Diabetes Mellitus, Type 2NCT00248352
A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease
A study testing Consultation with Endocrinologist, Counseling from Dietician and Counseling from Diabetes Educator in people with Diabetes Mellitus, Type 2 and Coronary Disease, run by Ottawa Heart Institute Research Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care. In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care by the existing diabetes care givers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Mellitus, Type 2, Coronary Disease
- What is being tested?
- Consultation with Endocrinologist, Counseling from Dietician and Counseling from Diabetes Educator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2005to Oct 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diabetes Mellitus, type 2, as defined by at least one of the following:
- Previous diagnosis of diabetes
- two glucose levels consistent with diabetes (fasting glucose >7.0 mmol/L or random glucose >11.0 mmol/L )
- HbA1C > 6.5% using DCCT standardized methods And
- Coronary Disease, as defined by at least one of the following:
- Admitting diagnosis of acute coronary syndrome defined by 2/3 of typical history, enzyme changes, dynamic ECG changes
Show all 11Show fewer
- Prior history of acute coronary syndrome defined as above
- Previously documented myocardial infarction
- Previous coronary revascularization procedure
- Coronary artery disease defined by coronary angiography
- Exercise or persantine nuclear perfusion imaging positive for ischemia
Who cannot join
- Refusal to enter the study
- Inability to understand consent forms and provide informed consent
- Anticipated length of non-ICU hospital stay less than 48 hours
- Diabetes Mellitus, type 1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team
The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care.
In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care by the existing diabetes care givers.
Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic educator and a dietician.
Read the detailed description
Patients with diabetes have a higher incidence of coronary artery disease and a worsened cardiac prognosis. Death from cardiovascular disease accounts for about 70% of all diabetes-related deaths (Booth, 2003). Diabetes is also a common problem among hospitalized cardiac patients. In Ontario, from 1995 to 1997, nearly 1/3 of the 104,471 patients admitted for acute myocardial infarction had diabetes (Booth, 2003). In these patients, hyperglycemia remains a marker for poor outcome despite improvements in coronary care (Wahab, 2002; Capes, 2000).
Several important questions regarding the diabetes care of cardiac patients admitted to hospital wards are yet to be answered. First, it is not known if better glycemic control during the ward phase of hospitalization in itself improves short-term outcomes. Second, assuming that short-term glycemic control is beneficial, it is not known which interventions are effective in accomplishing this. Third, assuming that putting more resources into the management and education of patients with diabetes will translate into long term benefits, it is not known whether this should be done during the "window of opportunity" provided by a cardiac admission or whether this intervention will be more effective if it is deferred until after discharge.
These critical treatment dilemmas have prompted the proposal for the GLUCOSE Pilot Study, a randomized, controlled study to examine the effectiveness of case-managed diabetes care using a multidisciplinary team approach in patients with diabetes admitted to manage concomitant ischemic heart disease. We have designed this protocol to study the effectiveness of case-managed diabetes care by a specialized endocrinology team and compare it to usual care as delivered by the attending cardiologist. Patients will be randomized to specialized endocrinology care or usual care at the time of their admission to the ward. The short-term outcome will be glycemic control of cardiac patients with diabetes while they are admitted to a cardiology ward. In order to compare this with a more typical model of post-discharge care, patients will be re-randomized at the time of discharge into case-managed or usual care groups. The long-term (primary) outcome will be glycemic control and risk factor reduction at 6 months. This factorial design will allow us to compare several treatment models and determine which is the most efficient and effective way to achieve the best long-term diabetes control and risk factor management in our patients.
- Conditions
- Diabetes Mellitus, Type 2, Coronary Disease
- Being tested
- Consultation with Endocrinologist, Counseling from Dietician, Counseling from Diabetes Educator, No intervention
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Chronic Disease
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Disease, Coronary Artery Disease, Diabetes Mellitus, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consultation with EndocrinologistBehavioural
Counseling from DieticianBehavioural
Counseling from Diabetes EducatorBehavioural
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| Case-Managed Care | Experimental | Randomized to case-managed care at admission and/or discharge Receives: Behavioral: Consultation with Endocrinologist; Behavioral: Counseling from Dietician; Behavioral: Counseling from Diabetes Educator |
| Usual Care | Other | Randomized to Usual Care at admission or discharge Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1C Levels at 6 Months Post Discharge
Outcome is measured by the difference between the baseline (time of discharge) measurement of HbA1C (in mmol/mol) and the measurement of HbA1C (in mmol/mol) at the 6 month follow-up post discharge.
Measured: Baseline (time of hospital discharge) to 6months post discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2005 (estimated)
- Study startFeb 2005
- Primary completionJul 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants are randomized to either case-managed care or usual care at the time of hospital admission, and re-randomized to either case-managed or usual care at time of discharge.
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Heart Institute Research Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard F. Davies, M.D., Principal investigator, University of Ottawa Heart InstittueJanine Malcolm, M.D., Principal investigator, Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248352
- Sponsor's protocol ID
- Glucose 101
- Status last verified
- Oct 2007
- First submitted
- 1 Nov 2005
- Last updated
- 22 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bhattacharyya A, Christodoulides C, Kaushal K, New JP, Young RJ. In-patient management of diabetes mellitus and patient satisfaction. Diabet Med. 2002 May;19(5):412-6. doi: 10.1046/j.1464-5491.2002.00716.x.
PubMed 12027930Booth G, Fang J. Acute complications of Diabetes: In Hux JE, Booth GL, Slaughter PM, Laupacis A (eds.). Diabetes in Ontario: An ICES Practice Atlas. Institute for Clinical Evaluative Sciences. 2003:2.21-2.51.
Brown SA. Meta-analysis of diabetes patient education research: variations in intervention effects across studies. Res Nurs Health. 1992 Dec;15(6):409-19. doi: 10.1002/nur.4770150603.
PubMed 1448572Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
PubMed 24070926Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.
PubMed 10711923Cavan DA, Hamilton P, Everett J, Kerr D. Reducing hospital inpatient length of stay for patients with diabetes. Diabet Med. 2001 Feb;18(2):162-4. doi: 10.1046/j.1464-5491.2001.00420.x.
PubMed 11251683Clement S. Diabetes self-management education. Diabetes Care. 1995 Aug;18(8):1204-14. doi: 10.2337/diacare.18.8.1204. No abstract available.
PubMed 7587866Davies M, Dixon S, Currie CJ, Davis RE, Peters JR. Evaluation of a hospital diabetes specialist nursing service: a randomized controlled trial. Diabet Med. 2001 Apr;18(4):301-7. doi: 10.1046/j.1464-5491.2001.00470.x.
PubMed 11437861Egan BM, Greene EL, Goodfriend TL. Nonesterified fatty acids in blood pressure control and cardiovascular complications. Curr Hypertens Rep. 2001 Apr;3(2):107-16. doi: 10.1007/s11906-001-0021-y.
PubMed 11276390Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.
PubMed 10197653Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.
PubMed 12556541Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999 Sep;22(9):1408-14. doi: 10.2337/diacare.22.9.1408.
PubMed 10480501Hux JE, Tang M. Patterns of prevalence and incidence of diabetes: In Hux JE, Booth GL, Slaughter APM, Laupacis (eds). Diabetes in Ontario: An ICES Practice Atlas. Institute for Clinical and Evaluative Sciences. 2003:1.1-1.18.
Janes JM, Bradley C, Rees A. Preferences for, and improvements in aspects of quality of life (QoL) with, insulin lispro in a multiple injection regimen. Diabetologia. 1997;40, Suppl. 1:A353.
Renders CM, Valk GD, Griffin SJ, Wagner EH, Eijk Van JT, Assendelft WJ. Interventions to improve the management of diabetes in primary care, outpatient, and community settings: a systematic review. Diabetes Care. 2001 Oct;24(10):1821-33. doi: 10.2337/diacare.24.10.1821.
PubMed 11574449
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team
- ClinicalTrials.gov ID
- NCT00248352
- Acronym / sponsor ID
- Glucose 101
- Conditions
- Diabetes Mellitus, Type 2, Coronary Disease
- Keywords
- Coronary Artery Disease, Diabetes Mellitus, Type 2, Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Ottawa Heart Institute Research CorporationUniversity, hospital or other
- Collaborators
- Sanofi, Pfizer
- Study start
- Feb 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 3 Nov 2005 (estimated)
- Results
- Posted 22 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare two ways to treat patients with Type 2 Diabetes, Standard Care or Case-Managed Care.
In-Patient Standard Care is guided by the assigned cardiologist and Out-Patient Standard Care by the existing diabetes care givers.
Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic educator and a dietician.
Detailed description
Patients with diabetes have a higher incidence of coronary artery disease and a worsened cardiac prognosis. Death from cardiovascular disease accounts for about 70% of all diabetes-related deaths (Booth, 2003). Diabetes is also a common problem among hospitalized cardiac patients. In Ontario, from 1995 to 1997, nearly 1/3 of the 104,471 patients admitted for acute myocardial infarction had diabetes (Booth, 2003). In these patients, hyperglycemia remains a marker for poor outcome despite improvements in coronary care (Wahab, 2002; Capes, 2000).
Several important questions regarding the diabetes care of cardiac patients admitted to hospital wards are yet to be answered. First, it is not known if better glycemic control during the ward phase of hospitalization in itself improves short-term outcomes. Second, assuming that short-term glycemic control is beneficial, it is not known which interventions are effective in accomplishing this. Third, assuming that putting more resources into the management and education of patients with diabetes will translate into long term benefits, it is not known whether this should be done during the "window of opportunity" provided by a cardiac admission or whether this intervention will be more effective if it is deferred until after discharge.
These critical treatment dilemmas have prompted the proposal for the GLUCOSE Pilot Study, a randomized, controlled study to examine the effectiveness of case-managed diabetes care using a multidisciplinary team approach in patients with diabetes admitted to manage concomitant ischemic heart disease. We have designed this protocol to study the effectiveness of case-managed diabetes care by a specialized endocrinology team and compare it to usual care as delivered by the attending cardiologist. Patients will be randomized to specialized endocrinology care or usual care at the time of their admission to the ward. The short-term outcome will be glycemic control of cardiac patients with diabetes while they are admitted to a cardiology ward. In order to compare this with a more typical model of post-discharge care, patients will be re-randomized at the time of discharge into case-managed or usual care groups. The long-term (primary) outcome will be glycemic control and risk factor reduction at 6 months. This factorial design will allow us to compare several treatment models and determine which is the most efficient and effective way to achieve the best long-term diabetes control and risk factor management in our patients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomized to either case-managed care or usual care at the time of hospital admission, and re-randomized to either case-managed or usual care at time of discharge.
| Arm | Type | Receives |
|---|---|---|
| Case-Managed Care | Experimental | Behavioral: Consultation with Endocrinologist, Behavioral: Counseling from Dietician, Behavioral: Counseling from Diabetes EducatorRandomized to case-managed care at admission and/or discharge |
| Usual Care | Other | Other: No interventionRandomized to Usual Care at admission or discharge |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Diabetes Mellitus, type 2, as defined by at least one of the following:
- Admitting diagnosis of acute coronary syndrome defined by 2/3 of typical history, enzyme changes, dynamic ECG changes
- Prior history of acute coronary syndrome defined as above
- Previously documented myocardial infarction
- Previous coronary revascularization procedure
Key exclusion criteria (4 listed)
- Refusal to enter the study
- Inability to understand consent forms and provide informed consent
- Anticipated length of non-ICU hospital stay less than 48 hours
- Diabetes Mellitus, type 1
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 |
|---|---|---|
| Consultation with Endocrinologist | Behavioural | Case-Managed Care |
| Counseling from Dietician | Behavioural | Case-Managed Care |
| Counseling from Diabetes Educator | Behavioural | Case-Managed Care |
| No intervention | Other | Usual Care |
Primary outcome
Change in HbA1C Levels at 6 Months Post Discharge
Time frame: Baseline (time of hospital discharge) to 6months post discharge
Outcome is measured by the difference between the baseline (time of discharge) measurement of HbA1C (in mmol/mol) and the measurement of HbA1C (in mmol/mol) at the 6 month follow-up post discharge.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12027930Bhattacharyya A, Christodoulides C, Kaushal K, New JP, Young RJ. In-patient management of diabetes mellitus and patient satisfaction. Diabet Med. 2002 May;19(5):412-6. doi: 10.1046/j.1464-5491.2002.00716.x.
- BackgroundBooth G, Fang J. Acute complications of Diabetes: In Hux JE, Booth GL, Slaughter PM, Laupacis A (eds.). Diabetes in Ontario: An ICES Practice Atlas. Institute for Clinical Evaluative Sciences. 2003:2.21-2.51.
- Background: PubMed 1448572Brown SA. Meta-analysis of diabetes patient education research: variations in intervention effects across studies. Res Nurs Health. 1992 Dec;15(6):409-19. doi: 10.1002/nur.4770150603.
- Background: PubMed 24070926Canadian Diabetes Association Clinical Practice Guidelines Expert Committee; Cheng AY. Canadian Diabetes Association 2013 clinical practice guidelines for the prevention and management of diabetes in Canada. Introduction. Can J Diabetes. 2013 Apr;37 Suppl 1:S1-3. doi: 10.1016/j.jcjd.2013.01.009. Epub 2013 Mar 26. No abstract available.
- Background: PubMed 10711923Capes SE, Hunt D, Malmberg K, Gerstein HC. Stress hyperglycaemia and increased risk of death after myocardial infarction in patients with and without diabetes: a systematic overview. Lancet. 2000 Mar 4;355(9206):773-8. doi: 10.1016/S0140-6736(99)08415-9.
- Background: PubMed 11251683Cavan DA, Hamilton P, Everett J, Kerr D. Reducing hospital inpatient length of stay for patients with diabetes. Diabet Med. 2001 Feb;18(2):162-4. doi: 10.1046/j.1464-5491.2001.00420.x.
- Background: PubMed 7587866Clement S. Diabetes self-management education. Diabetes Care. 1995 Aug;18(8):1204-14. doi: 10.2337/diacare.18.8.1204. No abstract available.
- Background: PubMed 11437861Davies M, Dixon S, Currie CJ, Davis RE, Peters JR. Evaluation of a hospital diabetes specialist nursing service: a randomized controlled trial. Diabet Med. 2001 Apr;18(4):301-7. doi: 10.1046/j.1464-5491.2001.00470.x.
- Background: PubMed 11276390Egan BM, Greene EL, Goodfriend TL. Nonesterified fatty acids in blood pressure control and cardiovascular complications. Curr Hypertens Rep. 2001 Apr;3(2):107-16. doi: 10.1007/s11906-001-0021-y.
- Background: PubMed 10197653Furnary AP, Zerr KJ, Grunkemeier GL, Starr A. Continuous intravenous insulin infusion reduces the incidence of deep sternal wound infection in diabetic patients after cardiac surgical procedures. Ann Thorac Surg. 1999 Feb;67(2):352-60; discussion 360-2. doi: 10.1016/s0003-4975(99)00014-4.
- Background: PubMed 12556541Gaede P, Vedel P, Larsen N, Jensen GV, Parving HH, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with type 2 diabetes. N Engl J Med. 2003 Jan 30;348(5):383-93. doi: 10.1056/NEJMoa021778.
- Background: PubMed 10480501Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999 Sep;22(9):1408-14. doi: 10.2337/diacare.22.9.1408.
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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.
Richard F. Davies, M.D. principal investigator
University of Ottawa Heart Instittue
Janine Malcolm, M.D. principal investigator
Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consultation with Endocrinologist, Counseling from Dietician and Counseling from Diabetes Educator in people with Diabetes Mellitus, Type 2 and Coronary Disease, run by Ottawa Heart Institute Research Corporation 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 11 inclusion and 4 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 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 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?
Yes. Results are posted in the registry (first posted 22 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 HbA1C Levels at 6 Months Post Discharge (time frame: Baseline (time of hospital discharge) to 6months post discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00248352, which also lists 27 linked publications.
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 Jun 2026.