Flash Glucose Monitoring Study for Diabetes

The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02898714

Acronym

FUTURE

Enrollment

2331

Registered

2016-09-13

Start date

2016-07-31

Completion date

2020-08-31

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Brief summary

On the first of July 2016, the Freestyle Libre Flash Glucose Monitor (FGM) will be reimbursed in Belgium by means of a new diabetes reimbursement program for adults. For children, the Freestyle Libre FGM is also reimbursed by means of a new reimbursement program from the first of August 2016 onwards. Making this the only way to receive the device in Belgium. To understand the impact of this new FGM on diabetes patients in UZ Leuven, OLVZ Aalst, and UZ Antwerp, we want to study the use of the device by our patients by means of an observational study where patients complete questionnaires at regular time points in the first year of usage and after 24 months Clinical data will be gathered during the routine clinical visits as part of the reimbursement program.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

4 Years to No maximum

Healthy volunteers

Inclusion criteria

* Signed informed consent * \>= 4 years * Using flash glucose monitoring

Exclusion criteria

* Doesn't want to sign the informed consent * \< 4 years * Not using flash glucose monitoring

Design outcomes

Primary

Measure	Time frame	Description
Quality of life	12 months	Change in quality of life measures from baseline to 12 months

Secondary

Measure	Time frame	Description
HbA1c	12 months	Change in HbA1c from baseline to 12 months
Severe hypoglycaemia	12 months	Change in severe hypoglycaemia frequency from baseline to 12 months
Quality of life	24 months	Change in quality of life measures from baseline to 24 months
Hospitalisations because of hypoglycaemia and/or ketoacidosis	12 months	Change in number of hospitalisations because of hypoglycaemia and/or ketoacidosis from baseline to 12 months
Work and school absenteeism	12 months	Change in work and school absenteeism from baseline to 12 months
Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)	12 months	Change in time spent in hypoglycaemia (\<54 mg/dL and \<70 mg/dL) from baseline to 12 months

Countries

Belgium

Outcome results