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

NCT02010541 | Unknown

• 1 other identifier: TECH-EDU-KIDS-T1D-2013
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes among young children, sensor, insulin pump, education, psychological support

Outcome Measures

Primary Outcomes (1)

• Glycaemic control

  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.

  3 months

Secondary Outcomes (1)

• knowledge on diet and diabetes management

  3 months

Other Outcomes (2)

• Number of adverse events

  3 months

• Quality of Life measures

  3 months

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• Slovenian Research Agency (ARRS): collaborator

Study Sites (1)

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

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tadej Battelino

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 13, 2014

Record last verified: 2014-02

Locations

SL (1)