Clinical trial NCT06638567: Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.
Official title: Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Surgical Site Infection
Keywords: Diabetes Mellitus
Basal bolus regimen
Surgical site infections
Sliding scale
Insulin regimen
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-10-15
Enrollment: 1008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, matched, cluster-randomised
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Surgical site infection
timeFrame: Until 30 days after surgery
Secondary outcomes:
measure: Postoperative hospital-acquired infections (non-SSI)
timeFrame: Recorded at 30 days postoperatively
measure: Length of stay in the hospital (LoS-Hos)
timeFrame: Recorded at 30 days postoperatively
measure: Hospital readmission
timeFrame: Recorded 30 days postoperatively
measure: Days at home (DAH30)
timeFrame: Recorded 30 days postoperatively
measure: Postoperative disability
timeFrame: Recorded 30 days postoperatively
measure: Quality of life (QoL) after surgery
timeFrame: Recorded 30 days postoperatively
measure: Glucose 2
timeFrame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
measure: Glucose 3
timeFrame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
measure: Glucose 4
timeFrame: Measured 4 times a day, until discharge from the hospital, up to 30 days.
measure: CGM1
timeFrame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
measure: CGM2
timeFrame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
measure: CGM3
timeFrame: Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
measure: Cost-effectiveness 1
timeFrame: Until 30 days after surgery
measure: Cost-effectiveness 2
timeFrame: Up to 30 days after surgery.
measure: Protocol adherence
timeFrame: During the hospital stay, until discharge
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
Study officials:
affiliation: Amsterdam UMC, location AMC
name: Sarah E. Siegelaar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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