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

NCT03368586 | Completed

• 1 other identifier: CER-VD 2016-00852
• Study Type: observational
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Flash Glucose Monitoring; Children; Adolescents

Outcome Measures

Primary Outcomes (1)

• FGM accuracy

  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 Outcomes (3)

• Participants satisfaction with the FGM system

  At last camp day

• Caregivers satisfaction with the FGM system

  At last camp day

• Sensor related-issues

  Through study completion, 1 week

Interventions

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.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead
• University Hospital, Geneva: collaborator

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael Hauschild, MD

  Lausanne University Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: December 11, 2017
• Study Start: July 2, 2016
• Primary Completion: July 30, 2016
• Study Completion: July 30, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: study end
• Access Criteria: not yet defined