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Flash Glucose Monitoring Study for Diabetes (FUTURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02898714
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : October 20, 2020
Sponsor:
Information provided by (Responsible Party):
prof dr Pieter Gillard, Universitaire Ziekenhuizen Leuven

Tracking Information
First Submitted Date September 7, 2016
First Posted Date September 13, 2016
Last Update Posted Date October 20, 2020
Study Start Date July 2016
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2018)
Quality of life [ Time Frame: 12 months ]
Change in quality of life measures from baseline to 12 months
Original Primary Outcome Measures
 (submitted: September 7, 2016)
Quality of life [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2018)
  • Quality of life [ Time Frame: 24 months ]
    Change in quality of life measures from baseline to 24 months
  • HbA1c [ Time Frame: 12 months ]
    Change in HbA1c from baseline to 12 months
  • HbA1c [ Time Frame: 24 months ]
    Change in HbA1c from baseline to 24 months
  • Severe hypoglycaemia [ Time Frame: 12 months ]
    Change in severe hypoglycaemia frequency from baseline to 12 months
  • Severe hypoglycaemia [ Time Frame: 24 months ]
    Change in severe hypoglycaemia frequency from baseline to 24 months
  • 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
  • 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
  • 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
  • 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
  • Work and school absenteeism [ Time Frame: 12 months ]
    Change in work and school absenteeism from baseline to 12 months
  • Work and school absenteeism [ Time Frame: 24 months ]
    Change in work and school absenteeism from baseline to 24 months
Original Secondary Outcome Measures
 (submitted: September 7, 2016)
Clinical care parameters [ Time Frame: 3 years ]
Change in HbA1c
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Flash Glucose Monitoring Study for Diabetes
Official Title The Impact of Flash Glucose Monitoring on Clinical Outcome Parameters in Diabetes Patients
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Diabetes
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 13, 2018)
2331
Original Estimated Enrollment
 (submitted: September 7, 2016)
1000
Actual Study Completion Date August 31, 2020
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT02898714
Other Study ID Numbers FUTURE-59342
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party prof dr Pieter Gillard, Universitaire Ziekenhuizen Leuven
Study Sponsor Universitaire Ziekenhuizen Leuven
Collaborators Not Provided
Investigators Not Provided
PRS Account Universitaire Ziekenhuizen Leuven
Verification Date October 2020