Type 1 Diabetes Mellitus
Conditions
Keywords
Flash Glucose Monitoring, Children, Adolescents
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 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.
Interventions
DEVICEFlash Glucose Monitoring
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 (FG) measurements 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) FG 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.
Sponsors
University Hospital, Geneva
University of Lausanne Hospitals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
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)).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FGM accuracy | through study completion, 1 week | Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants satisfaction with the FGM system | At last camp day | Participants satisfaction (Questionnaire,%) |
| Caregivers satisfaction with the FGM system | At last camp day | Caregivers satisfaction (Questionnaire,%) |
| Sensor related-issues | Through study completion, 1 week | Sensor related-issues will be recorded |
Outcome results
None listed