Flash Glucose Monitoring Study for Diabetes (FUTURE)

October 19, 2020 updated by: prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 12 months
Change in quality of life measures from baseline to 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life
Time Frame: 24 months
Change in quality of life measures from baseline to 24 months
24 months
HbA1c
Time Frame: 12 months
Change in HbA1c from baseline to 12 months
12 months
HbA1c
Time Frame: 24 months
Change in HbA1c from baseline to 24 months
24 months
Severe hypoglycaemia
Time Frame: 12 months
Change in severe hypoglycaemia frequency from baseline to 12 months
12 months
Severe hypoglycaemia
Time Frame: 24 months
Change in severe hypoglycaemia frequency from baseline to 24 months
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
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
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
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
24 months
Work and school absenteeism
Time Frame: 12 months
Change in work and school absenteeism from baseline to 12 months
12 months
Work and school absenteeism
Time Frame: 24 months
Change in work and school absenteeism from baseline to 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2020

Study Registration Dates

First Submitted

September 7, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2020

Last Update Submitted That Met QC Criteria

October 19, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUTURE-59342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe