Perioperative MedicineNCT07349199
Adherence to Clinical Guidelines on Perioperative Diabetes Care
An observational study of Perioperative Medicine and Diabetes (DM), run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative Medicine, Diabetes (DM), Diabetes Mellitus
- How many people
- 13,920 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 1 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 .
Who may be able to join
- Adults 18 years of age or older
- Type 1 or Type 2 diabetes mellitus requiring glucose-lowering medication
- Non-cardiac surgery lasting min. 1hour
Who cannot join
- Patients using insulin pump
- Planned surgery for pancreatectomy (complete or partial)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark
Copenhagen, 2400
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adults with type 1 or type 2 diabetes mellitus undergoing non-cardiac surgery >1 hour duration | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: Day 1 (defined as discharge from the post-anaesthesia care unit) until discharge from the surgical ward, up to 30 days postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start1 Jan 2017
- Primary completion31 Jan 2025
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative MedicineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Bispebjerg and Frederiksberg
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital
- Responsible party
- Principal investigator, Casper Pedersen, University Hospital Bispebjerg and Frederiksberg
- Investigators
- Christian S Meyhoff, Study chair, Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349199
- Sponsor's protocol ID
- R-25014694
- Status last verified
- Jun 2026
- First submitted
- 8 Jan 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Clinical Guidelines on Perioperative Diabetes Care in Hospitalised Patients. A Retrospective Cohort Study.
- ClinicalTrials.gov ID
- NCT07349199
- Acronym / sponsor ID
- R-25014694
- Conditions
- Perioperative Medicine, Diabetes (DM), Diabetes Mellitus
- Keywords
- Diabetic care, Perioperative medicine, Guidelines adherence, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,920 participants (actual)
- Lead sponsor
- University Hospital Bispebjerg and FrederiksbergUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Copenhagen, Steno Diabetes Center Sjaelland, Copenhagen University Hospital, Rigshospitalet, Bispebjerg Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with type 1 or type 2 diabetes mellitus undergoing non-cardiac surgery >1 hour duration | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 .
Key inclusion criteria (3 listed)
- Adults 18 years of age or older
- Type 1 or Type 2 diabetes mellitus requiring glucose-lowering medication
- Non-cardiac surgery lasting min. 1hour
Key exclusion criteria (2 listed)
- Patients using insulin pump
- Planned surgery for pancreatectomy (complete or partial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Frequency of missing insulin 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.
Frequency of insufficient 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian S Meyhoff study chair
Department of Anaesthesia and Intensive Care, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Medicine and Diabetes (DM), run by University Hospital Bispebjerg and Frederiksberg at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.