By Amy Tenderich
of www.DiabetesMine.com

From the did-you-know file: at any given time in the U.S. there over 900 clinical trials underway to study improved treatments and/or possible cures for diabetes. Can you imagine the time, effort, and money at work here? Yet surprisingly, despite the estimated 21 million people with diabetes in this country, most of these projects are struggling to find enough patients willing and able to participate. Why? Mainly because most patients either aren't aware of these studies or can't be bothered to sign up.

"Lots of trials are very narrowly limited to one or a few institutions," says Kate Lorig, director of the patient education research center at Stanford Medical Center. "If being in a trial requires going to see an unknown doctor at a distant location, many people won't participate. On top of that, the vast majority of diabetes patients see a primary care physician rather than an endocrinologist or diabetologist, so they'd be much less likely to hear about diabetes studies."

It's crazy, really, when you think about the potential benefits of participating in studies – whether for new drugs, new devices, or new software tracking programs. Your health gets lots of extra professional attention; you get access to some excellent new treatments, usually for free, since the sponsoring company pays for supplies and exams; and many studies even pay people to participate or offer incentives, such as a $10 Amazon.com certificate for each questionnaire filled out in a current Stanford web-based study. Some people find they get their best care and motivation when involved in this kind of program.

Plus you get the satisfaction of knowing that you're helping the diabetes community and future generations by fostering important scientific advances. So are you sold yet? Check out the National Institute of Health (NIH) web site ClinicalTrials.gov for a complete list of diabetes studies recruiting around the country. Still, there are a few things to consider before you volunteer.

Understanding Phases, Data Collection
One obvious concern is the safety of experimental drugs. So it's important to understand which phase a study is in. Phase I is generally a brand new drug or treatment given to a small group of people (20-80) for the first time to evaluate safety and side effects. If this makes you nervous, consider Phase II, a study on a larger group of people (100-300) for effectiveness, or Phase III, in which the new drug is given to very large groups of people (1,000-3,000) to confirm its effectiveness compared to existing treatments. Phase IV studies monitor the effects of long-term use of the drug or treatment, usually conducted after it has been approved by the government (FDA).

"It certainly is a challenge to recruit a cross-section of people," says Kevin McMahon, President & CEO and Diabetech, a company developing wireless devices for medical data monitoring. "Given the limited funding and time cycles of most studies, it's a shame that so many resources go into just recruiting. The other problem is outdated modes of data collection, which make for a lot of waste."

Data is typically collected every six months, especially for multi-site studies, still done by a person at a desk making phone calls to patients to ask for results, McMahon explains. Often it isn't until this six-month checkpoint or later that researchers first discover some patients haven't recorded their results or followed study instructions properly, so those patients must be dropped from the study. "If we were using wireless real-time monitoring, we would know that in a day," McMahon points out. His company Diabetech is developing a high-tech system for just this purpose. It also makes participating super-easy for patients because record-keeping is quick, immediate, and paperless.

We'll Call You?
So how do most people get connected with current studies? There's a whole association of Clinical Research Organizations (CROs) who act as go-between for companies, physicians, clinics, and regional centers looking to recruit patients into new drug and device trials. This is big, expensive business.

But the tactics are traditional, tried-and-true: engaging selected doctors' offices to recruit their patients (check for fliers on your doctor's bulletin board), placing ads in the newspaper (check the lifestyle section, especially on Sunday), and posting information on web sites – although a great portion of the patient population is not active on the Internet. This last point can be a stumbling block since an increasing number of studies are conducted over the web. For example, Stanford's latest project is an online diabetes self-management program for adults with Type 2 diabetes in the US. Absolutely no travel required! Just fill out a number of surveys, and you receive an A1c (three-month glucose) test kit which you're required to mail in.

But the point is, Stanford has had to do a lot of PR and marketing to get the word out about its study, because there's no easy starting point for finding a pool of eligible diabetes patients. Physicians are not obligated to report diabetes diagnoses in this country. Even the Centers for Disease Control (CDC) do not include diabetes when they compile reports on disease by state.

In hopes of filling that gap, Diabetech is also working on creation of a "universal registry" in which patients can choose to be listed as potential participants for an array of studies. "If it were easier to find and register for these studies, more people would participate," McMahon says.

In the meantime, it's worth asking your diabetes educator (CDE – if you have one) about research opportunities in your area. You might be surprised to find out what you're missing!

Amy Tenderich is host of the popular web log www.diabetesmine.com and is co-author of the new book, "Know Your Numbers, Outlive Your Diabetes," the first-ever hands-on guide to achieving a long and healthy life with diabetes. Find out how to get your free copy today.