Adherence to Clinical Guidelines on Perioperative Diabetes Care

Adherence to Clinical Guidelines on Perioperative Diabetes Care in Hospitalised Patients. A Retrospective Cohort Study.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Diabetes Mellitus; Perioperative Medicine; Diabetes (DM)

• Study Type: Observational
• Enrollment (Estimated): 22000

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The population consists of patients living with diabetes mellitus requiring glucose-lowering medication who undergo surgery in the period from Janurary 1st, 2017 to Janurary 1st, 2023 across hospitals in two regions of Denmark - the Capital Region and the Zealand Region of Denmark .

Description

Inclusion Criteria:

• Adults 18 years of age or older
• Type 1 or Type 2 diabetes mellitus requiring glucose-lowering medication
• Non-cardiac surgery lasting min. 1hour

Exclusion Criteria:

• Patients using insulin pump
• Planned surgery for pancreatectomy (complete or partial)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adults with type 1 or type 2 diabetes mellitus undergoing non-cardiac surgery >1 hour duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of correct insulin dose administration for hyperglycaemia	The proportion of hyperglycaemic events in which the recommended insulin dose, according to the interregional guideline, is administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.	Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of missing insulin administration for hyperglycaemia	The proportion of hyperglycaemic events in which the recommended insulin dose, according to the interregional guideline, is NOT administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.	Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.
Frequency of insufficient insulin dose administration for hyperglycaemia	The proportion of hyperglycaemic events in which a lower insulin dose than the recommended insulin dose, according to the interregional guideline, is administered. Correct dosing is defined as administration of the guideline-recommended dose of rapid-acting insulin (international units [IU], whole numbers) from 15 min. prior to 1 hour after detection of hyperglycaemia.	Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of hospital stay	Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (postopertaive length of hospital stay, assessed in days)	Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge
ICU admission	Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (admission to an intensive care unit after surgery)	Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30
All-cause mortality	Exploratory clinical outcome assessing non-adherent hyperglycaemia managment as an exposure of the outcome (all-cause mortality)	Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30

Collaborators and Investigators

• Sponsor: University Hospital Bispebjerg and Frederiksberg
• Collaborators: Rigshospitalet, Denmark; Bispebjerg Hospital; Steno Diabetes Center Copenhagen; Steno Diabetes Center Sjaelland
• Investigators: Study Chair: Christian S Meyhoff, Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): February 1, 2023
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 8, 2026
• First Submitted That Met QC Criteria: January 8, 2026
• First Posted (Actual): January 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Perioperative medicine; Guidelines adherence; Diabetic care
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus
• Other Study ID Numbers: R-25014694

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No