Skip to main content
OpenTrials
Completed

NCT Number: NCT04033705

DRIVE - Perioperative Period

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Portsmouth Hospitals NHS Trust

Portsmouth, Hampshire, PO63LY, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Freestyle Libre Pro glucose sensor

Device

Participants will wear a Freestyle Libre Pro glucose sensor for approximately 2 weeks prior to elective surgery and then for 2 weeks following surgery.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Length of hospital stay

    Time frame: This will be recorded at 2 weeks post surgery

    The number of days between hospital admission for elective surgery and the date of discharge

  2. Post operative infections

    Time frame: This will be recorded at 6 weeks post surgery

    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

Sponsors and collaborators

Lead sponsor

Portsmouth Hospitals NHS Trust

Other Gov

Registry information

Official study 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

Acronym: DRIVE-Periop

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 26, 2019
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.