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EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE

NCT06794658 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-31

No results posted yet for this study

Summary

The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.

The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel.

This is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion.

Researchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel.

Participants with diabetes will:

Use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition,

Control group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.

Conditions

Interventions

DEVICE

software

Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\_CAARING) will receive educational and prevention recommendations relative to diabetes.

Sponsors & Collaborators

  • Effice Servicios Para la Investigacion S.L.

    collaborator INDUSTRY

  • Persei Vivarium

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-11
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06794658 on ClinicalTrials.gov