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The Influence of Technology, Education and Psychological Support on Metabolic Control in Children With T1D

Conditions
Type 1 Diabetes
Registration Number
NCT02010541
Lead Sponsor
University Medical Centre Ljubljana
Brief 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glycaemic control3 months

We will determine HbA1c, average blood glucose, number of blood glucose readings/use of sensors, average AUC for sensor users, readings above and under target for both groups at the beginning and afer 3 months.

Secondary Outcome Measures
NameTimeMethod
knowledge on diet and diabetes management3 months

Questionnaire on diet, questionnaire on diabetes management; we will assess the knowledge on diet in T1D and diabetes management in both groups at the beginning, we will give support wherever needed and check after 3 months if it had an influence on metabolic control.

Trial Locations

Locations (1)

Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

🇸🇮

Ljubljana, Slovenia

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