DiabetesNCT01824277
DCI: A Community Based Pre-cardiac Surgery Diabetes Care Project
A study testing Structured Pre-operative Diabetes Optimization in people with Diabetes, run by Dr. Rakesh C. Arora at 2 sites in Canada.
Trial summary
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Structured Pre-operative Diabetes Optimization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2013to Jul 2018
- Phase
- Interventional
- 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
Who may be able to join
- Able to speak and understand English
- Age > 18
- Able to provide informed consent
- A1C>7%
- Placed on the waiting list for elective cardiac surgery in Manitoba
Who cannot join
- Progressive cognitive deficit or disease.
- Age < 18
- Unable to provide informed consent
- A1C<7%
- Undergoing emergent cardiac surgery
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Youville Diabetes Center
Winnipeg, Manitoba, R2H 0S8
I.H. AsperInstitute, St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.
The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.
Read the detailed description
This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).
- Conditions
- Diabetes
- Being tested
- Structured Pre-operative Diabetes Optimization
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Pre-operative Diabetes OptimizationOther
Patients will receive structured pre-operative diabetes optimization while they wait for surgery. Patients will be referred to the Youville Diabetes Center where they will undergo preoperative optimization of their diabetes management. This will include in-depth diabetes education and instruction pertaining to lifestyle modification (blood glucose monitoring, nutrition, and physical activity) to improve glycemic control. Pharmacologic therapy will be reviewed by the Youville Diabetes Center certified diabetes nurse educators.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | No intervention | Group 1 - Standard Pre-operative Diabetes Care |
| Group 2 | Experimental | Group 2 - Structured Pre-operative Diabetes Optimization Receives: Other: Structured Pre-operative Diabetes Optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C over the study period.
Measured: Baseline to the patients' 3-months post-operative appointment
Secondary outcomes (2)
Changes to the responses on the validated patient surveys
Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9.
Measured: Baseline to the patients' 3-months post-operative appointment
Changes in the patient perioperative outcomes
Surveys: Audit of Diabetes Quality of Life, Diabetes Treatment Satisfaction Questionnaire, and the SF-12 Health Related Quality of Life Questionnaire, Patient Health Questionnaire-9.
Measured: Baseline to the patients' 3-months post-operative appointment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Rakesh C. Arora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Rakesh C. Arora, St. Boniface Hospital
- Investigators
- Rakesh C Arora, MD, Principal investigator, University of ManitobaSora Ludwig, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824277
- Sponsor's protocol ID
- GRT2012-53
- Status last verified
- Aug 2018
- First submitted
- 31 Mar 2013
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Cardiac Surgery Initiative (DCI): A Community Based Pre-cardiac Surgery Diabetes Care Project
- ClinicalTrials.gov ID
- NCT01824277
- Acronym / sponsor ID
- GRT2012-53
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Dr. Rakesh C. AroraUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 4 Apr 2013 (estimated)
- 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.
The Canadian Diabetes Association recommends optimizing glycemic control to achieve a glycated hemoglobin (A1C) of less than 7% in patients with diabetes. Despite these recommendations, approximately 25% of patients undergoing cardiac surgery have evidence of suboptimal glycemic control (A1C>7%). Recent research has demonstrated that such patients experience a higher rate of post-operative complications and significantly worse short-term and long-term post-operative survival. Therefore, it is recommended that attempts should be made to improve glycemic control while patients wait for their elective surgery. However, at present processes of care that facilitate pre-operative glycemic control optimization do not exist in Canada.
The objective of this project is to determine the feasibility and effectiveness of a comprehensive community-based pre-operative diabetes optimization program for patients awaiting elective cardiac surgery.
Detailed description
This study is a randomized controlled trial and will investigate the feasibility and effectiveness of a pre-operative diabetes optimization program for patients with suboptimal glycemic control awaiting elective cardiac surgery. Consenting patients will be randomized to a Standard Pre-Operative Diabetes Care Group (Group 1) and a Structured Pre-Operative Diabetes Optimization Group (Group 2).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | No intervention | –Group 1 - Standard Pre-operative Diabetes Care |
| Group 2 | Experimental | Other: Structured Pre-operative Diabetes OptimizationGroup 2 - Structured Pre-operative Diabetes Optimization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Able to speak and understand English
- Age > 18
- Able to provide informed consent
- A1C>7%
- Placed on the waiting list for elective cardiac surgery in Manitoba
Key exclusion criteria (5 listed)
- Progressive cognitive deficit or disease.
- Age < 18
- Unable to provide informed consent
- A1C<7%
- Undergoing emergent cardiac surgery
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 |
|---|---|---|
| Structured Pre-operative Diabetes OptimizationPatients will receive structured pre-operative diabetes optimization while they wait for surgery. Patients will be referred to the Youville Diabetes Center where they will undergo preoperative optimization of their diabetes management. This will include in-depth diabetes education and instruction pertaining to lifestyle modification (blood glucose monitoring, nutrition, and physical activity) to improve glycemic control. Pharmacologic therapy will be reviewed by the Youville Diabetes Center certified diabetes nurse educators. | Other | Group 2 |
Primary outcome
Change in A1C over the study period.
Time frame: Baseline to the patients' 3-months post-operative appointment
2 secondary outcomes
Changes to the responses on the validated patient surveys
Time frame: Baseline to the patients' 3-months post-operative appointment
Changes in the patient perioperative outcomes
Time frame: Baseline to the patients' 3-months post-operative appointment
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 16 Aug 2018.
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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.
Rakesh C Arora, MD principal investigator
University of Manitoba
Sora Ludwig, MD principal investigator
University of Manitoba
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured Pre-operative Diabetes Optimization in people with Diabetes, run by Dr. Rakesh C. Arora at 2 sites 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 5 inclusion and 5 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 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in A1C over the study period. (time frame: Baseline to the patients' 3-months post-operative appointment). 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 16 Aug 2018.