The Effect of Frequent Continuous Glucose Monitoring Use on Glucose Variability in Preschoolers With Type 1 Diabetes

Completed

• Conditions: Continuous Glucose Monitoring; Children; Glucose Variability; Type 1 Diabetes

• Registration Number: NCT04558710
• Lead Sponsor: University of Ljubljana, Faculty of Medicine

Brief Summary

The purpose of this study is to determine whether continuous glucose monitoring will improve glucose variability as measured by the coefficient of variation of glucose levels in very young children with T1D. The study adopts an open-label, multi-centre, multinational, prospective registry-based population cohort design contrasting CGM use to SMBG alone in young children with type 1 diabetes over 12 months.

The primary endpoint is the difference between treatment modalities (CGM vs SMBG alone) in glycaemic variability, measured as the coefficient of variation of glucose levels, during the 12 months observational period. Other Key edpoints include time in range 70-180 mg/dl, time below range 70 mg/dl and time above range 180 mg/dl.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-09-30
• Study Completion: 2019-12-30
• Status Verified: 2020-09
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coefficient of variation	1 year

Secondary Outcome Measures

Name	Time	Method
Time in Range	1 year	Time in Range 70 - 180 mg/dl
Time Above Range	1 year	Time in Range above 180 mg/dl

Trial Locations

Locations (1)

Medical Faculty - University of Ljubljana; 🇸🇮 Ljubljana, Slovenia