Insulin treated diabetes

Kadir Hattat • 7 January 2020
in community General Aviation
37 comments
12 likes

Starting from 7 November 2019 the FAA is allowing insulin dependent diabetics to qualify for 1st and 2nd class medical certificates provided they go through an evaluation and use an approved CGM (Continuous Glucose Monitoring) device.

Improved insulin formulas and monitoring devices has made his condition (which affects at least 15% of human population) very manageable and potential for pilot incapacitation almost negligible, well, at least at a level comparable to other conditions that are allowed by EASA to get medical certification.

In the light of what the FAA and other authorities around the world has done and technological breakthroughs in diabetes management I find it totally unacceptable that the EASA still does not allow insulin dependent diabetic pilots to fly for a living. Leaving aside ATPL or CPL, not even PPL nor the lowly LAPL can get medical certificates if using insulin.

I feel it is about time EASA takes another look at this restriction which is archaic to say the least.

 

Comments (37)

John Franklin

I forwarded your comments to our medical experts and we'll come back to you with some feedback as soon as we can - just so you don't think we are ignoring the question.

Kadir Hattat

Thank you John for speedy action. I hope we can start something here because I really do feel that EASA is falling behind the times on this issue.

John Franklin

Hi Kadir,

The information from is our Medical colleagues is that firstly on the current situation according to AMC5 MED.B.095 (d)(3) the LAPL “Applicants with diabetes mellitus Type 2 treated with insulin may be assessed as fit with limitations for revalidation if blood sugar control has been achieved and the process under (e) and (f) is followed. An ORL is required. A TML for 12 months may be needed to ensure compliance with the follow-up requirements below. Licence privileges should not include rotary aircraft flying.” So there is an allowance for this already.

There is the possibility for changes on the particular pathology you write about in the next revision of Part-MED - although at the moment there is no clear timescale for this. Things are always under continual review and our Advisory Bodies with the National Authorities and industry organisations feed many things like this in the planning of the rulemaking and safety promotion plans.

It is also worth mentioning that France has already submitted an AltMoC on the topic of LAPL pilots with insulin dependent diabetes in order to alleviate this category of pilots while ensuring flight safety. This process enables any of the Member States to make changes before we manage to amend the IRs and AMC/GM.

Jonas Karbach

Hi John,
you mentioned "Things are always under continual review". Is there any possibility to be part of such a process? On the one hand to better understand the regulations/decisions and on the other hand to give some input from the point of view of a diabetic (Type 1)?

Best regards,
Jonas

Kadir Hattat

John, I again thank you very much for a prompt and informative response.
Does this mean if I get a French LAPL Med, I can freely fly across the EASA region?
That is of course when France starts issuing the medical certificates to diabetics.
Best regards

John Franklin

I am not sure the full details of the AltMoC is published, just the general Excel list. I am out of the office at the moment but will ask my colleagues for more information when I can get back to the office on Monday.

Douglas Cairns

I’m aware that Ireland and Austria can issue Class 1 Medicals for aircrew with insulin treated diabetes who have previously been commercial pilots, as long as they meet minimum diabetes control requirements. It was the UK that introduced this first in 2012 after which Ireland and subsequently joined/introduced the same. Since the FAA issued first Class Medicals earlier this, Australia has also issued a Class 1 Medical to a pilot with insulin treated diabetes. Given recently developments in the USA and Australia, I would also like to ask EASA when it will consider introducing Class 1 Medicals across all of EASA, and include aspiring pilots with diabetes who have not been commercial pilots before. Thank you.

Jaime Umpiérrez Miranda

EASA must reconsider it's position about that, and learn and copy if necessary the FAA protocol signed by specialist like endocrines. I hope so ...

Kadir Hattat

Or, should we go picket the EASA headquarters and have our voices heard?

Jonas Karbach

Hey there,
my name is Jonas and I joined this post, because that’s exactly the topic I have to deal with for years. In 2009 i got diabetes type 1 and almost having finished my license, I had to quit until now. The latest news from the FAA concerning CGM and the possibility of becoming an airline pilot in the USA made me do some research again. So I found this post and I am very excited to follow this topic. Maybe some day it’s possible to get a medical (at least for LAPL?!) with Insulin treated Diabetes and CGM...

Best regards and thanks for opening this post!
Jonas

Kadir Hattat

As you so correctly mentioned Jonas, (at least for LAPL!) This would give the EASA a statistical pool of pilots with insulin treated diabetes do they will begin having a database of their own if they don't trust the FAA.

Jonas Karbach

Hi, it's me again. I just want to place some facts and questions here I have thought about the last months (Maybe a responsible person will read it and can place it at a higher instance so they can discuss about it or whatever...):

11 years ago I lost my medical as I got insulin-treated Diabetes mellitus type 1. I had to accept that it's not safe to inject insulin and fly an aircraft. Yes, I totally agree that there is a higher risk of becoming unconscious when injecting insulin with a pen and only control the blood glucose with a blood glucose meter for example just every 2 hours. But since 2009 several years have passed and there were a lot of changes in the diabetes therapy methods.
So today I am equiped with some nice technology like an insulin pump with an CGM system. Those systems work so good, that (based on some research) the FAA allow pilots with insulin treated diabetes type 1 to get an ATPL! And here in Europe (Germany) I am not allowed to fly a Cessna for example with a LAPL? I know that the FAA and the EASA are two different agencies, but with this rule of the FAA american pilots are allowed to land a Boeing 747 at for example Frankfurt International Airport (the busiest airport in Germany)... And I am not allowed to fly a Cessna as mentionned above at a smaller airport which is like 50kms away... It's hard to understand and accept because totally simple - in america type 1 diabetes is the same type 1 diabetes we have here...and all over the world...

So far so good.
Why am I not allowed to participate my hobby for example with a safety pilot? For insulin treated type 2 diabetics there is an option to gain a medical with a safety pilots... type 1 diabetics should be rated as unfit. Why? Where is the risk if I have a "normal" healthy pilot next to me? Where is the difference for example to a scenic flight?:

Example 1: I participate at a scenic flight as a guest and I pass out because of low blood sugar. The pilot lands the aircraft.

Example 2: I participate at a flight where I am the pilot (with a safety pilot at my site) and I pass out. The safety pilots lands the aircraft.

Where is the risk? Where is the difference?

Example 2 mentionned above is the worst case of all cases and must be the point why type 1 diabetics are not allowed to get a medical. If I am wrong, please somebody correct me.
But how high is the risk of this example becoming true? Let's imagine I have a valid medical and a valid pilot licence with type 1 diabetes. I am planning to do a flight tomorrow. So I know: no sports, no shitty food 1 day before so there can't be an effect 1 day later.
If I go flying, the flights are not like 3,4,5,6,7 ...... hours, no! Most of them are just to have fun... 30 minutes, 1 hour... maybe 2 hours.. How high is the risk of passing out in this time when I have some cleary defined rules like checking blood sugar prior to departure and for example every 30 minutes.. Then I have the CGM system which checks my amount of sugar under my tissue. The values of the CGM have a maximum discrepancy compared to the blood sugar of +/- 40mg/dl.... and thats the worst case. For me both values are matching 95% of all the time very close to each other. And if thats even not enough we still can think of placing a safety pilot next to me. So, I don't know how you think, but for me there is a risk of passing out which is close to 0%... And I think all of us have a risk of passing out during a flight... even if the don't have diabetes!

To come back to the CGM system:
This system checks the sugar under the tissue every 5 minutes and its also displaying me the values and trends how it is developing. Also a warning and automatic stop of insulin is implemented, if the sugar is decreasing too fast and there is still too much insluin active in my body.
If such a warning appears during flight and i am unable to hear the warning sound, there is also a vibration warning me. So I have enough time to check my blood sugar as well and eat or drink some sugar.
Additionally, the CGM in combination with the insulin-pump are saving and analyzing sooo much data in numbers, diagrams, word, e.g. ... All those datas could be used to analyse the blood sugar values during a flight.

What more should come to allow insulin dependant diabetics to fly again? The next step would be to heal diabetes...

I can continue with some facts and questions until tomorrow but I hope my arguments are good enough to think or discuss about.
I know for agencies like EASA or whatever we are just small numbers... But why waiting for maybe something that's not necessary to wait..? We all have just one life. And some of us are just here to fly.

Have a good night,

Regards
Jonas

Daniel Vlaardingerbroek

Hi,

Any update on this matter? I got diagnosed in 2017 and had to stop my hobby (Gliding) because of it, I agree with the abovementioned posts that the technology is on a whole new level, which makes managing Diabetes Type 1 a lot easier! Heck, there are even whole closed-loop systems on the market now.... How far does technology need to go before EASA realises that it's safe to fly for us diabetics if we're managing our Diabetes properly? As far as I know there hasn't even been a single test run for type 1 diabetics, so I seriously question what EASA is waiting for, and I surely can't be the only one...

I am hoping that EASA will finally take this matter seriously and that they will look at it, because frankly speaking, this is taking way too long. EASA is definitely falling behind on their counterparts...

Kind regards,

Daniel

EDIT:

Just read this in the Research Agenda of EASA, doesn't look hopeful...

"New diagnostic measures are being developed that allow reliable
continuous blood glucose level monitoring. Furthermore, the
medical industry has developed automated insulin pumps that
allow the equipment to monitor the glucose level and administer
the insulin dose needed in an automated manner. Nevertheless,
the sensors used by all these type of equipment may be affected
by pressure changes and aircraft on-board environment. There are
no research studies available currently to assess the possibility of
their safe use in aviation environment and in order to alleviate the
requirements imposed to pilots with such pathology."

Jonas Karbach

...and where is the problem to start selecting data by allowing insulin treated type 1 diabetics to fly with a safety pilot(for the first time), like the type two‘s?

Kadir Hattat

Insulin pumps deliver insulin at a different rate at altitude but, I do not use a pump. Just a CGM. I think this should be considered. Also I use about 0.45 units of insulin per body kilogram. Every person and their condition is different. My advice to EASA is, “Nothing ventured, nothing gained”.
EASA should consider at least max 2 seat gliders, motorgliders and ultralights to start building up a database

Jakub Nadszyszkownik

Actually, first completed safety report on pilots with insulin-treated diabetes has been already published:

https://care.diabetesjournals.org/content/43/12/2923

As predicted, no safety concerns have been reported.
I don't understand argument pointed out by Research Agenda of EASA that CGM sensors have not been validated for use in aviation environment. Prior to COVID-19 pandemic millions of passengers were flying with CGM devices with no observed impact on quality of glucose readings. Moreover, above cited study refers to ongoing clinical trial on comparing the data obtained from CGM vs. conventional fingerstick glucose monitoring. Estimated study completion date was set on December 2020, so there is still a hope that we see the results soon.

https://clinicaltrials.gov/ct2/show/NCT04225455

Ricardo Rocha

I wonder if there would be a way to create a group of pilots interested in moving things forward in this area, and trying to establish contact with EASA. There seems to be a large pool of pilots that had to stop their activity even if they have access to technology that allows them to live a perfectly normal life - including participating in activities where blood sugar management is much more complicated than flying a leisure motor aircraft or glider.

Jonas Karbach

Thanks for that Ricardo! Looks like some nice Pre-Work! Reading all the documents, it sounds very practicable and safe to fly so. Clearly defined what and when to do.

Lubomir Kovalcik

[~4095] That's very well written. But I am afraid that it won't help me here at all till EASA actually change their medical requirements. Anyway maybe it would be good to point out, that risk of having hypoglycemia while flying is very low with CGM in combination with insulin pump, because it is not even physically demanding activity like hiking/running or other sports which could lead to sudden drops in blood glucose. I think that, actually flying can only lead to stressful situation or adrenaline rush, which temporarily increase your insulin resistance and leads to higher blood glucose, which have much lower risk of passing out in short time. It would take many hours and you would certainly notice this if you are wearing cgm or even not.

Daniel Micallef

I actually authored the documents mentioned in the thread - I am a doctor and got a pilot license while studying in the UK (which I can't use locally as I'm type I diabetic). I would be willing to help out too.
It's high time that a reasonable solution is found by EASA:
- Australia, Canada, the US, Austria, Ireland and the UK already have guidelines in place which have been used for several years - if there were safety issues, the relevant authorities would have repealed or modified the guidelines. It's not like EASA would be pioneering something which has never been tested in the world.
- The above allow even class I certification - possibly, the EASA can't start off even with LAPL's or class II's?
- I don't have personal experience with pumps (although FAA allows their use) but they should not be a limiting factor for certification.
- It is often mentioned that CGMs have not been tested in pressurised environments. This is again of limited relevance in most GA settings. It would also be very easy to study the reliability of CGMs and compare it to fingerprick measurement in a pressurised environment if there is some will. In addition, it is always a requirement to carry a backup device. As to the use of CGM in the cockpit, it's definitely easier than fingerprick. It's like having another instrument on the panel.
- Most guidelines are based on fingerprick measurements and they are applied safely. CGM makes the process many times safer by providing readings and trend arrows. In addition, during evaluation, CGM provides much more data (time in range and time in hypoglycaemia) than fingerprick measurements and HbA1c which in reality is of very limited utility.

Medicine should not be based on opinion particularly when there is an evidence-base to the contrary. In fact there are NO publications showing that there have been safety issues with type I diabetic pilots on insulin and in fact ALL publications conclude that there have been no safety issues.

While, sadly, not every diabetic will be motivated or fit for certification, it is discriminatory to ban certification for all type I diabetics on insulin, particularly when there are protocols which are used safely elsewhere and can be implemented with a few changes to reflect recent advances in the management of diabetes.

Let me know if I can be of any help in this.

Josefine Strømkvist

I’m a type 1 diabetic who has been dreaming about being a pilot since i was 3yo. I find it so frustrating that the EASA seem to have simply made up their mind on this matter despite the numerous positive reports. I’m going out of high school in 2 years, and i just can’t get myself to give up on my dream, it’s the only thing i want to do. If anyone here knows of a community where i can contribute or do anything at all (or know if the EASA seems to be doing anything about this) it’s very welcome!

Julia Kaiser

Hello,
My name is Julia.
I am also unfit to fly glider (SPL) due to diabetes type 1.
I have received my glider license 2019. A week after the last exam I went to the hospital with a diagnosis of type 1 diabetes.
A world fell apart for me at the moment I realized that I am unfit. Much worse than the diagnosis type 1 diabetes.
I hope so much that EASA will adjust their regulations to the new diabetes management.

Today a pilot from Australia contacted me via Instagram. Apparently it is allowed there with certain conditions (hypoglycaemia).
I am unfortunately also not satisfied with the solution of a safety pilot for gliding. Because at the moment I fly together with other pilots and have the opportunity to fly on the front seat.
Id like to fly solo and cross country and competitions. This is so annoying.
I hope so much that the rules will redesigned for private pilots.

Greetings from germany
Julia

Kadir Hattat

EASA shoul use the US FAA experience to allow glider, LSA and LAPL pilots to command their aircraft. EASA should do their homework, if necessary work with us to have a Diabetic medical certificate standards to allow EASA area pilots to be able to fly for pilots who will prove themselves worthy of earning such a certificate

Sten van den Broek

Hi everyone,
I just found this page and noticed that apparently i am not the only one trying to address this discussion.
I am a high-school student (17 years old) and fell in love with gliding. Even with my T1D diagnosis, my local aeroclub still allowed me to fly and join as a member, which i am very thankful for.
After receiving no response from EASA, i have contacted my country's government, and asked for a conversation to discuss this issue, hoping my country would be willing to consider requesting an ALTMoC themselves, just like France did recently. After lots of messages, waiting, and being redirected to others, i was able to talk with someone of high status in my government regarding aviation and infrastructure. I was eventually given the task to collect as much data and info about current ALTMoC's regarding T1D, as well as other promising news about research about T1D. I have done extensive research, and i put all the links and documents i found into one clear and accessible document. I have sent this, and i am currently awaiting further response.

I have discussed this with my doctor. I am 17 years old, My HBA1C is 51 (= 6,8 mmol/dL or 128,9 for mg/dL average over the last 3 months.) I do not have any medical complications due to my T1D, and i also never have lost consciousness as a result of low blood sugar in my 3 years of being a T1D patient. My doctor stated that my blood sugar levels are almost as close to a healthy person as they can get. And therefore, i would be safe to fly a glider (given my T1D would be strictly managed before and while flying)

I also recall being told that the current French ALTMoC request only applies to T2D patients who require additional insulin injections; not T1D patients who exclusively use insulin.

EASA is considering T1D for further research, but like Daniel stated, EASA mentiones the following:

"New diagnostic measures are being developed that allow reliable
continuous blood glucose level monitoring. Furthermore, the
medical industry has developed automated insulin pumps that
allow the equipment to monitor the glucose level and administer
the insulin dose needed in an automated manner. Nevertheless,
the sensors used by all these type of equipment may be affected
by pressure changes and aircraft on-board environment. There are
no research studies available currently to assess the possibility of
their safe use in aviation environment and in order to alleviate the
requirements imposed to pilots with such pathology."

These arguments can be very easily dismissed.

Any simple google search on the devices (CGM's and pumps) most commonly used by T1D patients shows that almost all of these devices have an operating range up to at least 3000m or ~9850 ft. (source: original manuals from manufacturers.) If there is anyone that can be trusted the most when it comes to numbers like these, it'd be the manufacturers themselves. Personally, i think there is no further study needed to confirm this. If the specs state that they work as intended within stated operating conditions, there's no reason to believe they won't. they (legally) can't post incorrect specifications..
And even if they DO want this to be verified, EASA can start a study/project with select participants to monitor how these devices work in certain conditions. But EASA does not seem to put in much effort to make such a study/protocol happen.

I think that in 2021, with the current developments and improvements that have been made, it is safe to let (healthy and stable!) T1D pilots fly with a LAPL/SPL license without further limitations, after approval from the patient's doctor.
I see no reason why EASA is hesitating.

Any further hesitation / postponing of improvements, research or contact from EASA is in my eyes not neccesary and unjustified.

Kind Regards,

-Sten van den Broek.

Daniel Vlaardingerbroek

Jonas Karbach and I also put together a document with some facts/questions regarding this topic (although only regarding LAPL medicals, not Class 1/2) and asked John Franklin to forward it to EASA's medical experts, just to put the issue on their radar again. This was already done in early March, but we were told a reply could take a couple of months (especially now that they're busy with COVID-19). So hopefully they will look at the issue again.

Good work Sten! Nice to hear from another Dutchie with the same issue as me. Who is your contact person here in NL?

Sten van den Broek

Hi Daniel!

I originally started off by contacting the ILT on Twitter, as well as contacting them on their official website. I eventually came in contact with Wim, the administrator/manager of the ILT Twitter account.
Wim kept me up to date about the progress regarding my message to the ILT.

Unfortunately, the ILT's 1st response was fairly underwhelming, and didn't provide me with information i didn't already know. I informed Wim about this, and he was able to give me the opportunity to talk with Rini de Jong, a person of high importance in the ILT. After some discussion about the topic, he gave me an e-mail address from Frederik Blaauw from the DGLM. I contacted Frederik Blaauw, and was able to plan a conversation.

After a brief conversation about the topic, and what i have achieved so far, he gave me the task to collect as many info as possible, regarding current ALTMoC's, and T1D developments.
About a month later, i had collected enough info, and i sent this document with the info to Frederik Blaauw. I am currently still awaiting a response. (Currently: May 03, 2021, waiting since early Jan 2021)
I am thinking of contacting Rini de Jong again and picking things up again on ILT's side.

Daniel Vlaardingerbroek

[~3569] Sounds good, I would definitely contact them again! It often just drops to the background of their to-do list, so refreshing them on it can't hurt :). Btw, check Facebook, so we can find easier ways to communicate.

Kadir Hattat

Excellent effort guys, lets get the EASA listen to our voice

Jonas Karbach

Julia, Daniel and me decided to create a WhatsApp Group concerning this topic. So beside this blog (where we can still continue collecting results and find new people), there is the opportunity to communicate with each other. If you want to join, just write a short email with your Name and mobile number to: FlyWithT1D@web.de (I created it specially for this type of usage)
I'll check it regularly.

Regards
Jonas

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