Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in Peopl… (NCT06624553) | Clinical Trial Compass
CompletedPhase 2
Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2
Spain50 participantsStarted 2022-11-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Satisfaction with the treatment
Timeframe: 3 months
Trial details
NCT IDNCT06624553
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau