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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-11

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.

The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki

Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Online telemonitoring group (G_CAARING)

The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables.

Group Type ACTIVE_COMPARATOR

software

Intervention Type DEVICE

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.

Retrospective Control group

The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Caaring

Eligibility Criteria

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Inclusion Criteria

* Patients with diabetes mellitus treated with insulin.
* Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
* Patients using a glucose monitoring system
* Patients who are able to complete the study questionnaires
* Informed consent is obtained from the patient.
* For 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 - For Caaring group: Patients must have sufficient technological skills to use a smartphone.

Exclusion Criteria

* Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.
* Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
* Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.
* Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
* Institutionalized patients
* Patients who are pregnant or breastfeeding.
* Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.

Eligible Sex

ALL

Accepts Healthy Volunteers

No