Skip to main content
OpenTrials
Completed

NCT Number: NCT03368586

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)).

Treatment and study plan

Flash Glucose Monitoring

Device

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.

Primary outcomes

  1. FGM accuracy

    Time frame: 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 outcomes

  1. Participants satisfaction with the FGM system

    Time frame: At last camp day

    Participants satisfaction (Questionnaire,%)

  2. Caregivers satisfaction with the FGM system

    Time frame: At last camp day

    Caregivers satisfaction (Questionnaire,%)

  3. Sensor related-issues

    Time frame: Through study completion, 1 week

    Sensor related-issues will be recorded

Sponsors and collaborators

Lead sponsor

University of Lausanne Hospitals

Other

Collaborators

  • University Hospital, Geneva

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Dec 11, 2017
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.