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.

Snap Decision

You grab a pack of gum at the checkout counter. It’s an impulse purchase and you don’t think about it. It’s a snap decision, made right then and there.

Choosing an insulin pump is anything but a snap decision. You research all of your options, talk with other people who wear pumps, weigh the pros and cons of each pump, and of course, find out if insurance will cover your pump and supplies.

In my case, my insulin pump choice was a snap decision. With a capital S.

unnamed-3The Asante Snap pump. 

After my warranty expired on my previous pump (Of course, it was pining for the fjords five weeks later.) and an opportunity to try the next generation of that company’s pump, I recognized that I needed to do further investigating. I’d only worn two brands of insulin pumps in the over 15 years of pumping. I am still happy with the choices I made back then, but back then, I didn’t have a lot of choices.

I cheer the fact that we have more choices now when it comes to insulin pumps and continuous glucose monitoring devices. Each pump and CGM has its strengths and weaknesses, which of course, means that some people will choose them based on their own needs, wants, and desires.

Here’s why I chose the Asante Snap Insulin Pump.

I Am Ricardo Montalbán

You can’t “test drive” a piece of gum. You buy it and if that new flavor isn’t what you wanted, you throw it away or foist it off onto someone else. It’s gum, right? Costs a buck? Pshh. Get outta here.

But it’s rare (or in some cases, impossible) to test out an insulin pump. This device is going to be a part of your life for a hopefully good, happy, healthy long time. And it’s not cheap. You choose a pump based on what you think it will do for you, go through the hoops (and oh, are there big, flaming hoops!) to get approval from everyone involved, only to find that… you hate it. I know some individuals who have returned their insulin pumps before the “trial” period is over, but it’s a big, ugly hassle and insulin pump companies don’t make it easy.

Asante gets that you should be able to take a pump for a test drive. Feel the rich Corinthian leather seats. Determine if what you want is what you actually get. They offer everyone who is interested in trying the Asante Snap pump a four-week free trial, including supplies, training, and support. I got to sit in the driver’s seat and go for a long drive. I wish all pump companies would do the same.

No More Rebel Yell Time In Range!

The four-week free trial is one thing. It’s another thing entirely when you discover that by not changing a single basal rate or bolus factor, that your time in range with your blood sugar skyrockets. (And when I say skyrockets, I mean supersonic space age shiny skyrockets.) Having the luxury of a Dexcom CGM allows me to see how my blood sugars play nicely (or not nicely) during the day. I was doing a lot of Billy Idol hair spikes. Without changing my eating habits or dosing timing, I saw spikes turn into smoother lines and when I downloaded my Dexcom (Finally able to do it on my Mac!), I was shocked. 80% time in range (for me, range is 70 – 180, but I’m already tightening the higher end).

Less lows. Less highs. All of a sudden, I wasn’t exhausted at the end of the day, chasing the blood sugar dragon. My head was clearer. I had energy. I thought it was a fluke, but after almost 8 weeks on this pump, I’ve come to realize it’s two things: the Asante Snap pump algorithm and the pre filled glass cartridges making this happen. I can’t take any credit for better blood glucose levels.

 Heart of Glass

The pre-filled glass cartridges not only help the insulin not degrade and lose potency as quickly as the plastic cartridges I once had to fill; it also cuts down on the time I used to fiddle around with pump  set-up. Doesn’t seem like a big deal, right? It’s a big deal. You get that I’m a two-minute sort of woman when it comes to diabetes.

Instead of the elaborate ritual of drawing up the insulin into a plastic cartridge, checking for bubbles, filling the tubing, checking for bubbles, priming the pump, checking for bubbles, I drop the cartridge into the pump body and it auto primes. In two minutes, I can complete an insulin pump set up, including a new insertion set. All that extra time I have now? I can rock out. 

(And I don’t have to hunt for a battery in the bottom of my purse. The battery for this pump is built into the pump body. You replace the pump body with the changing of the cartridge. Easy.)

I’m not the only one who thinks this is a good thing. I join Scott Johnson of Scott’s Diabetes, Melissa Lee of Sweetly Voiced and others who have switched from other pumps to Asante. Here’s what some people had to say about how easy it is…

The Little Things Add Up to Awesome

It’s the little things. A customizable color screen. A built in flashlight on the pump for those early morning BG checks. A missed bolus calculation if you stop your pump for a shower. (I never realized how much insulin I had missed even disconnecting for 20 minutes.) The ability to set alarms to NOT go off at 3am to wake you up to remind you to change your cartridge.

Some people prefer an integrated CGM and insulin pump. I tried it.  I’ve come to realize that I’m a Dexcom chick, tried and true. The other pump company with an integrated system has not yet updated its algorithm for increased accuracy. Plus… here’s the thing: The Dexcom G5 screen will be accessible to view on my iPhone I won’t even need to look at my pump to see my CGM graph.

When I was at AADE last summer and saw a glimpse of the future with Asante Snap (I sat next to Wil and we got to ooh and ahh at the demonstration, they announced not only would they be partnering with Dexcom for future upgrades, but they were the first company hooked up with Tidepool. (And you know how much I love them!). And then they blew everyone’s socks off my demonstrating bolusing the Asante Snap from an iPhone. I’ve never had a remote bolus device. I am totally ready for this. And when it does happen, it won’t cost me an arm and a leg (or a pancreas) to upgrade, because upgrades are $99. Straight. No chaser. 

I got to design my Snap. (Well, I got to have input. The Kid actually decided on the colors.)

No Pump is Perfect

No insulin pump is 100% perfect. (If it was, it would be called a pancreas and this blog wouldn’t exist.) I do miss the vibrating alarm option I had on my previous pump. I am a little jealous of other pumps that do have remote bolusing devices. I am a lot jealous of the current integrated pumps and CGM systems that work well. And I can’t upload my data at home; Asante currently uses the clinic version of Diasend.

I’ve talked with the management team at Asante. I’ve asked questions about their future models. They listen (and they even have a patient advisory board so they can get feedback). I see the Asante Snap becoming more perfect soon.

IMG_5863Time. In. Range.

Oh… that time in range. That blissful time in range that makes me feel more rested, less stressed, and looking forward to getting my A1C done. That makes it all worth while.

My new time in range makes my diabetes management easier and less about diabetes and more about me. 

Best Snap decision I’ve ever made.

I talked to Asante so much and gushed about how much this pump has improved my life that I’ve agreed to enter into a consulting agreement with Asante Solutions to write about my experiences pumping on their website. Please check the updated About page  for disclosures. Remember: My thoughts are my own. No one can make me write what I don’t feel or believe in on this blog. In fact, I get zero compensation for this – or any – blog posts on this blog. This is MY blog. MY words. MY thoughts. You get to read the uncensored version – always. 

About Last Night…

20131219-144526.jpg

The Kid had a temperature of 102.3 and would only sleep if I was her human teddy bear.
My father had knee replacement surgery and I ate a Clif bar for dinner waiting to see him in recovery.
I was exhausted. I muffled the Dexcom under my pillow so The Kid wouldn’t wake up.
It didn’t wake me up.
Bedtime BG: 98.
12:45a BG: 39.
A stupidly large glass of grape juice and a few cookies.
1:20a BG: 159.
Temp basal of 70% for two hours. Go back to bed.
4:38a BG: 465.
Remind myself that just 8oz. of that juice is 40g of carbs. Not going to even talk about those cookies.
In the process of rage bolusing, I run out of insulin in my pump.
The Kid wakes up and watches me refill a cartridge, dose, and drink a large (but not stupidly large) glass if water.
6:45a BG: 226.
Cup of coffee. Dose for cream.
9:14a BG: crash.

My blood glucose is now back to normal this afternoon, but I’m not.

Stress + stress + stress = the sad graph on my Dexcom.

(Dad is fine, The Kid is better, and I need a long nap.)

The Hiccuping Dexcom and Digital Xanax

Xanax, in digital molecular form.
Xanax, in digital molecular form.

We’ve come a long way from boiling pee with Benedict’s Solution to get an idea of our glucose levels. I’m impressed and content with my continuous glucose monitor (CGM) and how accurate and easy it is. Since I’ve consistently begun to use a Dexcom (I got a Dexcom Seven Plus and then upgraded to a Dexcom G4 last October), I’ve caught highs and lows that I know would have been a lot worse without wearing it.

Like much of the technology I use, I’ve become dependent upon my Dex. When it doesn’t work properly or when I’m not wearing a sensor, I suffer self doubt and “performance anxiety”. I don’t trust my body’s signals (and the Dexcom has shown there is a reason for that) when hypoglycemia and hyperglycemia hits and my increased blood glucose checks have me second guessing everything. The Dexcom calms me down, like a digital Xanax.

Dex has some issues over the past few weeks. It’s been hiccuping. I haven’t been calm.

I first noticed it when I was house hunting. An hour after breakfast, Dex would give me the dreaded three question marks for a few hours. Then it would start working for a few hours, but it was just teasing me. By late afternoon, question marks were back until late evening, when it would begin to give reading throughout the night. (I should be grateful for at least having the overnight numbers – and I am.) Lather, rinse, repeat for four days. Hiccup. Numbers. Hiccup. Numbers. Hiccup.

I didn’t want to rip the sensor out because it was my last one (my trip was extended and this was my extra sensor). Once I got home, it came out and I called Dexcom’s customer service, who replaced it for me and asked all sorts of salient questions about sweat, water, medications, and site location.

If it was a one time thing, this post wouldn’t have been written. The next sensor I inserted did the same thing, except it failed less than twelve hours after being in. Those three question marks mocked me. Dexcom was called again and in true amazing customer service form, there is another replacement sensor on its way. (Those things are expensive, yo.)

The newest sensor I put in yesterday hasn’t hiccuped, but I’m curious. Has anyone else has experienced this on again, off again hicupping Dexcom phenomenon? I began to worry that it was the transmitter battery flaking out on me, but it’s still reading OK. (The numbers could be better, but beggars can’t be choosers.)

For now, I have my digital Xanax back, it’s not hiccuping, and I’m happy.

The Obstacle Is The Path…

MazeI often end up down the Internet rabbit hole, much like a modern day Alice, finding myself in strange digital places reading wildly interesting things that have nothing to do with what I originally went to find. Sometimes it’s a nifty interactive media piece about concrete architecture in Brazil. Sometimes I learn more about a fictional character on TV than I will ever need to know. And sometimes, I come across wisdom that smacks me in the face.

I remember traipsing across Leo Babauta’s Zen Habits blog years ago, when it was still in its infancy. He now has over a million readers, so obviously he’s saying things that people believe are worth listening. I appreciate the control he has taken over his life and how he’s created a wonderful atmosphere for his family to blossom. I don’t read the blog often, but yesterday, on my Zite iPhone application, I ended up back at Leo’s doorstep. 

His post, The Obstacle is the Path, begins:

Often we’re discouraged because of some tough challenge or obstacle in our way. But a shift in mindset from a Zen proverb can change everything: “The obstacle is the path.”

The obstacle isn’t something standing in our way. It’s the way itself.

Look, I’m not going to discuss religion or spirituality here. (Or politics, but sex, well…. I’ve already gone there.) But I am going to talk about what I realized after I read what he had to share.

There are a lot of things in my life right now that I perceive as obstacles, but the one that has been the biggest obstacle is…

Me. 

I haven’t been able to get out of my own way when it comes to my diabetes and it’s time that I own up to it. 

Better control of my diabetes is the path I want to head down, but without the data (my road math), I don’t know which path will get me there. 

I have the top-of-the-line CGM, my Dexcom G4 Platinum. Have I ever downloaded the data that it’s captured? Nope. My excuse has been that it didn’t have a Mac program for the Dexcom Studio software. I grumbled that a lot of us have Macs, so why can’t they get their act together and make it Mac compatible. I’ve grumbled about this for months, all the while knowing that there is a workaround with the Mac Bootcamp program. John has offered to be my adorable IT tech support and even set it up for me a number of times. I refused. 

Look at me! I’m an obstacle!

I have a pump that allows me to download information about my blood glucose readings in relation (or opposition, as it sometimes happens) to my insulin delivery. Have I downloaded that data anytime in the last…um…two or three years? Nope. I know where the CareLink USB is. I’ve done it before. I just have been telling myself that it should be easier to do this. Easy? I remember writing blood sugars and dosages in a log book (but it’s commonly known that a lot of us fudged those at times). It’s easier than that. 

Look at me! I’m an obstacle!

I know how to count carbs. Have done it for years. But lately, I’ve been SWAGging (Scientific Wild Ass Guess) it in the biggest way. I complain that I never know how much I will eat at a meal or how fast I’ll digest that meal, so I tend to underdose and then play catchup later. Really? I’m too lazy to turn a box over and look at the carb count half the time. And “Heavens to Murgatroyd!” if I have a low blood sugar at night. I try very hard to follow the 15/wait 15 rule during the day, but it’s game over when the only light shining is from the refrigerator door.  Even my drink of choice is a juice box of 25g of white grape and apple juice. When I’m shaking, it’s hard to tell myself to stop frantically sucking through the straw. 

Look at me! I’m an obstacle!

I’m not a lolligagger when it comes to walking down a path. If I have a destination, I’m determined to get there without meandering. (Got to be honest. I don’t like exercise. There’s a story behind my reasons, but Oh! Look! Obstacle! is part of it.) I don’t tiptoe through the tulips, but if I don’t start to follow the right path using the map and the tools I already have but refuse to use, I’ll end up tromping all over myself. And I’m a delicate flower. 

When I continued down the rabbit hole, I found this passage from Paulo Coelho’s book, The Warrior of the Light:


A Warrior of the Light knows that certain moments repeat themselves. 

He often finds himself faced by the same problems and situations, and seeing these difficult situations return, he grows depressed, thinking that he is incapable of making any progress in life.

“I’ve been through all this before,” he says to his heart.

“Yes, you have been through all this before,” replies his heart.  “But you have never been beyond it.”

Then the Warrior realizes that these repeated experiences have but one aim:  to teach him what he does not want to learn.

 I may not be a Warrior of the Light, but I am a warrior and I need to learn.

It’s time to get the software, download the data, look at what I need to do, make the changes, and get out of my own way. I am the obstacle in the path, but not for long.