Diabetes Care in Nursing Home Residents: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
研究概览
简要总结
Diabetes is highly prevalent in the elderly, afflicting about 20% of older adults aged 65-75 years and 40% of adults >80years of age. It is expected that the number of elderly people suffering from diabetes will increase in the future, as general life expectancy is increasing.
Nursing home residents with diabetes have higher rates of serious comorbidities and have greater activity of daily living dependencies than other residents without diabetes. In addition, persons with diabetes have higher risk of hypertension, heart disease, stroke depression, cognitive impairment, and cardiovascular mortality than individuals without diabetes.
There are a few retrospective studies in elderly patients analyzing quality of diabetes care and glycemic control adjusted for medications and presence of co-morbidities in long-term care facilities; however, no previous randomized controlled trials have demonstrated benefits of glycemic control on clinical outcome, quality of life, and rate of acute metabolic complications (hyperglycemia and hypoglycemic events) in long-term care facilities. In addition, it is not known whether the use of basal insulin is superior to treatment with sliding scale insulin (SSI) in long-term care facility residents with type 2 diabetes.
Accordingly, the investigators propose to conduct a prospective randomized control trial comparing the efficacy and safety of the basal (glargine) insulin regimen and sliding scale regular insulin in the management of nursing home patients with T2DM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females > 60 years of age.
- •Blood glucose > 150 mg/dl and A1C > 7.5%.
- •A known history of T2DM, receiving either diet alone, oral monotherapy, or with any combination of oral antidiabetic agents (metformin, sulfonylureas, repaglinide, nateglinide, pioglitazone, rosiglitazone, sitagliptin).
- •Patients admitted for non-cardiac elective or emergency surgery or trauma.
排除标准
- •Subjects with increased blood glucose concentration, but without a known history of diabetes (stress hyperglycemia).
- •Subjects with a history of diabetic ketoacidosis and hyperosmolar hyperglycemic state (26).
- •Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, or impaired renal function (creatinine ≥ 3.5 mg/dl).
- •Patients with recognized or suspected endocrine disorders associated with increased insulin resistance, acromegaly, or hyperthyroidism
研究组 & 干预措施
BASAL PLUS
Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
干预措施: Insulin Glargine (Drug)
BASAL PLUS
Diabetic subjects receive insulin glargine once daily plus corrective doses of insulin glulisine before meals and bedtime as needed
干预措施: Insulin glulisine (Drug)
sliding scale regular insulin (SSRI)
Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
干预措施: Insulin (Drug)
结局指标
主要结局
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 70 mg/dL
时间窗: 3 months
Mean weekly blood glucose concentration less than 70 mg/dL at 3 months
Percent of Participants With a Mean Blood Glucose Concentration of Less Than 40 mg/dL
时间窗: 3 months
Mean weekly blood glucose concentration less than 40 mg/dL at 3 months
Mean of Weekly Fasting Blood Glucose Concentration
时间窗: 3 months
Mean weekly blood glucose concentration at 3 months
次要结局
- Mean Blood Glucose Concentration(Baseline)
- Mean of Glycosylated Hemoglobin (hbA1c)(6 months)
- Mean of Daily Blood Glucose Concentration(Baseline)
研究者
Guillermo Umpierrez
Professor of Medicine
Emory University