Glycemic Control and the Brain in Children With Type 1 Diabetes

Status:	Recruiting
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	14 - 17
Updated:	2/14/2018
Start Date:	February 1, 2018
End Date:	June 1, 2019
Contact:	Nelly Mauras, MD
Email:	nmauras@nemours.org
Phone:	904-697-3674

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 use either the patient's own insulin routine (injections or insulin pumps) or a
closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor
(CGM) and an insulin pump to automatically give insulin and may improve control of blood
sugars.

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

We found this trial at

sites

Nemours Children's Clinic

807 Childrens Way
Jacksonville, Florida 32207

(904) 697-3600