Flash Glucose Monitoring Study for Diabetes

Diabetes Clinical Trial

— FUTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02898714
• Other study ID #: FUTURE-59342
• Status: Completed
• Start date: July 2016
• Est. completion date: August 31, 2020

Study information

• Verified date: October 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2331
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

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