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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
50
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.
Natalia Mangas Fernandez
Barcelona, Spain
Satisfaction with the treatment
Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 3 months
Glucometrics
In each group, assess the change in blood glucose according to your monitoring method
Time frame: 3 months
The total number of visits
• The total number of visits (in person, by telephone and asynchronous telematics, if applicable).
Time frame: 3 months
Number of treatment
The number of treatment changes applied to the patient.
Time frame: 3 months
Duration of follow-up.
Duration of follow-up. A maximum follow-up of 3 months is expected in both groups. However, earlier completion is expected if the patient is discharged, requires hospital admission or an exclusion criterion is made before performing V7
Time frame: 3 months
HbA1c
The hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to your hemoglobin.
Time frame: Baseline and 3 months
Perception of hiperglicemia
The value of questions 3 of the DTSQ and % of local problems as security variables.
Time frame: 3 months
Perception of hypoglicemia
The value of questions 2 of the DTSQ and % of local problems as security variables.
Time frame: 3 months
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