DID YOU KNOW that 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,” Kate Lorig tells me. She is the 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. Also, 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. Also, 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.
Of course, if you’re considering volunteering, it’s always SAFETY FIRST. You’ll want to understand which phase a study is in:
Phase I – 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.
Phase II – a study on a larger group of people (100-300), for effectiveness.
Phase III – 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 that monitor the effects of long-term use of the drug or treatment, usually conducted after it has been approved by FDA.
Hey Neighbors! If you live in the Greater San Francisco Bay Area (Northern California), I have a clinical research outlet for you: the Mills-Peninsula Dorothy & James Frank Diabetes Research Institute, headed by the founder of the Diabetes Technology Society, Dr. David Klonoff. I happen to know that they are looking for participants with Type 1 or Type 2 diabetes, currently on or off insulin, for a variety of studies, including… a new class of rapid-acting insulin, inhaled insulin, a glucose clamp device, and new insulin delivery devices. Contact them at 650-696-4261. And let me know how it goes, will ya?
The flip side is that some of these studies take a ton of time and don’t necessarily reimburse participants for their time, or even their parking (which, at my doc’s office, is pretty costly and can add up for repeated visits made only for the study’s sake). The other argument is that some people don’t want to be guinea pigs. I’ve done studies where I was already at the doc’s office and just had to answer a survey (and yes, got reimbursed for that time), but I’m eligible for a new mom/newborn study and my husband feels strongly that our kid shouldn’t be a guinea pig for science. So it’s not always a question of not knowing about the studies or not wanting to be bothered.
Ironically, the better control a patient has of their condition, the fewer studies they may be eligible for. I have been disqualified for 3 trials in the last 2 years because my A1c wasn’t high enough! I am also somewhat irritated by the fact that more than 90% of the pharmaceutical industry’s clinical trials for diabetes are for type 2 treatments, most of the work done for type 1 is either for complications treatment or modifications to existing treatments. The upside is that a separate site, the Type 1 Diabetes TrialNet site (http://www.diabetestrialnet.org/tnet1.html) does outline studies that are looking exclusively for those with type 1.
You can use the search bar at clinicaltrials.gov to filter for only those trials that you might be interested in. For example, typing ‘type 1 diabetes’ returns 351 trials currently recruiting participants.
Not sure about how strict NIH is, but the National Institute of Mental Health will sometimes accept participants even if they do not meet every single qualification/exclusion. I am a therapist and I’ve had several of my clients participate in clinical trials even though they didn’t meet the exact qualifications. It’s worth a phone call even if you think you don’t qualify!
My problem is I have searched in my area and haven’t ever found many studies around here. Then of the ones that are, they are for type 2s.
Using http://www.clinicaltrials.gov/ct/search?term=diabetes%2C+cincinnati searching Cincinnati and diabetes I only recieved 35 studies.
Of all the studies, I qualify for none because I’m a type 1 with no complications. The ONLY ones I could qualify for are Exubera, however, I don’t see switching from an insulin pump to Exubera as a benefit since the control is less precise at this time with Exubera.
I’m actually registered for the Mills-Peninsula clamp study this coming week. This will be the second one I’ve done with them, too. The first one took about 6 hours and gave me ample chance to ask a lot of questions – both to the attending doctors/nurses and the folks who made the device that was being tested. I got paid $600 for my time, and the opportunity to participate was also very worthwhile.
Another thing to look out for if you live in the SF Bay Area are usability studies on glucose meters and pumps. I’ve participated in studies by design-giant IDEO, as well as with a couple of other smaller product design outfits like Cooper and Frog Design. Each time I spent about an hour talking about how I use my blood monitor, what I dis/like about it, and what additional features I would like. Then I spent a little time using a prototype and providing feedback. Easy as pie, and a good opportunity to see what may be coming in the future.
I don’t seem to be eligible for most trials. They want diabetes duration of X; they want complications; they want an A1c above 7%; they want type 2 diabetes.
The number given for the Diabetes Research Institute at Mills/Peninsula seems to be a direct line to VM for Dr. Klonoff himself – I called the secy number he left on the message and got the center…BTW
hi! i just found your blog and am glad it’s here!
i don’t fit most clinical trials either, although my a1c is consistently around 8. and the ones i do usually require me to drive (i don’t have a car) somewhere or go somewhere during working hours. they don’t seem to understand that most of us have to keep regular jobs to be able to afford insurance.