Clinical trials are research studies that test the safety and effectiveness of new drugs, treatments, and medical interventions. They help researchers find new and better ways to prevent, detect, and treat type 1 diabetes and other diseases and health conditions.

Even if you’re not currently thinking about participating in a clinical trial, it’s a good idea to learn the basics about how research studies for type 1 diabetes work. You or someone you love might be interested in joining one in the future.

1. You Can Help Advance Research and Access New Treatments

When you participate in a clinical trial, you may get access to new treatments that are in development, new combinations of treatments, or existing therapeutics under review for new types of use. Medical devices, such as insulin pumps and continuous glucose monitors, also undergo clinical trials.

Also, researchers have tested promising type 1 diabetes treatments called disease-modifying therapies (DMTs) in recent years. ”Disease-modifying” means the drug doesn’t just treat ongoing type 1 diabetes symptoms — it can slow, stop, and even reverse the autoimmune course of the disease.

In a clinical trial, the treatment being studied is called an “investigational drug” or “investigational therapy.” Every existing treatment approved by the U.S. Food and Drug Administration (FDA) has gone through a clinical trial, and some participants in those trials had early access to new therapies. By participating in a clinical trial, you could help advance research and diabetes treatment options for yourself and for people not yet diagnosed.

Your participation can also help ensure that the study population includes people of your age, biological sex, and racial/ethnic background. According to the FDA, Black and Hispanic people are more than 50 percent more likely to be diagnosed with diabetes than non-Hispanic white people. However, their representation in clinical trials is relatively low. Parents might be hesitant to enroll their child in a research study, but adult data can’t accurately predict how children will respond to a drug or device. To understand and improve diabetes management for everyone, diverse study populations are needed.

The specific goals of clinical trials vary, but researchers are often seeking answers to these types of questions:

• Is a new medication safe and effective?
• What dosage of an existing or new medication works best?
• Is a new diabetes treatment better than existing treatments?
• Does a new treatment cause fewer side effects than existing treatments?
• Does a new treatment help people who haven’t responded to other treatment options?

Only you know whether participating in a clinical trial is right for you. But if you’re interested in helping researchers improve diabetes management and prevention while trying new ways to control your blood sugar levels, have a conversation with your partner, family, and health care team.

2. You Could Receive a Placebo

A placebo, sometimes called a “sugar pill,” is designed to look like the diabetes treatment being studied but doesn’t have any active ingredients. To test the effectiveness of an investigational treatment, clinical trials may assign a group of participants a placebo to compare results. For example, in a study looking at how a new diabetes treatment affects body weight and glucose control, giving half the group a placebo helps researchers evaluate the effectiveness of the drug.

Placebos may also be used when a clinical trial is testing an existing treatment in combination with a new treatment. One group of participants might receive the existing treatment plus a placebo, and another group would receive the existing treatment in combination with the investigational drug or therapy.

In most trials, the group that receives the investigational treatment versus the group that takes a placebo — or existing treatment — is decided randomly to avoid bias. This process is called “randomization.” Many research studies are also double-blind, meaning neither the trial participants nor the researchers know which participants are receiving which treatment until the trial is over.

In some clinical trials, when the investigational treatment appears to be much more effective than the treatment it’s being compared to, the new treatment may be made available to all participants at some point in the study.

When considering a clinical trial, it’s important to ask questions about the study design and whether you would have access to the investigational treatment if it proves effective. In every clinical study, participants are informed if there is a chance they might receive a placebo, rather than the treatment under study.

3. You Will Be Protected

The safety of participants is a priority in clinical trials, and there are safeguards to protect you. These protections were carefully developed in response to historical wrongdoings in which individuals’ rights were not maintained in medical research.

In this day and age, clinical trials in the United States are overseen by the FDA, which is mandated by law to protect human safety. Other regulatory boards serve a similar function in countries around the world.

Institutional Review Board

In the United States, an ethical body called an institutional review board (IRB) approves and monitors the majority of clinical trials. The IRB’s role is to protect the safety and rights of participants in clinical research studies. IRBs assess studies to ensure that the potential benefits of clinical trials are significantly greater than the risks and that appropriate precautions are in place to protect participants. If it is determined during the trial that it’s no longer safe to proceed, the study will be discontinued.

Informed Consent

Before joining a research study, you’ll be given thorough information about the goals of the trial and potential risks for participants. Clinical trials are required to help you make an educated decision about volunteering in a study. This process is called informed consent.

All treatments, including standard treatments, have potential risks of adverse reactions or side effects. Clinical trials are meticulously designed to minimize risks. Participants in clinical trials are carefully monitored to determine if a treatment is safe and if the potential benefits outweigh the potential risks. The informed consent process gives you plenty of time to ask questions and consider whether you’re comfortable with the study before you join a clinical trial. This process allows you to discuss the trial with your doctor, family members, and others you rely on for advice.

You will also be given general information about the research study, such as how much time will be required, any costs, what kind of travel may be involved, and what the medical procedures of the trial involve. Costs for clinical trials are usually covered by the company or organization sponsoring the trial, along with health insurance.

There are different phases of clinical trials. Phase 1 trials focus primarily on the safety, dosage, method of taking treatment, and side effects of the investigational therapy. Phase 2 and phase 3 trials recruit larger numbers of participants and focus on efficacy (how well a treatment works) in addition to safety. After the FDA approves a new drug, researchers track its safety and effectiveness in the general public, trying to learn more about its benefits and the best way to use it. This is phase 4.

4. You Can Stop Participating at Any Time

When you agree to participate in a clinical trial, you are a volunteer. You have the right to withdraw from a research study at any time, for any reason, even if the study is still in progress. Signing consent documents and agreeing to participate in a trial is not a contract that requires you to stay in the trial if you choose to withdraw.

If you decide to leave a clinical study, let the research staff know, so that you can be formally withdrawn. Depending on the trial, you may need to undergo monitoring when discontinuing study treatment. If you are considering withdrawing, reach out to the study team or your doctor first, so you can discuss questions or concerns.

5. You Will Likely Qualify for Some, but Not All, Clinical Trials

Clinical trials for type 1 diabetes study a wide range of topics. They also have specific eligibility requirements. While one clinical research study may be recruiting pregnant people with diabetes, others will be looking for participants with pediatric diabetes, older adults willing to test hypoglycemia interventions, people awaiting pancreas or kidney transplants, and more.

If you’re not accepted for a clinical trial, it’s likely because you didn’t meet the specific eligibility requirements. However, don’t let this discourage you. There are always numerous clinical trials for type 1 diabetes underway.

6. You Can Search Online for Type 1 Diabetes Clinical Trials

Your doctor may be able to help you find type 1 diabetes clinical studies for which you are eligible. You can also search on your own.

Here are some places to start:

• American Diabetes Association
• Breakthrough T1D (formerly JDRF)
• City of Hope
• ClinicalTrials.gov
• Diabetes Research Institute Foundation
• National Institutes of Health
• TrialNet.org

Some organizations include research studies for type 1 diabetes and type 2 diabetes in the same list, so read the descriptions closely. If you find a clinical trial that interests you, discuss the information with your health care provider before enrolling. They can answer your questions and help you decide if it’s a good fit. Keep in mind that medical trials are usually carried out in large metropolitan areas. In some cases, you might need to travel anywhere from once a month to once or twice a year for blood tests, imaging, or other medical purposes.

7. You Should Keep Your Regular Doctor in the Loop

Many research studies include regular medical care and monitoring to evaluate side effects, quality of life, blood glucose levels, and more. However, despite the additional care and clinical visits you may have in a research study, people in clinical studies generally still see their regular health care providers for blood tests and other diabetes management.

The medical care you receive as part of the trial doesn’t replace comprehensive health care. Your doctors can coordinate with the research team to help ensure that the clinical trial treatment is compatible with any other diabetes treatments you’re taking. Your primary care provider or endocrinologist (a doctor specializing in conditions of the endocrine system, including diabetes) can help you understand how participating in a research study might affect your care.

Talk With Others Who Understand

On myT1Dteam, the social network for people with type 1 diabetes and their loved ones, more than 3,300 people come together to ask questions, give advice, and share their stories with others who understand life with type 1 diabetes.

Have you participated in a type 1 diabetes clinical trial? Are you thinking about enrolling in one? Share your experience in the comments below or on your Activities page.