Diabetes MellitusMedlinkNCT06256172
Medlink for Diagnosing of Diabetes Mellitus, COPD, CHF, Myasthenia Gravis and Hypertension
A study testing Medlink in people with Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, run by Olawuyi Racett Nigeria Ltd at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure
- What is being tested?
- Medlink
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jun 2023to 16 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- NONE
Who cannot join
- NONE
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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)
Read the 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)
- Conditions
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Myasthenia Gravis, Hypertension
- Being tested
- Medlink
- Medical subject headings
- Diabetes Mellitus, Pulmonary Disease, Chronic Obstructive, Heart Failure, Myasthenia Gravis, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedlinkDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Medlink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electrocardiography (ECG) (1 PQRS Interval acquired) using the ECG unit in Medlink
1 PQRS Interval is acquired.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Measurement is done Once daily for 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start16 Jun 2023
- Primary completion16 Dec 2023
- Study completion16 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Olawuyi Racett Nigeria Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Olawuyi, MPH, Study director, Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218Matthew Olawuyi, MBBS, Study chair, Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218Esther Olawuyi, D.Sc., Principal investigator, Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256172
- Sponsor's protocol ID
- M101
- Acronym
- Medlink
- Status last verified
- Feb 2024
- First submitted
- 11 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data Gathered from the Trial will be made available through Certified Publications
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medlink for Diagnosing of Diabetes Mellitus, COPD, CHF, Myasthenia Gravis and Hypertension
- ClinicalTrials.gov ID
- NCT06256172
- Acronym / sponsor ID
- Medlink / M101
- Conditions
- Diabetes Mellitus, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, Myasthenia Gravis, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Olawuyi Racett Nigeria LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2023 (actual)
- Primary completion
- 16 Dec 2023 (actual)
- Study completion
- 16 Dec 2023 (actual)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medlink RPM | Experimental | Device: MedlinkThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- NONE
Key exclusion criteria (1 listed)
- NONE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedlinkThe 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 RPM |
Primary outcome
Electrocardiography (ECG) (1 PQRS Interval acquired) using the ECG unit in Medlink
Time frame: Measurement is done Once daily for 2 weeks
1 PQRS Interval is acquired.
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
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Blood Pressure (Systolic and Diastolic Pressure) in mmHg and the average value is reported
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.
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Heart Rate in bpm and the average vallue is reported
5 readings of Blood Glucose in mmol/L using the Infrared Glucometer unit in Medlink is acquired and the average value is reported
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Blood Glucose in mmol/L and the average value is reported
5 readings of Pulse in bpm using the Pulse Rate unit in Medlink and the average value is reported
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Pulse in bpm and the average value is reported
5 readings of SPO2 in percent using the SPO2 unit in Medlink and the average value is reported
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of SPO2 or Blood Oxygen Saturation and the average value is reported
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
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Electromyography or Muscle Strength Power in the Beta band and the average value is reported
5 readings of Body Temperature in Degrees Celcius using the Body Temperature Unit of Medlink and the average value is reported.
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Body Temperature in Degrees Celcius and the average value is reported
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.
Time frame: Measurement is done Once daily for 2 weeks
Acquisition of 5 readings of Respiratory Data (FEV1, FVC, FEV1/FVC ratio) in L and the average value is reported
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Yes. Data Gathered from the Trial will be made available through Certified Publications
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Olawuyi, MPH study director
Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218
Matthew Olawuyi, MBBS study chair
Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218
Esther Olawuyi, D.Sc. principal investigator
Olawuyi Racett Nigeria Ltd. United Kingdom RC14668218
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medlink in people with Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, run by Olawuyi Racett Nigeria Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electrocardiography (ECG) (1 PQRS Interval acquired) using the ECG unit in Medlink (time frame: Measurement is done Once daily for 2 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.