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Completed

NCT Number: NCT03428932

Glycemic Control and the Brain in Children With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed Loop (Medtronic 670G)

Device

A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized

Standard care

Other

Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.

Primary outcomes

  1. Changes in Gray Matter Volume in the Brain

    Time frame: 6 months

    Trends in total and regional grey matter volume

Secondary outcomes

  1. Changes in Brain Activation (Dorsal Anterior Cingulate, Inferior Frontal Gyrus and/or Parietal Cortex)

    Time frame: 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.

  2. Changes in WASI-II Perceptual Reasoning Index (PRI)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Collaborators

  • Jaeb Center for Health Research
  • National Institutes of Health (NIH)
  • Stanford University
  • University of Iowa
  • Washington University School of Medicine
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 12, 2018
Registry last updated
May 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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