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Recruiting NCT05708040

Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)

Conditions: Type1diabetes

Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 48
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Location: Spain

Summary

Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.

Eligibility Criteria

Inclusion Criteria:Diagnostic criteria for DM1 according to ADACandidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.Acceptance of participation in the study and signing of the informed consentExclusion Criteria:GestationInstitutionalization, serious or terminal illness or renal replacement therapy.Inability to undertake the training and / or acquire the degree of knowledge to use both systemsRefusal to participate in the study or to sign the informed consent

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05708040). StuddyBuddy aggregates publicly available trial information.