CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 46 enrolled
Drug / intervention
Closed Loop (Medtronic 670G) +1 moredevice
Likely dose
Closed Loop (Medtronic 670G)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03428932
NCT03428932N/ACompleted
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Glycemic Control and the Brain in Children With Type 1 Diabetes

Nemours Children's Clinic·interventional·Posted Feb 12, 2018·Updated May 16, 2023

In Brief

A clinical study evaluating Closed Loop (Medtronic 670G) and Standard Care for Type 1 Diabetes Mellitus. Completed, enrolled 46 participants across 5 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), Washington University School of Medicine, Stanford University, University of Iowa, Yale University, Jaeb Center for Health Research

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 12, 2018
Enrollment StartFeb 1, 2018
Primary CompletionJul 1, 2019
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 8.4 years ago

Interventions

Closed Loop (Medtronic 670G)device

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

Standard Careother

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