Afrezza: Extreme Storage Challenge

During the early stages of Afrezza’s development, it was claimed that it could go without refrigeration for more than two months. However, the packaging instead says to only store at room temperature for 10 days. This extreme test goes 16x longer than the labelling to see how it still performs.

Since starting on Afrezza I have been wondering if Afrezza really does require refrigeration. As you will see in the video, where I stored the insulin was certainly much warmer than average room temperature.

The blister pack spent 161 days without refrigeration before this test. It was first put in the heated hothouse on August 22nd, and then taken out on December 5th (105 days). After that, it spent 56 days in the hottest room in my house during a typically hot Australian summer.  Melbourne had 20 days above 90° F (32.2° C), and 5 days above 100° F (37.8° C) during the test period.

Unlike the US, summer officially starts in Australia on December 1st. For an official temperature record of Melbourne over this period, visit this Bureau of Meterology page.

To test if Afrezza still worked, I used a can of Australian full strength Coke, (which has sugar as 100% sucrose in Australia). Sucrose and caffeine together make this drink raise glucose levels quickly. A control test using newly-ordered Afrezza stored in the fridge was also conducted (video will be uploaded soon). Basal insulin was the amazing Tresiba, and no food or other insulin had been taken prior to the tests.

Long story short, there was NO decrease in Afrezza’s efficacy after the five months. It worked flawlessly and glucose never left the non-diabetic levels. Glucose started at 4.2 mmol/L (75 mg/dL) and ranged from 3.8 mmol/L (68 mg/dL) to 4.6 mmol/L (83 mg/dL) during the test. I certainly won’t be requesting refrigerated shipping from the US anymore.

The significance of this really can’t be overstated. The Frio insulin cases we use when travelling barely work in tropical humidity. For diabetics who travel frequently, those who live in hot climates, or anyone who doesn’t want a fridge packed full of insulin, this is a game-changer.

Put simply, Afrezza does not need refrigeration and there is no other insulin on the market that can make this claim.

The manufacturer, Mannkind should capitalise on this feature, and submit revised storage conditions for approval. Extended room temperature storage is yet another major point of difference between Afrezza and all other insulins.

Matt

PS:  Full length footage of experiment will be uploaded soon.

Afrezza with Tresiba: A Perfect Match?

This video discusses my switch to the new Tresiba basal insulin for use with Afrezza. Is this ultralong-acting basal the perfect match for the ultrarapid-acting Afrezza?

After testing 18 different dose permutations of Lantus, I remained disappointed with my glucose levels between meals. Switching to Levemir improved things greatly, but introduced new problems each day.

A new basal called Toujeo contains identical ingredients to Lantus and still seems to be inconsistent in its release.  This study observed 50 people for 2 days on Toujeo. This figure shows that Toujeo’s release sometimes varied considerably between the two days and did not always lower glucose steadily throughout the day – its activity sometimes spiked or ran out.

That study was by the manufacturer of Toujeo and Lantus. Another study by its competitor showed that Lantus was over 300% more variable in its release over 24 hours than the new ultralong acting basal Tresiba.

They calculated the risk of experiencing more than double the usual maximum effect on any given day (potential hypoglycaemia) was <0.1% for Tresiba and 11% for Lantus. That’s a random hypo every 9 days on average! Plus random highs every 5.8 days on average. That’s the average for the whole group of people – some were far, far worse.

So I switched to Tresiba to see how it works with Afrezza.  It comes with many other advantages, and eliminates some routines that have ruled my life for 24 years!

The number of doses of Afrezza I use each day is reduced, including the dose I previously needed as soon as I woke up. Additionally, all of the problems introduced with Levemir are gone. It’s early days, but here’s a picture of where I’m at now.

Now that my basal is almost fully optimised, I can soon work on finding the optimal strategy for timing and dosing of Afrezza.

UPDATE: Tresiba has just received FDA approval in the US. Still waiting for Australian TGA approval.

Afrezza + Tresiba

It’s early days for Tresiba, but so far I’m very impressed.

FreeStyle Libre: 8 Weeks On

Here’s a video update about the FreeStyle Libre glucose monitoring device that I’ve now been using for about eight weeks.

Unfortunately three sensors have failed early. One gave some odd readings the day before and then gave an error saying the sensor needed to be changed.

The other two sensors kept saying I was dangerously low when I felt fine, but the system’s self-diagnostics didn’t detect the malfunction. I applied a second sensor and used a second reader, which showed a higher reading by about 2.0 mmol/L by the time I removed the sensor. It may have had something to do with the adhesive coming loose on the sensor – which hadn’t happened before.

Since recording the video, a third sensor has failed early, and underneath there was pronounced skin irritation (pictured below). This may be responsible for it becoming unstuck. Other users online have also found that their initial sensors worked fine, but their bodies seem to attack sensors applied later on. It’s happening in almost half of FreeStyle Libre users, and some are experimenting with a Compeed barrier between the skin and sensor. I might try this next time.

It’s also worth noting that the sensor applied most recently caused bleeding out of the hole immediately after application (also pictured below), but it hasn’t caused any issues so far.

Notice the skin irritation that may have caused the sensor to become unstuck. Also note the bleeding from the newly-installed sensor.

The skin irritation that might be linked to the sensor malfunction. Also note the bleeding from the newly-installed sensor, which did not seem to affect its performance.

Fortunately the incorrect Libre results are in a safe direction, and wouldn’t have resulted in an unsafe insulin dosage decision. However for the first time in six weeks, I have had to supplement the Libre with finger testing, as I need to be confident in my results while switching my basal to Tresiba.

Overall I still really like the Libre, but it would be amazing if it had the ability to transmit a high glucose alert (say, at 6.0 mmol/L) like a CGM. The Dexcom G6 coming in 2017 sounds like it might be a great (but expensive) alternative to the Libre. However, I’ve already got high hopes for a future Libre that might transmit via Bluetooth to an Apple Watch.

Also check out my video of applying the sensor.

FreeStyle Libre Sensor Application

If you’re wondering how the Libre sensor is applied, I made this video showing how it works.

The applicator is like a stamp that fires it into the skin and sticks the adhesive in one action. The application looks much friendlier than the Dexcom, and isn’t particularly painful.

Also check out this post which sums up my experience using the Libre for 8 weeks.

Afrezza and Levemir

This video update covers my switch to Levemir, and its nifty pen. Scroll down for my charts comparing the two.

The high variability of Lantus prevented me from further optimising my basal dose, and the issue makes some consider it dangerous.

So I decided to switch to Levemir. My experience with Levemir mirrors that of this user in the UK, who finds “the duration of the Levemir is frustrating, as the amount taken in each of the two injections is not quite enough to get me through a twelve hour duration“. Further, I need to be cautious during its peak.

As you can see in the video, the NovoPen Echo is very cool. However my third pen has already failed once already, and I hope it’s the top display that’s wrong and not the one on the side. Novo has asked me to send in the pens to investigate.

If I can get a pen I can trust, I would like to pair the NovoPen Echo with the longer acting, flat profile Tresiba basal (not yet available in Australia).

Update: I have since changed basal insulin to Tresiba. Novo has sent two replacement pens, and I await the results of their investigation into the faults.

The goalposts have shifted a lot in a couple of weeks.

The goalposts have certainly shifted a lot in a couple of weeks.

Afrezza Units & Insulin:Carb Ratios

This video explains why insulin:carb ratios don’t work with Afrezza, no matter how hard you try.

Afrezza works so differently to previous diabetes treatments, and yet there is nothing in the box explaining how or why. It works so differently that for a while I wondered if I had a bad batch.

This video explains why the labelling on the box is unhelpful and confusing. The units just can’t be compared, and it takes a while to work out that Afrezza has two independent effects.

The first phase begins immediately but it doesn’t lower blood glucose, instead it temporarily stops it rising. This effect seems to be responsible for all the weird and wonderful properties of Afrezza, the first phase does not happen with previous insulins.

The second phase, however, works like a small dose of injectable insulin. It lowers blood glucose, and takes longer to start working. This is the only phase of Humalog or Apidra.

Previous treatments work by flooding the body with an unnaturally high level of insulin for hours, in order to slowly lower high blood glucose levels. Afrezza stops blood glucose rising in the first place using the natural first phase signal to the liver instead. This means that for the first time much lower, more natural levels of insulin can now be used in Type 1 diabetics.

– Matt

 

Afrezza: Extreme Glucose Challenge

This video is a follow-up to the Extreme Coke Challenge.

Using fast-acting emergency glucose with 5g more sugar than the can of coke, and a higher starting blood glucose level, we see how Afrezza deals with this unlikely situation. Afrezza is so fast it doesn’t need a head start. This video shows why Afrezza is less effective when taken before a meal, and should be taken at least 10 minutes after starting most meals.

It is of interest that the final glucose reading in Coke video at 85 minutes after drinking the coke was 6.0 mmol/L. In this video, the glucose reading was 6.4 mmol/L at 80 minutes after drinking the glucose. This is 0.4 mmol/L difference between the two videos, which is identical to the starting difference. This suggests the results would have stayed in the non-diabetic range if Afrezza was not taken in advance.

Update: It will be interesting to re-run this experiment without giving Afrezza a head start, and see how different the result is now that I have switched basal.

-Matt

The unedited video can be downloaded below.

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Afrezza: Extreme Coke Challenge

This impressive video demonstrates how Afrezza works very differently to previous treatments for Type 1 diabetes.

Although I’m only 3 weeks in and still working it all out, I’m beginning to see how Afrezza can really widen the range of foods I could eat while still improving my glucose control. This is the best demonstration I could think of to show off its capabilities. For non-diabetics, read this for real experiences of would happen without Afrezza.


I did this test on an empty stomach. I started at 11:57am, the only thing I had consumed was a coffee at 9:27am. For this I had the small Afrezza dose (blue), so there was no residual glucose lowering going on.

I couldn’t have done this even a week ago, and feel like I am getting better control of my diabetes and a better understanding of Afrezza every day.
Carbs: Ice-cream 15.2g + 375mL Coke 40g = TOTAL 55.2g sugar
Lantus: 7u AM, 9u PM – (before Afrezza, Lantus was 10u AM, 9u PM)

Also see a follow up experiment using emergency glucose here.

The unedited files can be downloaded below.

-Matt

Update: The results for this experiment may be even more impressive now that I have further optimised my basal insulin type and dose. Expect a re-run in the future.

 

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