Glycemic Control and the Brain in Children With Type 1 Diabetes

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03428932

Run by

Nemours Children's Clinic

People needed

46

Starts

2018-02-01

Expected to finish

2019-07-01

Last updated by the study team

2023-05-16

Who can join

Age: 14 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stanford University — Palo Alto, California, United States
• Yale University — New Haven, Connecticut, United States
• Nemours Childrens Clinic — Jacksonville, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Washington University St. Louis — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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