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 & Tresiba Update

This post reflects on the positive impacts on my day-to-day life since switching to Afrezza and Tresiba, along with some new challenges. A simple mistake led to three weeks of terrible glucose results, and the cause took a while to track down.

The day after I have my best ever 24hr glucose result (see charts at bottom), my glucose levels began going out of control. Unexpected highs between meals led me to try increasing my basal dose. Then major lows began, so I started changing the time of dosing basal. My total daily dose of Afrezza dramatically increased. I even switched back to injectable bolus for two days to see if that would help.

When my basal cartridge ran out, I discovered what the problem was. I had accidentally refilled the pen with a Levemir cartridge. Both cartridges are green, and are in blank foil blister packs. The pen can also completely cover the label, depending on how the cartridge is rotated. I certainly won’t be making that mistake again.

Both cartridges have green rings and are in blank foil packs.

Both cartridges have green rings and are in blank foil packs.

When I restarted Tresiba, I dosed twice in the first 24 hours to try and speed up the transition. After the third dose, levels were returning to normal.

As troubleshooting this issue has consumed about three weeks, in the video I reflect on the positive impact that switching to Afrezza and Tresiba have had on my life so far. In addition, there are some new challenges that these treatments present.

Afrezza

All of the impracticalities of dosing insulin before a meal are gone. When I’ve eaten enough and I feel full, I now don’t have to force myself to finish the meal. If I want to share food I’m eating with someone else, I can offer it to them without having to explain that I have already had the insulin for everything that’s on my plate.

Cooking is a pleasure now I don’t need to weigh ingredients, or weigh dishes while serving. I no longer have to copy numbers from nutrition panels and look up web sites in order to perform a series of complex mathematical equations before every meal.

I am no longer constantly worrying about encountering another company like HelloFresh again, who provide diabetics with potentially lethal falsified carbohydrate data.

Previously, visiting friends for dinner required them listing all the ingredients and quantities for the meal before it was served. I avoided going to restaurants wherever possible to avoid the impossible task of dosing for unknown meals of unknown sizes being served at an unknown time. It’s an amazing feeling being relaxed for the first time in these settings.

However there are new challenges. Afrezza acts for a shorter length of time than injected insulins. Some fatty meals like pizza require split doses of injectable insulin. After about a year of trial and error I settled on injecting two doses five hours apart. Without a CGM, I don’t have alerts for when my glucose is going out of range so identifying the optimum timings using Afrezza will take some time. I hope to systematically develop some simple guidelines for dosing to help out others that are not using CGMs.

Tresiba

For the first time in my life, I can sleep in on weekends without glucose levels suffering. Many years ago I dosed Lantus once daily in the evening which allowed me to sleep in, however it was unable to last 24 hours so levels were rising in the evenings.

With Lantus and Levemir twice daily I had to return home at the same time every evening for my second dose, ruling out spontaneous social events. It’s liberating to be able to chose when I want to go home, rather than have my basal always counting down the minutes.

So far, I have not observed any detectable difference if I dose one morning and then wait until the next night. As summer approaches here, I am sure I will have more opportunities to test out the limits of Tresiba’s flexible dose spacing.

The only downside so far is managing the different basal requirements I have on the weekend. I imagine this was a problem before, but is highly visible now I’m using the FreeStyle Libre.

During the week, I eat three times a day and am less active that I am on weekends where I tend to eat twice daily. My solution so far is to eat or drink something sugary while doing extended physical activity like working in the garden.

23 Sep - Best Results. Note the Interquartile Range.

23 Sep – Best Ever 24hr Period. Note the tight interquartile range.

FreeStyle Libre Data

23 Sep – FreeStyle Libre Data

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.