The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children

NCT ID: NCT00875290

Last Updated: 2011-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-11-30

Brief Summary

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The purpose of this study is to see if the use of a real-time glucose sensor improves diabetes control in young children (less than 4 years old) with Type I diabetes when they are initiated on insulin pump therapy.

Detailed Description

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A randomized controlled clinical trial involving patients 0-3 yrs old with type 1 diabetes. After successful screening the subjects will be randomized into one of two groups: a CSII group alone and a CSII group + Real Time Sensor Augmentation group (RTSA) group. The CSII group will serve as the control for the CSII+RTSA group. The trial will last for one year.

Conditions

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Diabetes Mellitus, Type I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Observational arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Real-time glucose sensor

Subjects wear real-time glucose sensor

Group Type EXPERIMENTAL

Real-time glucose sensor

Intervention Type DEVICE

Children assigned to this intervention will use a real-time sensor continuously

Interventions

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Real-time glucose sensor

Children assigned to this intervention will use a real-time sensor continuously

Intervention Type DEVICE

Other Intervention Names

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Minimed Paradigm Real-time sensor

Eligibility Criteria

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Inclusion Criteria

* Children less than 4 years of age with Type I diabetes for at least 3 months

Exclusion Criteria

* Children greater than 4 years of age
* Monogenic diabetes
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seattle Children's Hospital

Principal Investigators

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Patricia Fechner, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Patricia Fechner, M.D.

Role: CONTACT

206-987-5037

Joyce Yi-Frazier, Ph.D.

Role: CONTACT

206-987-5037

Other Identifiers

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GerberPumpStudy

Identifier Type: -

Identifier Source: org_study_id

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