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Glycemic Control and the Brain in Children With Type 1 Diabetes

NCT03428932 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-05-16

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Closed Loop (Medtronic 670G)

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

OTHER

Standard Care

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

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Washington University School of Medicine

    collaborator OTHER

  • Stanford University

    collaborator OTHER

  • University of Iowa

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Jaeb Center for Health Research

    collaborator OTHER

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Nelly Mauras, MD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-01
Primary Completion
2019-07-01
Completion
2019-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03428932 on ClinicalTrials.gov