A Phase 2 interventional study of FreeStyle Libre 2, flash glucose monitoring in Diabetes Mellitus, Type 2, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-03.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Phase 2, Interventional, and Device feasibility
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 50 is below the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 342 studies on the registry; 64 are open to participants now.
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Diagnosed with DM2.
. Who have reached 18 years of age.
Exclusion Criteria:
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.
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.
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.
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
Plan to share: No
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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