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.

Two Minute Diabetes Advocacy: 21st Century Cure Act + CGM

708615_95129272One hundred years ago, those of us with Type 1 diabetes would be pushing up daisies. Pining for the fjords. Deader than doornails. Not living.

Today, thanks to amazing researchers and the advancement of technology, we are living longer, healthier lives. We are living in the 21st Century. No flying cars or Jetson butlers, but yet… we are making headway, at least on the healthcare front. But we need your help.

Here’s your two minute diabetes advocacy challenge for today.

(Less time than it takes to pop some microwave popcorn!)

The 21st Century Cures Act is a bipartisan (meaning both Democrats and Republicans are interested, which you know is rare!) attempt at vaulting U.S. healthcare into this century by changing the ways drugs, devices, and treatments are approved and marketed. It’s a whopper of a draft bill, currently, with five sections:

  • Title I—Putting Patients First By Incorporating Their Perspectives Into The Regulatory Process And Addressing Unmet Needs
  • Title II—Building The Foundation For 21st Century Medicine, Including Helping Young Scientists
  • Title III—Modernizing Clinical Trials
  • Title IV—Accelerating The Discovery, Development, And Delivery Cycle And Continuing 21st Century Innovation At NIH, FDA, CDC, And CMS
  • Title V—Modernizing Medical Product Regulation

If you want to read all 393 pages of the bill, have at it here.

There is a section for “Breakthrough Devices.” As The Regulatory Explainer (an amazing site!) explains:

As with breakthrough drugs, breakthrough devices are those which represent “breakthrough technologies,” are intended to treat conditions “for which no approved alternative exist,” offer “significant advantages over existing approved or cleared alternative,” are “otherwise in the best interest of patients”  and/or have the potential to “reduce or eliminate the need for hospitalization, improve patient quality of life.”

Continuous glucose monitors (CGM) fall soundly into that category and are currently covered under many private insurance plans (and some state plans), but once you age onto Medicare, if you have Type 1 diabetes and use a CGM, say good-bye to your coverage of that device. Out-of-pocket is your only option, and it’s cost-prohibitive. As people with Type 1 diabetes live longer, we are seeing that the tools that will help us most are not being offered by CMS/Medicare. This has to change.

We need to ask the Energy & Commerce subcommittee to include continuous glucose monitor (CGM) coverage for Medicare participants in the 21st Century Care Act.

Here’s where you can help in less than two minutes. (Throw that popcorn into the microwave right now.)

Got Twitter? Yes? Go!  

(No? Sign up for Twitter and help raise your voice to your representatives in Congress. They do listen! But it will take a little longer than microwave popcorn.)

Hit the start button on your microwave.

1. Click here. (http://www.stripsafely.com/the-twitter-page/) and read the quick info on that page.

2. Find out if your state representative is in the Energy & Commerce Subcommittee list on the page. (If you don’t know who your rep is, click here and enter your zip code. Voilà!)

3. Find your state and your rep and click on the “CGM in 21st Century Cures” and TWEET!

4. Share that page with everyone you know. (Look for the SHARE THIS link at the bottom of that page.)

5. You’re done. Carefully open that bag of microwave popcorn; contents may be hot!

Thank you for letting your representative in Congress know that including CGM coverage for Medicare participants is the right thing to do. No one should be denied coverage of this breakthrough diabetes device because of age!

My Affair With Earnest Hemingway…

1336773_53028368My affair with Earnest Hemingway is neither about love, nor about hate.

It is about his paucity of words and the emotions you must mortar into the cracks of his meanings.

It is about his inability to end a story (or even his life) with any hope or joy.

It is about his words that slip beneath my skin to leave me shivering.

It is about how I abhor reading the words he wove together and yet, a quote he gave has shaped my life and aptly explained my last few weeks.

Not Reading It Again

I was subjected to Old Man and The Sea twice in high school, pulling apart overarching themes and writing trite, hackneyed literary criticisms just like every other teenager. Why twice? Three high schools in four years means forced rereading of a few books. (MacBeth was a three time winner – middle school gave me a head start, Midsummer’s Night Dream was also twice, but thankfully, Crime and Punishment and a list of Russian names written down for reference was, thankfully, devoured only once.)

Upon reaching the third high school in January of my junior year, my English literature teacher handed the book we would be reading next. Old Man and The Sea. I handed it right back.

“I’m not reading it again. I’ve read it twice. Hated it twice. Dissected it twice. It’s depressing. Give me something else to read and I’ll do a separate assignment.” (Yes, even as a teenager, I was… is pushy the right word?)

So, my teacher brought in his personal copy of A Farewell to Arms by Ernest Hemingway for me. In retrospect, I think he did it to spite me. “Old Man and The Sea is depressing? I’ll show you depressing.” I read it and neared the end, clutching that tatter of hope his characters created for themselves.

Hemingway is an ASS.

If you were in my neighborhood as I read the last two pages, I apologize for the angry screams of: “COME ON! SERIOUSLY?! Hemingway is an ASS!” I stomped into class the next day, threw the book on my teacher’s desk, and muttered: “This sucked worse than The Old Man and The Sea.”

To this day, I have yet to read any of his other works. Don’t ask me to do so. There are many other pieces of literature that can depress me, but none with the compact, gut wrenching nature of his view on life. I get enough of that already from reality. (Lest you think I like sappy, happy movies or books… I abhor those, too.) One day, perhaps, I will have the strength and resolve to read the rest of his painful brilliance. For now, they wait.

But… he said something that, if I had any desire to tattoo my body, would be inked across my chest:

“The world breaks everyone, and afterward, some are strong at the broken places.” – A Farewell To Arms

COBRA

Over the past few weeks, the world did its best to break us. Two weeks after meeting our high deductible health plan’s deductible, John’s company surprised a few people by laying them off on the last day of October. Surprise! Including John.

All of the benefits: medical, dental, etc. was terminated “on the last day of the month“. That meant that day. My supplies (and new Dexcom transmitter) hadn’t been ordered. And I couldn’t get them ordered in time before the end of the day. OK, I thought. Breathe. I’ll just order them all when we purchase COBRA.

We’ve purchased COBRA before, but when I called to find out the cost, it was outrageous. Laughably outrageous. The representative gave me this advice:

“Purchase everything out of pocket and keep the receipts; if the total for the month was higher than the cost of COBRA, go ahead and pay COBRA and you’ll get reimbursed.”

We started to investigate other options, including Healthcare.gov’s plans for our state and found that those plans were better – and less expensive – than what we were paying if you factor in the high deductible. Yes, I know all about the pre-tax blah blah blah, but it was frustrating to think that we could have avoided the shenanigans with medical decision making this year if we had just eschewed his company’s crappy medical insurance plan and gone with a marketplace plan.

The World Breaks My Technology

A week later, my Dexcom transmitter died. It was a slow death and I knew it was coming, but when it finally shuffled off its digital coil, it was still jarring. It also felt like it said: “HAHA, I knew you didn’t order a replacement before your insurance kicked it!”

I went without, reminding myself that I went without continuous glucose monitoring for years. Of course, every time I checked my blood sugar, all I could think was: “What would the arrow say?” Blood glucose checks increased, but I felt unsure. I felt high, but I was within normal range. I felt shaky, but I was slightly high. Adjust, check, adjust, check. I didn’t trust how I felt. For good reason.

Et tu, Brute?

Then, in solidarity, my insulin pump died. Four weeks and two days out of warranty. I hadn’t ordered a new one because… you know the story. Deductible. Crappy coverage. It happened on a Friday night while I was across the country, but if your pump is going to stop working, it should stop working while you are standing with other Type 1s at the Diabetes Mine Innovation Summit.

“What the hell? I can’t bolus. Look!” I showed the pump to the group and the troubleshooting suggestions started to fly fast and furiously. “Try this!” “Take the battery out and see if it will reset!” “Let it time out and see if that will do anything!”

And then…

“It’s says Button Error.”

The groan was collective. In the fifteen years of pumping insulin, I had never had a catastrophic failure. And of course, with my head being not in the game, when I packed, what was the one thing I didn’t bring? The back up bottle of Lantus. My head started to go down the rocky road of microbolusing or finding an open pharmacy or spending time on the phone with the pump company begging for a loaner when one of the people standing in the group who uses the same pump as I do said something amazing:

“I have an extra pump that I travel with. You can borrow it.”

Do you know how hard it is to program an insulin pump with tears of gratitude in your eyes? Less than an hour after the failure of my pump, I was pumping again. BG upon reconnecting? 126. (I thought I was high. I felt high.)

Fortunately, my blood glucose monitors are holding steady. They obviously hadn’t gotten the memo that John had been laid off.

Suck It, Hemingway

Ernest thrived on making people miserable and ending his stories on a sad, introspective note. I’m no Hemingway (says the verbose woman writing this blog) and so the end of the story will be a happy one.

  • John recently accepted an offer for a better job – better pay, closer to home, doing what he loves.
  • Because I had done homework on Healthcare.gov, I was able to look at the medical insurance offered and decided we would choose a marketplace plan that is more expensive, but has better coverage – way better coverage and NO deductible for durable medical equipment. (I did a lot of homework, calling an insurance specialist and getting the answers about insulin pump and CGM coverage. It does pay to do your homework.)
  • The DOC (Diabetes Online Community) and the diabetes community are filled with amazing people. A friend sent me her transmitter and a few sensors to tide me over. I have had many others offer to help with supplies. I am a firm believer in paying it forward, but never expected to be the one receiving.
  • The posts I wrote about U.S. financial assistance and programs for people with diabetes and if you are a Type 1 without insurance  was meant to help others… but I reread my own words. Twice. Maybe three times. And unlike Hemingway, those words and programs that companies offer gave me hope.

So, Hemingway. You’re right… about (at least) one thing.

The world does break us all. And I am stronger in the broken places.

But unlike the old man and a solitary trek into the ocean to battle marlins and sharks and the metaphors meant to taken from your work, this part of my story ends on a happy note, filled with helpful people and a community that does what it can when it’s needed.

The End

 

 

A Beeping Mess

headphonesI’m a beeping mess right now.

And beeping is not a substitution for an expletive, although it could be. Since my trial of the Medtronic MiniMed 530G with Enlite, I’ve become my own electronica band, beeping melodically throughout the day and night. No rhyme or reason, thus no rhythm at the beginning, but I’m starting to see some trends.

The MiniMed 530G with Enlite has a unique feature beyond the Threshold Suspend (The pump suspends if the Enlite sensor says your BG reading is below your “low” threshold.). It has a “predicative high” or “predicative low” setting, which will warn you if the algorithm believes you are going to go outside of the ranges you have set. When we did the initial setup, I put my low range at 80 mg/dl and my high at 200 mg/dl. (I drop pretty quickly, so I’m trying to catch it before I get to that point where I am not thinking straight and ignore the sensor readings in favor of…well, anything, because I think it my blood sugar will come up on its own while I’m walking around. Hint: it doesn’t.)

It is the new equipment adjustment period or is it my body? The food choices I make? (Pizza, oh pizza… I love you, but that 400 mg/dl? Even my broken pancreas rolled its eyes.) I beep, look at the pump, and it says that a low is predicted, yet less than ten minutes later, it says that a high is predicted. I’m still not used to the arrows that are on the MiniMed screen and everything is pretty wonky overall. But I’m learning, and that’s the point of this trial. I will figure this out.

The accuracy is not really in question at this point. How do I know? Because along with the MiniMed 530G with Enlite, I threw my Dexcom G4 sensor onto my arm on Thursday. There have been several times when both the 530G and the G4 have buzzed and beeped at exactly.the.same.time. If there’s any inaccuracy issues, I’ve found that sometimes it’s the G4 and sometimes it’s the 530G, but neither one is perfectly accurate all the time. Thus is life.

I haven’t had a night in which beeping hasn’t woken me up. The Threshold Suspend alarm has gone off, only to check my blood glucose level and find it to be a beautiful 110. Other nights, I’ve woken myself up and I’m low, except the 530G hasn’t caught it. (Until a few minutes later when I’m standing in kitchen over a glass of juice.) That’s been frustrating, along with the lack of response by the system to recognize that I’m coming up from a low, insisting that despite my canceling the threshold suspend, it throws up another beep and alarm and threshold suspend less than 10 minutes later.

John and I have had several discussions about the “is it me or the technology?” He maintains that it’s the technology, and to a large degree, he’s right. I need to train the technology to work with me… and I am also recognizing that I need to begin basal testing again. (It’s springtime in Paris and my insulin regimen. Hooray!)

I’ll have to adjust the predictive settings as well with the trainer, so that I can cut down on the beeping. I do find that it causes undue stress (and I’m full up on stress, thankyouverymuch) and worry that I didn’t have before.

So, if you need me, just follow the beeping. I’ll be dancing with the glowsticks in the corner.

Guinea Pig: MiniMed 530G Insulin Pump with Enlite

OLYMPUS DIGITAL CAMERAIn second grade, Mr. Harris introduced us to our class pet: a black, tan, and white guinea pig named Zipper. He (she?) squeaked quietly in a large cage filled with shavings in the back of the room while we learned about math and good citizenship. I got to bring him home for one of our breaks and loved on that little guinea pig while our cat shot daggers from her eyes. She was jealous.

Hi. Please call me Zipper for the next 90 days.

The MiniMed 530G with Enlite will become my insulin pump/sensor system, along with all that it entails over the next three months, thanks to a trial offered to me by Medtronic.

Here are the details of the trial, as I’m all into disclosure:

Medtronic is loaning me the entire system for the 90 day trial, including the 530G pump, CGM transmitter, Bayer Contour Next Link meter and test strips, Enlite sensors, reservoirs, and infusion sets. After the trial is complete, I will return all unused supplies as well as the pump, transmitter, and Bayer blood glucose meter.

I will be providing feedback to Medtronic through a survey and a one hour phone call after the trial is over. I will go through the entire set up as if I am a new pump user, including meeting with a Medtronic trainer and using their protocols and help desk. I will be changing my infusion sets every three days and my Enlite sensor every six days.

They won’t be putting words into my mouth (which is great, because it’s already full of my own) and I will share my honest opinion, my ups and downs, and what I think about the system. They know I’m not one to dance around the real issues, so you’ll get what you always get from me: unabashed and never whitewashed realism.

I’ve worn a Medtronic MiniMed pump for years and I’ve been happy with it. As I have said before, when I first started on a pump, there were only two companies in the game. As I was moving to Europe, I chose the “not Minimed” company, but when I returned to the U.S., Minimed had jumped so far ahead in technology, it was a no-brainer.

Time marches on and the market has expanded, not just with insulin pumps but with CGMs, and this is where my trepidation comes in. I had tried the Sof-Serter and abandoned it due to pain and accuracy issues. When I attended the Medtronic Advocacy Summit in January, I spoke with several Medtronic employees who assured me that the new CGM is less painful to insert and more accurate than before.  We. Shall. See.

Why I’m Trying The MiniMed 530G with Enlite

I’m curious. (Isn’t that enough?)

I love my Dexcom CGM. I love its accuracy, it’s ability to eek past the recommended seven day readings, and the fact that my husband can take it from me and still watch my numbers as I snuggle in the other room with The Kid. (And yes, he has brought me a juice box when I didn’t realize I was going low.) I love my MiniMed Revel 723. My fingers know the buttons in the dark. It’s been a part of me for so long. There are other insulin pumps out there and I’ve petted some of them, wondering if I would like them just as much if not more than what I currently have.

But this Threshold Suspend thing that will stop insulin delivery if it goes below a decided upon BG level? Totally looking forward to that if it does what it’s supposed to do. My overnight lows, even with the Dexcom, are still pretty rough. I’m sleeping through my alarms until I get to the 55 mg/dl or below “prisoners are escaping” blare. By then, I’m wobbly, cranky, and I eat until I stop panicking. Total barrel full of fun the next day. As the Threshold Suspend is unique to the Medtronic Minimed 530G, it’s a big deal for me. Will it be worth giving up my Dexcom? Would it be better for me than the upcoming but not yet released Animas Vibe? Can I get over the non-open standard nature of Medtronic data?  We. Shall. See.

We. Shall. See.

I keep saying: “We. Shall. See.” because you’re basically taking me home for 90 days. You get to watch me run around like Zipper and observe this experiment in ThePerfectD.com habitat. Fun photos! Great stories! An expletive or two! (O.K., I hope not…) Reality.

I would like a water bottle on the side of my cage, please. Maybe filled with caffeine? Can you do that for me?

My name is Zipper and I’ll be wearing the MiniMed 530G with Enlite for the next 90 days.

Squeak.