Recruiting

Phase 3

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

Sponsor:

Seattle Children's Hospital

Code:

NCT00875290

Conditions

Diabetes Mellitus, Type I

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

Interventions

Real-time glucose sensor

Study Details

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.

Conditions

Diabetes Mellitus, Type I

Study ID

NCT00875290

Start date

Nov, 2008

Status verified date

Aug, 2011

Completion date

Nov, 2014

Anticipated

Primary completion date

Nov, 2014

Anticipated

Eligibility Criteria

Sex: All

Age: 0 - 3

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Control

Observational arm

experimental: Real-time glucose sensor

Subjects wear real-time glucose sensor

Interventions

Real-time glucose sensor

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Patricia Fechner, M.D.

206-987-5037 patricia.fechner@seattlechildrens.org

Joyce Yi-Frazier, Ph.D.

206-987-5037 joyce.yi-frazier@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Aug 5, 2011

Last verified

Aug, 2011

Keywords

Diabetes Mellitus, Type I
Children
Insulin pump therapy
Continuous glucose monitor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2011-08-05.