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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06256172
Other study ID # M101
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 16, 2023
Est. completion date December 16, 2023

Study information

Verified date February 2024
Source Olawuyi Racett Nigeria Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

MEDLINK IS A POCKET-SIZED MEDLINK is a pocket-sized, verbally interactive, programmable medical device that allows physicians to select which medical measurements they would like to take for a specific patient. The Physiological Parameters that can be measured by MEDLINK include, but is not limited to: Electrocardiography (ECG), Blood Pressure, Heart Rate, Blood Glucose, Pulse Rate, Blood Oxygen Saturation (SPO2), Electromyography (EMG) body temperature, and Respiratory Data. MEDLINK is a pocket-sized, verbally interactive, programmable medical device that allows physicians to select which medical measurements they would like to take for a specific patient. When the patient takes MEDLINK home and switches it on, the device verbally guides the patient to acquire the measurements requested by the his or her physician. This information is transmitted to the physican's email for medical analysis, check up and/or follow up. This Study was executed by TWO (2) MEDICAL CONSULTANTS: Dr. Michael Olawuyi (mgolawuyi@gmail.com) and Dr, Matthew Olawuyi (olawuyiracettnigerialtd@outlook.com)


Description:

MEDLINK is a pocket-sized, verbally interactive, programmable medical device that allows physicians to select which medical measurements they would like to take for a specific patient. The Physiological Parameters that can be measured by MEDLINK include, but is not limited to: Electrocardiography (ECG), Blood Pressure, Heart Rate, Blood Glucose, Pulse Rate, Blood Oxygen Saturation (SPO2), Electromyography (EMG) body temperature, and Respiratory Data. After programming of the device by the Physician, MEDLINK can be given to the desired patient to take home for Remote Patient Monitoring (RPM). When the patient switches on the device at home, MEDLINK verbally guides the patient to acquire the measurements requested by his or her Physician. This information is automatically and wirelessly transmitted to the Physician's Mobile Phone and Email Address for medical analysis, check up, and/or follow up. MEDLINK has its own software application that allows the Physician to view and analyse the measured Physiological Parameters for any Patient. MEDLINK also has the potential to allow Patient-Physician Communication during the RPM Period. One of the key innovations of MEDLINK is that it is able to acquire a diverse range of physiological parameters. This makes it useful to physicians in different areas of specialization in the medical field. In addition to this, MEDLINK also accurately measures all Physiological Parameters of the Patient through a single digit finger being inserted into the appropriate position in the pocket-device, making it extremely easy to use. MEDLINK is the first medical device that performs blood glucose measurement using Infrared Technology, as opposed to the standardized lancet finger-pricking technology. MEDLINK allows Physicians in any specialization to monitor patients outside of the hospital setting for as long as is needed. It can be used to monitor patients after they have been discharged from the hospital. It also allows individuals to have quality access to basic health care. Ten Patients were recruited for this Study and tested the use of MEDLINK in measuring physiological parameters and providing remote access to basic health care. This Study was executed by TWO (2) MEDICAL CONSULTANTS: Dr. Michael Olawuyi (mgolawuyi@gmail.com) and Dr, Matthew Olawuyi (olawuyiracettnigerialtd@outlook.com)


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date December 16, 2023
Est. primary completion date December 16, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - NONE Exclusion Criteria: - NONE

Study Design


Intervention

Device:
Medlink
The 10 Patients enrolled in this arm tested the ue of Medlink in Measuring and reporting their Physiological Paramters in Oder to remotely obtain access to health care for the following diseases: Myasthenia Gravis, Hypertension, Chronic Heart Failure, Diabetes Mellitus, and Chronic Obstruction Pulmonary Disorder.

Locations

Country Name City State
United Kingdom Olawuyi Racett Nigeria Ltd. London

Sponsors (1)

Lead Sponsor Collaborator
Olawuyi Racett Nigeria Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Electrocardiography (ECG) (1 PQRS Interval acquired) using the ECG unit in Medlink 1 PQRS Interval is acquired. Measurement is done Once daily for 2 weeks
Primary 5 readings of Blood Pressure (Systolic and Diastolic Pressure) in mmHg using the Blood Pressure unit in Medlink is acquired and the average value is reported Acquisition of 5 readings of Blood Pressure (Systolic and Diastolic Pressure) in mmHg and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of 1 beat of Heart Rate in bpm is acquired using the Heart Rate unit in Medlink and the average value is reported. Acquisition of 5 readings of Heart Rate in bpm and the average vallue is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of Blood Glucose in mmol/L using the Infrared Glucometer unit in Medlink is acquired and the average value is reported Acquisition of 5 readings of Blood Glucose in mmol/L and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of Pulse in bpm using the Pulse Rate unit in Medlink and the average value is reported Acquisition of 5 readings of Pulse in bpm and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of SPO2 in percent using the SPO2 unit in Medlink and the average value is reported Acquisition of 5 readings of SPO2 or Blood Oxygen Saturation and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of Electromyography (EMG) Power in Analog Values in the Beta Band is measured using the EMG unit in Medlink and the average value is reported Acquisition of 5 readings of Electromyography or Muscle Strength Power in the Beta band and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of Body Temperature in Degrees Celcius using the Body Temperature Unit of Medlink and the average value is reported. Acquisition of 5 readings of Body Temperature in Degrees Celcius and the average value is reported Measurement is done Once daily for 2 weeks
Primary 5 readings of Respiratory Data (FEV1, FVC, FEV1/FVC ratio) in L using the Respiratory unit in Medlink is acquired and the average value is reported. Acquisition of 5 readings of Respiratory Data (FEV1, FVC, FEV1/FVC ratio) in L and the average value is reported Measurement is done Once daily for 2 weeks
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