
This content originally appeared on diaTribe. Republished with permission.
By Andrew Briskin
Clinical trials are the center step between scientific discoveries within the lab and making these discoveries available to the general public. Find out how clinical trials work, the experience of participating, and the way you possibly can become involved.
While you could have heard about clinical trials that examine the security and effectiveness of latest diabetes medications, many other varieties of clinical research exist.
Clinical trials test latest technology, surgical procedures, behavioral therapies, hormonal interventions, and way more. A whole lot of diabetes-related trials could be operating at any given time, and so they all depend on volunteers to push ahead potential latest discoveries.
The essential objective of those trials is to guage the consequences that a selected medication, technology, or program has on health outcomes for individuals with diabetes.
Clinical trials are the essential step between cutting-edge research and bringing latest technologies and treatment options to most of the people, and so they require volunteers at every step of the best way.
Healthcare providers and diabetes researchers remain hard at work developing latest drugs, medical devices, and therapies for individuals with diabetes. There are currently over 2,000 clinical studies currently trying to enroll individuals with diabetes, spanning every part from latest insulins to telehealth, glucose-lowering medications, treatments for complications, mental health, and more.
For those who’re wondering what it’s like to affix a clinical trial or have some hesitancy, here is an outline of some things to think about during your seek for diabetes-related clinical trials.
How do clinical trials work?
Clinical trials typically include 4 phases, three of which must occur before any particular treatment receives FDA approval.
Phase 1 clinical trials
The primary two phases typically include a really small variety of participants (often lower than 100). Phase 1 trials test an experimental drug or treatment in a small group of individuals, often healthy volunteers, for the primary time to guage the treatment’s safety and discover any unintended effects.
Phase 2 clinical trials
Phase 2 trials test the experimental drug or treatment in a bigger, but still small group, including participants with the goal disease. Phase 2 helps determine the optimal dosage and see if it’s effective, in addition to further evaluating its safety.
Phase 3 clinical trials
In phase 3, the trial expands to incorporate tons of to 1000’s of research participants. The larger number of individuals helps researchers confirm that the treatment is effective in a bigger population, compare it to existing treatments which might be similar, and higher understand if the treatment could be used safely.
FDA approval and phase 4 clinical trials
If a treatment is deemed secure and effective after a phase 3 clinical trial, it may well undergo review by the FDA and potentially receive approval. Once approved, the treatment could be utilized by the general public.
Researchers proceed their work in phase 4, defining the characteristics of individuals a medicine or device works best for and expanding researchers’ understanding of how one can best use it. Phase 4 features a much larger variety of clinical trial participants than the primary three phases.
What’s participating in a clinical trial really like?
To higher understand the non-public perspective and potential advantages of joining a clinical trial, we spoke with several individuals with diabetes who’ve 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).
An actual-time CGM that’s inserted under your skin in your upper arm, Eversense transmits glucose data on to your smartphone and is replaced by a healthcare skilled every 90 days.
“Eversense was my first CGM since I knew I didn’t need a device that I needed to wear and rotate so often,” Trezona said. She explained that the trial lasted two years and included only just a few visits to the endocrinology clinic.
“I went in every 90 days to get the expired sensor removed, after which a brand new sensor implanted in my arm,” she said.
“Every six months, you’re asked to fill out a questionnaire on how you are feeling about managing your diabetes, and the way you are feeling in regards to the way the Eversense CGM works for you,” Trezona added. “These responses and my other results then went on to the FDA for his or her evaluation.”
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 distant 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 an ideal job of transitioning to a distant 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 proceed during a pandemic and that distant studies are a viable option.”
Nevertheless, 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 could be way more difficult than others.
“The 2 CGM studies I’ve done to date have involved long days of in-clinic sessions,” Wilson said. The studies involved doctors manipulating my glucose levels to a high range someday, then low on others. The forced highs and lows and being attached to an IV for 12 hours felt brutal on my body.”
As Wilson explained, not all studies are created equal. The period of time required and the risks and advantages to your health can vary based on the clinical research study. Make sure you read up on any trial that chances are you’ll potentially take part in and ask the research team a number of questions.
As well as, clinical trial participation requires you to sign an informed consent document specifying every part that shall be required of you and provides you a possibility to ask questions.
Why join a clinical trial?
There are numerous the reason why it is advisable to take part in a clinical trials study.
Studies can offer you access to a brand new drug, medical device, or extra care at no expense. Some offer compensation, though the quantity can vary widely depending on what the treatment is.
And by participating, you’re helping to bring the newest scientific discoveries to most of the people.
“As a teen in Latest York City, I actually needed a second job. Participating in research appeared like one of the interesting jobs I could have,” said Tackett. “Plus, participating in research studies gave me the chance to try latest medications and devices without having to spend a ton of cash.”
“Looking back, the necessities of a research study provided a little bit of structure for my type 1 diabetes care and held me accountable, helping me construct a routine around managing my diabetes,” she explained.
Participating in clinical trials helps advance diabetes research
Wilson mentioned that while she desires to help advance research for others with type 1 diabetes, compensation from the studies was a big factor.
“It’s okay to do studies only for the financial compensation. Don’t think less of yourself if this can be a viable option to get the resources you would like,” Wilson said.
Trezona added that she was motivated to achieve access to latest treatments and diabetes management tools – and to assist others who’ve diabetes.
“It advantages all of us who share this condition to assist advance research by participating,” she said.
Before joining
For those who are enthusiastic about participating in a clinical trial, you’ll want to get as much information as possible about what the trial is investigating. Different trials involve different levels of risk provided that medications and technologies could also be latest, so consider the possible complications that would 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 which might be in your mind,” Wilson said.
“What form of time is required of me? What’s the compensation? Are there short-term or long-term unintended effects to the treatment? I also ask my very own body for consent. Having a mental conversation with myself and knowing when my body is giving me an indication that I shouldn’t move forward,” she said.
For those who’re hesitant to sign on, start small
For individuals who could also be curious but are still unsure, Tackett said that you simply don’t must jump into an intensive clinical trial straight away.
“For those who’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 necessary to do not forget that every tiny step we absorb research eventually adds as much as something that may have an enormous effect on the community.”
Most clinical trials provide an inventory of “inclusion” and “exclusion” criteria, which could be found on clinicaltrials.gov. Inclusion criteria are aspects that help you participate, while exclusion criteria seek advice from aspects which may prevent you from participating. These criteria can include age, sex, severity of illness, previous treatment history, or other medical conditions.
How can I take part in a clinical trial?
While only a few clinical trial participants are included prior to phase 3, the thrill around an exciting latest treatment from the primary two phases could cause high demand for the trial, leaving many unable to become involved.
Nevertheless, there are numerous ways you possibly can stay informed about latest clinical trials and increase your possibilities of getting a spot.
Join online diabetes support groups
“I belong to several diabetes support groups online, which regularly gives me targeted ads for diabetes-related topics,” said Trezona.
“Through these groups, I stay awake thus far on the newest news and research in diabetes, which leads me to details about upcoming trials,” she said. “In past years, I even have also attended the JDRF Type 1 Summit, where many various experts speak about latest devices and research within the pipeline.”
Sustain with diabetes research and news
Maintaining with diabetes-related news and research is among the finest ways to search out out about latest trials which might be recruiting.
Subscribing to diatribe.org and testing our clinical trial resource hub is a superb option to start. Joining a diabetes support group may expand your network inside the diabetes community, providing you with access to a wealth of latest information.
“Expressing interest via email and a phone call to clinical trial organizations or local hospital research departments are an ideal option to get the ball rolling,” suggested Wilson.
Follow diabetes research institutions on social media
Adding to that, Tackett beneficial following your nearest diabetes research institutions on social media, which regularly post about actively recruiting studies. You can too go to the JDRF clinical trials page to search out trials near you and make contact with information for research staff.
Finally, talk along with your healthcare team to see for those who are eligible for any clinical trials they’re aware of, or if your individual clinic is conducting medical research as part of a bigger clinical trial.
“I tell folks that clinical trials are definitely price going into,” said Trezona. “While after all it is dependent upon your personal medical status, clinical trials are one option to bring latest technology to individuals who need it.”