Effects of an Activity Control System in Patients With Diabetes: a Randomized Controlled Trial

NCT ID: NCT04380844

Last Updated: 2020-12-24

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-11-01

Brief Summary

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Using a smart device (Beprevent) to monitor activities of daily living improves the lifestyle of patients with DM2

Detailed Description

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A 6-month randomized clinical trial to evaluate a home activity control system (Beprevent) in the management of the patient with DM2, through the individualized labeling of objects related to them. The study will include 20 patients with DM2 (10 in the intervention group and 10 in the control group) who live alone or with people who can´t move on their own. Data will be recorded to measure the degree of satisfaction of professionals and participants in the study, and clinical and epidemiological data at the start of the study (in its baseline situation) and at the end of the study (at 6 months), to assess the changes produced and Compare them between both study groups.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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artificial intelligence diabetes mellitus self-care telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Beprevent

10 will become part of the intervention group. Each of the participants in the intervention group is selected. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results.

Group Type ACTIVE_COMPARATOR

Beprevent

Intervention Type OTHER

10 will become part of the intervention group. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results.

patients only evaluated

10 will be included in the control group. During the period of the study, we will pass the same questionnaires in the participants assigned to the control group, also leaving a time interval of two weeks, and no device will be installed, nor will any monitoring be carried out in their homes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Beprevent

10 will become part of the intervention group. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* ≥ 18 years, with the ability to give informed consent
* Patient who has autonomy to carry out activities of daily living (Barthel = 100)
* patient diagnosed with Diabetes Mellitus
* patient in pharmacological treatment
* To live alone or with a person who cannot move on their own
* they do not plan to change their address in the 6 months after inclusion in the study

Exclusion Criteria

• DM2 patients whose most recent HbA1c value is ≤7%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jesús Gómez Lama, MD

Role: PRINCIPAL_INVESTIGATOR

Maimónides Biomedical Research Institute of Córdoba

David Pérez Cruzado

Role: PRINCIPAL_INVESTIGATOR

Universidad Católica San Antonio de Murcia

Central Contacts

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Antonio Luque

Role: CONTACT

Phone: 0034671596070

Email: [email protected]

PEDRO MONTAGUT MARTINEZ, nurse

Role: CONTACT

Phone: + (34) 630258878

Email: [email protected]

Other Identifiers

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orcid.org/0000-0002-869

Identifier Type: -

Identifier Source: org_study_id