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临床试验/NCT00248352
NCT00248352已完成不适用

GLUCOSE : Glucose Lowering by Usual Care Or Specialized Endocrinology Team

Ottawa Heart Institute Research Corporation2 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2005年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
169
试验地点
2
主要终点
Change in HbA1C at 6 months post discharge compared to baseline measure obtained at the time of discharge

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Case-Managed Care

Experimental

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

干预措施: Consultation with Endocrinologist (Behavioral)

Case-Managed Care

Experimental

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

干预措施: Counseling from Dietician (Behavioral)

Case-Managed Care

Experimental

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

干预措施: Counseling from Diabetes Educator (Behavioral)

Usual Care

Other

Randomized to Usual Care at admission or discharge

干预措施: No intervention (Other)

结局指标

主要结局

Change in HbA1C at 6 months post discharge compared to baseline measure obtained at the time of discharge

Change in 10 year cardiac risk as estimated by the UKPDS risk engine at 6 months post discharge compared to baseline measures obtained at time of discharge

Change in HbA1C Levels at 6 Months Post Discharge

时间窗: 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.

次要结局

  • Percentage of patients with capillary blood glucose values within a target range of > 4.0 mmol/L to < 10.0 mmol/L during hospitalization
  • Number of patients with one or more episodes of hypoglycemia defined as capillary blood glucose measurements < 4.0 mmol/L
  • Number of patients with one or more episodes of persistent hyperglycemia defined as three consecutive capillary blood glucose measurements > 15.0 mmol/L
  • Number of patients on prognosis improving medications (ACE inhibitor, ARB, Lipid Lowering Agents)
  • Number of patients having death, MI, stroke, recurrent ischemic event or readmission to hospital
  • Length of stay
  • Risk factor control at 6 months post discharge:
  • Blood pressure control, defined as percentage of patients within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • Lipid levels within 2003 Canadian Diabetes Association Clinical Practice Guidelines (December 2003)
  • Percentage of patients, who were smokers at time of index admission, who have quit
  • Exercise history
  • Patient satisfaction with inpatient diabetes management as measured by a standardized questionnaire administered prior to discharge
  • Diabetes self-care as assessed by questionnaire
  • Quality of life as assessed by questionnaire

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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