The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children (Gerber RTSA)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2011 by Seattle Children's Hospital.
Recruitment status was: Recruiting

Sponsor:

ClinicalTrials.gov Identifier:

NCT00875290

First Posted: April 3, 2009

Last Update Posted: August 5, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

The Gerber Foundation

Medtronic

Information provided by:

Seattle Children's Hospital

Tracking Information

First Submitted Date ^ICMJE

April 2, 2009

First Posted Date ^ICMJE

April 3, 2009

Last Update Posted Date

August 5, 2011

Start Date ^ICMJE

November 2008

Estimated Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Reduce blood glucose variability among 0-3 year old children with type I diabetes. [ Time Frame: 1 year ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00875290 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Number of adverse events [ Time Frame: 1 year ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Gerber Pump Trial: Effectiveness of Continuous Subcutaneous Insulin Infusion (CSII) and Real-Time Sensor Augmentation (RTSA) in 0-3 Years Old Diabetes Patients; A One Year Randomized Controlled Clinical Trial.

Brief Summary

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes Mellitus, Type I

Intervention ^ICMJE

Device: Real-time glucose sensor

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

Other Name: Minimed Paradigm Real-time sensor

Study Arms

No Intervention: Control
Observational arm
Experimental: Real-time glucose sensor
Subjects wear real-time glucose sensor

Intervention: Device: Real-time glucose sensor

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Unknown status

Estimated Enrollment ^ICMJE

Estimated Completion Date

November 2014

Estimated Primary Completion Date

November 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

3 Months to 3 Years (Child)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00875290

Other Study ID Numbers ^ICMJE

GerberPumpStudy

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Patricia Fechner, M.D., Seattle Children's Hospital

Study Sponsor ^ICMJE

Seattle Children's Hospital

Collaborators ^ICMJE

The Gerber Foundation
Medtronic

Investigators ^ICMJE

Principal Investigator:

Patricia Fechner, MD

Seattle Children's Hospital

PRS Account

Seattle Children's Hospital

Verification Date

August 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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