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

U

University Medical Centre Ljubljana

Status

Unknown

Conditions

Type 1 Diabetes

Study type

Observational

Funder types

Other

Identifiers

NCT02010541
TECH-EDU-KIDS-T1D-2013

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

Under 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

insulin pump group
Description:
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).
RT (real time) -CGMS group
Description:
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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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