A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI). The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen. Adult patients with type 2 diabetes will be included in this multi-centre study. Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery. Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation. Participants will be monitored intensively and insulin dosage will be adjusted adequately to the measured glucose values by the treatment team. The sample size is based on the SSI incidence rates. Wards are matched into pairs with comparable baseline incidence rates and in each pair, one ward will be randomly assigned to the intervention group; the other serves as the control. 18 wards from 8 participating centres are planned to be recruited, this translates to 9x2x56=1008 evaluable participants. Keywords: Diabetes mellitus, basal bolus, sliding scale, insulin regimen, surgical site infections
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,008
Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively
Amsterdam UMC
Amsterdam, Netherlands
RECRUITINGSurgical site infection
Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI. SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.
Time frame: Until 30 days after surgery
Postoperative hospital-acquired infections (non-SSI)
Incidence of hospital-acquired infections, other than surgical site infections
Time frame: Recorded at 30 days postoperatively
Length of stay in the hospital (LoS-Hos)
Length of stay in the hospital, measured in days from admission to discharge from the hospital.
Time frame: Recorded at 30 days postoperatively
Hospital readmission
Rate of hospital readmissions within 30 days after surgery
Time frame: Recorded 30 days postoperatively
Days at home (DAH30)
Patient-reported number of days at home after surgery, between 0 and 30.
Time frame: Recorded 30 days postoperatively
Postoperative disability
Patient-reported level of disability 30 days after surgery, using the WHODAS-2.0 questionnaire. Summarized in a score between 0-100.
Time frame: Recorded 30 days postoperatively
Quality of life (QoL) after surgery
Patient-reported health-related quality of life 30 days after surgery, using the EuroQol 5D5L questionnaire, summarized in a score between 0 and 1.
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Time frame: Recorded 30 days postoperatively
Glucose 2
Incidence of grade 2 hypoglycemia, a blood glucose below 3.0mmol/L.
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 3
Incidence of grade 1 hyperglycemia, a blood glucose above 10.0mmol/L.
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
Glucose 4
Incidence of grade 2 hyperglycemia, a blood glucose above 14.0mmol/L.
Time frame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
CGM1
Percentage of time within glycaemic target range (3.9-10.0 mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM2
Percentage of time below glycaemic target range (\<3.9mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
CGM3
Percentage of time above glycaemic target range (\>10.0mmol/L) per day and over hospital admission. This is measured with the continuous glucose monitor (CGM).
Time frame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
Cost-effectiveness 1
The cost-effectiveness of the basal bolus insulin regimen compared to the sliding scale regimen, considering the costs per prevented of SSI in a cost-effectiveness analysis.
Time frame: Until 30 days after surgery
Cost-effectiveness 2
The number of quality adjusted life years (QALYs) gained after a cost-utility analysis.
Time frame: Up to 30 days after surgery.
Protocol adherence
The adherence to the protocol until discharge from the hospital
Time frame: During the hospital stay, until discharge