Type 1 Diabetes Research Study for Teens

Ages 12 to 17

If you were recently diagnosed with type 1 diabetes (T1D), you may be able to take part in a research study.

The CNP-103 Clinical Trial is researching an investigational study therapy to see if it may help people with T1D in the future. An “investigational therapy” is a new medicine that is still being researched and can only be used in research studies like this one.

What Is This Study About?

Right now, there is no medicine that treats the root cause of T1D. Researchers are hoping to change that.

Doctors are studying a therapy called CNP-103 to see if it may help the immune system stop attacking the pancreas. The goal is to learn if this treatment may help protect the cells that make insulin.

Researchers want to learn how CNP-103 works and if it is safe for people who were recently diagnosed with T1D. Because the treatment is still being studied, it can only be given in a research study like this one.

Teens who join the study will visit the study clinic regularly so doctors and nurses can check their health and learn more about how the treatment works.

Can I Join the Study?

You may be able to join if you:

  • Are 12 to 35 years old
  • Have been diagnosed with T1D in the past 6 months
  • Are currently taking insulin or certain other diabetes medicines

Not everyone will be able to join the study. The study doctor will ask questions about you and your health, and you can choose if you want to join the study after you learn more.

What Will Happen If I Join?

The study has 3 main parts:

Screening

The study team will make sure the study is a good match for you.

Study Treatment

If you join the study, you will either get the study therapy or a placebo through an IV.

Follow-Up

After your last dose, the study team will continue checking your health.

This study will last about 13 months and include 10 checkups at the study doctor’s office.

Never Had an IV Before?

It’s normal to feel nervous. The IV may feel like a quick pinch when it is placed, but many people say it gets easier once it starts. You might feel a warming or cooling sensation as the study treatment enters your body through the IV, but you should not feel any pain.

The treatment slowly drips from a bag and takes a few hours. A nurse or doctor will watch you closely the whole time. While this is taking place, you can read, do your homework, or use your phone.

If you want to know more about clinical research and this study, feel free to ask questions every step of the way.

See if you may qualify

About the Therapy

The therapy is called CNP-103. It does not replace insulin. You will still take insulin and care for your diabetes as usual.

The goal of CNP-103 is to help keep your diabetes from getting worse over time. In the future, this may mean you won’t need higher doses of insulin as you get older.

In this study:

  • Some people will get CNP-103
  • Others will get a placebo (looks like CNP-103 but has no medicine)

Most people in the study – about 2 to 3 times as many – will receive the study therapy. No matter which one you get, doctors and nurses will closely monitor your health throughout the study.

How the Therapy Is Designed to Work

Healthy Pancreas

Insulin-producing cells (called beta cells) produce the insulin your body needs to regulate blood sugar.

In a healthy body, the immune system protects you from unwanted things like germs and infections. It leaves your insulin-producing cells (called beta cells) alone, allowing them to produce the insulin your body needs to regulate blood sugar.

  • Insulin allows your body to take the energy from the food you eat and move it into your body’s cells, where it’s used for energy.

Pancreas with T1D

The immune system mistakenly attacks the beta cells in the pancreas.

In people with T1D, the immune system mistakenly attacks the beta cells in the pancreas. The damage from this attack leads to the beta cells not being able to produce insulin properly. Without insulin, sugar stays in the blood and makes the sugar levels in your blood too high, causing your body to not get enough energy where it needs it (in its cells).

Pancreas with T1D After CNP-103

The goal of CNP-103 is to protect your remaining beta cells so they can continue to produce insulin.

CNP-103 is designed to "retrain" your immune cells to recognize beta cells as friendly. By calming this autoimmune attack, the goal is to protect your remaining beta cells so they can continue to naturally produce insulin.

Questions You Might Have

New medicines are not possible without clinical study volunteers to take part in studies. It's important to know that no matter your age, it’s your body and your choice. You have the right to ask every question on your mind and to feel safe and put your own well-being first.

Here are answers to some common questions teens and families ask about the study.

A clinical research study, or clinical trial, is a term for when scientists test new medicines to see if they work well and are safe. Research studies are the process we use to approve new medicines to be used in the future outside of a research study.

An investigational therapy means that scientists don’t know everything about the medicine yet and need to learn more. An investigational therapy can’t be used outside of clinical research yet.

A placebo looks the same as the therapy but does not contain medicine. Placebos help researchers compare results and understand how well the study therapy works.

Yes. You can leave the study at any time.

You and a parent or guardian must give permission before you can join the study if you are under 18 years old.

Yes. The study team will check your health regularly to make sure you are doing well.

Some tests may involve needles, like blood draws or IV infusions where you will be connected to an IV for several hours. The study team will explain everything ahead of time and make sure you are as comfortable as possible.

Yes. The study therapy does not replace insulin. You will continue your usual diabetes care during the study. The goal of CNP-103 is to help keep your diabetes from getting worse over time. In the future, this may mean you won’t need higher doses of insulin as you get older.

Many people in the study can continue their normal activities, including sports. The study doctor will talk with you and your parent or guardian about what is safe for you during the study.

The study team will work with you and your parents to schedule visits at times that are easiest for you.

Explore Patient and Caregiver Resources

Learn more about the CNP-103 Clinical Trial and managing life with diabetes with these resources. They can help you, your family, and your doctor understand the study and decide if participation might be right for you.

Study Brochure

Download the study brochure to learn more about the CNP-103 Clinical Trial.

Download

Breakthrough T1D

Find support and education for families living with T1D.

Visit website

Children’s Diabetes Foundation

Learn about programs and events for children with T1D in the Colorado area.

Visit website

Type 1 United

Learn about T1D programs and events in the Washington area.

Visit website