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

Tracking Information
First Submitted Date ICMJE	April 2, 2009
First Posted Date ICMJE	April 3, 2009
Last Update Posted Date	August 5, 2011
Study Start Date ICMJE	November 2008
Estimated Primary Completion Date	November 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 2, 2009)	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; (submitted: April 2, 2009)	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; (submitted: April 2, 2009)	40
Original Estimated Enrollment ICMJE	Same as current
Estimated Study 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	No
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	No
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