Main
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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:
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German Clinical Trials Register |
Last refreshed on:
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4 March 2024 |
Main ID: |
DRKS00011751 |
Date of registration:
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23/02/2017 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Flash Glucose Measurements in Children with Type 1 Diabetes – Accuracy, Bias and Clinical Impact of Measurement Errors.
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Scientific title:
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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:
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24/07/2016 |
Target sample size:
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80 |
Recruitment status: |
Complete |
URL:
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http://drks.de/search/en/trial/DRKS00011751 |
Study type:
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interventional |
Study design:
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Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: other
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Phase:
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N/A
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Countries of recruitment
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Poland
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Contacts
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Name:
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Agnieszka
Szadkowska |
Address:
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Sporna 36/50
91-738
Lódz
Poland |
Telephone:
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607145644 |
Email:
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agnieszka.szadkowska@wp.pl |
Affiliation:
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Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz |
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Name:
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Agnieszka
Szadkowska |
Address:
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Sporna 36/50
91-738
Lódz
Poland |
Telephone:
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607145644 |
Email:
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agnieszka.szadkowska@wp.pl |
Affiliation:
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Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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E10
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Type 1 diabetes mellitus
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Intervention(s)
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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.
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Primary Outcome(s)
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FreeStyle Libre accuracy measured as mean absolute relative difference and % of readings described as "clinically accurate" according to error grids.
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Secondary Outcome(s)
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children`s opinions after using the device - assessed with "FreeStyle Libre Satisfaction questionnaire" - custom questionnaire
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Source(s) of Monetary Support
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Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
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Ethics review
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Status: Approved
Approval date: 12/07/2016
Contact:
Bioethical Committee of Medical University of Lodz
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