DiabetesNCT02864212
Development of a Methodology to Design a High Order Sliding Mode Controller for Drug Dosage
An observational study of Diabetes and Hypertension, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Diabetes, Hypertension, Anesthesia
- How many people
- 30 participants
- Where
- 1 siteMexico
- Study dates
- Sep 2014to Dec 2021
- Phase
- Observational
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients scheduled for surgery in the Cardiology Hospital CMNSXXI or treated with fast-acting insulin in the Cardiology Hospital CMNSXXI
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I, II, II
Who cannot join
- Impossibility to measure depth of anesthesia or invasive blood pressure. Impossibility of using glucose monitor.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Unidad de Investigación Médica en Enfermedades Metabólicas IMSS
Mexico City, Mexico City, 06720
About this study
The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.
Read the detailed description
The aim of this observational study is to create a database to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.
The observed drugs in this study are fast acting insulin, propofol and sodium nitroprusside.
The effect of insulin will be measured by a continuous glucose monitor, the effect of propofol by a bispectral index monitor and the the effect of sodium nitroprusside by a invasive blood pressure monitor.
- Conditions
- Diabetes, Hypertension, Anesthesia
- Medical subject headings
- Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Glucose monitoring | Glucose will be monitor in patients using fast-acting insulin. | |
| Depth of anesthesia monitoring | Depth of anesthesia will be monitor in patients undergoing cardiac surgery. | |
| Blood pressure monitoring | Invasive blood pressure will be monitor in patients undergoing cardiac surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose
The glucose will be measured by a continuous glucose monitor. For the group of patients for diabetes.
Note: This protocol has three primary outputs because its objective is to create a database of each output to analyze the response to the associated drug (insulin, propofol and sodium nitroprusside.
Measured: Every 5 minutes during 3 days.
Bispectral Index
Depth of anesthesia will be measured by a Bispectral Index monitor.
Measured: Every second during surgery
Invasive blood pressure
Measured: Every 5 minutes during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2014
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ana Gallardo, Dr, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864212
- Sponsor's protocol ID
- R-2014-785-063
- Status last verified
- Jul 2020
- First submitted
- 29 Jul 2016
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Methodology to Design a High Order Sliding Mode Controller for Drug Dosage
- ClinicalTrials.gov ID
- NCT02864212
- Acronym / sponsor ID
- R-2014-785-063
- Conditions
- Diabetes, Hypertension, Anesthesia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Sep 2014 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 11 Aug 2016 (estimated)
- 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.
The aim of this observational study is to create a data base to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.
Detailed description
The aim of this observational study is to create a database to extract feature of fast-acting drugs that can be monitor in real time to design control strategies based on high order sliding mode controller to create a robust drug infusion system.
The observed drugs in this study are fast acting insulin, propofol and sodium nitroprusside.
The effect of insulin will be measured by a continuous glucose monitor, the effect of propofol by a bispectral index monitor and the the effect of sodium nitroprusside by a invasive blood pressure monitor.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Glucose monitoring | – | –Glucose will be monitor in patients using fast-acting insulin. |
| Depth of anesthesia monitoring | – | –Depth of anesthesia will be monitor in patients undergoing cardiac surgery. |
| Blood pressure monitoring | – | –Invasive blood pressure will be monitor in patients undergoing cardiac surgery. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients scheduled for surgery in the Cardiology Hospital CMNSXXI or treated with fast-acting insulin in the Cardiology Hospital CMNSXXI
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I, II, II
Key exclusion criteria (1 listed)
- Impossibility to measure depth of anesthesia or invasive blood pressure. Impossibility of using glucose monitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose
Time frame: Every 5 minutes during 3 days.
The glucose will be measured by a continuous glucose monitor. For the group of patients for diabetes. Note: This protocol has three primary outputs because its objective is to create a database of each output to analyze the response to the associated drug (insulin, propofol and sodium nitroprusside.
Bispectral Index
Time frame: Every second during surgery
Depth of anesthesia will be measured by a Bispectral Index monitor.
Invasive blood pressure
Time frame: Every 5 minutes during surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ana Gallardo, Dr principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Hypertension, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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 Mexico. 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?
Results are not available in the source record.
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?
Glucose (time frame: Every 5 minutes during 3 days.). The study lists 3 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 6 Aug 2020.