An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System

• Sponsor: Jessa Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03071159
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 7.5

Study Details

Study Description

Brief Summary

Medium-term (6-12 months) evaluation of the use, the identified problems, the usability and the effect on the metabolic control of the FreeStyle Flash Libre glucose monitoring system in 90 children by questionnaires and routine measurement of HbA1c values.

Condition or Disease	Intervention/Treatment	Phase
Flash Glucose Monitoring; Metabolic Control	Device: FreeStyle Flash Libre glucose monitoring system	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Medium-term Evaluation of the Use, the Identified Problems, the Usability and the Effect on the Metabolic Control of the FreeStyle Flash Libre Glucose Monitoring System
• Actual Study Start Date: Mar 10, 2017
• Anticipated Primary Completion Date: Mar 10, 2018
• Anticipated Study Completion Date: Mar 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: cases children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care)	Device: FreeStyle Flash Libre glucose monitoring system; glucose monitoring system with sensors

Outcome Measures

Primary Outcome Measures

1. Usability of the FreeStyle Flash Libre glucose monitoring system [6-12 months follow up]

   Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire

Secondary Outcome Measures

1. Problems associated with the FreeStyle Flash Libre glucose monitoring system [6-12 months follow up]

   Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire

2. The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients [6-12 months follow up]

   The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Type 1 diabetes mellitis

• Being followed in the Pediatric Diabetes Unit of the Jessa Hospital

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jessa Hospital	Hasselt		Belgium	3500

Sponsors and Collaborators

• Jessa Hospital

Investigators

• Study Director: Guy Massa, MD, PhD, Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jessa Hospital
• ClinicalTrials.gov Identifier: NCT03071159
• Other Study ID Numbers: JessaH
• First Posted: Mar 6, 2017
• Last Update Posted: Jan 23, 2018
• Last Verified: Feb 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jessa Hospital: Flash Glucose Monitoring; Usability; Metabolic control

Study Results

No Results Posted as of Jan 23, 2018