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)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Type1diabetes

Treatments: Device: Minimed 780G system; Device: InPen Medtronic

Study type: Interventional

Funder types: Other

Identifiers

NCT05708040

189/22

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Closed loop system

Active Comparator group

Description:

Minimed 780G (Medtronic)

Treatment:

Device: InPen Medtronic

SmartPen

Experimental group

Description:

InPen (Medtronic)

Treatment:

Device: Minimed 780G system