5 Things to Know About Diabetes Clinical Trials
If you have been diagnosed with Type 1 or Type 2 diabetes, your doctor has probably prescribed you a whole regiment of medications and lifestyle changes. However, diabetes is one of the most common diseases in the United States and other countries around the world. As such, there are scientists all over the world working on new treatments, medications, and potential cures for diabetes.
These new cures must go through safety and efficacy testing, which happens in 3 phases of clinical trials. You can help doctors and researchers test potential treatments and medications for diabetes by joining a clinical trial! But first, you have to know where to find clinical trials and how to enroll.
In this article, we’ll cover everything you need to know about diabetes, current treatments for diabetes, and how to find clinical research studies. Plus, we’ll cover exactly what it means to join a clinical trial and how to begin your enrollment into a medical research program.
1. What are the different types of Diabetes?
Diabetes is a disease associated with the body’s ability to utilize glucose (from sugar and other carbohydrates) within the bloodstream. People with diabetes have an inability to control glucose levels within the bloodstream. When glucose levels remain too high for long periods of time, damage to the kidneys, eyes, and other vital organs can occur. Untreated diabetes can lead to serious medical complications and is a serious concern for public health.
There are two different forms of diabetes that are common. Type 1 diabetes is thought to be an autoimmune disorder where immune cells inappropriately attack the pancreas. Cells in the islet of the pancreas secrete the peptide hormone insulin, which in turn tells cells to uptake glucose from the bloodstream. When these cells are damaged by Type 1 diabetes, no insulin can be released and glucose levels remain very high.
By contrast, Type 2 diabetes is considered “insulin resistance.” In other words, Type 2 diabetes occurs when the cells of your body develop an inability to respond to the insulin present. This type of diabetes seems to be caused mostly by diet and lifestyle choices, though there may be some genetic components. Certain biomarkers like blood pressure, weight, hypoglycemia, cardiovascular disease, and family members who are diabetic can be risk factors for poor glycemic control and potential diabetes. Type 2 diabetes can sometimes be prevented if it is treated in the prediabetes phase.
2. What causes Diabetes?
Essentially, the two types of diabetes have different causes. Type 1 Diabetes (also known as juvenile diabetes because it typically presents symptoms in children) is most probably caused by genes related to the immune system and interactions with the environment (i.e. your diet). Type 1 diabetes is considered an autoimmune disorder because your immune system attacks and destroys cells within the pancreas that normally release insulin. Without insulin, cells in your body have no way to uptake glucose, leading to heightened glucose levels and the symptoms they cause.
By contrast, Type 2 Diabetes typically develops later in life and is considered “insulin resistant” diabetes. Essentially, if you eat foods that cause continuous glucose spikes on a regular basis, your body stops responding as strongly to the amount of insulin produced by your pancreas. Eventually, this can lead to a condition where your pancreas cannot produce enough insulin - mostly seen in older adults. Thus, people with Type 2 diabetes are not always dependent on taking insulin until late in the disease’s progression.
Scientists are still examining the causes of diabetes, though there has been some exciting research on the genetics of diabetes in the last 10 years.
Genetics of Type 1 Diabetes and Type 2 Diabetes
The genetics of diabetes is very complex, especially given that there are two completely different forms of diabetes that are common.
With Type 1 diabetes, there are some fairly clear correlations between certain genes and the risk of developing type 1 diabetes. However, there is not a clear enough connection between the genes involved and the prevalence of the disease to consider Type 1 diabetes entirely genetic. The genes involved are related to proteins in the immune system that cause the immune system to target certain cells. In certain environmental conditions, these genes can direct the immune system to attack the islet of the pancreas, leading to Type 1 Diabetes.
As for Type 2 diabetes, the genetic correlations are much less clear. Type 2 diabetes is often found within families and communities, though this is more likely due to shared lifestyle and dietary habits than it is due to shared genetics. In fact, the prevalence of type 2 diabetes is on the rise in countries that share the “western diet”, have high rates of obesity, and have low levels of physical activity. That being said, there have been a few genes that have been correlated to an increased risk of diabetes within certain ethnic groups and families above and beyond the risks created by the “western lifestyle.”
3. Preventing and Treating Diabetes
While there are no cures for type 1 or type 2 diabetes, there are certain medicines and interventions that can help patients manage their symptoms and keep their blood sugar levels in check. Most diabetes patients need to learn how to use a blood glucose monitor device to keep track of their blood sugar levels. All of the diabetes treatments below should be prescribed by a healthcare provider, especially for high-risk patients with poor metabolic control over their blood glucose level or with a reduced quality of life.
Patients with type 1 diabetes need to regularly administer insulin since the damage in their pancreas organs precludes them from producing the necessary amount. In certain cases, doctors may recommend the transplantation of an insulin pump that automatically delivers insulin to the bloodstream. The Diabetes Control and Complications Trial (DCCT) was a double-blind, large-scale study that showed glucose control and general diabetes control were possible in most patients.
Patients with new-onset type 2 diabetes mellitus can sometimes manage the condition with lifestyle changes, including severe changes to the diet, increased exercise, and weight loss. However, once the condition progresses to a certain level even these patients may need to administer insulin or take other diabetes medications (such as metformin) to regulate their blood glucose levels.
4. Latest Discoveries about Diabetes
Recent research into diabetes has focused on the many different diabetes subtypes. Monogenic diabetes (diabetes caused by a single-gene mutation) has much better treatment outcomes than polygenic (multiple genes) diabetes. Part of this disparity is that monogenic diabetes can typically be diagnosed when children are less than 6 months old. This gives doctors a head-start in treatment and the treatment regimen is clearly defined.
By contrast, polygenic diabetes typically relies on multiple criteria to diagnose the condition, which can be stratified in different ways based on the healthcare provider and circumstance. This makes polygenic diabetes a much more difficult condition to treat effectively. Essentially, since there are so many more inputs and variables at play, it makes it harder for doctors to predict and counter the effects of polygenic diabetes.
Other studies have focused on the social determinants of diabetes. The authors concluded that there is a plethora of evidence that supports associating diabetes with socioeconomic stasis, neighborhood and physical environment, food environment, health care, and social context. In fact, the authors even go as far as saying, “Inequities in living and working conditions and the environments in which people reside have a direct impact on biological and behavioral outcomes associated with diabetes prevention and control.” In other words, there is a strong connection between your environment and your risk of developing type 2 diabetes.
Still, other researchers are actively researching new and different treatments for diabetes. For example, the drug sotagliflozin was recently tested in diabetes patients to see if it could lower the incidence of death by cardiovascular disease. Trials like these are not always focused on curing diabetes itself, but they are more focused on treating the symptoms and preventing the more serious outcomes of the disease.
5. What Are Clinical Trials?
Clinical trials represent the final stage in the development of a new drug, treatment, or intervention. Before the Food and Drug Administration (FDA) will approve a drug or treatment, it must go through 3 phases of clinical trials. The first phase includes the smallest number of volunteer research subjects and typically just ensures the basic safety of the procedure or medication. Phase two clinical trials typically include dozens to hundreds of participants as researchers look for both side effects and outcomes of the treatment. Phase three trials include thousands of participants to find the rarest side effects and best estimates of the effectiveness of a new drug or treatment.
Clinical trials typically begin with a recruitment period, where trial participants enroll and the timeline of treatments is established. If you are interested in joining a clinical trial, you typically must sign up during this enrollment period. Then, a randomized system sorts patients into experimental and control groups, so researchers can accurately measure changes to beta-cell function, conduct glucose monitoring over time, and measure other interventional outcomes based on their method of diabetes care.
Why Do People Join Clinical Studies?
One major misconception about clinical trials is that enrolling in a clinical trial is simply a way to get early access to the “newest” and “best” medications and treatments available. The whole point of a clinical trial is to test the safety and effectiveness of medication or treatment. In fact, because scientists need to compare the outcomes of the experimental group with a baseline, at least half the people in every clinical trial will not be on the experimental medication or treatment. These patients will either receive a placebo (a faux medication with no effect) or a standardized treatment like insulin and dietary changes.
So, you should not join a diabetes study just because you think you may get access to a more effective diabetes medication. Most people join clinical trials to help doctors and researchers find more effective treatments and medications for all people with diabetes. Some studies do provide some forms of compensation, but this is usually just enough to cover your travel expenses to and from the research facility.
Where to Find Clinical Trials for a Diabetic
Since diabetes is such a prevalent disease in many parts of the globe, there is ample opportunity to join a clinical research study. The websites below represent some of the best places to find research opportunities in your area. To increase your chances of being accepted for a clinical trial, be prepared to give details of your medical history. Clinicians will want to know whether you have type 1 or type 2 diabetes and other aspects to determine how severe your disease is. Here is a list of websites where you can start your search for clinical trials that are typically offered as multicenter studies at many locations concurrently:
- American Diabetes Association - Clinical Trials
- National Institute of Diabetes - Clinical Trials for Diabetes
- Mayo Clinic - Diabetes Clinical Trials
- Center Watch - Diabetes mellitus Clinical Trials
- TrialNet - Type 1 Diabetes Clinical Trials
However, you should also check with your doctor for any trials that are being conducted in your local area. Your doctor may know the primary researcher or have other connections to the trial that can help you get connected. For instance, the research institutions below are found on the East and West Coasts and they are offering several clinical trials each. Other specialized Diabetes research centers can be found across the U.S. and in several countries around the world.
- University of California San Francisco - Diabetes Clinical Trials
- University of Massachusetts Medical School - Diabetes Center of Excellence
National Institutes of Health (NIH), U.S. National Library of Medicine - Diabetes
Centers for Disease Control and Prevention (CDC) - What is Diabetes?
National Institute of Diabetes and Digestive and Kidney Diseases - What is Diabetes?
Journal of the American Society of Nephrology - Genetics of Diabetes and Its Complications
Alimentary Pharmacology and Therapeutics - Review article: diabetes, genetics, and ethnicity
New England Journal of Medicine - The Genetics of Type 1A Diabetes
The Israel Medical Association Journal - The Benefits of Integrating Nutrition into Clinical Medicine
Diabetologia - Precision diabetes: learning from monogenic diabetes
American Diabetes Association Diabetes Care - Social Determinants of Health and Diabetes: A Scientific Review
New England Journal of Medicine - Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease
American Diabetes Association Diabetes Care - The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study at 30 Years: Overview