Adherence to Clinical Guidelines on Perioperative Diabetes Care

NCT07349199 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 22000

Last updated 2026-03-17

No results posted yet for this study

Summary

Patients who undergo major surgery face a 15-30% risk of serious adverse events, including a 1-5% mortality risk in the first month after surgery. For patients with diabetes, the risk is even greater, and it is often aggravated by complications associated with hyper- and hypoglycaemia. Complications, such as wound infections, cardiovascular, and neurological events, not only affect patients negatively, but it challenges health care systems due to prolonged length of stays and increased need of care post-discharge.

Several factors make it particularly difficult to establish glycaemic control and stable blood sugar in patients with diabetes. Patients' usual glucose-lowering medications are often paused, and fasting is required at least six hours prior to the operation. Surgery induces a post-surgical stress response that may include both stress-hyperglycaemia and reduced gastrointestinal function. Furthermore, a patient's usual symptoms of hyper- and hypoglycaemia may be altered due to the anaesthetics.

The existing guidelines on perioperative diabetic care include recommendations on treatment and glucose monitoring from the preoperative fasting period to the postoperative phase where oral intake of food and drinks can be resumed. Intravenous glucose-insulin infusions are used during preoperative fasting, intraoperatively and postoperatively until patients can resume oral intake of food and drinks. After this, subcutaneous insulin administrations following the sliding scale insulin regimen are administered to the patients to treat hyperglycaemia and supplemental glucose (perorally or intravenously) in case of hypoglycaemia. The blood sugar levels are monitored via point-of-care (POC) blood glucose tests every hour during glucose-insulin infusions and four to six times daily in the postoperative period.

In spite of these guidelines, prospective studies have shown that blood glucose levels are outside the normal range in 40-60% of the time following major surgery, and usually due to hyperglycaemia.

In this registry study, we investigated how guidelines for perioperative diabetes care were implemented in Danish hospitals from 2017-2023. The primary hypothesis was that, in the 20% of cases with detected hyperglycaemia, insufficient insulin was provided thus not following exiting guidelines.

Conditions

Sponsors & Collaborators

  • Steno Diabetes Center Copenhagen

    collaborator OTHER
  • Steno Diabetes Center Sjaelland

    collaborator OTHER_GOV
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Bispebjerg Hospital

    collaborator OTHER
  • University Hospital Bispebjerg and Frederiksberg

    lead OTHER

Principal Investigators

  • Christian S Meyhoff · Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2023-02-01
Completion
2026-06-01

Countries

  • Denmark

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07349199 on ClinicalTrials.gov