A Study Comparing Standard Care for Diabetes to Case-managed Care for Diabetes in Patients With Coronary Artery Disease

NCT00248352 | Completed Results

• 1 other identifier: Glucose 101
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 1

Brief 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. Case-Managed care involves a consult with an endocrinologist and counseling from a diabetic educator and a dietician.

Conditions

Diabetes Mellitus, Type 2; Coronary Disease

Keywords

Coronary Artery Disease; Diabetes Mellitus; Type 2; Chronic Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (time of hospital discharge) to 6months post discharge

Study Arms (2)

Case-Managed Care

EXPERIMENTAL

Randomized to case-managed care at admission and/or discharge

Behavioral: Consultation with Endocrinologist; Behavioral: Counseling from Dietician; Behavioral: Counseling from Diabetes Educator

Usual Care

OTHER

Randomized to Usual Care at admission or discharge

Other: No intervention

Interventions

Consultation with Endocrinologist BEHAVIORAL

Case-Managed Care

Counseling from Dietician BEHAVIORAL

Case-Managed Care

Counseling from Diabetes Educator BEHAVIORAL

Case-Managed Care

No intervention OTHER

Usual Care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Sanofi: collaborator
• Pfizer: collaborator

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Related Publications (27)

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  PMID: 10197653 BACKGROUND

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  PMID: 12556541 BACKGROUND

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  PMID: 10480501 BACKGROUND

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  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 11574449 BACKGROUND

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Disease; Coronary Artery Disease; Diabetes Mellitus; Chronic Disease

Interventions

Referral and Consultation; Endocrinologists

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration; Physicians; Health Personnel; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Richard F. Davies
• Organization: University of Ottawa Heart Institute

613-696-7325

Study Officials

• Richard F. Davies, M.D.

  University of Ottawa Heart Instittue

  PRINCIPAL INVESTIGATOR

• Janine Malcolm, M.D.

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 3, 2005
• Study Start: February 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: October 1, 2007
• Last Updated: June 22, 2026
• Results First Posted: June 22, 2026

Record last verified: 2007-10

Locations

CA (1)