Flash Glucose MonitoringNCT03071159
An Evaluation of the FreeStyle Libre Flash Glucose Monitoring System
A study testing FreeStyle Flash Libre glucose monitoring system in people with Flash Glucose Monitoring and Metabolic Control, run by Jessa Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Flash Glucose Monitoring, Metabolic Control
- What is being tested?
- FreeStyle Flash Libre glucose monitoring system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 10 Mar 2017to 10 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes mellitis
- Being followed in the Pediatric Diabetes Unit of the Jessa Hospital
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Jessa Hospital
Hasselt, 3500
Guy Massa, MD, PhD
About this study
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
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.
- Conditions
- Flash Glucose Monitoring, Metabolic Control
- Being tested
- FreeStyle Flash Libre glucose monitoring system
- Keywords
- Flash Glucose Monitoring, Usability, Metabolic control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Flash Libre glucose monitoring systemDevice
glucose monitoring system with sensors
| Study group | Role | What they receive |
|---|---|---|
| cases | Other | children (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care) Receives: Device: FreeStyle Flash Libre glucose monitoring system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the FreeStyle Flash Libre glucose monitoring system
Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire
Measured: 6-12 months follow up
Secondary outcomes (2)
Problems associated with the FreeStyle Flash Libre glucose monitoring system
Problems associated with the FreeStyle Flash Libre glucose monitoring system by a questionnaire
Measured: 6-12 months follow up
The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients
The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients by measurement of the HbA1c values
Measured: 6-12 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start10 Mar 2017
- Primary completion10 Mar 2018 (estimated)
- Study completion10 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flash Glucose MonitoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guy Massa, MD, PhD, Study director, Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071159
- Sponsor's protocol ID
- JessaH
- Status last verified
- Feb 2017
- First submitted
- 1 Mar 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03071159
- Acronym / sponsor ID
- JessaH
- Conditions
- Flash Glucose Monitoring, Metabolic Control
- Keywords
- Flash Glucose Monitoring, Usability, Metabolic control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 10 Mar 2018 (estimated)
- Study completion
- 10 Mar 2018 (estimated)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cases | Other | Device: FreeStyle Flash Libre glucose monitoring systemchildren (4-18 years) with type 1 diabetes mellitis using the FreeStyle Flash Libre glucose monitoring system (standard care) |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Type 1 diabetes mellitis
- Being followed in the Pediatric Diabetes Unit of the Jessa Hospital
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FreeStyle Flash Libre glucose monitoring systemglucose monitoring system with sensors | Device | cases |
Primary outcome
Usability of the FreeStyle Flash Libre glucose monitoring system
Time frame: 6-12 months follow up
Usability of the FreeStyle Flash Libre glucose monitoring system by a questionnaire
2 secondary outcomes
Problems associated with the FreeStyle Flash Libre glucose monitoring system
Time frame: 6-12 months follow up
The effect of the FreeStyle Flash Libre glucose monitoring system on the metabolic control in patients
Time frame: 6-12 months follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Individual participant dataSharing planned: No
Related trials for Flash Glucose Monitoring
Active, not recruitingObservational study
FSL2 Post Approval Study for Pediatric and Young Adults Patients
Diabete Mellitus
Active, not recruitingObservational study
Predicting Dysglycemia in Individuals With Gestational Diabetes Immediately Postpartum Using Continuous Glucose Monitoring
Gestational Diabetes, Prediabetes; Complicating Pregnancy
Active, not recruiting
The FreeStyle Libre Enabled Reduction of A1c Through Effective Eating and Exercise Study
Diabetes Mellitus, Type 2
Active, not recruiting
Long-Term Feedback Effect of FGM in Newly-Diagnosed T2D Patients
Type 2 Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Massa, MD, PhD study director
Department of Pediatric Diabetology, Jessa Ziekenhuis, Stadsomvaart 11, B3500
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Flash Libre glucose monitoring system in people with Flash Glucose Monitoring and Metabolic Control, run by Jessa Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Massa, MD, PhD (+32 11 30 96 34, guy.massa@jessazh.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the FreeStyle Flash Libre glucose monitoring system (time frame: 6-12 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.