Diabetes Mellitus, Type I
Conditions
Keywords
Diabetes Mellitus, Type I, Children, Insulin pump therapy, Continuous glucose monitor
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.
Interventions
DEVICEReal-time glucose sensor
Children assigned to this intervention will use a real-time sensor continuously
Sponsors
The Gerber Foundation
Medtronic
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 3 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduce blood glucose variability among 0-3 year old children with type I diabetes. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events | 1 year |
Countries
United States
Contacts
Primary ContactPatricia Fechner, M.D.
Backup ContactJoyce Yi-Frazier, Ph.D.
Outcome results
None listed