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

December 8, 2017 updated by: Michael Hauschild, University of Lausanne Hospitals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

70

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
through study completion, 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants satisfaction with the FGM system
Time Frame: At last camp day
Participants satisfaction (Questionnaire,%)
At last camp day
Caregivers satisfaction with the FGM system
Time Frame: At last camp day
Caregivers satisfaction (Questionnaire,%)
At last camp day
Sensor related-issues
Time Frame: Through study completion, 1 week
Sensor related-issues will be recorded
Through study completion, 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

University Hospital, Geneva

Investigators

  • Principal Investigator: Michael Hauschild, MD, Lausanne University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 2, 2016

Primary Completion (Actual)

July 30, 2016

Study Completion (Actual)

July 30, 2017

Study Registration Dates

First Submitted

November 24, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (Actual)

December 11, 2017

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER-VD 2016-00852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

study end

IPD Sharing Access Criteria

not yet defined

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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