ICON Early Phase Services is conducting a research study for adults ages 18-45 with Type 1 diabetes. This study is being done to advance the understanding of Type 1 diabetes.
Vital signs, physical examinations, blood glucose level and pregnancy tests will be performed. Blood samples will be obtained during this study.
Participants will complete up to 4 visits:
- Visit 1, which includes study screening
- Visit 2
- Visit 3
- Visit 4 end of study
To determine if you fully qualify, it will be necessary to obtain blood. For more information, see below.
If you are able to answer “YES” to the following statements, you may qualify for this study.
- I am a healthy adult, meaning no significant medical conditions
- I am between 18 and 45 (inclusive) years old
- I weigh at least 110 lbs.
- I am a Type 1 diabetic and I was diagnosed before the age of 30
- I agree not to smoke while at the clinic and to abide by the rules of the clinic, which is a non-smoking facility
- If Female, I am not pregnant or breastfeeding
- If Female and capable of becoming pregnant, you are eligible to participate if you are taking oral contraceptives or using other forms of birth control
- If Female, you are eligible to participate if you are taking hormone replacement therapy for menopausal symptoms and prevention of osteoporosis
- If Female, you are eligible to participate if precancerous conditions of the uterine cervix has been treated successfully
- I am able to communicate effectively in English with the study personnel
- I do not have any uncontrolled medical conditions
- I have not donated a unit of blood within the previous 2 months
- I do not have any heart condition or disease that has not been medically evaluated, or had symptoms within the last 6 months, or experienced a change in heart condition that resulted in changing medications within the last 6 months
- I do not have any condition or therapy resulting in impaired blood clotting and bleeding, for example hemophilia
- I do not have a fever or an active infection and I am not taking any antibiotics
- I do not have a history of bleeding problems
- I have not had a blood transfusion within the past 12 months
- I have not had cancer or cancer treatments within the past 12 months. You are not eligible to donate if you have had leukemia, lymphoma, Hodgkin’s Disease or other cancers of the blood. (NOTE: Eligibility depends on the type of cancer and treatment history.)
- I am not at risk for Creutzfeldt-Jacob disease due to having received a brain covering graft or human pituitary growth hormone injections
- I do not have a blood relative who had Creutzfeldt-Jakob disease
- I have not recently had oral surgery
- I have not had Ebola virus infection or disease
- I have not had syphilis or gonorrhea in the last 12 months
- I do not have sickle cell disease
- I have not had any heart disease symptoms (e.g., chest pain) in the last 6 months and I do not have any limitations or restrictions on daily activities
- I do not have hemochromatosis (hereditary)
- I do not have hepatitis or jaundice
- I do not have active tuberculosis and I am not being treated for active tuberculosis
- I have not been exposed to the Zika virus
- I have recently had a vaccination for influenza, tetanus or meningitis. You are eligible providing you are symptom-free and fever-free. This includes the Tdap vaccine or the HPV Vaccine (example, Gardasil).
- I have not been exposed to malaria recently
- You are eligible if you have been taking over-the-counter oral homeopathic medications, herbal remedies, aspirin or nutritional supplements. (NOTE: Certain drugs are exclusionary.)
- I have not had a recent history of alcoholism or drug/chemical abuse
- I have not had cancer within the past 5 years (except for skin cancer or cancer in situ)
It is important to understand that even if you feel that you meet all the above criteria, you are still required to complete the protocol screening procedures. Scheduling a screening appointment does not guarantee that you will qualify for that study. Additionally, subjects are screened on a first come-first served basis and studies may complete enrollment prior to your visit. Additionally, no guarantees can be made regarding group assignments for any particular study. ICON will not assume any liability for lost time, travel or failure to qualify.
Be sure to bring all of your medications with you to your screening appointment.
Please note, you need to bring a valid, non-expired photo ID with you when you attend your screening visit. We accept a government issued identification card such as a driver's license, state issued ID card, or passport. Also, be advised that we cannot accept a military ID as we are legally prohibited from copying that form of identification for our records. You will be required to show this same photo ID at all study visits.
You will be filling out paperwork for the study. Please arrive at least 30 minutes in advance of your screening appointment. If you are late for your appointment you may not be seen or may need to reschedule.