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Clinical Trials: Should I Be in One?

What you need to know about being part of a diabetes research study.



By the dLife Editors

What are clinical trials?

A clinical trial is a research study of an investigational drug, device, or other medical therapy in which people can participate as volunteers. These studies (sometimes called trials or protocols) are used to help evaluate the safety and efficacy of potential new treatments for diabetes and other medical conditions.

Many protections and safeguards for volunteer patients are built into the clinical research process. There are strict rules for clinical trials, which are monitored by the National Institutes of Health and the U.S. Food and Drug Administration, as well as the institution (e.g., hospital or university) in which the study is being done.


Pros and cons of participating in clinical trials

Potential benefits of participating in a clinical trial include:

  • Patients taking part in NIH Clinical Center studies are seen by a team of expert doctors, dentists, nurses, technicians, and support staff.
  • Patients often are first to receive promising new treatments before they become available in the community.
  • Patients are helping others with the same disease, both today and in the future.

Clinical research comes with some risks, just as routine medical care does. Researchers are required to tell potential participants about all potential risks and benefits of a clinical trial.

Before deciding to participate in a diabetes research study, you should carefully weigh these risks against possible benefits. Talk to your doctor, family members, and the appropriate research staff as you weigh your options.

You may or may not receive direct benefit for yourself as a result of participating in research, but in either case, you will know that the knowledge gleaned from the trial may help others.


Who participates?

  • Children and adults wishing to improve their own health. They may be patients with a newly diagnosed medical problem, or they may have had the problem for some time. They may also simply have a family history of a certain disease.
  • Healthy volunteers who want to help advance knowledge about the causes, progression, or treatment of disease also can participate in clinical research. They provide important information to researchers by helping them compare how healthy people differ from those who have a specific disease.

To participate, patients and healthy volunteers must meet certain requirements, which are different for each study.


Diabetes clinical trials

At any one time, there are thousands of diabetes related trials going on in the United States. A quick search of “type 2 diabetes” at ClinicalTrials.gov, returns over 8,000 trials that are actively recruiting. Diabetes related trials focus on various topics, including but not limited to:

  • Studies determining the effectiveness of new diabetes drug therapies
  • Assessing insulin pump therapy in type 2 diabetes
  • The impact of rheumatoid arthritis on the course of type 2 diabetes
  • Using stem cells that come from the umbilical cord/placenta to treat type 2 diabetes
  • Comparing self-monitored blood glucose to continuous glucose monitoring
  • Comparing diet and medical therapy versus bariatric surgery in type 2 diabetes

For more information:

  • To find a clinical trial,visit https://clinicaltrials.gov/ and search for key words or topics you are interested in.
  • For a list of questions to ask your doctor, visit the National Institutes for Health website.
  • Check out gov’s glossary to help you understand words and phrases frequently used when talking about clinical trials.
  • If you’re still wondering what it’s like to join a clinical trial even after asking your doctor questions, check out these personal stories shared by people who have participated in research through the National Institutes of Health.

Adapted from the National Institutes of Health (see sources).

Sources

National Institute of Diabetes and Digestive and Kidney Diseases. 2017. “Clinical trials.” National Institutes of Health. Accessed March 23, 2017.
https://www.niddk.nih.gov/health-information/clinical-trials/Pages/default.aspx

National Institutes of Health. 2017. “ClinicalTrials.gov.” National Institutes of Health. Accessed March 23, 2017.
https://clinicaltrials.gov/

National Institutes of Health. 2017. “NIH Clinical research trials and you: The basics.” National Institutes of Health. Accessed March 23, 2017.
https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics

National Institutes of Health. 2017. “Program for Healthy Volunteers.” National Institutes of Health. Accessed March 23, 2017.
https://www.cc.nih.gov/participate/studies/healthy_vol_prg.html

National Institutes of Health. 2017. “Why do researchers do different kinds of clinical studies?” National Institutes of Health. Accessed March 23, 2017.
https://www.nih.gov/sites/default/files/health-info/clinical-trials/infographic-why-researchers-different-kinds-clinical-studies.pdf

Updated by Julia Telfer, 3/17.


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