Diabetes Mellitus, Type 2, Surgical Site Infection
Conditions
Keywords
Diabetes Mellitus, Basal bolus regimen, Surgical site infections, Sliding scale, Insulin regimen
Brief summary
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.
Detailed description
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
Interventions
OTHERBasal bolus insulin regimen
Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively
Sponsors
ZonMw: The Netherlands Organisation for Health Research and Development
Abraham Hulst, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Multicenter, matched, cluster-randomised
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 or older * Diagnosed with type 2 diabetes mellitus * Undergoing gastointestinal or vascular surgery * Admitted to one of the participating surgical wards * Expected duration of stay at least one overnight stay * Willing and able to provide informed consent
Exclusion criteria
* Diagnosed with type 1 diabetes mellitus * Female of child-bearing potential who is pregnant or breastfeeding. * Undergoing complete pancreatectomy * Undergoing bariatric surgery * Patients using a continuous insulin pump at home * Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical site infection | Until 30 days after surgery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in the hospital (LoS-Hos) | Recorded at 30 days postoperatively | Length of stay in the hospital, measured in days from admission to discharge from the hospital. |
| Hospital readmission | Recorded 30 days postoperatively | Rate of hospital readmissions within 30 days after surgery |
| Days at home (DAH30) | Recorded 30 days postoperatively | Patient-reported number of days at home after surgery, between 0 and 30. |
| Postoperative disability | Recorded 30 days postoperatively | Patient-reported level of disability 30 days after surgery, using the WHODAS-2.0 questionnaire. Summarized in a score between 0-100. |
| Quality of life (QoL) after surgery | Recorded 30 days postoperatively | Patient-reported health-related quality of life 30 days after surgery, using the EuroQol 5D5L questionnaire, summarized in a score between 0 and 1. |
| Glucose 2 | Measured 4 times a day, until discharge from the hospital, up to 30 days. | Incidence of grade 2 hypoglycemia, a blood glucose below 3.0mmol/L. |
| Glucose 3 | Measured 4 times a day, until discharge from the hospital, up to 30 days. | Incidence of grade 1 hyperglycemia, a blood glucose above 10.0mmol/L. |
| Postoperative hospital-acquired infections (non-SSI) | Recorded at 30 days postoperatively | Incidence of hospital-acquired infections, other than surgical site infections |
| CGM1 | Measured with a 5-minute interval, until discharge from the hospital, up to 30 days. | 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). |
| CGM2 | Measured with a 5-minute interval, until discharge from the hospital, up to 30 days. | 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). |
| CGM3 | Measured with a 5-minute interval, until discharge from the hospital, up to 30 days. | 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). |
| Cost-effectiveness 1 | Until 30 days after surgery | 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. |
| Cost-effectiveness 2 | Up to 30 days after surgery. | The number of quality adjusted life years (QALYs) gained after a cost-utility analysis. |
| Protocol adherence | During the hospital stay, until discharge | The adherence to the protocol until discharge from the hospital |
| Glucose 4 | Measured 4 times a day, until discharge from the hospital, up to 30 days. | Incidence of grade 2 hyperglycemia, a blood glucose above 14.0mmol/L. |
Countries
Netherlands
Contacts
Primary ContactAyla Y. Stobbe, MD
Backup ContactSarah E. Siegelaar, MD, PhD
Outcome results
None listed