Postoperative Basal Bolus or Sliding Scale Insulin Regimen in DM2 and Its Effect on Surgical Site Infections.

Last updated: January 28, 2025
Sponsor: Abraham Hulst, MD, PhD
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 2

Diabetes Prevention

Diabetes And Hypertension

Treatment

Basal bolus insulin regimen

Clinical Study ID

NCT06638567
GUIDE trial
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 1008
Treatment Group(s): 1
Primary Treatment: Basal bolus insulin regimen
Phase:
Study Start date:
January 03, 2025
Estimated Completion Date:
September 30, 2027

Study 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

Connect with a study center

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

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