Type 1 Diabetes Mellitus
Conditions
Brief summary
The objectives of this clinical study is to evaluate the efficacy continuous glucose monitoring (CGM) use on glucose variability (GV) in preschool children with T1D treated with CSII. Downloads from CGM and CSII saved in pdf from will be retrospectively reviewed and analysed for all preschool children with type 1 diabetes in Slovenia. Glucose variability and other glycemic parameters will be analyzed separately for periods when CGM was used (CGM and SMBG data) and compared to periods when CGM was not used (SMBG only data).
Interventions
DEVICECGM ON
The period of time when continuous glucose monitoring was used, in edition to SMBG
DEVICECGM OFF
The period of time when continuous glucose monitoring was not used, only SMBG
Sponsors
University of Ljubljana, Faculty of Medicine
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Years
Inclusion criteria
1. Subject with Type 1 diabetes (> 6 months since diagnosis) 2. Insulin infusion pump CSII therapy for at least 3 months 3. Age ≤ 7 years 4. HbA1c at inclusion ≥ 6.5 and \< 10 5. BMI SDS - below the 95th percentile for age
Exclusion criteria
1. Concomitant diseases that influence metabolic control 2. Participation in any other interventional study 3. Known or suspected allergy to trial products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose variability | Three years | Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean intersticial glucose | Three years | Mean glucose as measured with CGM |
| Mean blood glucose | Three years | Mean glucose as measured with SMBG |
| HbA1c | Three years | glycosilated hemoglobin |
Countries
Slovenia
Outcome results
None listed