Type 1 Diabetes
Conditions
Keywords
type 1 diabetes among young children, sensor, insulin pump, education, psychological support
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.
Interventions
None listed
Sponsors
Slovenian Research Agency (ARRS)
University Medical Centre Ljubljana
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycaemic control | 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
| Measure | Time frame | Description |
|---|---|---|
| knowledge on diet and diabetes management | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | 3 months | — |
| Quality of Life measures | 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 |
Countries
Slovenia
Outcome results
None listed