Glycemic Control and the Brain in Children With Type 1 Diabetes
Type 1 Diabetes Mellitus
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Insulin pump, Closed loop, Brain development, Pediatric, Type 1 Diabetes, MRI, Cognitive development
Eligibility Criteria
Inclusion Criteria:
- Be at least 14 and not yet 18 years old
- Must have been diagnosed with T1D prior to 5 years old but after 6 months
- For those diagnosed prior to 1 year of age, a positive blood test for an antibody marker will be required
- Have been born term or near term (≥34 weeks) and weighed more than≥ 2 kg (4.4lbs) at birth
- Be in puberty
Exclusion Criteria:
- History of intellectual disability, language or learning disability identified before diagnosis of diabetes, or enrollment in a self-contained special education program
- ADD/ADHD and/or on stimulant medication
- Any known genetic or medical problem that could impair brain development
- Abnormalities of the brain/nervous system, visual or hearing problem
- History of seizures not associated with fever before diabetes diagnosis
- Previous inpatient psychiatric treatment
- Unable to have a MRI of the head due to having metal: including metal ear tubes, full set of braces in mouth (retainer is acceptable), other appliances, or vascular clip
Sites / Locations
- Stanford University
- Yale University
- Nemours Childrens Clinic
- University of Iowa
- Washington University St. Louis
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Standard Care
Closed-Loop
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.
Subjects will transition from their current treatment (insulin pump or injections) onto the Medtronic 670G insulin pump (intervention arm as a comparator) and will have close contact with the study team. Neurocognitive testing and brain MRI/fMRI will be done at enrollment and 6 months.