A Telemedicine Platform for Patients With Type 1 Diabetes Mellitus Treated With an Hybrid Closed Loop System

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal1 site in 1 country23 target enrollmentMay 1, 2021

ConditionsDiabetes Mellitus, Type 1

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus, Type 1
Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Enrollment: 23
Locations: 1
Primary Endpoint: Impact on quality of life
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

January 27, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Impact on quality of life

Time Frame: 12 months

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.