Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Sponsor University Medical Centre Ljubljana
Collaborator Slovenian Research Agency (ARRS)
Start date December 2013
End date April 2014
Trial size 40 participants
Trial identifier NCT02010541, TECH-EDU-KIDS-T1D-2013

Summary

The first purpose of this study is to is to compare metabolic control of type 1 diabetes among children under the age of 7 years who use an insulin pump and a real-time (RT) glucose sensor, and children who use only insulin pump; the investigators will also determine dietary habits, their knowledge of type 1 diabetes management and emotional aspects of experiencing illness in the family, in both groups of children.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
20 children below the age of 7 years who use an insulin pump for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin).
20 children below the age of 7 years who use an insulin pump and RT-CGMS on regular basis for at least 6 months, more than 6 months of duration of type 1 diabetes, complete remission, no associated disease (normal blood pressure for age, only therapy insulin). pump for at least 6 months, and children below the age of 7 years who use RT-CGMS on regular

Primary Outcomes

Measure
Glycaemic control
time frame: 3 months

Secondary Outcomes

Measure
knowledge on diet and diabetes management
time frame: 3 months

Eligibility Criteria

Male or female participants up to 7 years old.

Inclusion Criteria: - age up to 7 years - insulin pump for at least 6 months - more than 6 months of duration of type 1 diabetes - complete remission - normal blood pressure for age, only therapy insulin. Exclusion Criteria: - age over 8 years - type 1 diabetes less than 6 months - insulin pump less than 6 months - still in remission - associated diseases on drug therapy, high blood pressure

Additional Information

Official title The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by University Medical Centre Ljubljana.