Telemedicine for Patients With an Hybrid Closed Loop System

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Telemedicine Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT04900636

317/19

Details and patient eligibility

About

The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnostic criteria for DM1 according to ADA
• They must have access to the technology that allows monitoring (mobile phone and / or computer as well as having an internet connection)
• 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 the telemedicine platform.
• Refusal to participate in the study or to sign the informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

23 participants in 2 patient groups

Telemedicine Arm

Experimental group

Description:

Use of a telemedicine platform combined with face-to-face visits according to protocol

Treatment:

Device: Telemedicine Arm

Control Arm

No Intervention group

Description:

conventional follow-up according to routine clinical practice.