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NCT Number: NCT06638567

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Infections Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Surgical Site Infection Surgical Wound Infection Wound Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basal bolus insulin regimen

Other

Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively

Primary outcomes

  1. Surgical site infection

    Time frame: 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 outcomes

  1. Postoperative hospital-acquired infections (non-SSI)

    Time frame: Recorded at 30 days postoperatively

    Incidence of hospital-acquired infections, other than surgical site infections

  2. Length of stay in the hospital (LoS-Hos)

    Time frame: Recorded at 30 days postoperatively

    Length of stay in the hospital, measured in days from admission to discharge from the hospital.

  3. Hospital readmission

    Time frame: Recorded 30 days postoperatively

    Rate of hospital readmissions within 30 days after surgery

  4. Days at home (DAH30)

    Time frame: Recorded 30 days postoperatively

    Patient-reported number of days at home after surgery, between 0 and 30.

  5. Postoperative disability

    Time frame: 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.

  6. Quality of life (QoL) after surgery

    Time frame: 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.

  7. Glucose 2

    Time frame: 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.

  8. Glucose 3

    Time frame: 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.

  9. Glucose 4

    Time frame: 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.

  10. CGM1

    Time frame: 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).

  11. CGM2

    Time frame: 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).

  12. CGM3

    Time frame: 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).

  13. Cost-effectiveness 1

    Time frame: 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.

  14. Cost-effectiveness 2

    Time frame: Up to 30 days after surgery.

    The number of quality adjusted life years (QALYs) gained after a cost-utility analysis.

  15. Protocol adherence

    Time frame: During the hospital stay, until discharge

    The adherence to the protocol until discharge from the hospital

Study contacts

Contact information is provided by the study sponsor or research team.

Ayla Y. Stobbe, MD

CONTACT

[email protected]

0031205669111

Sarah E. Siegelaar, MD, PhD

CONTACT

[email protected]

0031205669111

Sponsors and collaborators

Lead sponsor

Abraham Hulst, MD, PhD

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study 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.

Acronym: GUIDE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 15, 2024
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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