Medlink for Diagnosing of Diabetes Mellitus, COPD, CHF, Myasthenia Gravis and Hypertension (Medlink)

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)

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Myasthenia Gravis; Congestive Heart Failure
• Intervention / Treatment: Device: Medlink

Detailed 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)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, EC1V 2NX
    • Olawuyi Racett Nigeria Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• NONE

Exclusion Criteria:

• NONE

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Medlink RPM; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Olawuyi Racett Nigeria Ltd
• Investigators: Study Director: Michael Olawuyi, MPH, Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218; Study Chair: Matthew Olawuyi, MBBS, Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218; Principal Investigator: Esther Olawuyi, D.Sc., Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2023
• Primary Completion (Actual): December 16, 2023
• Study Completion (Actual): December 16, 2023

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Estimated): February 13, 2024

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Immune System Diseases; Neoplasms; Autoimmune Diseases of the Nervous System; Autoimmune Diseases; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Endocrine System Diseases; Disease Attributes; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Nervous System Neoplasms; Paraneoplastic Syndromes, Nervous System; Paraneoplastic Syndromes; Neuromuscular Junction Diseases; Chronic Disease; Heart Failure; Hypertension; Diabetes Mellitus; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Muscle Weakness; Myasthenia Gravis
• Other Study ID Numbers: M101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data Gathered from the Trial will be made available through Certified Publications
• IPD Sharing Time Frame: Data is available as of 20/01/2024 until 20/01/2034
• IPD Sharing Access Criteria: Data is available to all the public
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No