Preschool CGM Use and Glucose Variability in Type 1 Diabetes

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT03293082
• Lead Sponsor: University of Ljubljana, Faculty of Medicine

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-09
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-26
• Study Start: 2017-09-30
• Primary Completion: 2017-09-30
• Study Completion: 2017-09-30
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose variability	Three years	Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

UMC - University Children's Hospital Ljubljana; 🇸🇮 Ljubljana, Slovenia