Pharmacist Intervention for Glycemic Control in The Community (The RxING Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The change in HbA1c from baseline to week 26
研究概览
简要总结
Background: Approximately 1.9 million Canadians are living with diabetes and this is estimated to increase by 75% over the next few decades. Pharmacists are front line primary healthcare professionals who see patients with diabetes frequently and in Alberta, they have been allowed to prescribe medications and order laboratory tests. As such, pharmacists could systematically identify poorly controlled diabetes patients and provide greater access to diabetes interventions to improve blood sugar control.
Objective: The aim of this study is to determine the effect of a community pharmacist intervention on blood sugar control in individuals with poorly controlled diabetes.
Project description:
100 adults with type 2 diabetes and uncontrolled blood sugar will be defined by the participating pharmacists. Blood sugar control is going to assessed using hemoglobin A1c test (a blood test to measure individual's blood sugar control over the last 3 months). This test requires obtaining a blood spot from the patient which will be obtained by pricking his/her fingertip. Based on the hemoglobin A1c test result the pharmacist will assess the patient's need for insulin glargine, if the patient needs insulin glargine the pharmacist is going to prescribe it for him/her and educate him/her on its use. Patients are going to be followed up closely by the pharmacists for 6 months with regular updates to the patients' family physicians. This multi-centre study should demonstrate pharmacists' ability to improve glycemic control and improve access to care.
详细描述
BACKGROUND/RATIONALE:
Approximately 1.9 million Canadians are living with diabetes. Estimates are that this number will increase by 75% over the next few decades. Glycemic control in patients with type 2 diabetes mellitus is poor, and poorly controlled patients contribute significantly to the cost of primary health care in Canada. 10% of all acute care hospital admissions in 2006 were attributed to diabetes and its complications.
As type 2 diabetes is a progressive disease, most patients with type 2 diabetes will eventually require insulin. In patients who present with type 2 diabetes and a HbA1C over 9%, insulin can be started immediately, however, historically physicians generally perceive their to be patient difficulties in starting insulin therapy.
INSIGHT demonstrated improved glycemic control with addition of insulin glargine to oral hypoglycemic agents in patients with type 2 diabetes. However, physicians are often reluctant to initiate insulin in these patients. In addition, physicians do not have a system to systematically identify potential candidates for insulin add-on therapy
Pharmacists are front line primary care professionals who see patients with diabetes more frequently than family physicians and as such, could systematically and proactively identify patients with type 2 diabetes with poor glycemic control as a public health approach to chronic disease management. This approach has been used successfully by our group in the past with dyslipidemia and hypertension management involving patients with diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female over 18 years of age
- •Type 2 diabetes for at least 6 months
- •Taking 1 or more oral hypoglycemic agents
- •Patient attending your community pharmacy where you decided that addition of insulin glargine may be of benefit to the patient
- •Baseline HbA1c 7.5 - 11%
- •Signed informed consent
排除标准
- •Have used, or currently using, Insulin
- •History of ketoacidosis
- •Works night shift
- •Renal impairment(Serum Creatinine: females ≥ 124 mmol/l, males ≥ 133 mmol/l)
- •Clinically unstable
- •Unwilling/unable to attend follow up visits
- •Unlikely to adhere to study procedures (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism)
研究组 & 干预措施
Insulin glargine
10 units at bedtime of insulin glargine will be prescribed to the patients who has HbA1c levels of 7.5-11%. Insulin glargine dose is going to be titrated by increments of 1 unit daily by the patient to achieve a morning fasting glucose of <=5.5mmol/L
干预措施: Insulin glargine (Drug)
结局指标
主要结局
The change in HbA1c from baseline to week 26
时间窗: 6 months
The change of the patients' HbA1c between the baseline and the 26 week visits
次要结局
- Quality of life and patient satisfaction.(6 months)
- Proportion of patients achieving the target HbA1c(6 months)
- Type and degree of dosage changes in oral hypoglycemic agents(6 months)
- Persistence on insulin glargine(6 months)
- Safety(6 months)
- Health economic evaluation(6 months)
研究者
Ross T. Tsuyuki
Professor of Medicine (Cardiology) and Director, EPICORE Centre University of Alberta
University of Alberta