Telemedicine for Patients With an Hybrid Closed Loop System

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Telemedicine ArmDEVICE

Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Lía Nattero Chávez

Madrid, Please Select, Spain

Outcomes

Primary Outcomes

Impact on quality of life

Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are: * Interference of diabetes in everyday life (the minimum value: 12 and maximum value: 60) higher scores mean a worse outcome * Self-care (the minimum value: 11 and maximum value: 55) higher scores mean a better outcome * Well-being (the minimum value: 6 and maximum value: 30) higher scores mean a better outcome, and * Worry about the disease (the minimum value: 5 and maximum value: 25) higher scores mean a worse outcome.

Time frame: 12 months

Secondary Outcomes

Metabolic control

A1c levels

Time frame: 12 months

Data from ClinicalTrials.gov

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