Comparison of CGM in Non-randomised Real Life Study of Real-time and Intermittently Scanned Systems in Patients With Type 1 Diabetes

Charles University, Czech Republic1 site in 1 country187 target enrollmentJune 1, 2019

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Charles University, Czech Republic
Enrollment: 187
Locations: 1
Primary Endpoint: Changes in glycated haemoglobin (HbA1c)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up.

Registry

clinicaltrials.gov

Start Date

June 1, 2019

End Date

September 30, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Charles University, Czech Republic

Responsible Party

Principal Investigator

Jan Soupal, MD

Principal Investigator

Charles University, Czech Republic

Eligibility Criteria

Inclusion Criteria

•patients with T1D naive to rt-CGM and FGM
•Type 1 diabetes for \> 1 year
•≥ 18 years old
•CSII without automatic functions or MDI

Exclusion Criteria

•previous rtCGM or FGM use
•treatment with insulin pump with automatic functions
•severe noncompliance
•known severe diabetic retinopathy and/or macular edema
•lactation, pregnancy, or intending to become pregnant during the study
•a condition likely to require MRI
•use of acetaminophen-containing medication
•unwillingness to use the study device for \>70% of time

Outcomes

Primary Outcomes

Changes in glycated haemoglobin (HbA1c)

Time Frame: Up to 13 months

Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.

Secondary Outcomes

Percentage of time in hyperglycemic ranges(Up to 13 months)
Percentage of time in hypoglycemic ranges(Up to 13 months)
Changes in glycemic variability(Up to 13 months)
Incidence of severe ketoacidosis(Up to 13 months)
Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor(Up to 13 months)
Mean sensor glucose concentration(Up to 13 months)
Incidence of severe hypoglycaemia(Up to 13 months)
Percentage of time in target ranges(Up to 13 months)