The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes

This content originally appeared on Beyond Type 1. Republished with permission.

By Makaila Heifner

Let’s face it, there are a lot of research studies out there, and we mean… a lot. But one you should definitely know about is The protect learn about. Especially if you or a loved one was recently diagnosed with type 1 diabetes (T1D).

The PROTECT learn about aims to understand how the investigational medicine, teplizumab, works in children and young adults who have recently been diagnosed with T1D, as well as assessing if there are any side effects while taking the medication. This cure is still being evaluated in clinical studies and has not been approved by the FDA for treating T1D. In previous studies of high-risk individuals, teplizumab was shown to delay the onset of T1D an average of nearly 3 years (35 months).

Who Is Eligible for the learn about?

This learn about will include 300 children and adolescents in clinics across the United States, Canada, and Europe that meet the following criteria:

1. Age 8-17 years old
2. Diagnosed with T1D in the previous 6 weeks
3. Positive for 1 of 5 T1D autoantibodies (test to be done as part of the study) 4. Ability to produce a minimum amount of your own insulin (test to be done as part of the study)
4. Otherwise generally healthy, with no other significant medical conditions, recent or history of infections, or taking medicines that might interfere with teplizumab

If you meet all the criteria, the next step is to visit a learn about clinic, where the study team will:

• Discuss the study in more detail and explain what participation would mean for you or your youngster.
• Talk through the potential benefits and risks of being involved in the study.
• Ask questions and carry out medical tests to determine whether you or your little lad are right for the study and the study is right for you or your youngster.

If you and/or your child are interested in potentially participating in the PROTECT study, click here to find a study clinic near you.

Before the study begins, you/and your child must agree to and sign an Informed Consent Form which explains the study in detail, any potential risks or benefits of participation, as well as your rights and responsibilities as a participant of the study.

All study-related cure and care will be provided to eligible patients without charge; however, patients will not receive any compensation for their participation in the study. Patients who decide to participate are capable to withdraw from the study at any time for any reason.

Participants do not have to change their primary doctors as the study provides short-term study-related care only. Patients are encouraged to tell their regular doctors about taking part in a clinical research study. Some medicines are prohibited to take while part of the study so a patient’s physician may want to contact the study physician to request additional info.

How Does It Work?

If you/or your child are selected to be part of this study, you/your child will be positioned in one of two groups, either the teplizumab crew or the placebo group (meaning you/your child will receive no treatment). Deciding who will be placed in each group is chosen at random by a computerized system, and neither you/your child nor the study doctor will know which treatment group you/your child was placed in. This is done so that results from the different groups can be handled the same way.

Over the duration of the study, you/your child will receive 2 courses of study medicine given by intravenous (IV) infusion. The IV infusion usually lasts about 30 minutes and will be given daily over 12 days on 2 separate occasions, 6 months apart.

The study will endure just over a year and a half (the study reports the study will last up to 84 weeks) and require 36 study clinic visits, including the initial screening, treatment courses, and observation periods.

During visits to the study clinic, you/your child will be asked several questions and perform a series of study-related medical tests. These tests are done in order to understand how the treatment is affecting you/your child and how well the body is responding to the medication.

Identifiable information (for instance, name or address) will not be accessible to anyone who is not directly part of this study; additionally, The Sponsor (the company carrying out the study) will not have access to any personal information that is submitted through the study’s website.

Why?

The treatment works by interfering with the cells that destroy the insulin-producing beta cells in the pancreas. If the treatment successfully interferes with these cells (T cells) patients who are taking teplizumab may be able to continue producing their own insulin and reduce their need for insulin injections, have better control over their blood glucose, and experience fewer complications from T1D.

Visit theprotectstudy.com to learn more about PROTECT.

Diabetes Daily

The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes