Adherence to Clinical Guidelines on Perioperative Diabetes Care

NCT07349199 | Active Not Recruiting

• 1 other identifier: R-25014694
• Study Type: observational
• Target: 22,000
• Locations: 1 country
• Sites: 1

Brief 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

Perioperative Medicine; Diabetes (DM); Diabetes Mellitus

Keywords

Diabetic care; Perioperative medicine; Guidelines adherence; Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Frequency of missing insulin administration for 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

  Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.

Other Outcomes (3)

• Postoperative length of hospital stay

  Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge

• ICU admission

  Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30

• All-cause mortality

  Day 1 (defined as discharge from the post-anaesthesia care unit) until Day 30

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 .

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Bispebjerg and Frederiksberg: lead
• Steno Diabetes Center Copenhagen: collaborator
• Steno Diabetes Center Sjaelland: collaborator
• Rigshospitalet, Denmark: collaborator
• Bispebjerg Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Christian S Meyhoff

  Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD student

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 16, 2026
• Study Start: January 1, 2017
• Primary Completion: February 1, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)