7 Noteworthy Diabetes Clinical Trials Recruiting NOW…

elixir-1312949-639x468Clinical trials are the only way that we are going to get better treatments, better devices, and better…cures.

Here are seven noteworthy diabetes clinical trials recruiting now that you might want to look into and see if you (or anyone you know) might be eligible to volunteer.

Click on the titles of each trial to get more info straight from the ClinicalTrials.gov website. 

(Remember… some clinical trials may have you take a placebo in lieu of the investigational drug. Some clinical trials may require extra visits, invasive testing, and travel. You need to think about what the benefits and risks are for trial participation. That being said… nothing ventured, nothing gained.)

Repeat BCG Vaccinations for the Treatment of Established Type 1 Diabetes

The purpose of this study is to see if repeat bacillus Calmette-Guérin (BCG) vaccinations can confer a beneficial immune and metabolic effect on Type 1 diabetes. Published Phase I data on repeat BCG vaccinations in long term diabetics showed specific death of some of the disease causing bad white blood cells and also showed a short and small pancreas effect of restored insulin secretion. In this Phase II study, the investigators will attempt to vaccinate more frequently to see if these desirable effects can be more sustained.

Eligible volunteers will either be vaccinated with BCG in a repeat fashion over a period of four years or receive a placebo treatment. The investigators hypothesize that each BCG vaccination will eliminate more and more of the disease causing white blood cells that could offer relief to the pancreas for increased survival and restoration of insulin secretion from the pancreas.

If you’re interested and meet the criteria (and the location, as the trial is being conducted in Boston and requires weekly injections for the first year… don’t know if you can do this at home…), you should send an email to: diabetestrial@partners.org

This is Dr. Denise Faustman’s lab and website. Check out the details and what she’s doing.

Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD)

Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.

If you are on multiple daily injections, this might be a great opportunity to participate in a really interesting study if you are willing to wear a continuous glucose monitor (CGM) and possibly a pump. Check out the inclusion/exclusion criteria and locations, then send an email or call to either:

Eileen Casal, RN, MSN 858-875-9774 ecasal@dexcom.com
 David Price, MD 858-875-9525 dprice@dexcom.com

A Trial Comparing Continuous Glucose Monitoring With and Without Routine Blood Glucose Monitoring in Adults With Type 1 Diabetes (REPLACE-BG)

The primary objective of the study is to determine whether the routine use of Continuous Glucose Monitoring (CGM) without Blood Glucose Monitoring (BGM) confirmation is as safe and effective as CGM used as an adjunct to BGM.

This study will determine if we can actually make treatment decisions based on our CGM alone when we feel it is accurate, not verifying it with a finger-stick blood glucose check.

This. Is. Huge.

Why? Because one of the reasons why Medicare, Medicaid, and some insurance companies refuse to pay for a continuous glucose monitor, claiming it’s just an adjunct to a blood glucose meter and we still have to check to make treatment decisions. (And we know better, don’t we?) This trial has a lot of inclusion and exclusion criteria, but seriously… if you can do this, you will help the entire T1 diabetes community get access to this device.

Contact either person for more info:

 Katrina Ruedy, MSPH 813-975-8690 kruedy@jaeb.org
 Nhung “Leena” Nguyen, MPH, CCRP 813-975-8690 nnguyen@jaeb.org

Glucose Variability Pilot Study for the Abbott Sensor Based Glucose Monitoring System-Professional

This is to trial the Abbot Libre system, which is a sensor with “flash monitoring” for individuals with Type 2 diabetes. How cool is that? They currently need participants in the following locations: San Diego, Detroit, Kansas City, MO and Pearland, TX. If you meet the criteria, shoot Dr. Karinka an email for more info and get enrolled.

Shridhara Alva Karinka, Ph.D. 510-749-6393 shridhara.alva@abbott.com

A Study To Assess The Safety Of PF-06342674 In Adults With Type 1 Diabetes

If you are a newly diagnosed (within the last two years) adult (over 18), you can participate in a Phase 1 clinical trial for a biological drug, examining safety issues. Again, look at the criteria and locations, then if you are interested, call:

Pfizer CT.gov Call Center 1-800-718-1021

Please refer to this study by its ClinicalTrials.gov identifier: NCT02038764

In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor

This is a Medtronic study for their next step in the artificial pancreas technology pathway. (And hello… “Enlite 3 sensor!”)

All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.

The more patients willing to participate in artificial pancreas technology trials, the faster this technology will become available! Take a look at the locations and criteria and if you’re able to do this trial, contact:

Julie Sekella (818) 576-5171 julie.sekella@medtronic.com

Along those same lines…

Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes

This is a BIG. DEAL. for people with diabetes in the United States. If on this trial, you get to wear the MMT-670G insulin pump, using it with the closed loop algorithm.

Closed Loop. Closed Loop. Need we say more?

Contact: Thomas P Troub(818) 576-3142 thomas.troub@medtronic.com to get involved.

There are so many studies out there that need our help. We help ourselves AND all people with diabetes. Do what you can. If you can’t participate, share this post with someone who might be able to volunteer.

Thugging Diabetes

smiles-1187708-639x457Vegetables and I have not been fast friends over the years. I enjoy their company when they’re accompanied with cheese or if they’re prepared so exotically that they coax me into trying them. If they’re in season, at their peak of popularity, I’ll throw a few vegetables in the shopping cart. But we’re not best buds.

It’s not because of diabetes, but there is a correlation. After my diagnosis, I became well acquainted with the Diabetes Exchange Diet. If you’ve ever had the pleasure of hearing: “You can have 1 milk, 2 breads, 1 meat, and 1 fat for breakfast,” you’ll know where this is leading…

Some vegetables AREN’T vegetables.

Peas, according to school lunch, are vegetables, but not to the Diabetes Exchange Diet. Same went for corn and potatoes. Vegetables I liked as a kid. Vegetables that I ate. Now, I had to choose between a piece of bread and a 1/2 cup of corn or peas? Bread won every time. I loved V-8 juice, so my vegetable portion was often chugged on the way out the door… if at all.

Lettuce is also not a vegetable. It’s a “free food” along with cucumbers and celery. (But one tablespoon of dressing is considered one fat. Do you know how little and sad that tablespoon of ranch dressing looked?) I wanted food that had ballast. Not rabbit food. I was starving. Always starving. (Remember that my diabetes management wasn’t management at all; it was chaos.)

It didn’t take long for me to turn my back on vegetables. Even after I stopped denying myself insulin and got my head together (or as together as it’s going to get), I just never thought to myself: “Hmmm… a bunch of veggies would hit the spot right about now.”

But I’m older now. Wiser.  I’m trying to cook more (and in doing so, blew up my stove, but I don’t think it was my cooking…) and from scratch. We’ve had hits and misses, but I wanted to switch it up a bit.

Enter The Thug

Across my Facebook feed one day came this video…

(Warning – while hysterically funny, it’s also not appropriate to play at a loud volume at work, around small children, or easily offended by the use of any swear worse than “gee willikers!”)

My fingers practically tripped over themselves rushing to order Thug Kitchen so I could, as they put it, eat some goddamned vegetables.

This cookbook has no meat, no eggs, and no dairy in any of the recipes. I’m cool with that, but some people might not be. What is in abundance is profanity, so if you’re not cool with that, this cookbook might not be for you.

In the few weeks that Thug Kitchen has been in my possession, I’ve made some small changes to what I eat that have made an impact on my daily diabetes management: one involves vegetables and the other doesn’t.

Thug Smoothies

It was almost like a vegetarian Dr. Seuss Green Eggs and Ham question : “Would you try a green smoothie?” Neither of us seemed thrilled, but neither of us would admit it. We followed the recipe (which involved spinach, lots and lots of spinach) and lo and behold, much like Sam I Am’s friend… we loved it. And most importantly, it didn’t spike my blood sugars like I thought it would, even with the addition of fruit. I think that all my previous smoothie attempts in the past failed because I used regular milk and yogurt. This recipe? Filling and no spiking.

I broke our old blender because I’ve been making so many smoothies. (Wait… I blew up the stove, broke the blender…is the universe trying to tell me something?) We got a hefty, hearty, Sons of Anarchy strong blender replacement. Breakfast or lunch, I’m getting veggies in a swirly concoction.

Thug Oatmeal610rW-BTUyL._SX409_BO1,204,203,200_

I have long been a “get a coffee in me before I can function” individual and that’s usually the extent of my breakfast. (Yes, I know. Bad.) But I know exactly how much to bolus for how I like my coffee and no spike. Everything else is a toss-up until now.

Hooked now on the oatmeal recipe in Thug Kitchen and no.freaking.spike. Yeah, it takes a little while to make, but I do a huge batch and shove it in the fridge for later in the week. I get a warm belly, a slow-digesting breakfast, and I feel better. (No veggies in the oatmeal, just to be clear.)

Slowly Thugging Diabetes

I’m not shilling the cookbook. I’m talking about how I’m slowly thugging my diabetes.

Making small changes to my diabetes management over the last few months has been eye-opening. Different ways to bolus, to eat, to include yoga and some very mindful mediation, down to adding a medication that I never thought I would. And the result?

The lowest A1C I’ve had in years and not a single severe hypoglycemic episode in the last few months.

We aren’t meant to act like a major organ 24/7/365. (Well, some people can act like a big glutenous muscle…) We weren’t meant to calculate and regulate and feel guilty if we don’t get it right.

I’m thugging my diabetes, small change by small change. All of us can thug diabetes, whether it’s making a conscious decision to eat more veggies or walk a little further (or start to walk!) or try something different. What works for me may not work for you, but what works for you might work for someone else.

How are you thugging your diabetes? What do you want to try? I’d love to hear from you!

 

Cursing The Darkness

candle-1421437-639x847“It is better to light a candle than curse the darkness.”

I allowed my candle to be snuffed out last week and spent a few days cursing the darkness.

Social media is a two-edged sword. It allows me to connect with like-minded individuals, transforming what can be a lonely existence with a chronic illness into one filled with support. Strangers become confidants and sometimes even lifelines. Communities blossom, become stronger, make the world a better place with the addition of social media.

It can also suck. Strangers can also become critics, seeking attention through negative attitudes. They prescribe to the idea that they can be wrong at the top of their lungs and someone will listen and believe them. There’s an entire world out there that is fueled by the perpetuation of misperceptions. (Helllooooo…. Crossfit.)

Normally, when faced with an Internet troll, I remind myself that keyboard courage is a real thing. People hid behind a computer and say things they would never say standing in front of that person. These individuals simply are unable to have a civil conversation online. ‘Bow gracefully and step away’, I mumble to myself. ‘You have other things more worthy of your attention.’

I got caught with my computer pants down. Coming off of a few weeks of traveling and intense conversations with people who matter, I was emotionally and physically drained. Out of nowhere, there were a few social media interactions that pushed the boundaries of politeness  went for the jugular about what I was doing, who I thought I was, and my place in the community – from more than one person in the space of a few hours.

Let’s get this straight: I am no angel.

black-and-white-eye-1254497-640x480I am not altruistic; The Diabetes Collective and the Diabetes Patient Advocacy Coalition are passions of mine because I benefit directly from my efforts and the efforts of others. I have been told (by both friends and employers) that I can be condescending, passive-aggressive, abrasive, aggressive, and a few more “you’ve got to work on your ability to work with others.” I run with scissors. I can be quick to anger. I can be an asshole.

Take them all as character flaws and know that I am acutely aware that I am not perfect. (Helloooo… title of my blog?) But… I’m a perfectionist, holding up impossible standards that I will never reach. Diabetes makes anyone with perfectionist tendencies feel like a failure. It’s taken me a long time to get over that.

I am also incredibly sensitive, want to be loved as much I as love others, seek to learn from my mistakes, and extend a hand to help whenever it’s needed. It took me years to laugh at myself or not spiral into anger or sadness when someone picked on me. (I was/am easy pickin’, too. I’m tiny with a weird name.)

Bone weary, drained, thinking intently over the previous few days “where do I belong in this growing community?”, and the tacit confirmation of a friendship lost set me up for a wailing wind that blew through my soul and snuffed the candle I work very hard to keep lit.

Cursing the darkness, I let it be known to my group on friends on Facebook that I had reached my limit of putting myself out there. I was done sharing, done being passionate, done. Just done.

It’s cold in the dark. Quiet. Isolated. It’s not where I like to be and there are moments that I think sharing my story and my life openly on this blog and on social media puts me in danger of having my candles blown out. We’ve all seen the damage that social media can do to one’s psyche. It happens every day.

My beautiful friends, being who they are, responded with soothing words and candles of their own to light the way out of the dark for me. I am grateful to them.

This is why the blog has been quiet as of late. I’ve had to do some much needed introspection and think about how I reacted and how I would react in the future if this happened again, which we all know, social media being what it is, probably will.

I don’t have answers, but thanks to people who know who I am (sometimes better than I do myself), at least I’m not cursing the darkness.

 

 

 

Diabetes Patient Advocacy Coalition

Today, please take a moment to head over to http://www.diabetespac.org and review the latest actions that you can take to let policy makers know that diabetes isn’t a box to be checked.

WE_ARE_DPAC-01

 

 

 

Hypoglycemia + Heart = Things You Need To Know ASAP

 

Does this illustration scare you?

It should.

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I first encountered this slide during an academic lecture given by Dr. Mikhail Kosiborod, MD when I attended the International Hospital Diabetes Meeting in May. He was sharing data about cardiovascular events and outcomes. (If you’re not an academic, the smart people begin to sound like Charlie Brown’s teachers after a while.) But when this illustration came onto the screen, I frantically scribbled the study’s authors down.

This slide was the first time I saw so plainly what was happening to me when I had a moderate hypoglycemic episode. (Dr. Kosiborod said that a “moderate” hypo was 57 mg/dl or less.) Not just the “I feel like I’m dizzy and not all here and let’s concentrate on something insignificant and is it hot in here?” reaction. This was what was going on inside without me feeling most of it. 

Complications are not always from high blood glucose levels

We all know the long-term implications of high blood sugars. It’s that same old “-Opathy” chant that everyone sings loudly: “Retinopathy-neuropathy-nephropathy” with the back-up singers humming: “Don’t forget about stroke and amputation and arteriosclerosis and…big finish, everyone! Gum disease!”

But with lows, it’s a quick ditty: “Unconciousness, seizure, death.” It’s not a chart-topper, but it can be #1 with a bullet if you’re hypoglycemic. When I had those times of “Whoa…let’s stand in the kitchen and daze off into space,” it didn’t feel like I was doing any damage to my body. Sure, I felt like my head had been run over by Gravedigger and I was treading in molasses for several hours after some lows, but I recovered. Or so I thought. Now?

I am setting myself up for long-term complications with repeated moderate low blood sugars. So are you. 

Here’s what happens (you can follow along with the slide, but I’ll break it down in terms we all understand):

Inflammation

Every moderate hypoglycemic reaction sends out wonderful proteins to increase inflammation in our body. (I’ll cut to the chase. We don’t want that.) They are:

Vascular endothelial growth factor (VEGF ), is a signal protein that helps to promote the growth of new blood vessels. We need VEGF as we grow in a womb (to create the blood vessels), after exercise or injury, and VEGF can help create new blood vessels when there is an obstruction. But, much like really good food, it’s only good in moderation. Too much of it (“overexpression”) can contribute to asthma, retinal problems, and  cancers.  The levels go up when we have a moderate hypoglycemic episode.

C-reactive protein (CRP) is a protein released in response to inflammation. Some of our organs, like colons, show a greater risk of cancer when they’re chronically inflamed. This lovely protein also raises our risk for heart disease, high blood pressure, and coronary artery disease.

Interleukin 6 (IL-6) is an interleukin (No, I’m not a medical professional or a biology whiz, so I had to look it up. Fancy word for protein) that does double duty: it promotes inflammation and can help with healing in certain situations. In this case, when we have a low, it’s under the inflammation category. And it gets busy.

“IL-6 stimulates the inflammatory and auto-immune processes in many diseases such as diabetes,[22]atherosclerosis,[23]depression,[24]Alzheimer’s Disease,[25]systemic lupus erythematosus,[26]multiple myeloma,[27]prostate cancer,[28]Behçet’s disease,[29] and rheumatoid arthritis.[30]” – Wikipedia

Endothelial Dysfunction

Vasoconstriction, the narrowing of blood vessels, is not something you want unless you need to stop a massive bleed. But, when you don’t need to stop a hemorrhage, it’s not often something super to have going on. Vasoconstriction raises blood pressure (which is why vasoconstrictor medications are given to people with low blood pressure) and can cause erectile dysfunction. You know what else causes vasoconstriction? Caffeine. Sigh.

Time for a breather. Here’s a picture of a bunny, because this stuff is pretty heavy. Warning, after the bunny, there are no more cute things. 

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Abnormal Blood Coagulation

If it’s a medical term and it starts with “abnormal”: uh-oh.

Factor VII is another protein in our body that helps the clotting process. Too little Factor VII = hemophilia. Too much Factor VII = clotting when there shouldn’t be. Moderate hypoglycemic episodes increase this protein in the body.

Neutrophils are white blood cells. When inflammation starts, neutrophils head towards the area of inflammation. Because our body is doing the inflammation dance when we’re having a moderate low, neutrophils show up for the party, too.

Platelet Activation – platelets help to staunch bleeding by clumping and clogging a blood vessel. Great for stopping bleeding, of course, but lousy when the result is thrombosis. We increase platelet activation when we’re low.

Sympathoadrenal Response

We release adrenaline, epinephrine and norepinephrine as our blood sugar sinks into the basement. It’s that “fight or flight” feeling; that “out-of-control and my heart is racing” feeling. It’s our body’s adrenal response to get us to do something.

When we have multiple hypos, we can developed a suppressed sympathoadrenal response – and that’s hypoglycemic unawareness. Clinicians talk about raising a target blood glucose level because a person with diabetes has hypo unawareness to retrain the body to have that adrenal response again.

But your nervous system also factors into play here. Your autonomic nervous system. Your heart is part of this system. A moderate hypo causes your heart to beat faster (“Thud-thud-thud”) and can cause long-term issues with the timing of your heart (arrhythmia). We’re making our hearts work harder.

It’s Not Over When You Think It’s Over

Your blood glucose level comes up and the hypo is over. But what happened to your body is not over. Not by a longshot. This is what I learned at the symposia at ADA’s 75th Scientific Sessions on Hypoglycemia.

And it’s this:

Vascular issues can last up to two days and blood coagulation issues for up to a week. 
Every moderate hypoglycemic episode builds up inflammation and coagulation responses in my body. One sucky hypo a week was not uncommon for me, even with a Dexcom.

What Am I Doing Now?

I’m doing everything to prevent a moderate or severe low blood sugar. The research I did shows me that I can change the way I react to my lows and help prevent these “issues” from happening.

My CGM is constantly on my body and I’ve set it to alarm at 80mg/dl so that I’m still in my right mind to look at it and take action if I need to do so. Has this helped?

Yes. 

Instead of alarming at 70, when I often tell myself that I’m invincible and that my blood sugar will go back up on its own (I’ve said this to myself a lot…Yes, I know. False.), I’m catching that low. It also has prevented the response of eating everything in the kitchen because I’m in “fight or flight” (or “stuff your face or pass out”) mode. My stress level is lower and I feel more in control.

And that is what this post is about… giving you the info and giving you the opportunity to help yourself, because while you can’t control having diabetes, you can control how you manage it. And hypos are not so innocent.