Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes, glucose monitoring, satisfaction, diabetes technology
Brief 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.
Detailed 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.
Interventions
DEVICEFreeStyle 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
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Open and exploratory parallel randomized single-center clinical trial in a 1:1 ratio of three months duration. A computerized randomization by blocks of 10 without blinding will be performed.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with the treatment | 3 months | Diabetes Treatment Satisfaction Questionnaire (DTSQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total number of visits | 3 months | • The total number of visits (in person, by telephone and asynchronous telematics, if applicable). |
| Number of treatment | 3 months | The number of treatment changes applied to the patient. |
| Duration of follow-up. | 3 months | 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 |
| Glucometrics | 3 months | In each group, assess the change in blood glucose according to your monitoring method |
| Perception of hiperglicemia | 3 months | The value of questions 3 of the DTSQ and % of local problems as security variables. |
| Perception of hypoglicemia | 3 months | The value of questions 2 of the DTSQ and % of local problems as security variables. |
| HbA1c | Baseline and 3 months | The hemoglobin A1c (HbA1c) test measures the amount of blood sugar (glucose) attached to your hemoglobin. |
Countries
Spain
Outcome results
None listed