to study search History No further version available for comparison

Flash Glucose Measurements in Children with Type 1 Diabetes – Accuracy, Bias and Clinical Impact of Measurement Errors.

Organizational Data

DRKS-ID:
DRKS00011751
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2017-02-23
Last update in DRKS:
2017-02-23
Registration type:
Retrospective

Acronym/abbreviation of the study

Flash Glucose Measurements - ABC study

URL of the study

No Entry

Brief summary in lay language

FreeStyle Libre is a device for Flash Glucose Monitoring, a system that measures glycaemia in the intestitial fluid and can one day replace manual tests from capillary blood. The sensor is placed in the subcutaneous tissue and changed by patients every 14 days. To obtain the glucose level, patient needs to scan the sensor with a dedicated reading device. System has only recently entered the European market and its reliability “in the field” needs to be grounded in non-laboratory studies. The purpose of this study was to test the accuracy of FreeStyle Libre in real-life conditions and its reception by children with type 1 diabetes during a summer camp. We evaluated the accuracy of the system and tried to elucidate factors that affect it. We determined how much this accuracy iinfluenced children`s clinical decisions. Finally, we described participants` attitude toward the device.

Brief summary in scientific language

The aim of this study was to test the accuracy of FreeStyle Libre, a device for Flash Glucose Monitoring, in pediatric patients with type 1 diabetes during summer camp conditions. The accuracy of the device was measured in reference to manual blood glucose measurements performed simultaneously with glucometer and described as mean absolute relative difference (MARD). The clinical accuracy of the device was be analyzed with appropriate error grids. Children`s reception of the system was evaluated using questionnaires.

Health condition or problem studied

ICD10:
E10 - Type 1 diabetes mellitus
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 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.

Endpoints

Primary outcome:
FreeStyle Libre accuracy measured as mean absolute relative difference and % of readings described as "clinically accurate" according to error grids.
Secondary outcome:
children`s opinions after using the device - assessed with "FreeStyle Libre Satisfaction questionnaire" - custom questionnaire

Study Design

Purpose:
Other
Allocation:
N/A (single arm study)
Control:
  • Uncontrolled/single arm
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Single (group)
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Poland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz, Lodz, Poland Łódź

Recruitment period and number of participants

Planned study start date:
No Entry
Actual study start date:
2016-07-24
Planned study completion date:
No Entry
Actual Study Completion Date:
2016-08-08
Target Sample Size:
80
Final Sample Size:
79

Inclusion Criteria

Sex:
All
Minimum Age:
7 Years
Maximum Age:
18 Years
Additional 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

Addresses

Primary Sponsor

Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Sporna 36/50
91-738 Łódź
Poland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Associate Professor Agnieszka Szadkowska
Sporna 36/50
91-738 Łódź
Poland
Telephone:
607145644
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Associate Professor Agnieszka Szadkowska
Sporna 36/50
91-738 Łódź
Poland
Telephone:
607145644
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Associate Professor Agnieszka Szadkowska
Sporna 36/50
91-738 Łódź
Poland
Telephone:
607145644
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Department of Pediatrics, Oncology, Hematology and Diabetology, Medical University of Lodz
Sporna 36/50
91-738 Łódź
Poland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Bioethical Committee of Medical University of Lodz
Żeligowskiego 5/9
90-752 Łódź
Poland
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://bip.umed.pl/SitePages/DevHome.aspx#Komisja_Bioetyki_ds__Bada%C5%84_na_Ludziach

Vote of leading Ethics Committee

Date of ethics committee application:
2016-07-04
Ethics committee number:
RNN/223/16/KE
Vote of the Ethics Committee:
Approved
Date of the vote:
2016-07-12

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
Study protocol
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry