1 What is Type 1 diabetes?
By 2050, it is expected that 5 million people in the United States will have type 1 diabetes (T1D), of which 600,000 will be under 20 years old. In T1D, your body is unable to create enough insulin. Insulin is a hormone (a type of protein) that regulates the levels of glucose (or sugar) circulating in your blood. When you eat a meal, your blood sugar levels rise. Insulin is then released by the pancreas to return blood sugar levels to normal. However, in T1D, your body is unable to produce enough insulin to maintain your blood sugar at a healthy level. If your blood sugar is not controlled, it can cause a number of unwanted effects over time. Symptoms of T1D may include: unquenchable thirst, frequent urination, weight loss, lack of energy, blurry vision, stomach pain, nausea or vomiting.
2 How does the investigational medicine work?
The investigational medicine, teplizumab, is a protein designed to regulate the immune response (the body’s defense against infection/disease) and protect the body from damage caused by T1D.
3 Will I experience any unwanted effects from the investigational medicine?
All medicines, whether approved or investigational, may cause unwanted effects. The potential and known side effects of the investigational medicine are listed in the Informed Consent Form. If you or your child experience any discomfort during the study, you or your child can contact the study doctor at any time to discuss the best course of action. Throughout the study, you or your child’s health will be monitored continuously. You or your child’s participation in the study will be stopped if you, your child, or the study doctor have any concerns.
4 What if I want to leave the study early?
It is voluntary to join the study and you or your child can leave the study at any time and for any reason; this decision will not affect any future medical care that you or your child may receive. You or your child may also be removed from the study if the study doctor decides that continuing is not in your or your child’s best interest. If a decision to leave is made, you or your child will be asked to return to the study clinic to undergo final tests and assessments.
5 Do I need to ask my regular doctor before participating in this study?
We encourage you or your child to inform your regular doctor that you or your child are taking part in a clinical research study. There are some medicines that are prohibited to take while on the study and your or your child’s doctor may wish to contact the study team (with your permission) to request additional information.
6 Will I have to switch doctors?
No. The PROTECT Study will provide short-term study-related care only. Clinical research studies do not provide extended or comprehensive primary health care. At the end of the study, you or your child’s care will return, in full, to your or your child’s regular doctor.
7 Will I be compensated for my participation in this study?
You or your child will not receive payment for taking part in this study. However, the study medicine and all study-related care will be provided without charge. Expenses associated with taking part in this study, for instance travel to or from the study clinic, may be reimbursed. Please refer to the Informed Consent Form for further details.
8 Who will have access to the information collected during the study?
You or your child’s personally identifiable information (PII), e.g. name and address, will not be accessible to anyone who is not directly associated with this study, except with your permission or as required by law. The Sponsor (the company carrying out the study) will not have access to any PII submitted through this website. Any information gained from this study may be used for publishing results. However, this information will be combined with other participant data and will not be used to identify participants.