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

NCT ID: NCT02010541

Last Updated: 2014-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-05-31

Brief Summary

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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

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Conditions

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Type 1 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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insulin pump group

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).

No interventions assigned to this group

RT (real time) -CGMS group

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

No interventions assigned to this group

Eligibility Criteria

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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
Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Slovenian Research Agency (ARRS)

UNKNOWN

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Tadej Battelino

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tadej Battelino

Role: STUDY_CHAIR

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

Locations

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

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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TECH-EDU-KIDS-T1D-2013

Identifier Type: -

Identifier Source: org_study_id

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