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Flash Glucose Monitoring Study for Diabetes (FUTURE)

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ClinicalTrials.gov Identifier: NCT02898714
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
prof dr Pieter Gillard, Universitaire Ziekenhuizen 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.

Condition or disease
Diabetes

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Study Type : Observational
Actual Enrollment : 2331 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients
Study Start Date : July 2016
Actual Primary Completion Date : August 31, 2019
Estimated Study Completion Date : June 12, 2020



Primary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    Change in quality of life measures from baseline to 12 months


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898714


Locations
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Belgium
UZ Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: prof dr Pieter Gillard, Principal Investigator, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02898714    
Other Study ID Numbers: FUTURE-59342
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: November 20, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases