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

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. Identifier: NCT00875290
Recruitment Status : Unknown
Verified August 2011 by Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : April 3, 2009
Last Update Posted : August 5, 2011
The Gerber Foundation
Information provided by:
Seattle Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type I Device: Real-time glucose sensor Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : November 2008
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
No Intervention: Control
Observational arm
Experimental: Real-time glucose sensor
Subjects wear real-time glucose sensor
Device: Real-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously
Other Name: Minimed Paradigm Real-time sensor

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

Secondary Outcome Measures :
  1. Number of adverse events [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00875290

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Contact: Patricia Fechner, M.D. 206-987-5037
Contact: Joyce Yi-Frazier, Ph.D. 206-987-5037

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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
The Gerber Foundation
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Principal Investigator: Patricia Fechner, MD Seattle Children's Hospital

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Responsible Party: Patricia Fechner, M.D., Seattle Children's Hospital Identifier: NCT00875290     History of Changes
Other Study ID Numbers: GerberPumpStudy
First Posted: April 3, 2009    Key Record Dates
Last Update Posted: August 5, 2011
Last Verified: August 2011
Keywords provided by Seattle Children's Hospital:
Diabetes Mellitus, Type I
Insulin pump therapy
Continuous glucose monitor
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs