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

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ClinicalTrials.gov Identifier: NCT02010541
Recruitment Status : Unknown
Verified February 2014 by Tadej Battelino, University Medical Centre Ljubljana.
Recruitment status was:  Active, not recruiting
First Posted : December 12, 2013
Last Update Posted : February 13, 2014
Sponsor:
Collaborator:
Slovenian Research Agency (ARRS)
Information provided by (Responsible Party):
Tadej Battelino, 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.

Condition or disease
Type 1 Diabetes

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes
Study Start Date : December 2013
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Insulin

Group/Cohort
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).
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



Primary Outcome Measures :
  1. Glycaemic control [ Time Frame: 3 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 :
  1. knowledge on diet and diabetes management [ Time Frame: 3 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.


Other Outcome Measures:
  1. Number of adverse events [ Time Frame: 3 months ]
  2. Quality of Life measures [ Time Frame: 3 months ]
    CBCL 1 ½-5 or CBCL 6-18 questionnaire, PSI questionnaire, Experiences in Close Relationships- Relationship Structures questionnaire; we will assess if the psychological issue is an important factor in diabetes management



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children that have diabetes in Slovenia are controlled at the Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL and the population will be taken from here
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010541


Locations
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Slovenia
Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Slovenian Research Agency (ARRS)
Investigators
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Study Chair: Tadej Battelino Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

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Responsible Party: Tadej Battelino, Head, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02010541     History of Changes
Other Study ID Numbers: TECH-EDU-KIDS-T1D-2013
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: February 13, 2014
Last Verified: February 2014
Keywords provided by Tadej Battelino, University Medical Centre Ljubljana:
type 1 diabetes among young children, sensor, insulin pump, education, psychological support
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs