Status:
COMPLETED
Glycemic Control and the Brain in Children With Type 1 Diabetes
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
Washington University School of Medicine
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
14-17 years
Phase:
NA
Brief Summary
The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03428932
Start Date
February 1 2018
End Date
July 1 2019
Last Update
May 16 2023
Active Locations (5)
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1
Stanford University
Palo Alto, California, United States, 94305
2
Yale University
New Haven, Connecticut, United States, 06511
3
Nemours Childrens Clinic
Jacksonville, Florida, United States, 32207
4
University of Iowa
Iowa City, Iowa, United States, 52242