Treatment

Diabetes Clinical Trials

David Mendosa Health Guide July 12, 2011
  • People with diabetes enroll in clinical trials for several reasons. But before we do we need to know all the pros and cons.

    One of the best ways to learn about clinical trials is a new website. Corengi.com, which stands for Clinical Options Research Engine, can match us to appropriate clinical trials.

    But before you sign up for one I recommend that you take a look at its new video, “What ARE Clinical Trials?” In five short minutes the video explains many of the key concepts in clinical research. It explains, for example,  the different phases of clinical trials, it highlights the differences between interventional and observational trials, it provides examples of inclusion and exclusion criteria, and it describes the purpose of an Institutional Review Board.


    Ryan Luce, Corengi’s president and founder, told me that his company produced the video to help people with diabetes understand more about “the convoluted process” of clinical research.

    We focus on type 2 diabetes trials now,” Ryan says. “We really need to get an analogous tool for type 1. And we plan to add several other chronic conditions later.”

    Right now, Ryan says, the best resource for people with type 1 diabetes is the JDRF Clinical Trials Connection site. But for type 2 diabetes, he says -- while admitted his obvious bias -- that “We're really the best resource because we are transparent about where our data comes from, we are comprehensive (having all the trials in the U.S.), and we drill down to the trials that are clinically appropriate with the matching engine.”

    That’s a lot of data to sift. At present 343 type 1 diabetes clinical trails are ongoing round around the world, including 163 in the U.S. For type 2 diabetes the numbers are 802 and 318 respectively.

    By participating in a clinical trial, you can take an active role in your own health care, gain access to new treatments that are not yet available to the public, and obtain expert medical care at leading health care facilities during the trial. You can also help others by contributing to medical research.

    But clinical trials can also have risks. Even if the treatment works for you, its side effects can be serious. Plus, taking part in one of these studies can require a lot of your time.

    I asked Ryan about the risks. “Clinical trials have a lot of checks and balances,” he replied. “A lot of people are always trying to minimize the risks, but for some trials it is very difficult to eliminate risks. Whenever you are taking any sort of medicine, you always have some risks.”

    He points out that cancer researchers and patients, for example, are willing to tolerate more risk. “But diabetes is more manageable, so we tolerate less risk.”

    Besides, it depends on what type of trial you participate in. One type is interventional, which could be a drug, surgery, diet, or exercise, and the other type is observational.

    “A ton of observational trials have little or no risk,” Ryan says. “They draw your blood, look at the genetic component, or ask questions about diet and exercise. Although only about one-fifth of diabetes trials are observational, because they need so many more people, this is more than half of the volunteer opportunities that are out there.”


  • Anyway, people with diabetes who have participated in clincial trials describe it as a positive experience, according to several studies that Ryan sent me. One study of patient satisfaction with cancer trials shows that 95 percent said their participation was worth it, 90 percent would do it again, and 85 percent would recommend it to others. Another study of cancer patients in trials found that while understanding was a problem, their satisfaction was “very high.”


    Corengi’s own research also shows positive results from 145 people with diabetes whom they surveyed who had participated in a clinical trial. Of these, 63 percent were very positive, and 26 percent were somewhat positive. None of them would not recommend that others look into clincial trials, while 88 percent would make that recommendation and the rest were unsure.

    But what does Corengi get out of this? To be blunt, how does it make money?

    “We want to help these patients,” Ryan replied, “but we are also creating a business. We want to be a for-profit company and have a comprehensive listing of all the clinical trials. We are transparent where we are getting that info and who is paying us.”

    Corengi makes its money, Ryan further explained, by allowing trial locations and sponsors to get better exposure on the website by paying a monthly fee.  They get their trial bumped to the top of the matching page and they get their logo -- which can function as a link -- both on the matches page as well as the trial detail page.

    “Two important things,” he continued, “are that we have all trials on the tool, regardless if you pay us or not. And
    these promotions only show up if you are clinically appropriate for the trial and if you are geographically close, within 200 miles.”

    I ended the interview by asking Ryan if he himself had participated in a clinical trial. Funny that you should ask, he replied. He told me that had been thinking about volunteering for one seeking healthy people.

    Ryan know where to look for that information and what the pros and cons of participating in a clinical trial are. You will too after seeing the video on his site and checking out your options.