Telemedicine for Patients With an Hybrid Closed Loop System

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Telemedicine Arm

• Registration Number: NCT04900636
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-25
• Status Verified: 2022-06
• Primary Completion: 2023-01-27
• Study Completion: 2023-01-27
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telemedicine Arm	Telemedicine Arm	Use of a telemedicine platform combined with face-to-face visits according to protocol

Primary Outcome Measures

Name	Time	Method
Impact on quality of life	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.

Secondary Outcome Measures

Name	Time	Method
Metabolic control	12 months	A1c levels

Trial Locations

Locations (1)

Lía Nattero Chávez; 🇪🇸 Madrid, Please Select, Spain