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

NCT06624553 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DEVICE

FreeStyle Libre 2, flash glucose monitoring

Currently, at the Hospital de la Santa Creu i Sant Pau, when starting monitoring in people with DM2, capillary glycemia monitoring is used, following the therapeutic education protocols in basal insulinization in the debut of DM2 and in optimization of treatment, protocols that are also applied to similar cases. The intervention group (FreeStyle Libre 2) will be provided with the necessary material to carry out the monitoring via a glucose sensor. Satisfaction with treatment will be assessed at the final study visit.

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-28
Primary Completion
2023-02-28
Completion
2023-05-28

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06624553 on ClinicalTrials.gov