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

Abraham Hulst, MD, PhD

Status: Enrolling

Conditions: Surgical Site Infection; Diabetes Mellitus, Type 2

Treatments: Other: Basal bolus insulin regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT06638567

GUIDE trial

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,008 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,008 participants in 2 patient groups

Basal Bolus

Experimental group

Description:

Patients daily dose of insulin is calculated by their treatment team: In insulin naive patients 0.4-0.5IU/kg and 0,3IU/kg for patients aged\>70 or patients with impaired kidney function with an estimated glucose filtration rate \<60ml/min and 80-100% of own insulin for insulin-users. They receive half of this daily dose in long-acting insulin once a day. The other half of their total daily dose of insulin is provided as short-acting mealtime insulin. This short-acting insulin is administered before each meal. When needed, extra insulin can be given when needed. The measurements of blood glucose values are before each meal and at bedtime (4x/day).

Treatment:

Other: Basal bolus insulin regimen

Sliding Scale

No Intervention group

Description:

Short-acting insulin is administered when blood glucose value is above 10,0 mmol/L according to a standardized dosage schedule. The measurements of blood glucose values are before each meal and at bedtime (4x/day).