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

Type 1 Diabetes Clinical Trial

Official title:

The Influence of Diabetes Related Technology, Education and Psychological Support on Metabolic Control in Young Children With Type 1 Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02010541
• Other study ID #: TECH-EDU-KIDS-T1D-2013
• Status: Active, not recruiting
• Phase: N/A
• First received: December 9, 2013
• Last updated: February 12, 2014
• Start date: December 2013
• Est. completion date: May 2014

Study information

• Verified date: February 2014
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Locations

Country	Name	City	State
Slovenia	Dept. of Pediatric Endocrinology, Diabetes & Metabolism, University Children's Hospital, UMCL	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana	Slovenian Research Agency (ARRS)

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of adverse events		3 months	No
Other	Quality of Life measures	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	3 months	No
Primary	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	No
Secondary	knowledge on diet and diabetes management	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.	3 months	No