Study-related Medical Tests and Examinations
The following tests and examinations will occur at different times throughout the study:
Questions about you or your child’s medical history, current/previous medicines, lifestyle and any allergies.
Weight – your or your child’s weight is measured so that the dose of investigational medicine or placebo can be adjusted to suit your or your child’s body size.
Physical exam – both a partial and a full physical exam will be conducted. The partial physical exam involves an assessment of your or your child’s general appearance (head, eyes, ears and throat), an examination of your or your child’s neck, heart, lungs and abdomen, and an evaluation of your or your child’s arms, legs and skin. The complete physical exam includes all these with the addition of checking the appearance of the genitalia, and a neurologic examination.
Vital signs – the study team will check your or your child’s temperature, pulse, and breathing rate. They will also measure blood pressure using an inflatable cuff positioned around the arm.
Tuberculosis (TB) test – a test will be undertaken to see if you or your child has been infected with TB.
Glucose test – the study team will measure how much glucose is in your or your child’s blood. One way they can do this is to use a continuous glucose sensor, which is a device applied underneath the skin. They may also use a finger-prick test.
Blood tests – blood samples will be taken to check your or your child’s general health and the presence of certain chemicals (including the investigational medicine) in your or your child’s blood. If you or your child are able to have children your blood may also be used to test for pregnancy.
Urine tests – you or your child will be asked to provide a sample of urine so that the study team can use it to check your or your child’s general health and the presence of certain chemicals (including the investigational medicine) in the urine. If you or your child are able to have children your or your child’s urine may also be used to test for pregnancy.
Mixed Meal Tolerance Test (MMTT) – so that the study team can measure how much insulin your or your child’s body is producing in response to food, you will be asked to take a nutritional supplement drink (containing a balanced mixture of protein, carbohydrate, and fat).
Symptom assessments – the study team will ask questions and observe physical symptoms. You or your child will also be asked to compete questionnaires about daily activities (writing, eating, dressing) and overall quality of life.
Discussion of any side effects that may have been experienced and use of any other medications since the last visit. You will also be asked to complete questionnaires about how you or your child are feeling and how T1D has affected or is affecting your or your child’s life.