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Clinical Trials/NCT07349199
NCT07349199CompletedNot Applicable

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

University Hospital Bispebjerg and Frederiksberg1 site in 1 country13,920 target enrollmentStarted: January 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
13,920
Locations
1
Primary Endpoint
Frequency of correct insulin dose administration for hyperglycaemia

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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)

Arms & Interventions

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

Outcomes

Primary Outcomes

Frequency of correct insulin dose administration for hyperglycaemia

Time Frame: Day 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 Outcomes

  • 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.)

Investigators

Sponsor
University Hospital Bispebjerg and Frederiksberg
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Casper Pedersen

MD, PhD student

University Hospital Bispebjerg and Frederiksberg

Study Sites (1)

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