The Effectiveness of Continuous Glucose Monitoring in Diabetes Treatment for Infants and Young Children
Phase 3
- Conditions
- Diabetes Mellitus, Type I
- Registration Number
- NCT00875290
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Reduce blood glucose variability among 0-3 year old children with type I diabetes. 1 year
- Secondary Outcome Measures
Name Time Method Number of adverse events 1 year
Trial Locations
- Locations (1)
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Seattle Children's Hospital🇺🇸Seattle, Washington, United States