Telemedicine for Patients With an Hybrid Closed Loop System

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04900636
• Other study ID #: 317/19
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: January 27, 2023

Study information

• Verified date: June 2022
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Telemedicine Arm
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.

Locations

Country	Name	City	State
Spain	Lía Nattero Chávez	Madrid	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	Metabolic control	A1c levels	12 months