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DiabetesFUTURENCT02898714

Flash Glucose Monitoring Study for Diabetes

An observational study of Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 years and older
Conditions the study is for
Diabetes
How many people
2,331 participants
Where
1 siteBelgium
Study dates
Jul 2016to 31 Aug 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • Signed informed consent
  • >= 4 years
  • Using flash glucose monitoring

Who cannot join

  • Doesn't want to sign the informed consent
  • < 4 years
  • Not using flash glucose monitoring

Trial locations and contacts

1 site in 1 country.

Belgium1 site

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

About this study

Official title: 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.

Conditions
Diabetes
Medical subject headings
Diabetes Mellitus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quality of life

    Change in quality of life measures from baseline to 12 months

    Measured: 12 months

Secondary outcomes (11)

  1. Quality of life

    Change in quality of life measures from baseline to 24 months

    Measured: 24 months

  2. HbA1c

    Change in HbA1c from baseline to 12 months

    Measured: 12 months

  3. HbA1c

    Change in HbA1c from baseline to 24 months

    Measured: 24 months

  4. Severe hypoglycaemia

    Change in severe hypoglycaemia frequency from baseline to 12 months

    Measured: 12 months

  5. Severe hypoglycaemia

    Change in severe hypoglycaemia frequency from baseline to 24 months

    Measured: 24 months

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

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

    Measured: 12 months

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

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

    Measured: 24 months

  8. Hospitalisations because of hypoglycaemia and/or ketoacidosis

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

    Measured: 12 months

  9. Hospitalisations because of hypoglycaemia and/or ketoacidosis

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

    Measured: 24 months

  10. Work and school absenteeism

    Change in work and school absenteeism from baseline to 12 months

    Measured: 12 months

  11. Work and school absenteeism

    Change in work and school absenteeism from baseline to 24 months

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study startJul 2016
  3. Primary completion31 Aug 2019
  4. Study completion31 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,331 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02898714
Sponsor's protocol ID
FUTURE-59342
Acronym
FUTURE
Status last verified
Oct 2020
First submitted
7 Sep 2016
Last updated
20 Oct 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Aernouts C, Belde SPW, Lambrechts J, Mertens J, Ledeganck KJ, Francque SM, De Block CEM. Metabolic dysfunction-associated steatotic liver disease is associated with worse time in ranges in type 1 diabetes. Diabetes Obes Metab. 2024 Sep;26(9):3781-3790. doi: 10.1111/dom.15723. Epub 2024 Jun 25.

    PubMed 38924290

  • De Meulemeester J, Charleer S, Visser MM, De Block C, Mathieu C, Gillard P. The association of chronic complications with time in tight range and time in range in people with type 1 diabetes: a retrospective cross-sectional real-world study. Diabetologia. 2024 Aug;67(8):1527-1535. doi: 10.1007/s00125-024-06171-y. Epub 2024 May 24.

    PubMed 38787436

  • Charleer S, De Block C, Bolsens N, Van Huffel L, Nobels F, Mathieu C, Gillard P. Sustained Impact of Intermittently Scanned Continuous Glucose Monitoring on Treatment Satisfaction and Severe Hypoglycemia in Adults with Type 1 Diabetes (FUTURE): An Analysis in People with Normal and Impaired Awareness of Hypoglycemia. Diabetes Technol Ther. 2023 Apr;25(4):231-241. doi: 10.1089/dia.2022.0452. Epub 2023 Feb 3.

    PubMed 36648249

  • 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.

    PubMed 33740049

  • 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.

    PubMed 31843948

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of life (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02898714, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.

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