Diabetes MellitusDRIVE-PeriopNCT04033705
DRIVE - Perioperative Period
An observational study of Diabetes Mellitus and Surgical Procedure, Unspecified, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study will investigate if the HbA1c result before surgery which assesses glucose control over the longer term, can accurately predict what happens to the glucose levels and glucose profile following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Surgical Procedure, Unspecified
- What is being tested?
- Freestyle Libre Pro glucose sensor
- Type of treatment
- Medical device
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jun 2019to 27 Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 diabetes who are undergoing elective primary total hip or knee replacement surgery at Queen Alexandra Hospital.
Who may be able to join
- Diagnosed with type 2 diabetes (on diet, oral, injectable and / or insulin therapy for diabetes)
- Be scheduled for primary elective hip or knee replacement surgery at Queen Alexandra Hospital
- Willing and able to give informed consent for participation in the study
Who cannot join
- Enrolled in another study that may affect glycaemic control over the 4-6 week period of active data collection with the sensor
- Taking oral steroids for longer than 2 weeks that incorporates the 4-6 week period of active data collection with the sensor
- Currently pregnant or planning pregnancy
- On dialysis
- Taking antipsychotic medication
- Non primary surgery (including emergency or revision surgery)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO63LY
About this study
Official title: To Explore the Association Between Preoperative Indicators of Glycaemic Control and Perioperative Glycaemia Associated Risk in Patients With Type 2 Diabetes Undergoing Elective Orthopaedic Surgery Using Continuous Glucose Monitoring
This study will investigate if the HbA1c result before surgery which assesses glucose control over the longer term, can accurately predict what happens to the glucose levels and glucose profile following surgery. This will be recorded using continuous glucose monitoring sensors which are worn by participants pre and post elective surgery.
Read the detailed description
The research question addressed in this study is how preoperative markers of diabetes control correspond with the fluctuations in glucose levels which occur around surgery measured using continuous glucose monitoring (CGM). At present a HbA1c blood test prior to surgery is routinely used to infer the surgical risk associated with a person's glucose levels. HbA1c gives a measure of average blood glucose levels over the preceding 2-3 months and the joint British diabetes society guidelines recommend aiming for an HbA1c of 69mmol/mol or less before planned surgery.
However the HbA1c does not give a complete picture of a person's diabetes control and the evidence behind this threshold is incomplete. Furthermore due to the physiological stress of surgery and counterregulatory hormone release glucose levels can be more dynamic and unpredictable in this population. With CGM glucose levels are recorded multiple times an hour, revealing glucose variation and the amount of time the person's glucose levels spend above and below the ideal range which is understood to be associated with increased risks. This study aims to examine how such glucose patterns and 'at risk' time periods when glucose levels are outside of the target range correspond with different levels of HbA1c before surgery. This is an important area of study as diabetes is becoming increasingly prevalent in surgical patients and is associated with worse outcomes. Using new technologies to evaluate predictors of such harmful patterns in glucose levels is therefore vital.
Individuals who are eligible for this study are those with type 2 diabetes undergoing elective primary hip or knee replacement surgery. This is an observational study. Participants will wear a Freestyle Libre Pro glucose sensor for 2 weeks before and 2 weeks immediately post their surgery. The investigators will also collect information about participants recovery.
Duration of the study will be up to 8 weeks. The study will take place at Portsmouth Hospital NHS trust.
- Conditions
- Diabetes Mellitus, Surgical Procedure, Unspecified
- Being tested
- Freestyle Libre Pro glucose sensor
- Keywords
- Perioperative, Continuous glucose monitoring, CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre Pro glucose sensorDevice
Participants will wear a Freestyle Libre Pro glucose sensor for approximately 2 weeks prior to elective surgery and then for 2 weeks following surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
The time spent within, above and below the target glucose range (4-10mmol/L) in the preoperative period
The percentage of time spent within and outside of the target glucose range recorded by the glucose sensor
Measured: At week 2 following enrollment (this is pre surgery)
The time spent within, above and below the target glucose range (4-10mmol/L) in the post operative period
The percentage of time spent within and outside of the target glucose range recorded using the glucose sensor
Measured: At week 4 following enrollment (this is post surgery)
Secondary outcomes (2)
Length of hospital stay
The number of days between hospital admission for elective surgery and the date of discharge
Measured: This will be recorded at 2 weeks post surgery
Post operative infections
Investigators will record if the participant required antibiotics for infection from any source additional to those routinely prescribed as per hospital policy for the procedure
Measured: This will be recorded at 6 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start11 Jun 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Kate Millar, MBChB, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04033705
- Sponsor's protocol ID
- PHT/2019/23
- Acronym
- DRIVE-Periop
- Status last verified
- Apr 2023
- First submitted
- 1 Jul 2019
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Explore the Association Between Preoperative Indicators of Glycaemic Control and Perioperative Glycaemia Associated Risk in Patients With Type 2 Diabetes Undergoing Elective Orthopaedic Surgery Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT04033705
- Acronym / sponsor ID
- DRIVE-Periop / PHT/2019/23
- Conditions
- Diabetes Mellitus, Surgical Procedure, Unspecified
- Keywords
- Perioperative, Continuous glucose monitoring, CGM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 26 Jul 2019 (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.
This study will investigate if the HbA1c result before surgery which assesses glucose control over the longer term, can accurately predict what happens to the glucose levels and glucose profile following surgery. This will be recorded using continuous glucose monitoring sensors which are worn by participants pre and post elective surgery.
Detailed description
The research question addressed in this study is how preoperative markers of diabetes control correspond with the fluctuations in glucose levels which occur around surgery measured using continuous glucose monitoring (CGM). At present a HbA1c blood test prior to surgery is routinely used to infer the surgical risk associated with a person's glucose levels. HbA1c gives a measure of average blood glucose levels over the preceding 2-3 months and the joint British diabetes society guidelines recommend aiming for an HbA1c of 69mmol/mol or less before planned surgery.
However the HbA1c does not give a complete picture of a person's diabetes control and the evidence behind this threshold is incomplete. Furthermore due to the physiological stress of surgery and counterregulatory hormone release glucose levels can be more dynamic and unpredictable in this population. With CGM glucose levels are recorded multiple times an hour, revealing glucose variation and the amount of time the person's glucose levels spend above and below the ideal range which is understood to be associated with increased risks. This study aims to examine how such glucose patterns and 'at risk' time periods when glucose levels are outside of the target range correspond with different levels of HbA1c before surgery. This is an important area of study as diabetes is becoming increasingly prevalent in surgical patients and is associated with worse outcomes. Using new technologies to evaluate predictors of such harmful patterns in glucose levels is therefore vital.
Individuals who are eligible for this study are those with type 2 diabetes undergoing elective primary hip or knee replacement surgery. This is an observational study. Participants will wear a Freestyle Libre Pro glucose sensor for 2 weeks before and 2 weeks immediately post their surgery. The investigators will also collect information about participants recovery.
Duration of the study will be up to 8 weeks. The study will take place at Portsmouth Hospital NHS trust.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 diabetes who are undergoing elective primary total hip or knee replacement surgery at Queen Alexandra Hospital.
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes (on diet, oral, injectable and / or insulin therapy for diabetes)
- Be scheduled for primary elective hip or knee replacement surgery at Queen Alexandra Hospital
- Willing and able to give informed consent for participation in the study
Key exclusion criteria (6 listed)
- Enrolled in another study that may affect glycaemic control over the 4-6 week period of active data collection with the sensor
- Taking oral steroids for longer than 2 weeks that incorporates the 4-6 week period of active data collection with the sensor
- Currently pregnant or planning pregnancy
- On dialysis
- Taking antipsychotic medication
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 |
|---|---|---|
| Freestyle Libre Pro glucose sensorParticipants will wear a Freestyle Libre Pro glucose sensor for approximately 2 weeks prior to elective surgery and then for 2 weeks following surgery. | Device | – |
Primary outcome
The time spent within, above and below the target glucose range (4-10mmol/L) in the preoperative period
Time frame: At week 2 following enrollment (this is pre surgery)
The percentage of time spent within and outside of the target glucose range recorded by the glucose sensor
The time spent within, above and below the target glucose range (4-10mmol/L) in the post operative period
Time frame: At week 4 following enrollment (this is post surgery)
The percentage of time spent within and outside of the target glucose range recorded using the glucose sensor
2 secondary outcomes
Length of hospital stay
Time frame: This will be recorded at 2 weeks post surgery
Post operative infections
Time frame: This will be recorded at 6 weeks post surgery
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 7 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Kate Millar, MBChB principal investigator
Portsmouth Hospitals NHS Trust
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 Mellitus and Surgical Procedure, Unspecified, run by Portsmouth Hospitals NHS Trust 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 3 inclusion and 6 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 7 Apr 2023. 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?
The time spent within, above and below the target glucose range (4-10mmol/L) in the preoperative period (time frame: At week 2 following enrollment (this is pre surgery)). The study lists 2 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 7 Apr 2023.