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

NCT06256172 | Completed DMC

• 1 other identifier: M101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Diabetes Mellitus; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure; Myasthenia Gravis; Hypertension

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (1)

Medlink RPM

EXPERIMENTAL

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

Interventions

Medlink DEVICE

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.

Medlink RPM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• NONE

You may not qualify if:

• NONE

Sponsors & Collaborators

• Olawuyi Racett Nigeria Ltd: lead

Study Sites (1)

Olawuyi Racett Nigeria Ltd.

London, EC1V 2NX, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive; Heart Failure; Myasthenia Gravis; Hypertension

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Vascular Diseases

Study Officials

• Michael Olawuyi, MPH

  Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218

  STUDY DIRECTOR

• Matthew Olawuyi, MBBS

  Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218

  STUDY CHAIR

• Esther Olawuyi, D.Sc.

  Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 13, 2024
• Study Start: June 16, 2023
• Primary Completion: December 16, 2023
• Study Completion: December 16, 2023
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data is available as of 20/01/2024 until 20/01/2034
• Access Criteria: Data is available to all the public

Locations

GB (1)