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Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

NCT00760526 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2016-10-19

Study results available
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Summary

The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DEVICE

Continuous glucose monitor

Daily use of a continuous glucose monitor

DEVICE

Home blood glucose monitor

Home monitoring 3 or more times a day

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Roy W Beck, MD, PhD · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-06-30
Completion
2012-01-31

Countries

  • United States

Study Locations

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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 NCT00760526 on ClinicalTrials.gov