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)

Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)

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.

Inclusion Criteria:

• Diagnostic criteria for DM1 according to ADA
• Candidates 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 consent

Exclusion Criteria:

• Gestation
• Institutionalization, serious or terminal illness or renal replacement therapy.
• Inability to undertake the training and / or acquire the degree of knowledge to use both systems
• Refusal to participate in the study or to sign the informed consent