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

Seattle Children's Healthcare System

Status and phase: Unknown; Phase 3

Conditions: Diabetes Mellitus, Type I

Treatments: Device: Real-time glucose sensor

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00875290

GerberPumpStudy

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 months to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Control

No Intervention group

Description:

Observational arm

Real-time glucose sensor

Experimental group

Description:

Subjects wear real-time glucose sensor

Treatment:

Device: Real-time glucose sensor