Glycemic Control and the Brain in Children With Type 1 Diabetes

Nemours Children's Health

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: Closed Loop (Medtronic 670G); Other: Standard Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03428932

00000766

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 14 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Standard Care

Active Comparator group

Description:

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.

Treatment:

Other: Standard Care

Closed-Loop

Active Comparator group

Description:

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.

Treatment:

Device: Closed Loop (Medtronic 670G)