NCT03293082
Completed
Not Applicable
The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes
University of Ljubljana, Faculty of Medicine1 site in 1 country40 target enrollmentSeptember 30, 2017
ConditionsType 1 Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- University of Ljubljana, Faculty of Medicine
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Glucose variability
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject with Type 1 diabetes (\> 6 months since diagnosis)
- •Insulin infusion pump CSII therapy for at least 3 months
- •Age ≤ 7 years
- •HbA1c at inclusion ≥ 6.5 and \< 10
- •BMI SDS - below the 95th percentile for age
Exclusion Criteria
- •Concomitant diseases that influence metabolic control
- •Participation in any other interventional study
- •Known or suspected allergy to trial products
Outcomes
Primary Outcomes
Glucose variability
Time Frame: Three years
Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose
Secondary Outcomes
- Mean intersticial glucose(Three years)
- Mean blood glucose(Three years)
- HbA1c(Three years)
Study Sites (1)
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