Flash Glucose Monitoring Study for Diabetes

Universitaire Ziekenhuizen KU Leuven2,331 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,331

Conditions

Diabetes

Eligibility

Sex: ALLMin age: 4 Years

Medical Language ↔ Plain English

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

Locations (1)

UZ Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Quality of life

Change in quality of life measures from baseline to 12 months

Time frame: 12 months

Secondary Outcomes

Quality of life

Change in quality of life measures from baseline to 24 months

Time frame: 24 months

HbA1c

Change in HbA1c from baseline to 12 months

Time frame: 12 months

HbA1c

Change in HbA1c from baseline to 24 months

Time frame: 24 months

Severe hypoglycaemia

Change in severe hypoglycaemia frequency from baseline to 12 months

Time frame: 12 months

Severe hypoglycaemia

Change in severe hypoglycaemia frequency from baseline to 24 months

Time frame: 24 months

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

Time frame: 12 months

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

Time frame: 24 months

Hospitalisations because of hypoglycaemia and/or ketoacidosis

Change in number of hospitalisations because of hypoglycaemia and/or ketoacidosis from baseline to 12 months

Time frame: 12 months

Hospitalisations because of hypoglycaemia and/or ketoacidosis

Change in number of hospitalisations because of hypoglycaemia and/or ketoacidosis from baseline to 24 months

Time frame: 24 months

Work and school absenteeism

Change in work and school absenteeism from baseline to 12 months

Time frame: 12 months

Work and school absenteeism

Change in work and school absenteeism from baseline to 24 months

Time frame: 24 months