Clinical trial NCT02898714: Flash Glucose Monitoring Study for Diabetes
Official title: The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 2331
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 4 years with diabetes using FGM after entering in the new diabetes reimbursement program in Belgium in UZ Leuven, OLVZ Aalst and UZ Antwerp.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Quality of life
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 24 months
measure: HbA1c
timeFrame: 12 months
measure: HbA1c
timeFrame: 24 months
measure: Severe hypoglycaemia
timeFrame: 12 months
measure: Severe hypoglycaemia
timeFrame: 24 months
measure: Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)
timeFrame: 12 months
measure: Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)
timeFrame: 24 months
measure: Hospitalisations because of hypoglycaemia and/or ketoacidosis
timeFrame: 12 months
measure: Hospitalisations because of hypoglycaemia and/or ketoacidosis
timeFrame: 24 months
measure: Work and school absenteeism
timeFrame: 12 months
measure: Work and school absenteeism
timeFrame: 24 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
citation: Broos B, Charleer S, Bolsens N, Moyson C, Mathieu C, Gillard P, De Block C. Diabetes Knowledge and Metabolic Control in Type 1 Diabetes Starting With Continuous Glucose Monitoring: FUTURE-PEAK. J Clin Endocrinol Metab. 2021 Jul 13;106(8):e3037-e3048. doi: 10.1210/clinem/dgab188.
citation: Charleer S, De Block C, Van Huffel L, Broos B, Fieuws S, Nobels F, Mathieu C, Gillard P. Quality of Life and Glucose Control After 1 Year of Nationwide Reimbursement of Intermittently Scanned Continuous Glucose Monitoring in Adults Living With Type 1 Diabetes (FUTURE): A Prospective Observational Real-World Cohort Study. Diabetes Care. 2020 Feb;43(2):389-397. doi: 10.2337/dc19-1610. Epub 2019 Dec 16.