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Accuracy, Satisfaction and Usability of a FGM System Among Children and Adolescents Attending a Diabetes Summer Camp

Type 1 Diabetes Mellitus Clinical Trial

Official title:
Accuracy, Satisfaction and Usability of a Flash Glucose Monitoring System Among Children and Adolescents Attending a Diabetes Camp

Clinical Trial Summary

The aim of this study was to assess accuracy, satisfaction and usability of the FGM among children and adolescents with T1DM. The primary outcome was to assess the accuracy of the FGM system. Secondary outcomes included satisfaction and usability of the device as well as assessment of sensor-related issues.

Clinical Trial Description

The aim of this study was to assess the accuracy, satisfaction and usability of a Flash Glucose Monitoring system (FGM) in children and adolescents with type 1 diabetes mellitus (T1DM) and attending a 1-week diabetes summer camp, supervised by a multidisciplinary team of health care providers. The camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG) values were measured in parallel with unmasked Flash Glucose measurements (FGM) using the FGM reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were taken before snacks, between the meals or overnight and BG was measured only in cases of low (<4.0 mmol/L) or high (>15.0 mmol/L) FGM values or when symptoms were discordant with sensor readings. Sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the FGM was completed by patients and caregivers at study completion. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03368586
Study type Observational
Source University of Lausanne Hospitals
Contact
Status Completed
Phase N/A
Start date July 2, 2016
Completion date July 30, 2017
View Details
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