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Completed

NCT Number: NCT02898714

Flash Glucose Monitoring Study for Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

4 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Quality of life

    Time frame: 12 months

    Change in quality of life measures from baseline to 12 months

Secondary outcomes

  1. Quality of life

    Time frame: 24 months

    Change in quality of life measures from baseline to 24 months

  2. HbA1c

    Time frame: 12 months

    Change in HbA1c from baseline to 12 months

  3. HbA1c

    Time frame: 24 months

    Change in HbA1c from baseline to 24 months

  4. Severe hypoglycaemia

    Time frame: 12 months

    Change in severe hypoglycaemia frequency from baseline to 12 months

  5. Severe hypoglycaemia

    Time frame: 24 months

    Change in severe hypoglycaemia frequency from baseline to 24 months

  6. Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)

    Time frame: 12 months

    Change in time spent in hypoglycaemia (<54 mg/dL and <70 mg/dL) from baseline to 12 months

  7. Time in hypoglycaemia (<54 mg/dL and <70 mg/dL)

    Time frame: 24 months

    Change in time spent in hypoglycaemia (<54 mg/dL and <70 mg/dL) from baseline to 24 months

  8. Hospitalisations because of hypoglycaemia and/or ketoacidosis

    Time frame: 12 months

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

  9. Hospitalisations because of hypoglycaemia and/or ketoacidosis

    Time frame: 24 months

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

  10. Work and school absenteeism

    Time frame: 12 months

    Change in work and school absenteeism from baseline to 12 months

  11. Work and school absenteeism

    Time frame: 24 months

    Change in work and school absenteeism from baseline to 24 months

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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

Acronym: FUTURE

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 13, 2016
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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