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NCT06624553: Diabetes type2
Satisfaction With FreeStyle Libre 2 Monitoring Versus Capillary Blood Glucose Monitoring in People With DM2
Phase 2 trial testing FreeStyle Libre 2, flash glucose monitoring in Diabetes Mellitus, Type 2 in 50 participants. Completed in 28 May 2023.
28 February 2023
Quick facts
| Lead sponsor | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 50 |
| Start date | 28 November 2022 |
| Primary completion | 28 February 2023 |
| Estimated completion | 28 May 2023 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- FreeStyle Libre 2, flash glucose monitoring
Conditions studied
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Who can join
18 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06624553
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
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Currently open trials in the same condition.
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- NCT07242469 — A Clinical Trial of MK-1403 in Participants With Type 2 Diabetes Mellitus (MK-1403-006) · Phase 1 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06624553 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Last refreshed: 3 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06624553.
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