Flash Glucose Monitoring Study for Diabetes

Completed

• Conditions: Diabetes

• Registration Number: NCT02898714
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-09-07
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Primary Completion: 2019-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2331

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life	12 months	Change in quality of life measures from baseline to 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium