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NCT06624553: Diabetes type2

Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2

Completed Phase 2 Last updated 3 October 2024
What this trial tests

Phase 2 trial testing FreeStyle Libre 2, flash glucose monitoring in Diabetes Mellitus, Type 2 in 50 participants. Completed in 28 May 2023.

Timeline
28 November 2022
Primary endpoint
28 February 2023
28 May 2023

Quick facts

Lead sponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposedevice feasibility
Enrollment50
Start date28 November 2022
Primary completion28 February 2023
Estimated completion28 May 2023
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Who can join

18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The FreeStyle Libre 2 system is a Flash glucose monitoring system that, after a scan, provides information on interstitial glucose for the last 8 hours in the form of a reading every 15 min. The system is approved for non-adjuvant use for therapeutic decision-making. The acceptability and effectiveness of the FSL is well documented in patients with type 1 and 2 diabetes mellitus (DM2). Most of the studies in patients with DM2 have been developed in patients with insulin treatment, either basal or with multiple doses. For all these reasons, we proposed an exploratory study to evaluate satisfaction with treatment (main variable) in people with DM2 who start glucose monitoring in the Endocrinology Day Hospital context compared to patients who use capillary blood glucose monitoring. These are patients treated in a context of debut/acute decompensation/intercurrent pathology, who will not necessarily be using insulin treatment. The aim is to know if the use of FSL2 provides benefits of user satisfaction with the treatment, assessed with the Diabetes Treatment Satisfaction Questionnaire at the end of follow-up (mean score of all items); in this context.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Diabetes Mellitus, Type 2

Currently open trials in the same condition.

Other Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06624553.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing