Everything You Should Know About Clinical Trials
Clinical trials are the middle step between scientific discoveries in the lab and making these discoveries available to the public. Learn how clinical trials work, the experience of participating, and how you can get involved.
While you may have heard about clinical trials that examine the safety and effectiveness of new diabetes medications, many other types of trials exist. Clinical trials also test new technology, surgical procedures, behavioral therapies, hormonal interventions, and much more. Hundreds of diabetes-related trials might be operating at any given time, and they all rely on volunteers to push ahead potential new discoveries.
The main objective of these trials is to evaluate the effects that a specific medication, technology, or program has on health outcomes for people with diabetes.
Clinical trials are the essential step between cutting-edge research and bringing new medications and technologies to the general public, and they require volunteers at every step of the way.
If you’re wondering what it’s like to participate in a clinical trial, are eager to get involved, or have some hesitancy, here is an overview of some things to consider during your search for diabetes-related clinical trials.
How do clinical trials work?
Clinical trials typically include four phases, three of which must happen before any particular treatment receives FDA approval. The first two phases typically include a very small number of participants (usually less than 100). Phase I trials test an experimental drug or treatment in a small group of people, often healthy volunteers, for the first time to evaluate the treatment’s safety and identify any side effects. Phase II trials test the experimental drug or treatment in a larger, but still small, group, including participants with the target disease to determine the optimal dosage and to see if it is effective, as well as further evaluating its safety.
In Phase III, the trial expands to include several hundred, or thousands, of participants. The larger number of participants helps researchers confirm that the treatment is effective in a larger population, compare it to existing treatments that are similar, and better understand if the treatment can be used safely.
If a treatment is deemed safe and effective after Phase III, it can undergo review by the FDA and potentially receive approval, which then allows the treatment to be used by the public. Researchers will continue their work in Phase IV, defining the characteristics of the people the medication or device works best for and expanding the researcher’s understanding of how to best use it. Phase IV trials include a much larger number than the first three phases.
What is participating in a clinical trial really like?
To better understand the personal perspective of joining a clinical trial, we spoke with several people with diabetes who have been, or still are, involved in clinical trials. Jeanine Trezona, a member of the diaTribe’s Community Dialogue facebook group, has had type 1 diabetes for over 40 years and is participating in a Phase IV, post-approval study for the Eversense implantable continuous glucose monitor (CGM).
Eversense, a real-time CGM that is inserted under your skin in your upper arm, transmitting glucose data directly to your smartphone, is replaced by a healthcare professional every 90 days.
“Eversense was my first CGM, since I knew I did not want a device that I had to wear and rotate so often,” Trezona said. She explained that the trial will last two years and includes only a few visits to the endocrinology clinic.
“I go in every 90 days to get the expired sensor removed, and then a new sensor implanted in my arm,” she said. “Every six months, you are asked to fill out a questionnaire about how you feel about managing your diabetes and how you feel about the way the Eversense CGM works for you. These responses and my other results go directly to the FDA for their analysis.”
Sarah Tackett, who was diagnosed with type 1 diabetes in 2013 and has participated in studies for an automated insulin delivery (AID) system and various medications, had a somewhat different experience participating in a remote study.
“For the past two years, I’ve been in a study evaluating the at-home use of an AID system,” she said. “The study team did a great job of transitioning to a remote study when COVID hit in 2020. They send device supplies and blood sample kits to my home, and I can mail the samples back to the lab. It’s great to see that research can continue during a pandemic and that remote studies are a viable option.”
However, many studies still require participants to be in-person. Dalyce Wilson, who has participated in trials for Novolog insulin, multiple CGMs, and other non-diabetes related studies since being diagnosed with type 1 over 20 years ago, describes how some studies can be much more difficult than others.
“The two CGM studies I’ve done so far have involved long days of in-clinic sessions,” she said. The studies involved doctors manipulating my glucose levels to a high range one day, then low on others. The forced highs and lows and being hooked up to an IV for 12 hours felt brutal on my body.”
As Wilson explained, not all studies are created equal. The amount of time required of you and the risks to your health can vary based on the trial, so be sure to read up on any trial that you may potentially participate in and ask the researchers lots of questions. Every trial requires you to sign a consent form – specifying everything that will be required of you and providing you an opportunity to ask questions.
Why participate in a clinical trial?
There are many reasons why you might want to participate in a clinical trial. It can give you access to the newest treatments and extra care at no expense (sometimes receiving compensation – though the amount can vary widely depending on what the treatment is). And by participating you are helping to bring the latest scientific discoveries to the general public.
“As a young person in New York City I really needed a second job, and participating in research sounded like one of the most interesting jobs I could have,” said Tackett. “Plus, participating in research studies gave me the opportunity to try new medications and devices without having to spend a ton of money. Looking back, the requirements of a research study provided a bit of structure for my T1D care and held me accountable, helping me build a routine around managing my diabetes.”
Wilson mentioned that while she wants to help advance research for others with type 1 diabetes, the compensation from the studies was a significant factor. “It’s OK to do studies just for the financial compensation – don’t think less of yourself if this is a viable way to get the resources you need,” she said.
Trezona added that she was motivated to gain access to new diabetes management tools and to help others who have diabetes. “It benefits all of us that share this condition to help advance research by participating,” she said.
If you are thinking about participating in a clinical trial, be sure to get as much information as possible about what the trial is investigating. Different trials involve different levels of risk given that these medications and technologies may be new, so consider the possible complications that could occur, especially if the treatment has not previously been given to people.
“Don’t be afraid to open up with the researchers or nurses about things that are on your mind about the study,” said Wilson. “What kind of time is required of me? What is the compensation? Are there short term or long-term side effects to the treatment? I also ask my own body for consent, having a mental conversation with myself and knowing when my body is giving me a sign that I shouldn’t move forward.”
For those who are curious but unsure, Tackett added that you don’t necessarily have to jump into a full clinical trial.
“If you’re hesitant about participating in full clinical trials, I’d recommend starting small by completing surveys and just sharing your personal experiences to have an impact on research,” she said. “I think it’s important to remember that every tiny step we take in research eventually adds up to something that can have a huge effect on the T1D community.”
Clinical trials will have a list of “inclusion” and “exclusion” criteria, which can be found on clinicaltrials.gov. Inclusion criteria are factors that allow you to participate, while exclusion criteria refer to factors that might prevent you from participating. These factors can include age, sex, severity of illness, or other medical conditions.
How can I participate in a clinical trial?
While clinical trials typically include very few participants prior to Phase III, the buzz around an exciting new therapy from the first two phases can cause high demand for the trial, leaving many unable to get involved. However, there are many ways you can stay informed about new clinical trials and increase your chances of getting a spot.
“I belong to several diabetes support groups online, which often gives me targeted ads for diabetes-related topics,” said Trezona. “Through these groups, I stay up to date on the latest news and research in diabetes, which leads me to information about upcoming trials. In past years, I have also attended the JDRF Type 1 Summit, where many different experts talk about new devices [and] research in the pipeline.”
Keeping up with diabetes-related news and research is one of the best ways to find out about new trials that are recruiting. Subscribing to diatribe.org and checking out our clinical trial resource hub is an excellent way to start. Joining a diabetes support group can also expand your network within the diabetes community, giving you access to a wealth of new information.
“Expressing interest via email and a phone call to clinical trial organizations or local hospital research departments are a great way to get the ball rolling,” suggested Wilson.
Adding to that, Tackett recommended following your nearest diabetes research institutions on social media, which often post about actively recruiting studies. You can also go to the JDRF clinical trials page to find trials near you and contact information for the leaders of the studies.
Finally, talk with your healthcare team to see if you are eligible for any clinical trials they are aware of, or if your own clinic is conducting research as part of a larger trial.
“In my support group, someone asked me about clinical trials, and I gave them the link to the clinicaltrials.gov website to start,” said Trezona. “I tell people that clinical trials are definitely worth going into, and while of course it depends on your personal medical status, clinical trials are one way to bring new technology to people who need it.”