Study Subject

Something that has always been a big fear of mine regarding my diabetes, and potential complications, has been loosing my vision. I think this is a common fear for those of us with diabetes, since the first things we hear about are going blind, loosing limbs, and our kidneys failing.

Around 10 years ago, my yearly visits at the eye doctor began to show the signs of diabetes in my eyes. They were small, but there. At first, it was devastating for me. There was nothing to be done.
Over time, the spots disappeared and then came back again and never left. There was no change to my vision, and literally nothing that I could do, other than do my best to control my blood sugars and hope that my eyes held steady without getting worse.

See, when you have diabetes, your blood sugars are not normal all the time. This causes issues with your eyes because the blood sugars can make your eyes think that there need to be more, new vessels in them. So they begin to develop. The problem is, these vessels aren't supposed to be there so their weak and can leak and bleed. The bleeding causes vision loss, and at that point, it is typically treated with injections of medication and laser surgery.

I had those vessels and spots in my eyes, but they weren't bleeding. Yet. Back in the summer of 2017, I had a scheduled eye appointment with my eye doctor, and while I was waiting on him, I noticed a sign on the back of the door advertising a study for those with Diabetic Macular Edema (the term for the leaky vessels and spots) but no bleeding. When the doctor came in, we talked about my eyes, and without me bringing it up, he suggested I might be a good candidate for the study.

Ultimately, the study involved an existing medication that is used to treat bleeding in the eyes. It is injected into the eye, and they wanted to see if the medication could be used BEFORE the bleeding began, to help hold off, or improve the state of the leaky vessels and spots in the eyes. Before the vision damage and the laser surgery.

They gave me some information on the study (okay, a TON of information on the study), and I took it home to think about it and to pray. Ultimately I decided to give it a try. There was no guarantee I would even qualify for the study, so it couldn't hurt to try.

The initial visit involved a LOT. It was around 6 hours of tests (vision tests, pregnancy tests, blood pressure, medical history, EKG, medical history, pictures of my eyes, etc). The doctor was only interested in submitting my left eye (the eye with the most damage) to the study, but they were through and did everything for both eyes just in case.

This ultimately turned out to be a good thing. My left eye was rejected by the study as having too much damage. On a whim, they submitted my right eye and the study accepted it! What this meant was that I was going to be part of a double blind study. Meaning my doctor and myself would not know if I was getting the medication or not. Only the doctor who would give me the injections and the study coordinator would be aware.

 

I was concerned about my left eye, as it was showing more damage, but I found out that the company had allowed the doctor to actually treat my left eye with the medication for SURE, no blind study at all. This was amazing for me and I was more than happy.

Fast forward a bit over a year, I'm still in the study. This study is two years long, so I still have until next summer. I have gone to the eye doctor anywhere from every three weeks to every eight weeks. Each time I go, there are pictures involved. Sometimes there are blood draws. Sometimes there is dye injected (not into my eyes, but to help take pictures of my eyes).

Each time, I get an injection in my study eye (the right eye). For a while, I also received an injection in my left eye that I know has the medication. After several visits, my eye doctor (the one who does not know if I am getting the medication in my study eye), stopped me from getting the injections in my left eye because the eye looked so much better. I went from November to May with no injection in my non-study eye. I had one more injection in that eye and have not had another since.

 

I'll say that I've seen the pictures of both my eyes. My left eye (non-study eye) that I know has been getting medication looks amazing. The spots and leaky vessels that were there before are nearly gone. There are a few tiny spots here and there, but the leaky vessel spot that had caused me so much worry is now gone. What remains are the outlines of where the blood was and some small white spots that my eye doctor has told me are like scar tissue. In my study eye, the spots that were there have diminished greatly, though I can't be 100% sure that I'm getting the medication in that eye. I will say that the "before" and "after" pictures and comparing to the improvement in my non-study eye, I can assume that I am.

I'm doing this study for selfish and non-selfish reasons. Selfish, because I want the latest medicine. I want to keep my vision. I want to avoid laser surgery. Non-Selfish because I have too many friends with diabetes who have vision problems, have dealt with laser surgery and vision loss because of diabetes. And maybe if there had been an option like this, they would have had a different story. Maybe it will help the others out there who aren't to the point of vision damage yet.

I still have a little over a year left in this study. My hope is that my eyes will have improved so much that there isn't much else to do. I always said I wanted to be part of a diabetes study, but this was NEVER what I imagined. Let's be honest, I was thinking new technology! This, however, has been an amazing experience so far. Sure, injections in ones eyes aren't joyful, but they aren't nearly as bad as I imagined, and the benefits outweigh everything else.

I'll Still Use the Nima Sensor

There were new reports today from Gluten Free Watchdog regarding the Nima gluten sensor. Third party testing released from Nima showed that the gluten sensor is wrong much of the time.

There were false positives (times when the sensor showed gluten, when it was actually at 20 parts per million or less) about 8% of the time. This is an issue because you may think that something isn't safe to eat, when in fact it is. Twenty parts per million (or 20 ppm) or less is safe, per the FDA and medical research, for a person with Celiac disease.

There were false negatives (times when the test showed negative, when in fact it wasn't) about 20% of the time, with nearing 100% accuracy only when the levels of gluten neared 40 ppm. This is an issue because you may think something is safe, when in fact it isn't.

These things tend to scare people. In fact, they scare me a bit, but I still have the Nima sensor, and I plan to continue to use it. Here's why:

I feel like this technology is promising. It's a start. It isn't perfect. Even if it WAS perfect, 100% of the time, the piece of food you test could be fine, but three inches over on your plate could be something that was cross contaminated.

My hope is that this technology will improve. That it will inspire other companies to come up with similar (better, faster, cheaper) products. My hope is that it will one day be considered a medical device, complete with FDA approval and that insurance will cover it. 

For me, having a sensor that gets it 

right some of the time is better than 

not knowing all of the time.

I'm still fairly new to the Celiac game. It's scary, and my tests keep coming back in ways I'm not thrilled with (a.k.a. I feel like I'm not getting better). Add to that the fact that I have zero symptoms when I ingest gluten, and I'm flying blind. 

For me, having a sensor that gets it right some of the time is better than not knowing all of the time.  So for now, I'll continue to pay out of pocket for this technology. I'll take the risk. It's worth it for me.

Everything starts somewhere. With diabetes, insulin pumps used to be the size of a backpack. Blood sugar meters were large, inaccurate and took forever to come back with a reading. Constant glucose  monitoring systems were inaccurate, and painful. Technology improved. I want to believe that will happen with Celiac technology as well.

How Do You Educate the Educated?

One of the things that comes up too often in our diabetes community would be the number of those we loose to undiagnosed diabetes. Too often, adults and children are lost because a doctor misdiagnoses Type 1 diabetes as the flu, or a parent or the undiagnosed adult, assumes it is the flu and doesn't seek medical care. We can't stop those who don't seek medical care, but when a medical professional misdiagnoses Type 1 as the flu, people often die.

I know it's like beating a dead horse (a terrible saying we have in the South), but we always put forth suggestions (including a blood glucose test for anyone presenting flu symptoms) and I'm not sure anything ever actually happens. I know we'd all love to see these changes. And perhaps it will happen. How do we educate those who are educated to diagnose Type 1 diabetes?

As I've also been thrown head first into the whole Celiac world, I've found that medical professional negligence at diagnosis isn't relegated to Type 1 diabetes. I've discovered that it also happens to those with Celiac. While the death isn't as immediate for those with Celiac (if they are undiagnosed or incorrectly diagnosed), it can lead to years of suffering, other diseases, and death.

Some of the long-term health conditions are listed on celiac.org. Two of them are listed as iron deficiency anemia, and vitamin and mineral deficiencies, both of which I had a my time of diagnosis. These are the least of the issues, others include increased instances of cancer, early onset osteoporosis, central and peripheral nervous system disorders, etc.

According to Celiac.org, 1 in 100 people worldwide have Celiac disease. More than 40% of people with Celiac disease appear to have no symptoms at all (I count myself among that 40%, despite the fact that I had celiac related anemia, and I'm fairly certain my years of anxiety and depression were also closely linked to undiagnosed Celiac). Approximately two and a half million Americans have undiagnosed Celiac disease. This pdf file contains a quick guide to Celiac.

One of the first things that any respectable gastroenterologist will tell you is NOT to stop eating gluten if you think you might have Celiac disease. The Gluten Intolerance Group  states "Do I have celiac disease, non-celiac gluten sensitivity, or wheat allergy? Diagnosis is key to this knowing the answer to this question and being able to follow the diet that is right for you. This is also the most important reason not to start a gluten-free diet before being tested and getting a diagnosis."  

Yet, so many medical professionals (and well meaning friends, co-workers, family members) will say "stop eating gluten for a week and see how you feel." Or more professionally, advise their patients of a food elimination diet to see if a person has food sensitivities. I've only had Celiac disease (diagnosed) for seventeen months, and I've had at LEAST three people that have told me their doctor told them to stop eating gluten, and did not advise them to be tested for Celiac disease.

It happened again today. I was tagged in a post of someone I don't know by a friend. It was asking about my Nima sensor, and I responded. Then I read the original post. It was a mother who's child potentially has gluten and dairy issues. The doctor advised going gluten and dairy free for a while to see how the child feels. I do my best to hold it together, but I always have to step in. I tried to give some information, a few links of information, and really  tried to impress upon her to not remove gluten until being tested for celiac disease.

Here's the deal: If you have Celiac disease and aren't diagnosed, when you remove gluten you start to feel better. Yet you have to currently be consuming gluten to be tested for celiac disease. If you stop eating gluten you can never get an accurate and confirmed Celiac diagnosis unless you start to consume gluten, on a regular basis, for around six weeks before being tested. Who is going to  go back on gluten if they feel so much better without it?! Therefore, you don't get a diagnosis.

I can't state where it was that I got this information (I simply don't remember), but there was a gastroenterologist in the Europe who specialized in Celiac. When he came to the U.S. around 20 or so years ago, he was told to pick another specialty because "celiac is a European disease." This is information that was being taught in our medical schools up until fairly recently, if my information is correct. Due to this, medical professionals were taught about it, but that it was rare.

Celiac is not a food allergy. You can't diagnose it properly using food elimination methods, as you can so many food allergies. In my personal opinion, if a doctor thinks that gluten could be an issue, they should always test for Celiac. According to Gluten Intolerance Group, diagnosis for Celiac should start with a blood test (sound familiar DOC?) to test for tTG, EMA, and DGP antibodies. They also state "Because no one of these tests is ideal, panels are often used."   The follow up by saying that "if this screening suggests Celiac disease, a small intestine biopsy is the next step to confirming diagnosis." This can confirm damaged villi (the hallmark of celiac disease).

These are the exact steps my doctor used. I was screened by my general practitioner, the panel came back suggestion Celiac, she scheduled me an appointment with a gastroenterologist and TOLD ME TO CONTINUE TO EAT GLUTEN. I met with the gastroenterologist who scheduled my biopsy and TOLD ME TO CONTINUE TO EAT GLUTEN. There were six weeks between my positive blood screen and my biopsy. I had a strong feeling, based on my knowledge that 8 - 10% of those with Type 1 diabetes have Celiac, that I would have Celiac as well. I spent that six weeks eating all the things I knew I'd not get after my biopsy results came back.

I'm blessed. I had a good general practitioner that  listened to me and didn't brush off my symptoms (exhaustion for no reason). She suggested the Celiac screening and I'm glad she did. But not everyone is as blessed as me. What happens when your GP suggests you eliminate foods? Especially if you have gastrointestinal symptoms? The average person is going to listen. I probably would have. What happens then? You live a life on a gluten free diet that you will never know if you actually have Celiac Disease, a wheat allergy, a gluten sensitivity, or other related issues. You won't know which diet is best for you. And you won't know what follow-up care to get, what tests to have done, and what other issues to look for.

There are tons of stories floating around on the internet (and in gluten-free support groups all over the world) of people who were misdiagnosed, ignored, told to eliminate gluten without a proper diagnosis. I wondered to myself today, "Do doctors have to take continuing education classes?" I did some research. They do. My state of Tennessee requires 40 hours of continuing education classes every two years. Two of those hours are required, by state law, to be in controlled substance prescribing (opioid epidemic anyone?). There are no other requirements. I'm not sure what kind of continuing education that doctors take, but I wonder if there's a way to have some sort of requirement made regarding new and changing medicine. Maybe they all are. But how do we get out the word about the fact that Celiac is NOT just a "European disease" and that some people (40%) don't present with gastrointestinal symptoms?  How do we get out the word that the "flu" could be a deadly disease that will kill someone because it is actually Type 1 diabetes?

General practitioners don't have it easy. They have to be a jack-of-all-trades. They have to know a little about a lot. You can't catch everything. But I think we as a society (and as a medical community of caregivers, patients, and professionals) could do a better job about getting out the word about disease that can affect so many people, causing long term health complications, other health issues, and death. According to JDRF.org, about 1.25 million Americans are living with Type 1 diabetes. If my math is correct, this means there are actually more people living with Celiac disease than with Type 1 diabetes (I had no idea!).

Either way, we have two disease that can be diagnosed fairly easily (a simple blood test) and it often doesn't happen. A simple blood test that could save a life, and improve the health of so many others. What do we do to make this happen? Is it still beating a dead horse to ask the question again? How do we change these things? How do we educate those who are trained to diagnose illnesses? How do we educate the educated?

Celiac, Diabetes, and my Crazy Life

It's been a busy several months for me. I have a ton of stuff going on with work, and when I'm home, it seems like I'm always doing something. Not to mention the month of February was NOT my friend (for multiple reason). But here's to focusing on the positives.


First off, I've started on the MiniMed 670G! I got the pump back in January and started wearing it, and then got trained on the new sensors and auto mode just a couple of weeks ago. It has been a learning curve, but I will say this: I am sleeping more peacefully most nights. Almost no overnight alarms.

Day times are still a little rough, but I've been told it takes a while for the system to "learn" your body. And I have a couple of friends who are on the system and are in LOVE with it. They both have told me that once it learns you, it is so much easier. I'm crossing my fingers for that. I have great hope for this hybrid-closed loop system.

I had another blood draw/visit at my Celiac doctor to see how things were going. Truthfully, I don't know that I'm ever going to get used to the lack of immediate numbers in Celiac disease (more on that later). All of my blood tests are still positive, but the one that I get that has numbers does show a drastic drop (in a good way) of antibodies. It was previously 1:160. Recently it was 1:80. That's amazing, but still not less than 1:10, which is what the ultimate goal is. It isn't perfect, but it does make me feel like I'm on the right track.

I also attended the JDRF Middle Tennessee Type One Summit in January. I love that this is an event that happens every year. It's a chance to be around others like me. And it's a chance to learn some things. I always enjoy learning new things, and I truly appreciate the effort that JDRF Middle Tennessee does to make sessions for both families of those with children with diabetes, as well as adults with diabetes. It was the first time I hadn't done social media for the event in a few years, so it was kind of cool to sit through an entire session and not pop from one to another to try to document as much as possible. That said, I've always enjoyed doing social media for the event in the past as well.

I've been chatting with a friend about rebranding my blog, which is another huge thing happening around my world. Not sure if or when it's going to happen, but it's something that might happen. I'd like to find others with Celiac, others with Diabetes, and others with AND (there are so many people out there with multiple auto-immune diseases.

I also made a costly investment related to my Celiac, but I felt like it was something I needed to do. A company called Nima makes a sensor that can detect gluten in food. In other words, it's like a blood sugar meter for food. Down sides: It's takes several minutes, it's expensive, it isn't covered by insurance, and it only gives you a "gluten found" or a happy face if no gluten.

Each capsule to detect food (like test strips) is between $5-$7 and they are one time use capsules. Obviously, I can't use them on everything I eat, but they could come in handy when I'm suspicious or am eating somewhere new.

So far I have only used three capsules. One I messed up, one I found out that the food I've been eating a restaurant up the street isn't gluten free, and one I used at a place that wasn't on any of my apps and turns out their steak fajitas were safe.

I'm looking forward to seeing where this technology goes. Perhaps someday insurance will cover them, we'll be able to reuse capsules, and the technology will be quicker, smaller, etc. I feel like this may be what people felt like when the first blood sugar meters were coming out. I remember my meters from the mid 80s and they were crazy and took forever and took SO much blood.
I'll take it as a good step forward. I love it because with no gastrointestinal symptoms, I don't know when I'm getting glutened. This could help with that.

On that note, those with peanut allergies, Nima is releasing a similar system to detect peanuts. Who knows what's next!?

Here's to seeing what the next several months holds and seeing what life brings my way.