Preschool CGM Use and Glucose Variability in Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effect of Continuous Glucose Monitoring Use on Glucose Variability in Preschool Children With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293082
• Other study ID #: CGM-GV-Preschool- SI-01
• Status: Completed
• Phase: N/A
• First received: September 21, 2017
• Last updated: October 2, 2017
• Start date: September 30, 2017
• Est. completion date: September 30, 2017

Study information

• Verified date: September 2017
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2017
• Est. primary completion date: September 30, 2017
• Gender: All
• Age group: N/A to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• CGM ON
The period of time when continuous glucose monitoring was used, in edition to SMBG
• CGM OFF
The period of time when continuous glucose monitoring was not used, only SMBG

Locations

Country	Name	City	State
Slovenia	UMC - University Children's Hospital Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose variability	Glucose variability as SD and CV of glucose levels measured with CGM and blood glucose	Three years
Secondary	Mean intersticial glucose	Mean glucose as measured with CGM	Three years
Secondary	Mean blood glucose	Mean glucose as measured with SMBG	Three years
Secondary	HbA1c	glycosilated hemoglobin	Three years