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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: German Clinical Trials Register
Last refreshed on: 4 March 2024
Main ID:  DRKS00011751
Date of registration: 23/02/2017
Prospective Registration: No
Primary sponsor: Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Public title: Flash Glucose Measurements in Children with Type 1 Diabetes – Accuracy, Bias and Clinical Impact of Measurement Errors.
Scientific title: Flash Glucose Measurements in Children with Type 1 Diabetes – Accuracy, Bias and Clinical Impact of Measurement Errors. - Flash Glucose Measurements - ABC study
Date of first enrolment: 24/07/2016
Target sample size: 80
Recruitment status: Complete
URL:  http://drks.de/search/en/trial/DRKS00011751
Study type:  interventional
Study design:  Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other  
Phase:  N/A
Countries of recruitment
Poland
Contacts
Name: Agnieszka    Szadkowska
Address:  Sporna 36/50 91-738 Lódz Poland
Telephone: 607145644
Email: agnieszka.szadkowska@wp.pl
Affiliation:  Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Name: Agnieszka    Szadkowska
Address:  Sporna 36/50 91-738 Lódz Poland
Telephone: 607145644
Email: agnieszka.szadkowska@wp.pl
Affiliation:  Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Key inclusion & exclusion criteria
Inclusion criteria: - patients diagnosed with type 1 diabetes mellitus
- participants of the annual summer camp for children with diabetes organized by the Department
- a signed consent of a parent for child`s enrollment in the study
- a signed consent of underage participant (16 to 18 years old)

Exclusion criteria: - lack of child`s consent to use the device

Age minimum: 7 Years
Age maximum: 18 Years
Gender: All
Health Condition(s) or Problem(s) studied

E10
Type 1 diabetes mellitus
Intervention(s)
Group 1: Patients were eqiupped with FreeStyle Libre Sensors on the first day of the study and underwent supervised glycemic testing (on days 3rd, 7th and 11th of the study), using simultaneously FreeStyle Libre reading device and glucometer.
Primary Outcome(s)
FreeStyle Libre accuracy measured as mean absolute relative difference and % of readings described as "clinically accurate" according to error grids.
Secondary Outcome(s)
children`s opinions after using the device - assessed with "FreeStyle Libre Satisfaction questionnaire" - custom questionnaire
Secondary ID(s)
Source(s) of Monetary Support
Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 12/07/2016
Contact:
Bioethical Committee of Medical University of Lodz
Results
Results available:
Date Posted:
Date Completed: 08/08/2016
URL: http://drks.de/search/en/trial/DRKS00011751#studyResults
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