DRIVE - Perioperative
Research type
Research Study
Full title
How do preoperative indicators of glycaemic control describe glycaemia associated risk in the perioperative period measured using continuous glucose monitoring in patients with type 2 diabetes undergoing elective orthopaedic surgery.
IRAS ID
256731
Contact name
Michael Cummings
Contact email
Sponsor organisation
Portsmouth Hospitals NHS Trust
Duration of Study in the UK
1 years, 3 months, 1 days
Research summary
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 an 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.
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 we know from recent research is associated itself 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. We will also collect information about their recovery. Duration of the study will be up to 8 weeks. The study will take place at Portsmouth Hospital NHS trust.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0205
Date of REC Opinion
22 May 2019
REC opinion
Further Information Favourable Opinion