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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
| Pfizer | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Case-Managed Care | Experimental | Randomized to case-managed care at admission and/or discharge |
|
| Usual Care | Other | Randomized to Usual Care at admission or discharge |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Consultation with Endocrinologist | Behavioral |
| ||
| Counseling from Dietician |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Diabetes Mellitus, type 2, as defined by at least one of the following:
Coronary Disease, as defined by at least one of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard F. Davies, M.D. | University of Ottawa Heart Instittue | Principal Investigator |
| Janine Malcolm, M.D. | Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Ottawa Heart Institute | Ottawa | Ontario | K1Y 4W7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12027930 | Background | 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. | |
| Background | Booth 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. | ||
| 1448572 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Inpatient /Usual Outpatient Diabetes Care | randomized to standard care for inpatient setting at University of Ottawa Heart Institute and after discharge from hospital |
| FG001 | Case Managed Inpatient/Usual Outpatient Diabetes Care |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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.
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| Behavioral |
|
| Counseling from Diabetes Educator | Behavioral |
|
| No intervention | Other |
|
| Background |
| 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. |
| 24070926 | Background | Canadian 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. |
| 10711923 | Background | Capes 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. |
| 11251683 | Background | Cavan 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. |
| 7587866 | Background | Clement S. Diabetes self-management education. Diabetes Care. 1995 Aug;18(8):1204-14. doi: 10.2337/diacare.18.8.1204. No abstract available. |
| 11437861 | Background | Davies 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. |
| 11276390 | Background | Egan 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. |
| 10197653 | Background | Furnary 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. |
| 12556541 | Background | Gaede 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. |
| 10480501 | Background | Golden 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. |
| Background | Hux 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. |
| 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. |
| 11574449 | 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. |
| 9742976 | Background | Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1998 Sep 12;352(9131):837-53. |
| 11794168 | Background | van den Berghe G, Wouters P, Weekers F, Verwaest C, Bruyninckx F, Schetz M, Vlasselaers D, Ferdinande P, Lauwers P, Bouillon R. Intensive insulin therapy in critically ill patients. N Engl J Med. 2001 Nov 8;345(19):1359-67. doi: 10.1056/NEJMoa011300. |
| 12446057 | Background | Wahab NN, Cowden EA, Pearce NJ, Gardner MJ, Merry H, Cox JL; ICONS Investigators. Is blood glucose an independent predictor of mortality in acute myocardial infarction in the thrombolytic era? J Am Coll Cardiol. 2002 Nov 20;40(10):1748-54. doi: 10.1016/s0735-1097(02)02483-x. |
| 11845552 | Background | Lawlor D, Vandewater D, Ur E. Diabetes. Case management. Can Nurse. 2002 Jan;98(1):27-30. No abstract available. |
| 10546009 | Background | Levetan CS, Passaro MD, Jablonski KA, Ratner RE. Effect of physician specialty on outcomes in diabetic ketoacidosis. Diabetes Care. 1999 Nov;22(11):1790-5. doi: 10.2337/diacare.22.11.1790. |
| 7598138 | Background | Levetan CS, Salas JR, Wilets IF, Zumoff B. Impact of endocrine and diabetes team consultation on hospital length of stay for patients with diabetes. Am J Med. 1995 Jul;99(1):22-8. doi: 10.1016/s0002-9343(99)80100-4. |
| 9169397 | Background | Malmberg K. Prospective randomised study of intensive insulin treatment on long term survival after acute myocardial infarction in patients with diabetes mellitus. DIGAMI (Diabetes Mellitus, Insulin Glucose Infusion in Acute Myocardial Infarction) Study Group. BMJ. 1997 May 24;314(7093):1512-5. doi: 10.1136/bmj.314.7093.1512. |
| 7797776 | Background | Malmberg K, Ryden L, Efendic S, Herlitz J, Nicol P, Waldenstrom A, Wedel H, Welin L. Randomized trial of insulin-glucose infusion followed by subcutaneous insulin treatment in diabetic patients with acute myocardial infarction (DIGAMI study): effects on mortality at 1 year. J Am Coll Cardiol. 1995 Jul;26(1):57-65. doi: 10.1016/0735-1097(95)00126-k. |
| 9066459 | Background | Queale WS, Seidler AJ, Brancati FL. Glycemic control and sliding scale insulin use in medical inpatients with diabetes mellitus. Arch Intern Med. 1997 Mar 10;157(5):545-52. |
| 14578238 | Background | Polonsky WH, Earles J, Smith S, Pease DJ, Macmillan M, Christensen R, Taylor T, Dickert J, Jackson RA. Integrating medical management with diabetes self-management training: a randomized control trial of the Diabetes Outpatient Intensive Treatment program. Diabetes Care. 2003 Nov;26(11):3048-53. doi: 10.2337/diacare.26.11.3048. |
| 12153606 | Background | Manzella D, Carbonella M, Ragno E, Passariello N, Grella R, Paolisso G. Relationship between autonomic cardiac activity, beta-cell function, anthropometrics and metabolic indices in type II diabetics. Clin Endocrinol (Oxf). 2002 Aug;57(2):259-64. doi: 10.1046/j.1365-2265.2002.01596.x. |
| 9314634 | Background | Koproski J, Pretto Z, Poretsky L. Effects of an intervention by a diabetes team in hospitalized patients with diabetes. Diabetes Care. 1997 Oct;20(10):1553-5. doi: 10.2337/diacare.20.10.1553. |
randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by usual oupatient care after discharge. |
| FG002 | Usual Inpatient / Case Managed Outpatient Diabetes Care | randomized to standard routine inpatient Diabetes Care followed by outpatient care managed by Nurse Educator, Nutritionist and Diabetologist . |
| FG003 | Case Managed Inpatient and Outpatient Care | randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by case managed outpatient care for Diabetes by Nurse Educator, Nutritionist and Diabetologist after discharge. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Inpatient /Usual Outpatient Diabetes Care | randomized to standard care for inpatient setting at University of Ottawa Heart Institute and after discharge from hospital |
| BG001 | Case Managed Inpatient/Usual Outpatient Diabetes Care | randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by usual oupatient care after discharge. |
| BG002 | Usual Inpatient / Case Managed Outpatient Diabetes Care | randomized to standard routine inpatient Diabetes Care followed by outpatient care managed by Nurse Educator, Nutritionist and Diabetologist . |
| BG003 | Case Managed Inpatient and Outpatient Care | randomized to Diabetes Care managed by Nurse Educator, Nutritionist and Diabetologist while inpatient at the University of Ottawa Heart Institute, followed by case managed outpatient care for Diabetes by Nurse Educator, Nutritionist and Diabetologist after discharge. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mmol/mol | Baseline (time of hospital discharge) to 6months post discharge |
|
|
|
Baseline (Hospital discharge) to 6-month post-discharge followup
Adverse events are reported between the two main arms of the study (Usual Care vs Case Managed Care), however it does not further break down the results between participants with an HbA1C <10 or >10 at baseline. Adverse events are noted between care types only as the study aimed to identify if a personalized approach to diabetes management.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Outpatient Diabetes Care | Participants receiving the usual care for diabetes management | 10 | 87 | 52 | 87 | 18 | 87 |
| EG001 | Case Managed Outpatient Diabetes Care | 5 | 82 | 49 | 82 | 21 | 82 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders |
| |||
| Cardiac Admissions | Cardiac disorders |
| |||
| Diabetes related admissions | Metabolism and nutrition disorders |
| |||
| Cardiac Emergency room visits | Cardiac disorders |
| |||
| Diabetes Emergency room visits | Metabolism and nutrition disorders |
| |||
| Stroke | Nervous system disorders |
| |||
| Transient Ischemic Attack | Nervous system disorders |
| |||
| Myocardial Infarction | Cardiac disorders |
| |||
| Coronary Revascularization | Cardiac disorders |
| |||
| Hypoglycemia | Metabolism and nutrition disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetes related eye changes | Eye disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard F. Davies | University of Ottawa Heart Institute | 613-696-7325 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| D003920 | Diabetes Mellitus |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D000072097 | Endocrinologists |
| ID | Term |
|---|---|
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010820 | Physicians |
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|