NCT02898714

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,331

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

3.2 years

First QC Date

September 7, 2016

Last Update Submit

October 19, 2020

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Change in quality of life measures from baseline to 12 months

    12 months

Secondary Outcomes (11)

  • Quality of life

    24 months

  • HbA1c

    12 months

  • HbA1c

    24 months

  • Severe hypoglycaemia

    12 months

  • Severe hypoglycaemia

    24 months

  • +6 more secondary outcomes

Eligibility Criteria

Age4 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

Related Publications (4)

  • 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.

    PMID: 38787436DERIVED

  • 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.

    PMID: 36648249DERIVED

  • 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.

    PMID: 33740049DERIVED

  • 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.

    PMID: 31843948DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 13, 2016

Study Start

July 1, 2016

Primary Completion

August 31, 2019

Study Completion

August 31, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)