Preschool CGM Use and Glucose Variability in Type 1 Diabetes

University of Ljubljana, Faculty of Medicine

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: CGM OFF; Device: CGM ON

Study type: Observational

Funder types: Other

Identifiers

NCT03293082

CGM-GV-Preschool- SI-01

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: All

Ages: Under 7 years old

Volunteers: No Healthy Volunteers

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