With all the talk about mice in cure research (over 2 million results for "mice diabetes research" on Google!), you might think there is absolutely no way for you — a human — to participate in the magic of modern science. But there are actually a lot of studies going on right now that need participation from PWDs with both type 1 and type 2 diabetes.
Worried about risking your health on something too experimental? You should know that when a drug or medical device is being developed, Human Clinical Trials are the last phase of study, aka the point at which scientists are ready to show just how well the new treatment works in people. The prior phases of study are done to show safety and efficacy in animals (usually mice), because doing this kind of experiment in humans is dangerous and expensive. This phased approach is one of the reasons why research is so doggone slow.
Remember that not all clinical trials are for cure research. Some are designed to find ways to predict diabetes, while others study new tools for managing diabetes, like the artificial pancreas. Still others are done to provide clinical data about the efficacy of a particular drug or device even after it has been FDA approved (such as showing whether or not one drug or tool is more effective in lowering A1C than another).
Feeling geographically challenged? Even though most clinical studies are done in major cities, like New York, Boston, San Francisco and Seattle, many of these centers have some travel budget for those interested. It's crucial for studies to have enough people enrolled, because each trial needs to have the smallest possible margin of error. If you fit the profile, it couldn't hurt to ask whether they'd be willing to transport you in!
If you are interested in enrolling in a clinical trial, but have some questions or hesitations, the American Diabetes Association's site offers a great section called Participating in Clinical Trials. It offers suggested questions that you can ask about the trial, including info on safety, drugs and placebos, and other FAQs.
NEWSFLASH: FDA Clears Dexcom Share Direct
Dexcom gets regulatory approval of its 'on-the-go' mobile apps for CGM data-sharing.
State of the Union: It's Time to Cure Diabetes
President launching new precision medicine initiative to better treat, cure diseases like diabetes.
'Robotic Pancreas' Appears On American Idol
Carlos Santana's nephew Adam Lasher shows off Dexcom G4 during live performance.
Still wondering why? Many of you may simply have the sense that you'd like to be "part of the solution," doing something positive for the D-community and future generations by helping with research. But there are some immediate tangible benefits as well: being part of a clinical study means your health gets lots of extra attention, both from yourself and from the medical professionals running the study. Some people find they get their best care and motivation under this kind of close scrutiny. Added benefits are free stuff, since the clinic or sponsoring company pays for supplies and exams.
Ready to start looking?! Here are a few key online resources for folks interested in finding out what clinical trials are currently underway:
This website is the National Institutes of Health's (NIH) warehouse of all clinical trials being done... everywhere. They currently list over 100,000 clinical trials being done in 174 countries. There are 723 studies for type 1 diabetes, and 2,703 studies for type 2. Wow! Unfortunately, it can take a few steps to narrow down which studies you might be eligible for. When you get to the site, click on the short cuts:
- Clinical trials for Type 1 diabetes
- Clinical trials for Type 2 diabetes
There really aren't any good ways of narrowing things down after that. Since most studies require you to be of a certain age, live in a certain area, have diabetes for a certain length of time, or be on a specific kind of diabetes treatment regimen, this website fails in the Usefulness category.
Which brings us to...
JDRF's Clinical Trials Connection allows for more in-depth search options and also allows users to receive regular emails notifying you of new trials in your area. Users can create a free profile, indicating your relationship to the PWD (self, child, or sibling), your age, date of diagnosis, and your area. You can also add additional states to which you're willing to travel in order to participate in a trial. Then you can select to receive an update of trials every 2 weeks, 1 month, 3 months, 6 months or never.
Note that Clinical Trials Connection uses the exact same source for describing each study as ClinicalTrials.gov, so once you click on the trial, you'll see the same information. Eligibility is listed at the bottom of the page, and also a list of any exclusionary factors that the search engine didn't ask, such as A1c level, other chronic illness or medication. You'll still have to sort through the results before applying, but this at least helps narrow down your search.
Corengi (which stands for Clinical Options Research Engine) is another free clinical trials search engine, but specifically for type 2 diabetes. Users are required to sign up and create a profile, and unlike JDRF's Clinical Connections, the profile asks specific questions, such as race, recent lab work, other medical conditions, and whether or not you're on Metformin. All these questions are optional, although they would help with final search results since they do most of the legwork for you.
Search results include a brief description, along with a yellow box highlighting any specific inclusion or exclusion requirements. The trial information is separated by tabs, with study requirements and contact information broken out. There is also a link to the ClinicalTrials.gov webpage for the description of the trial.
Other Clinical Trials Websites:
The Immune Tolerance Network currently has two studies going looking into the possibility of halting type 1 diabetes near diagnosis. Those studies are the START trial and the RETAIN study, and they both require that you or your child be diagnosed with type 1 diabetes within the last three months. The START trial requires participants to be at least 12 years old, while the RETAIN trial starts at age 8.
TRIALNet is an international collaborative study designed to look at preventing, delaying, or reversing the onset of type 1 diabetes. TRIALNet is actually operating two studies: the Natural History Study and the Diabetes Intervention Study. The Natural History Study is a screening for those who could be at-risk, like siblings or children of a PWD, and analyzing blood samples to see if the diabetes antibodies (indicators that diabetes may develop) are present. The Diabetes Intervention Study itself has two parts: the first is to prevent or slow down the disease onset in those identified as being at-risk for type 1 diabetes, and the second is to preserve insulin production in newly diagnosed type 1 patients (again, you have to be diagnosed within 3 months to qualify).
Clinical trials are critical if we are ever going to make any progress in finding some answers to curing (and better treating) this wretched disease. So take a gander at some of these websites... And if you do participate in any trials, please let us know. We'd love to hear the gritty details of your experience "ousting the mouse"!