Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03368586
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2017-11-24
Brief Title:
Accuracy Satisfaction and Usability of a FGM System Among Children and Adolescents Attending a Diabetes Summer Camp
Sponsor:
University of Lausanne Hospitals
Organization:
University of Lausanne Hospitals
Study Overview
Official Title:
Accuracy Satisfaction and Usability of a Flash Glucose Monitoring System Among Children and Adolescents Attending a Diabetes Camp
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 readers 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 40 mmolL or high 150 mmolL 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None