The Effectiveness of Continuous Glucose Monitoring in Dia... | NCT00875290

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

NCT00875290

Sponsor

Seattle Children's Hospital

Status

Unknown status

Last Update Posted

Aug 5, 2011Estimated

Enrollment

40Estimated

Phase

Phase 3

Conditions

Diabetes Mellitus, Type I

Interventions

Real-time glucose sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Nov 2014Estimated

Completion Date

Nov 2014Estimated

First Submitted Date

Apr 2, 2009

First Submission Date that Met QC Criteria

Apr 2, 2009

First Posted Date

Apr 3, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2011

Last Update Posted Date

Aug 5, 2011Estimated

Name	Class
The Gerber Foundation	OTHER
Medtronic	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	No Intervention	Observational arm
Real-time glucose sensor	Experimental	Subjects wear real-time glucose sensor	Device: Real-time glucose sensor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Real-time glucose sensor	Device	Children assigned to this intervention will use a real-time sensor continuously	Real-time glucose sensor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduce blood glucose variability among 0-3 year old children with type I diabetes.		1 year

Secondary Outcomes

Measure	Description	Time Frame
Number of adverse events		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Months

Maximum Age

3 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patricia Fechner, M.D.	Contact	206-987-5037		patricia.fechner@seattlechildrens.org
Joyce Yi-Frazier, Ph.D.	Contact	206-987-5037		joyce.yi-frazier@seattlechildrens.org

Overall Officials

Name	Affiliation	Role
Patricia Fechner, MD	Seattle Children's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seattle Children's Hospital	Recruiting	Seattle	Washington	98105	United States

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided