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.

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.

Inclusion Criteria:

• Type 1 diabetes mellitus, children and adolescents participating at the diabetes summer camp.

Exclusion Criteria:

• Acute health condition (infectious disease), known allergy to medical adhesives or with a skin condition (e.g. atopic dermatitis)).

Children and adolescents, aged 6-18 years old, with type 1 diabetes mellitus, participating at the diabetes summer camp.

The study protocol and informed consent form will be publicly available. Individual participant data (IPD) collected in this study, including participants individual data, cannot be shared.

study end

not yet defined