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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04380844
Enrollment
20
Registered
2020-05-08
Start date
2021-02-01
Completion date
2021-11-01
Last updated
2020-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

artificial intelligence, diabetes mellitus, self-care, telemedicine

Brief summary

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

Detailed description

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.

Interventions

OTHERBeprevent

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.

Sponsors

Universidad Católica San Antonio de Murcia
CollaboratorOTHER
Maimónides Biomedical Research Institute of Córdoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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%

Design outcomes

Primary

MeasureTime frameDescription
Diabetes Knowledge Questionnaire15 minutsThe Diabetes Knowledge Questionnaire (DKQ-24) is a questionnaire made up of 24 questions about basic knowledge of the disease (10 items), glycemic control (7 items) and prevention of complications (7 items). The questions are closed, with answer options yes, no and I don't know. Its maximum score is 24. The patient has better knowledge about diabetes the higher the score.

Contacts

Primary ContactAntonio Luque
uicec@imibic.org0034671596070
Backup ContactPEDRO MONTAGUT MARTINEZ, nurse
pedromontagut@hotmail.com+ (34) 630258878

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026