DRIVE - Perioperative Period (DRIVE-Periop)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Surgical Procedure, Unspecified
• Intervention / Treatment: Device: Freestyle Libre Pro glucose sensor

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 Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

• Study Contact: Name: Kate Millar, MBChB; Phone Number: 5965 +442392286000; Email: kate.millar@porthosp.nhs.uk
• Study Contact Backup: Name: Michael Cummings, FRCP; Phone Number: 6260 +442392286000; Email: Michael.cummings@porthosp.nhs.uk

Study Locations

• United Kingdom
  • Hampshire
    • Portsmouth, Hampshire, United Kingdom, PO63LY
      • Portsmouth Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes who are undergoing elective primary total hip or knee replacement surgery at Queen Alexandra Hospital.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	At week 4 following enrollment (this is post surgery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	The number of days between hospital admission for elective surgery and the date of discharge	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	This will be recorded at 6 weeks post surgery

Collaborators and Investigators

• Sponsor: Portsmouth Hospitals NHS Trust
• Investigators: Principal Investigator: Kate Millar, MBChB, Portsmouth Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 25, 2019
• First Posted (Actual): July 26, 2019

Study Record Updates

• Last Update Posted (Actual): April 7, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Perioperative; CGM; Continuous glucose monitoring
• Other Study ID Numbers: PHT/2019/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No