Diabetes MellitusNCT04679025
Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital
An observational study of Diabetes Mellitus and Surgery, run by University of Calgary at 1 site in Canada.
Trial summary
Patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Surgery, Hyperglycemia
- What is being tested?
- Exposure - postoperative hyperglycemia
- How many people
- 7,633 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2019to 31 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients undergoing a surgical procedure at the Foothills Medical Centre who were admitted for at least 24-hours.
Who may be able to join
- Underwent inpatient surgical procedure at the Foothills Medical Centre between Apr 1 2019 and March 31 2020
- Stayed in hospital for more than 24-hours after surgery
Who cannot join
- Younger than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital: A Cross-sectional, Exploratory Study
Patients with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care.
This cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin A1c measurement, postoperative point-of-care testing for glucose (POCT), had hyperglycemia, and received basal bolus insulin regimens for treatment. We performed an exploratory analysis comparing length of stay (LOS) in patients with and without diabetes who had and did not have postoperative hyperglycemia.
- Conditions
- Diabetes Mellitus, Surgery, Hyperglycemia
- Being tested
- Exposure - postoperative hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure - postoperative hyperglycemiaOther
Postoperative hyperglycemia (blood or capillary glucose > 10.0 mmol/L) within 72 hours of a surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Diabetes with postoperative hyperglycemia | Patients with known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who had postoperative hyperglycemia (point of care test > 10.0 mmol/L). Receives: Other: Exposure - postoperative hyperglycemia | |
| Diabetes without postoperative hyperglycemia | Patients with known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who did not have postoperative hyperglycemia (point of care test > 10.0 mmol/L). | |
| No diabetes with postoperative hyperglycemia | Patients without known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who had postoperative hyperglycemia (point of care test > 10.0 mmol/L). Receives: Other: Exposure - postoperative hyperglycemia | |
| No diabetes and no postoperative hyperglycemia | Patients without known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who did not have postoperative hyperglycemia (point of care test > 10.0 mmol/L). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of point of care blood glucose measurements in 24-hours after surgery
Measured: 24-hours post surgery
Proportion of patients who have hyperglycemia
blood or capillary glucose > 10 mmol/L
Measured: 24-hours after surgery
Secondary outcomes (3)
Proportion of patients who have moderate hyperglycemia
blood or capillary glucose 14.0-17.9 mmol/L
Measured: 24-hours after surgery
Proportion of patients who have severe hyperglycemia
blood or capillary glucose > 18.0 mmol/L
Measured: 24-hours after surgery
Hospital Length of stay
Hospital length of stay (days)
Measured: Until study completion (up to one year from surgical procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Apr 2019
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 7,633 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shannon Ruzycki, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04679025
- Sponsor's protocol ID
- HREBA.CC-19-0157
- Status last verified
- Dec 2020
- First submitted
- 11 Dec 2020
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data is available from the study principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Gaps in Screening and Monitoring for Postoperative Hyperglycemia in a Canadian Hospital: A Cross-sectional, Exploratory Study
- ClinicalTrials.gov ID
- NCT04679025
- Acronym / sponsor ID
- HREBA.CC-19-0157
- Conditions
- Diabetes Mellitus, Surgery, Hyperglycemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,633 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 22 Dec 2020 (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 with and without diabetes who have postoperative hyperglycemia have worse outcomes than patients with in-target blood sugars. Previous quality improvement work suggests numerous barriers and clinical inertia may contribute to quality gaps in glycemic management for surgical patients. Using a framework for perioperative glycemic management, we sought to measure quality gaps in perioperative glycemic care.
This cross-sectional study used administrative data to measure the proportion of surgical patients with and without known diabetes who underwent preoperative hemoglobin A1c measurement, postoperative point-of-care testing for glucose (POCT), had hyperglycemia, and received basal bolus insulin regimens for treatment. We performed an exploratory analysis comparing length of stay (LOS) in patients with and without diabetes who had and did not have postoperative hyperglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetes with postoperative hyperglycemia | – | Other: Exposure - postoperative hyperglycemiaPatients with known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who had postoperative hyperglycemia (point of care test > 10.0 mmol/L). |
| Diabetes without postoperative hyperglycemia | – | –Patients with known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who did not have postoperative hyperglycemia (point of care test > 10.0 mmol/L). |
| No diabetes with postoperative hyperglycemia | – | Other: Exposure - postoperative hyperglycemiaPatients without known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who had postoperative hyperglycemia (point of care test > 10.0 mmol/L). |
| No diabetes and no postoperative hyperglycemia | – | –Patients without known diabetes (Discharge Abstract Database or hemoglobin A1c > 6.5%) who did not have postoperative hyperglycemia (point of care test > 10.0 mmol/L). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing a surgical procedure at the Foothills Medical Centre who were admitted for at least 24-hours.
Key inclusion criteria (2 listed)
- Underwent inpatient surgical procedure at the Foothills Medical Centre between Apr 1 2019 and March 31 2020
- Stayed in hospital for more than 24-hours after surgery
Key exclusion criteria (1 listed)
- Younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure - postoperative hyperglycemiaPostoperative hyperglycemia (blood or capillary glucose > 10.0 mmol/L) within 72 hours of a surgical procedure | Other | Diabetes with postoperative hyperglycemia, No diabetes with postoperative hyperglycemia |
Primary outcome
Number of point of care blood glucose measurements in 24-hours after surgery
Time frame: 24-hours post surgery
Proportion of patients who have hyperglycemia
Time frame: 24-hours after surgery
blood or capillary glucose > 10 mmol/L
3 secondary outcomes
Proportion of patients who have moderate hyperglycemia
Time frame: 24-hours after surgery
Proportion of patients who have severe hyperglycemia
Time frame: 24-hours after surgery
Hospital Length of stay
Time frame: Until study completion (up to one year from surgical procedure)
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 22 Dec 2020.
- Individual participant dataSharing planned: Yes. Data is available from the study principal investigator upon reasonable request.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Diabetes Mellitus and Surgery, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 1 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 22 Dec 2020. 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 Canada. 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?
Number of point of care blood glucose measurements in 24-hours after surgery (time frame: 24-hours post surgery). The study lists 2 primary outcomes in all. 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 22 Dec 2020.