Glycemic Control and the Brain in Children With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Other: Standard Care; Device: Closed Loop (Medtronic 670G)

• Registration Number: NCT03428932
• Lead Sponsor: Nemours Children's Clinic

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-24
• Study Start: 2018-02-01
• Study First Submitted QC: 2018-02-08
• Study First Posted: 2018-02-12
• Status Verified: 2019-07
• Primary Completion: 2019-07-01
• Study Completion: 2019-07-01
• Disposition First Submitted: 2020-10-21
• Results First Submitted: 2023-03-09
• Results First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Results First Posted: 2023-05-16
• Disposition First Posted: 2023-05-16
• Last Update Posted: 2023-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	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.
Closed-Loop	Closed Loop (Medtronic 670G)	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.

Primary Outcome Measures

Name	Time	Method
Changes in Gray Matter Volume in the Brain	6 months	Trends in total and regional grey matter volume

Secondary Outcome Measures

Name	Time	Method
Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)	6 months	Blood Oxygen level diffusion (BOLD) Functional Magnetic Resonance Imaging (fMRI) was measured to assess functional activation occurring during "no-go" relative to "go" trials during a Go/No-Go cognitive task. Parameter estimates for an individual subject are obtained by modeling the subject's BOLD time series at each voxel against the expected BOLD response to a given task. Statistical weights (i.e., parameter estimates of activation strength) are determined based on how closely the observed and expected signals agree for each task condition to create parameter maps over the entire brain. Higher-level parameter estimates are generated via contrasts of the estimates from specific task conditions, which can lead to positive or negative values, depending on the relative activation of the conditions.
Changes in WASI-II Perceptual Reasoning Index (PRI)	6 months	The Wechsler Abbreviated Scale of Intelligence second edition (WASI-II) was used. The WASI-II is composed of four subtests: Block Design, Vocabulary, Matrix Reasoning, and Similarities. The WASI-II used in this study produces a Perceptual Reasoning Index (PRI) score from the Block Design and Matrix Reasoning subtests' age-corrected scaled scores. The index scores are derived from a summation of the comprising scaled scores. The PRI score range is: 50-150. Higher scores mean better outcomes. Change over time in the PRI score is reported in each group.

Trial Locations

Locations (5)

Yale University; 🇺🇸 New Haven, Connecticut, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Nemours Childrens Clinic; 🇺🇸 Jacksonville, Florida, United States

Washington University St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States