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

January 28, 2025 updated by: Abraham Hulst, MD, PhD

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

1008

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Basal Bolus

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).
Other: Basal bolus insulin regimen
Combination of long-acting and short-acting insulin in a proactive schedule for achieving better blood glucose values postoperatively
No Intervention: Sliding Scale
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Until 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hospital-acquired infections (non-SSI)
Time Frame: Recorded at 30 days postoperatively
Incidence of hospital-acquired infections, other than surgical site infections
Recorded at 30 days postoperatively
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.
Recorded at 30 days postoperatively
Hospital readmission
Time Frame: Recorded 30 days postoperatively
Rate of hospital readmissions within 30 days after surgery
Recorded 30 days postoperatively
Days at home (DAH30)
Time Frame: Recorded 30 days postoperatively
Patient-reported number of days at home after surgery, between 0 and 30.
Recorded 30 days postoperatively
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.
Recorded 30 days postoperatively
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.
Recorded 30 days postoperatively
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.
Measured 4 times a day, until discharge from the hospital, up to 30 days.
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.
Measured 4 times a day, until discharge from the hospital, up to 30 days.
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.
Measured 4 times a day, until discharge from the hospital, up to 30 days.
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).
Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
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).
Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
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).
Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.
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.
Until 30 days after surgery
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.
Up to 30 days after surgery.
Protocol adherence
Time Frame: During the hospital stay, until discharge
The adherence to the protocol until discharge from the hospital
During the hospital stay, until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abraham Hulst, MD, PhD

Collaborators

ZonMw: The Netherlands Organisation for Health Research and Development

Investigators

  • Principal Investigator: Sarah E. Siegelaar, MD, PhD, Amsterdam UMC, location AMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2025

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

March 10, 2024

First Submitted That Met QC Criteria

October 10, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GUIDE trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Complete data collection methods and results will be shared with other researchers upon a formal request made to the principal investigator including a detailed motivation for the request.

IPD Sharing Time Frame

One year after reviewed publication of the primary results

IPD Sharing Access Criteria

Official request to the principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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