Flash Glucose Monitoring Study for Diabetes

NCT ID: NCT02898714

Last Updated: 2020-10-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2331 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2020-08-31

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.

Conditions

Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 4 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

prof dr Pieter Gillard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 38787436 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36648249 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33740049 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31843948 (View on PubMed)

Other Identifiers

FUTURE-59342

Identifier Type: -

Identifier Source: org_study_id