Type 1 Diabetes Clinical Trials and Your Child

Should your child participate in a type 1 diabetes (T1D) clinical trial?

Imagine a world where drugs are tested only on adults, but then prescribed to children. Imagine a world where children were unique in experiencing certain diseases – think type 1 diabetes - but treatments had to be developed without being tested on them.

As recently as the 1970s, drugs were not tested on children or pregnant women. The unfortunate result of this was that physicians prescribed adult drugs “off label”, simply guessing at safe dosages, usually by weight. In too many instances, failure to test led to bad, or even tragic, treatment outcomes.

Children are not small adults. Their bodies metabolize drugs differently at different stages of development. The liver of a child may not be able to process a drug out of the body at the same rate the liver of an adult can. This can lead to overdoses or damage to the growing child's body.

Fortunately, the thinking on this issue has changed. Legislation was passed in 1977 and updated in 1995 that detailed the rules for such testing. Safeguards were built into the testing programs, including the requirement of administration and supervision of these trials by those with training and experience in treating children.

Parents can give informed consent to their child’s participation, because they are deemed capable of understanding what is involved. A child cannot. To protect the child, further safeguards include allowing a child over the age of 7 to “opt out” of participation in a program, even if the parents are willing. Because there is often financial compensation made to parents for the child’s participation, this “opt out” provision is the counter to pressure to participate that might be applied by the parents.

Testing venues must be child-friendly, and only staff experienced in working with children need apply. The potential benefits to the child must be paramount. A child who requires treatment may not be given a placebo, but might instead receive an alternate treatment as a control. Pain medications may not be withheld from infants.

There are many clinical trials that are not about drugs, but are instead looking at genetic profiles, nutritional supplements, or non-drug therapies for T1D. Some of all of these types of trials can be found on Diabetes TrialNet.org (http://www.diabetestrialnet.org/studies/index.htm), JDRF.org (https://trials.jdrf.org/patient/), ChildrenwithDiabetes.com (http://www.childrenwithdiabetes.com/studies/), or on the National Institutes of Health clinical trials website (https://www.clinicaltrials.gov/).

You can also speak with your pediatrician or endocrinologist about trials that might be available in your area.

Sources: Medscape and Food and Drug Administration

Image courtesy: NCI, NIH

More Articles

Diabetic shoes are important as a common side effect of diabetes is "peripheral neuropathy," which causes loss of sensation in the extremities....

There’s something inherently playful about bouncing, which is why so many people enjoy rebounding. Rebounding, or exercising on a mini-trampoline...

Do not let pictures of yoga experts with their bodies twisted into bizarre, compact shapes fool you. Even people with stiff muscles, creaky joints...

One of the hardest parts about adopting a low-carb diet is giving up traditional baked goods and sweets. The good news, however, is that low-carb...

Insulin injections are a way of life for many people with type 1 or type 2 diabetes, but for some people, they can be a little intimidating at...

More Articles

You may think beer, wine, and liquor would be categorized as food, but in reality, alcohol is a drug. Just like medications, alcohol has powerful...

With such a marked increase in the number of new diabetes cases, more people are wondering if type 1 diabetes...

Diabetic shoes are important as a common side effect of diabetes is "peripheral neuropathy," which causes loss of sensation in the extremities....

Experts estimate that somewhere in the world a person with diabetes will lose a lower extremity every half minute due to a wound. One of the...

One of the hardest parts about adopting a low-carb diet is giving up traditional baked goods and sweets. The good news, however, is that low-carb...

Anyone can develop a fungal skin infection, but people with diabetes are more prone to them. A common cause of fungal infections in those with...

Many diabetics struggle to control the sudden blood sugar spikes that can occur after meals. Knowing why blood sugar spikes happen and making...

Do not let pictures of yoga experts with their bodies twisted into bizarre, compact shapes fool you. Even people with stiff muscles, creaky joints...

People often get diabetes and hypoglycemia confused with one another, believing that they are two different names for the same condition. In...

Diabetes is a health condition that disrupts the body’s normal production of insulin. Currently, more than one million Americans are diagnosed...

Insulin injections are a way of life for many people with type 1 or type 2 diabetes, but for some people, they can be a little intimidating at...

With diabetes, it all used to be really simple: Type 1 diabetes was known as “childhood-onset,” and type 2 was “adult-onset” diabetes. The cause...

There’s something inherently playful about bouncing, which is why so many people enjoy rebounding. Rebounding, or exercising on a mini-trampoline...

The medical community relies heavily on the goodwill of its citizens, as giving blood and organ donations help save thousands of lives every year...

There are several misconceptions about Diabetes. Learn more about the top misconceptions vs. facts surrounding Type 2 Diabetes below.

86...