement Panel.

Using Copilot to Navigate Medical Papers

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Adapted from https://thatcrmblog.wordpress.com/2024/05/05/using-copilot-to-navigate-microsoft-licensing/

For those of us who read medical papers, it can be rough sailing. The texts are written for medical professionals and not the rest of us. There is the excellent D-Coded Diabetes Research but they have only D-Coded a handful of papers, so what do we do about the rest?

I wondered if AI could come to our aid and it turns out Bing Copilot can be really useful.

Bing Copilot can Read PDFs

As well as answering questions on web sites, you can open a PDF file in Edge, and Copilot will review the content and answer questions on it, almost instantly. At the time of writing, this is the link for the Type 1 Consensus Report from the EASD and ADA. From here you can open a PDF version of the full report. At 37 pages, I am more than happy for Copilot to navigate the jargon, footnotes and tables instead of me.

So how did it go? The first test was to see if it could read a flowchart. Browsing through the document, I found one describing the diagnosis of type 1 diabetes. Asking what to do for an adult over the age of 35, it did a pretty good job of walking through the process.

My next test was to read a table and return results. It also passed with flying colours and even gave additional context.

While the above questions were a little artificial to establish it could read the document accurately, we can ask more practical questions such as what medications can be taken to help manage type 1 diabetes (other than insulin).

We need to be careful though as, if we do not specify to use the document exclusively, it will go off to the internet which may or may not be desirable.

Asking this question without confining it to the document brings back a slightly different list of proposed medications.

and while this list is not endorsed by the EASD/ADA consensus we can still assess the sources if we want to explore more.

So What if Copilot Gets it Wrong?

I figured the best person to ask was Copilot themselves and, sure enough, they confirmed it is possible for it to get it wrong and gave sensible advice as a consequence.

As discussed in my article on AI from my other blog, common sense, as provided by a human, should prevail. As Edge Copilot provides sources (and links to where it read the information in the document) it makes sense to double-check these before putting one’s health on the line, using a carefully curated health care team as a sanity check. However, as a tool for quickly reading through a jargon-filled document and pointing me to the key places of interest on a specific topic, I see this as a very useful tool.

The 12 Levers You Can Pull To Manage Diabetes

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My perspective on managing diabetes is it requires a multi-faceted approach. I refer to the strategic elements of this approach as ‘levers’. The way I see it, it is a case of working out how hard you can personally pull each lever and which ones work for you.

What are your Goals?

Before a strategy can be put in place, we must have an idea of where we are heading, what are our goals? These can be big, hairy audacious goals (I want completely normal blood sugars) or smaller ones (I want to reduce my HbA1c). With goals in mind, we can start to use the levers to get us there.

My goals are:

  • Minimise daily management to avoid burnout
  • Reduce my HbA1c to a point where my risk of long-term complications is no more than 2x baseline

That’s it! Goals do not need to be complicated and, in my case, one is qualitative (minimise management) and the other quantitative (based on my previous blog, getting an HbA1c under 7.0% is good, getting under 6.4% without hypos is better).

What External Factors Can Hinder Us?

In moving towards our goals, there are factors which may impede our progress. T1D Mum provided this great summary of “social determinants of health” which impact our lives.

While ‘Individual Lifestyle Factors’ speaks directly at the levers I am referring to, as we more further out, our ability to influence the impact on our lives becomes harder e.g. ‘Water and Sanitation’ without significant upheaval to our lives e.g. changing one’s job/home/country or, as t1d mum suggested through advocacy and demand for change. Perhaps we should include advocacy as a lever to address this although it is a slow moving one.

Levers You Can Pull

I brainstormed as many levers as I could think of and went to social media to see what other levels people could come up with.

These are the ones the collective came up with in no specific order:

Let us go through them.

Food

Arguably the lever which gets talked about the most and possibly one of the easiest to pull in some fashion. Clearly, reducing the amount of fast-acting carbohydrates will help with blood sugar spikes but, after this, we may adopt a different approach, based on our goals, beliefs, and social context.

For some, a ‘carnivore’ approach is the way to go given muscle tissue has many of the nutrients our body requires with zero carbohydrates. For others, a plant-based diet which reduces insulin resistance makes more sense.

Given how tightly food in woven into human culture, it is hard to give hard and fast rules about how to pull the food lever which will apply universally. Everyone will have an idea of the changes they can practically make to their diet to steer them towards their goals.

Sleep

The CDC gives a great summary of the benefits of sleep for people with diabetes. The very short version is a good night’s sleep is a relatively simple lever to pull to help you towards your goals. Tim Street correctly points out though that adjusting sleep patterns can have unpredictable effects to basal rates and glucose levels (Dawn Phenomenon) so make changes slowly.

Exercise

It is news to no one that exercise is beneficial to health in general and diabetes specifically. Again, I will pull out Dr. Dessi Zaharieva’s exercise slide to summarize the benefits.

Medication

Gone are the days when the only medication for diabetes was insulin. We now have drugs which reduce insulin resistance (Metformin), actively remove glucose from the blood (SGLT2is), and restore the satiety response (GLP1s) as well as many others and many more coming.

It may not be a lever any of us relish pulling but it is there for us to use as we see fit.

Technology

Even in the seven years since my diagnosis, technology has progressed significantly and continues to do so. We now have commercial looping systems which act as an artificial pancreas and, while not perfect, they can provide tremendous benefit in managing, for example, overnight levels.

Health Care Team

A good health care team is vital for good management. They act as a source of expertise as well as a sounding board for your own thoughts and discoveries. The ability to engage with the health care team or adjust its composition varies greatly from, for example, rural to urban areas which can limit how much this lever can be pulled and how effective it is.

Social Media, Online Resources, and Peer Support

Another resource for information and ideas, social media, online resources and peer support, like the health care team should be carefully curated so they work for you, rather than against you. Unlike the health care team, a lot of what is found online is unregulated so, even more than the health care team, critical thinking is needed to work out what is useful, what is unfounded, and what the agenda is behind the information. For example, I trust PubMed much more than medical ‘evidence’ from Twitter or Facebook. However, in terms of looping and success in managing LADA, online discussion groups have been essential. As Tim Street puts it “Peer Support…opens minds to methods that may help…”

Family, Friends, and Allies

Online support is one lever but support in the real world is another we can pull. As Tomorrow’s Gone suggests, having family and friends who are ‘followers’ to CGM data, who can help out on sick days, tell you when dinner is going to be ready so meals can be effectively managed, or do supply-runs when they unexpectedly run out is a great asset to have. Tomorrow’s Gone also mentions making allies of others such as the school a person with type 1 diabetes attends by providing a care plan.

Financial Status

There is flexibility in money and, therefore, financial status can greatly impact our success in managing diabetes. It is also one of the hardest levers to pull given the inherent expense in managing diabetes and the financial commitments of everyday life e.g. we may want to use certain technologies or medications but cannot afford them. Therefore, getting financial advice and stabilising finances with a budget can be a great lever to pull.

Time

As we can plan our finances, so too we can plan our time and give ourselves flexibility to explore other levers such as exercise or sleep. While none of us want to be a slave to a strict time regime, some planning and organisation can provide benefit.

Stress/Wellbeing/Mental Health

Stress hormones can cause havoc with blood glucose levels and maintaining good mental health is vital to keep the diabetes gremlin in its cage. Whether it is doing something relaxing such as meditation or yoga, or regularly seeing a mental health professional, there are ways we can keep our mind clear to tackle the demands of the body.

Education

This arguably overlaps with some of the other levers such as having an effective health care team and making good use of online resources but, as it also covers physical media such as books or university courses, I have called it out as a distinct lever.

Also, you are your best advocate in managing this disease. You know your body better than anyone and have the greatest motivation to keep you healthy. Arguably, this can only be done if you are educated about your body, about diabetes, and about the levers you intend to pull.

Education regarding your own body is an interesting one because this knowledge can only come from self-experimentation and not from the internet, a book, or a university. Dave Dikeman mentions practical knowledge of insulin dosing as an example which is vital if manually injecting and can be quite individual, depending on insulin resistance and diet.

Education can come from a variety of sources, such as those mentioned, and, for me, empowers and amplifies many of the other levers available.

No Lever Acts in Isolation and Levers can be Inconsistent

As you read through it may have occurred to you that some levers affect others, as mentioned with education. Also, levers may not always act the same way. For example, with a women’s monthly cycle insulin resistance can significantly change, affecting the way insulin, food, and exercise impact the body.

For this reason, I believe there is not one lever which is more important than any other and over-reliance on any one lever can set us up for failure. For example, an over-reliance on technology means we may be in big trouble if it fails. Using diet, being educated on how to inject safely as a backup, and having a robust support network means we have contingencies if technology fails. As Steve Norris sums it up “I think the problem is that the levers don’t pull consistently, nor do they act in isolation. A holistic, yet unburdened, approach is important…”