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

NCT03368586 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2017-12-11

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Flash 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 & Collaborators

  • University Hospital, Geneva

    collaborator OTHER

  • University of Lausanne Hospitals

    lead OTHER

Principal Investigators

  • Michael Hauschild, MD · Lausanne University Hospitals

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-02
Primary Completion
2016-07-30
Completion
2017-07-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03368586 on ClinicalTrials.gov