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Adherence to Clinical Guidelines on Perioperative Diabetes Care

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07349199
Enrollment
13920
Registered
2026-01-16
Start date
2017-01-01
Completion date
2026-06-01
Last updated
2026-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes (DM), Diabetes Mellitus, Perioperative Medicine

Keywords

Diabetic care, Perioperative medicine, Guidelines adherence, Diabetes Mellitus

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.

Interventions

None listed

Sponsors

University Hospital Bispebjerg and Frederiksberg
Lead SponsorOTHER
Steno Diabetes Center Copenhagen
CollaboratorOTHER
Steno Diabetes Center Sjaelland
CollaboratorOTHER_GOV
Rigshospitalet, Denmark
CollaboratorOTHER
Bispebjerg Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Frequency of correct insulin dose administration for hyperglycaemiaDay 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.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.

Secondary

MeasureTime frameDescription
Frequency of missing insulin administration for hyperglycaemiaDay 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.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.
Frequency of insufficient insulin dose administration for hyperglycaemiaDay 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.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.

Countries

Denmark

Contacts

STUDY_CHAIRChristian S Meyhoff

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 25, 2026