Telemedicine for Patients With an Hybrid Closed Loop System

September 7, 2023 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Please Select
      • Madrid, Please Select, Spain, 28034
        • Lía Nattero Chávez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine Arm
Use of a telemedicine platform combined with face-to-face visits according to protocol
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.
No Intervention: Control Arm
conventional follow-up according to routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic control
Time Frame: 12 months
A1c levels
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

  • Principal Investigator: Lía Nattero Chávez, MD PhD, Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 27, 2023

Study Registration Dates

First Submitted

May 18, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 317/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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