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.

Sleep And Diabetes: Perchance to Dream?

photo-17She was born five weeks (and one day) early. A little bit of a low blood sugar upon arrival , so she went off to the NICU for a few days. The nurses fought over who could hold her; she was the only baby in an open bassinet who could be picked up.

“We were going to move her to the intermediate care nursery, but she had a brief bradycardia incident.”

As parents who didn’t brush up on the NICU speak before arriving, we learned quickly that her heartbeat had slowed because she forgot to breathe. It’s common amongst preemies, but it’s still a freakout show when you hear that it’s happening to your child. Forgot to breathe? What?!!!! Despite that “brief” moment and a few others just like it, she came home with us 96 hours after she was born. (John and I occasionally raised our eyebrows at each other as we were being discharged. They’re letting us take her? Wait…. we’re not ready.)

The first few weeks postpartum are tough, regardless of how the birth all went down, and due to her feeding schedule (every.two.hours), I was a little extremely loopy. The cycle was feed her, burp her (careful not to pat her back so hard that I knocked her head off, because that was also one of my concerns), put her back to sleep, then pump breast milk for the next round so that I could get some sleep and John (or my parents when they visited) could take over.

I cat napped with my hand on her chest, feeling her heartbeat and her little chest rise and fall. I refused to sleep deeply. She slept next to me within arms’ reach. And I had quiet panic attacks. What if she stopped breathing and I wasn’t there? What if I was sleeping and she needed me?

What if she…died?

No matter what someone else says to allay your fears, there is always that deeply rooted feeling of unrest that claws at the base of your spine. She did not have any more bradycardia moments. She kept breathing.

She likes to snuggle next to me and fall asleep now, and I still find myself watching her little chest rise and fall.

I think I will try to watch that forever.

Yeah, so what does your story about The Kid have to do with sleep and diabetes?

Sleeping with diabetes is like having a preemie. Will I go low tonight? Will I wake up for the low and treat it myself? Will I stay in the low for hours and… I can’t even think about it.

My CGM is the hand on my chest. I have dear friends who have slept through the CGM alarms and have needed help to bring them out of severe hypoglycemia. I know of parents whose fears were realized. There are no words.

For parents of children with diabetes, my heart aches for their fears. Every time the alarm goes off and they check their sleeping child at night, the fear rises. Using CGMs and the jaw-dropping technology of Nightscout, a DIY remote monitoring for Dexcom have helped those parents immensely.

Elizabeth Stone said:

“Making the decision to have a child – it is momentous. It is to decide forever to have your heart go walking around outside your body. ”

She didn’t mention the pancreas, but we get it.

For those of us who have diabetes or have a loved one with diabetes, sleep is not restful. When we do, we dream… of days of freedom from the fear of lows and what those bring. It’s well documented that sleep and Type 1 diabetes don’t go well together:

But there is hope:

10429423_10152665504092328_8015680368277849861_n
3am Hellraiser in pigtails.

There is no magic wand or pixie dust to help us sleep. And sometimes, no matter how adorable they are, they still raise hell at 3am. I know this from experience.

But there are devices/products/software/services that can lessen the burden. And I encourage you… if you haven’t investigated them, check them out.

If you haven’t heard of Nightscout or the #wearenotwaiting movement, get on over to the Nightscout website. Some of the stories of individuals using this will make you smile and make you grateful for the smart people who help us get our data to where it needs to go: in the hands of those who can help us immediately when things go south. 

And then there’s Tidepool. Howard and his team are rocking it big time, working with device companies to make our data readable and workable and easy to understand and I.want.Nutshell. right now.

And, of course, if you haven’t heard about the Bionic Pancreas, well… here. I am a fan. A big fan. Like, Beatles girl screaming and swooning fan.