Everything You Should Know About Clinical Trials

This content originally appeared on diaTribe. Republished with permission.

By Andrew Briskin

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 clinical research exist.

Clinical trials 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 technologies and treatment options to the general public, and they require volunteers at every step of the way.

Healthcare providers and diabetes researchers remain hard at work developing new drugs, medical devices, and therapies for people with diabetes. There are currently over 2,000 clinical studies currently looking to enroll people with diabetes, spanning everything from new insulins to telehealth, glucose-lowering medications, treatments for complications, mental health, and more.

If you’re wondering what it’s like to join a clinical trial 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.

Phase 1 clinical trials

The first two phases typically include a very small number of participants (usually less than 100). Phase 1 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 2 clinical trials

Phase 2 trials test the experimental drug or treatment in a larger, but still small group, including participants with the target disease. Phase 2 helps determine the optimal dosage and see if it’s effective, as well as further evaluating its safety.

Phase 3 clinical trials

In phase 3, the trial expands to include hundreds to thousands of research participants. The larger number of people 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.

FDA approval and phase 4 clinical trials

If a treatment is deemed safe and effective after a phase 3 clinical trial, it can undergo review by the FDA and potentially receive approval. Once approved, the treatment can be used by the public.

Researchers continue their work in phase 4, defining the characteristics of people a medication or device works best for and expanding researchers’ understanding of how to best use it. Phase 4 includes a much larger number of clinical trial participants than the first three phases.

What is participating in a clinical trial really like?

To better understand the personal perspective and potential benefits 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. She participated in a phase 4, post-approval study for the Eversense implantable continuous glucose monitor (CGM).

A real-time CGM that is inserted under your skin in your upper arm, Eversense transmits glucose data directly to your smartphone and is replaced by a healthcare professional every 90 days.

“Eversense was my first CGM since I knew I didn’t want a device that I had to wear and rotate so often,” Trezona said. She explained that the trial lasted two years and included only a few visits to the endocrinology clinic.

“I went 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’re asked to fill out a questionnaire on how you feel about managing your diabetes, and how you feel about the way the Eversense CGM works for you,” Trezona added. “These responses and my other results then went directly to the FDA for their analysis.”

Virtual clinical trials vs. in-person clinical trials

Sarah Tackett, who was diagnosed with type 1 diabetes in 2013, has participated in studies for automated insulin delivery (AID) systems and various medications and 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 research participants to be in person. Dalyce Wilson, who was diagnosed with type 1 over 20 years ago, has participated in trials for Novolog insulin, multiple CGMs, and other non-diabetes-related studies. She 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,” Wilson 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 and the risks and benefits to your health can vary based on the clinical research study. Be sure to read up on any trial that you may potentially participate in and ask the research team lots of questions.

In addition, clinical trial participation requires you to sign an informed consent document specifying everything that will be required of you and provides you an opportunity to ask questions.

Why join a clinical trial?

There are many reasons why you might want to participate in a clinical trials study.

Studies can give you access to a new drug, medical device, or extra care at no expense. Some offer compensation, though the amount can vary widely depending on what the treatment is.

And by participating, you’re 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. 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 type 1 diabetes care and held me accountable, helping me build a routine around managing my diabetes,” she explained.

Participating in clinical trials helps advance diabetes research

Wilson mentioned that while she wants to help advance research for others with type 1 diabetes, compensation from the studies was a significant factor.

“It’s okay 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,” Wilson said.

Trezona added that she was motivated to gain access to new treatments and diabetes management tools – and to help others who have diabetes.

“It benefits all of us who share this condition to help advance research by participating,” she said.

Before joining

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 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,” Wilson said.

“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,” she said.

If you’re hesitant to sign on, start small

For those who may be curious but are still unsure, Tackett said that you don’t have to jump into an intensive clinical trial right away.

“If you’re hesitant about participating in full clinical trials, I’d recommend starting small,” she said. “Completing surveys and sharing your personal experiences has an impact on research. 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 community.”

Most clinical trials provide 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 criteria can include age, sex, severity of illness, previous treatment history, or other medical conditions.

How can I participate in a clinical trial?

While very few clinical trial participants are included prior to phase 3, the buzz around an exciting new treatment 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.

Join online diabetes support groups

“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,” she said. “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.”

Keep up with diabetes research and news

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.

Follow diabetes research institutions on social media

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 research staff.

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 medical research as part of a larger clinical trial.

“I tell people that clinical trials are definitely worth going into,” said Trezona. “While of course it depends on your personal medical status, clinical trials are one way to bring new technology to people who need it.”

Learn more about diabetes and clinical research studies

Why I Keep Participating in Clinical Trials for Diabetes Innovations
Putting Time in Range at the Forefront of Clinical Trials
Diversity in Diabetes Clinical Trials

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