Preschool CGM Use and Glucose Variability in Type 1 Diabetes

University of Ljubljana, Faculty of Medicine40 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

CGM ONDEVICE

The period of time when continuous glucose monitoring was used, in edition to SMBG

CGM OFFDEVICE

The period of time when continuous glucose monitoring was not used, only SMBG

Eligibility

Sex: ALLMax age: 7 Years

Medical Language ↔ Plain English

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

Locations (1)

UMC - University Children's Hospital Ljubljana

Ljubljana, Slovenia

Outcomes

Primary Outcomes

Glucose variability

Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose

Time frame: Three years

Secondary Outcomes

Mean intersticial glucose

Mean glucose as measured with CGM

Time frame: Three years

Mean blood glucose

Mean glucose as measured with SMBG

Time frame: Three years

HbA1c

glycosilated hemoglobin

Time frame: Three years

Data from ClinicalTrials.gov

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