Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2 (Diabetes type2)

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

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: FreeStyle Libre 2, flash glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06624553

IIBSP-FSL-2021-150

Details and patient eligibility

About

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.

Full description

When the doctor determines that the patient who has attended the Endocrinology and Nutrition Day Hospital needs to start glucose monitoring and goes to the nursing office, if he meets the inclusion criteria, he will be asked to participate in the study. After signing the informed consent, the control group (MGC) or intervention group (FSL2) will be randomised. The necessary therapeutic education for glucose monitoring will be carried out in parallel with the other necessary aspects of Diabetes Therapeutic Education.

Follow-up visits in both groups will take place 24-48 hours after the first visit, a week, 2 weeks, and 1, 2, and 3 months after the first visit. During visits, frequently according to usual clinical practice, by the nurse and/or doctor, therapeutic decisions will be made based on the monitoring system assigned to the patient.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with DM2.

  . Who have reached 18 years of age.

• Who are candidates to start glucose monitoring according to the usual clinical practice of the Endocrine Day Hospital of the Hospital de Sant Pau.

• That they are not using any glucose monitoring tool. These may be patients with debut diabetes, worsening control with high HbA1c levels, or starting treatment with glucocorticoids. Patients may have any of these conditions, or similar ones, as long as they meet the other inclusion criteria and none of the exclusion criteria. Similarly, no specifications are made for drug treatment prior to or initiated at the recruitment visit.

Exclusion criteria

• Pregnant or expecting to be during the duration of the study.
• Assessed by the healthcare professional responsible for proposing the study to them as more harmful than beneficial their inclusion in it.

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Control group. Capilary glucose monitoring

No Intervention group

Description:

The patient randomized to the control group, capillary glucose monitoring, will be provided with the necessary material for six weeks (Free Style Optium glucometer, puncturer, Free Style Optium strips, lancets and record book) and the objectives, technique of analysis, recording and interpretation. The patient/carer will be asked to practice before leaving the office to ensure that they perform the technique correctly and effectively.

Intervention group. FreeStyle Libre 2

Experimental group

Description:

The patient randomized to the intervention group (FSL2) will be provided with the necessary material for six weeks (sensor, applicator and reader or mobile application (App)) and the objectives, analysis, recording and interpretation technique will be explained. The patient will be helped to register in the application and share the data with the hospital. The patient will carry out the first readings before leaving the consultation to ensure that they are carried out correctly.

Treatment:

Device: FreeStyle Libre 2, flash glucose monitoring