Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Diabetes Mellitus

Treatments: Device: Guardian RT

Study type: Interventional

Funder types: Other

Identifiers

NCT01016457

SHEBA-07-4980-KMA-CTIL

Details and patient eligibility

About

The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.

Enrollment: 15 estimated patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Duration of diabetes for more than 6 months
• Use of insulin pump for more than 3 months

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)