Glycemic Control and the Brain in Children With Type 1 Diabetes

April 21, 2023 updated by: Nemours Children's Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94305
        • Stanford University
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Childrens Clinic
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa
    • Missouri
      • Saint Louis, Missouri, United States, 63126
        • Washington University St. Louis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Standard Care
Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
Active Comparator: Closed-Loop
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.
Device: Closed Loop (Medtronic 670G)
A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Gray Matter Volume in the Brain
Time Frame: 6 months
Trends in total and regional grey matter volume
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nemours Children's Clinic

Collaborators

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

Investigators

  • Principal Investigator: Nelly Mauras, MD, Nemours Children's Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

July 1, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 12, 2018

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000766

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with the NIH data sharing policy, a de-identified database will be placed in the public domain after the completion of the study. This will be timed if possible with publication of the manuscripts that will result from these studies. In addition, formal requests for data will be accepted and reviewed by the DirecNet Steering Committee. If the request is approved, the Data Coordinating Centers will provide the data in a format mutually agreeable to the requesting party.

IPD Sharing Time Frame

After completion of the study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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